Comparative Effectiveness Research holds extraordinary implications for healthcare stakeholders, notably the pharmaceutical, biotechnology, and medical technology industries; patients; physicians; hospitals; the federal Medicare program; state Medicaid programs; and health plans. In addition to guiding and hopefully improving day-to-day decisions by clinicians and patients, Comparative Effectiveness Research will be extraordinarily influential in coverage and reimbursement decisions.

Here is a quick primer on the massive new Comparative Effectiveness Research program in the U.S., including major changes enacted in the new health reform law.

Comparative Effectiveness Research Defined:

Comparative Effectiveness Research (CER) means research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of two or more medical treatments, services, or items (e.g., drugs, biologics, devices).

More specifically, this includes comparisons of:

• Prescription drugs and biologics
• Medical devices
• Diagnostic tests and diagnostic tools
• Surgical procedures
• Protocols or guidelines for patient treatment
• Care management practices
• Prevention activities

Conceptually, CER looks at medical interventions across the range of prognostic, preventive, diagnostic, therapeutic, rehabilitative, and palliative care. Health policy experts have increasingly proposed that CER should also assess the effectiveness of models or systems of health care delivery. Therefore, there is a degree of interaction and overlap between CER and health services research.

CER studies may compare similar treatments - like comparing several drugs in a therapeutic class - or compare clinical effectiveness of different approaches, like comparing a drug and a surgical procedure for the treatment of the same condition.

CER employs a variety of research methods, including randomized controlled trials, meta-analyses, and observational cohort analyses. In addition to conducting the clinical effectiveness and comparative effectiveness research itself, CER also involves building of the necessary infrastructure (data, research methods, staff, training, etc.). To meet the demands of CER, researchers are developing and testing new methodologies and data sources.

To have any real value, the results of CER must be actionable, with findings effectively translated for and disseminated to the full range of decision makers.

Challenges and Controversies in Comparative Effectiveness Research:

The goal of CER is to increase our collective knowledge of what works and to improve decision making by physicians, patients, purchasers, and payors. However, by its very nature and because of the aggresive use of CER in the UK and other countries, CER raises many difficult or controversial questions. Here are a just a few examples:

1. Should CER look only at clinical effectiveness, with eye to giving physicians and patients more information to guide their decisions?
2. Should CER also look at cost effectiveness and cost-benefit analysis?
3. Should CER influence or drive coverage and reimbursement decisions by Medicare and other government health programs?
4. Who should set research priorities? How should research priorities be set? What are the research priorities?
5. Since many studies look at large populations, how do we ensure research reflects special populations and doesn't unintentionally discriminate against sub-groups? For example, if a drug, device, or surgical procedure works best for 80% of patients, what about the other 20%?
6. How should CER guide physician decision making or should government and payor policies be used to incent or require physicians and other providers to practice consistent with CER findings?

In a new issue brief, Gene Rich, MD from Mathematica Policy Research and Elizabeth Docteur, MS from the Center for Studying Health System Change discuss key challenges to successful implementation of the large and ambitious federal CER program. They explain how resolution of these challenges "may prove critical to the future role of this research in U.S. health care."

Comparative Effectiveness Research in Other Countries:

Here is an interesting new comparison on the Use of Comparative Effectiveness Research in Drug Coverage and Pricing Decisions in Denmark, England, France, Germany, the Netherlands, and Sweden.

Comparative Effectiveness Research Prior to 2009:

In the U.S., federally sponsored Comparative Effectiveness Research has been conducted largely by the HHS Agency for Healthcare Research and Quality (AHRQ). The bulk of the AHRQ managed CER is conducted through university-based research centers under contract with AHRQ.

Prior to 2009, the AHRQ Effective Health Care Program spent a modest $15-$30 million annually. The AHRQ Effective Health Care Program was established under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).

AHRQ posts a wealth of reader-friendly information at www.effectivehealthcare.ahrq.gov.

Expansion of Federal Comparative Effectiveness Research in 2009:

In 2009, as part of the ARRA (Recovery Act), Congress appropriated $1.1 billion for comparative effectiveness research - $300 million for the Agency for Healthcare Research and Quality (AHRQ), $400 million for the National Institutes of Health, and $400 million for allocation at the discretion of the HHS Secretary.

Congress created a Federal Coordinating Council through which various federal agency heads could set CER priorities. Under a federal contract, an Institute of Medicine (IOM) committee recommended 100 priorities for CER.

HHS' latest status report on Recovery Act spending details how AHRQ, NIH, and the Secretary's office are using the $1.1 billion.

Major Changes to Federal Comparative Effectiveness Research in Health Reform Law:

In the new federal health reform law - Patient Protection and Affordable Care Act (PPACA) - Congress created several major changes to the federal Comparative Effectiveness Research program.

Starting October 2010, a new Patient Centered Outcomes Research Institute (PCORI) will be responsible for overseeing the federal comparative effectiveness research program. PCORI will set the national CER agenda and conduct research through contracts with federal agencies and grants and contracts with universities and researchers.

PCORI will operate as federally funded quasi-independent non-profit organization. The PCORI 19-member governing board will have 17 members appointed by Comptroller General of the US (head of the Government Accountability Office, an agency of Congress) plus directors AHRQ and NIH. The Comptroller General will designate the board chair and vice chair. Congress disbanded the Federal Coordinating Council for CER.

Patient Centered Outcomes Research Institute has a a very broad mission in the law:

Assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations, and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of medical treatments, services, and items.

The actual research will be delegated by PCORI to AHRQ and NIH. AHRQ and NIH, in turn, will contract out work to universities and research centers.

The Patient Centered Outcomes Research Institute will use a variety of expert panels. To help to ensure rigor of research methods, this includes a 15-member Methodology Committee appointed by the Comptroller General.

By law, PCORI is required to use open, transparent processes for decision making and include peer review. Wide, fast dissemination of research finding is also required. AHRQ will be responsible for translation and dissemination of evidence from CER to patients, clinicians, and other decision makers.

Expect to see federal officials, particularly the Obama Administration, using terms like "patient-centered research" instead of comparative effectiveness.

Permanent Funding Stream for Comparative Effectiveness Research:

PPACA, the health reform law, establishes a new, permanent funding stream for CER that, once fully implemented, will generate about $600 million annually for PCORI research priorities.

Specifically, health plans and self-insured employers (via TPAs) must pay a new federal tax of $2 per person they insure, generating $300 million or more each year starting in FY 2013. Another $150 million will come annually from Medicare. Finally, Congress also appropriated $50 million in FY 2011 and $150 million annually from FY 2012 through FY 2019. In effect, PCORI will also have unused ARRA CER funding at its disposal.

The latest issue of the journal American Health & Drug Benefits includes a valuable mix of studies and articles of interest to decision makers. Topics include health reform, bundled payment, drug pricing, benefit design, Medicaid, medication therapy, and specific clinical conditions.

The Health Reform Law: Key Changes to Be Implemented in 2010
By Kip Piper, MA, FACHE

Federal Drug Price Controls in Medicaid: Expansion of Mandated Rebates under Health Reform Law
By Kip Piper, MA, FACHE

Prevalence of Treated Bipolar Disorders and Associated Comorbidities in Managed Care and Medicaid Populations
By Jeff J. Guo, PhD; Nick C. Patel, PharmD, PhD; Hong Li, PhD; and Paul E. Keck Jr, MD. With Stakeholder Perspective by Nirav R. Shah, MD, MPH

Impact of Etanercept Treatment on Absenteeism and Productivity: The Work Loss and Productivity Survey
By Denise Globe, PhD; Peter Mazonson, MD, MBA; Chris Santas, MBA; Regina Murphy, MBA; Annie Cheng; Xingyue Huang, BPharm, PhD; and Arthur Kavanaugh, MD. With Stakeholder Perspective by Atheer A. Kaddis, PharmD

Health Benefit Coverage, Reimbursement, and Influences on Traditional Pharmaceutical Channels
By F. Randy Vogenberg, RPh, PhD. With Stakeholder Perspective by Gary M. Owens, MD

Bundled Payment: A Promising Initiative of Payment Reform
By Jim Evans

Impact of 2 Copay Waivers in a Generic Incentive Program
By Anthony F. Liu, MSCS; Tom Jecklin; Geoffrey Lee; and James Hogan

Medication Adherence: Effectiveness of Physician Alerts to Resolve Potential Gaps in Pharmacotherapy
By Joshua N. Liberman, PhD; Janice Moore, MPH; Asif Ally, RPh, MBA; and Troyen A. Brennan, JD, MD

New Approaches to Treating HCV Infection
By Caroline Helwick

Promising New Approaches to Multiple Sclerosis Medications: AAN 2010
By Alice Goodman

The June issue of AHDB includes highlights from the 2010 annual meeting of the Academy of Managed Care Pharmacy:

Read or Download June 2010 Issue:

To read or download the June 2010 issue, click here. To read or download specific articles in PDF, click here.

American Health & Drug Benefits:

American Health & Drug Benefits is available in print and online at www.AHDBonline.com. AHDB is a peer-reviewed journal for 30,000 decision makers in health plans, prescription drug plans, PBMs, the federal Medicare program, state Medicaid programs, and the pharma, biotech, and medical device and diagnostics industries.

Kip Piper is health policy editor of American Health & Drug Benefits.

MedPAC released its Medicare Data Book for 2010, with a wide range of useful information on Medicare spending, utilization, beneficiaries, providers, health plans, drug plans, access, and quality. The format is reader-friendly charts and tables with bulleted summaries.

Specifically, the latest MedPAC Data Book includes information on:

MedPAC also provides an array of charts and tables on Medicare providers and care settings, with data on Medicare spending, percent of beneficiaries using the service, number of providers, volume, length of stay, and, where available, profit margins, if
applicable. Provider types covered include inpatient hospitals, outpatient hospitals, physicians, skilled nursing facilities, home health agencies, long-term care hospitals, inpatient rehabilitation facilities, ambulatory surgical centers, dialysis facilities, and hospice.

MedPAC - the Medicare Payment Advisory Commission - advises Congress on Medicare policy.

Creating a wellness-based healthcare system is the focus on a new series of articles published by American Health and Drug Benefits, a peer reviewed journal. They cover a wide spectrum of topics on how to build and support prevention and wellness, particularly for chronic conditions. The ideas and information are particularly timely given the array of prevention and wellness initiatives in the Patient Protection and Affordable Care Act (PPACA):

The 5 Eras of Healthcare Finance: Wellness as a Clinical Model by Thomas McCarter, MD, FACP; Farrah N. Daly, MD, MBA; and Keri Cooper

Epidemiology and Impact of Chronic Diseases: The Promise of Prevention by Nirav R. Shah, MD, MPH

Bending the Curve, Changing Provider Organization: Implications for Wellness-Based Healthcare by Lawton Robert Burns, PhD, MBA

Wellness-Based Healthcare: Economic Incentives and Benefit Design by Gene Reeder, RPh, PhD

Wellness-Based Healthcare Policy: Medicare, Medicaid, and Private Insurance by Kip Piper, MA, FACHE

FDA Policies and Wellness-Based Healthcare: Approving and Paying for Prevention by Scott Gottlieb, MD

The Diabetes Ten City Challenge: Value-Based Benefit Design for Wellness-Based Care by Toni Fera, BPharm, PharmD

The Role of Wellness for Large Corporations: Trends and Models by Wayne M. Lednar, MD, PhD

Employers and a Culture of Health by Alberto M. Colombi, MD, MPH

Healthcare Reform: Impacts on Business by F. Randy Vogenberg, RPh, PhD

Pharmaceutical R&D Strategy and the Transition to Personalized Healthcare Planning by Michael F. Murphy, MD, PhD

The Role of Health Plans in Prevention and Wellness by Gary M. Owens, MD

Patient Engagement: From Medication Adherence to Health and Wellness by James T. Kenney, Jr, RPh, MBA

The Geisinger Model: Research Is a Core Asset by
Nirav R. Shah, MD, MPH; J.B. Jones, PhD, MBA; and Walter F. Stewart, PhD, MPH

Click here to read or download the above collection on Wellness-Based Healthcare System of Chronic Diseases: Prevention, Intervention, and Innovation (PDF).

Kip Piper is health policy editor of American Health and Drug Benefits. The journal's 30,000 subscribers include decision makers in health plans, drug plans, Medicare, and Medicaid.

An interesting new report assesses a variety of medical malpractice reforms. The study synthesizes the evidence or theoretical predictions regarding several leading medical malpractice reform ideas.

The report synthesizes published evidence on 8 reforms widely used by states:

• Caps on non-economic damages
• Pretrial screening panels
• Certificate of merit requirements
• Attorney fee limits
• Joint and several liability rule reform
• Collateral source rule reform
• Periodic payment
• Statutes of limitation or repose

These reforms are evaluated based on their effects on frequency and cost of malpractice claims, medical liability system overhead costs, health care providers' liability costs, defensive medicine (including utilization and spending), supply of health care services (including physician supply and patient health insurance coverage), and quality of care.

The report also reviews 6 other, more innovative but largely untested medical malpractice reforms:

• Schedules of non-economic damages
• Health courts
• Disclosure and offer programs
• Safe harbors for physician adherence to evidenced-based clinical practice guidelines
• Subsidized reinsurance that is made conditional upon meeting particular patient safety goals
• Enterprise medical liability

Based on theoretical predictions, the authors suggest that most of these latter reforms are promising enough to merit demonstrations.

The study was commissioned by the Medicare Payment Advisory Commission (MedPAC) and produced by Michelle M. Mello, JD, PhD, professor of law and public health at the Harvard School of Public Health and Allen Kachalia, MD, JD, assistant professor at the Harvard Medical School and medical director for quality and safety, Brigham and Women's Hospital.

The Medicare Payment Advisory Commission (MedPAC) has released its Medicare payment recommendations to Congress for 2011. In addition to specific recommendations for payment updates for fee-for-service providers and Medicare Advantage plans, MedPAC's report includes interesting information and analysis on spending trends, consequences of rapid spending on Medicare and the overall health care system, and the process of assessing payment adequacy.

MedPACs informative, 381-page report includes detailed Medicare reimbursement recommendations for:

• Inpatient hospital services (Inpatient Prospective Payment System or IPPS)
• Outpatient hospital services (Outpatient Prospective Payment System or OPPS)
• Physician services
• Ambulatory surgical centers
• Outpatient dialysis services
• Hospice services
• Post-acute care providers: Skilled nursing facility services, home health services, inpatient rehabilitation facility services, and long-term care hospital services
• Medicare Advantage plans (Medicare Part C)

The report also includes:

• Status report on the Medicare Part D prescription drug program.
• Comparison of quality among Medicare Advantage plans and between Medicare Advantage and fee-for-service Medicare.

To read or download the full report, click here (PDF). To select specific topics in the report, click here.

Here are articles from the latest issue of American Health & Drug Benefits. AHDB is a peer-reviewed journal for 30,000 decision makers in health plans, PBMs, Medicare, Medicaid, and the pharma and biotech industries:

Orphan Drug Pricing and Payer Management in the United States: Are We Approaching the Tipping Point? by Rebecca Hyde and Diana Dobrovolny, with Stakeholder Perspective by Kavita V. Nair, PhD.

Physicians' Perceptions of Reimbursement as a Barrier to Comprehensive Diabetes Care by Alyssa Pozniak, PhD; Lois Olinger, MA; and Victoria Shier, MA, with Stakeholder Perspective by Gary M. Owens, MD

Hypertension Management: An Update by Quang Nguyen, DO; Joann Dominguez, MD; Loida Nguyen, PharmD; and Nageshwara Gullapalli, MD.

Competition from Biosimilars an Incentive for Innovation by Dalia Buffery, MA, ABD

Emerging Trends in Breast Cancer Management by Caroline Helwick

Rheumatology Pipeline Boasts Innovation, ID Line Is Drying Up: ACR/IDSA 2009 by Alice Goodman

Cardiology Pipeline Is Promising: AHA 2009 by Wayne Kuznar

Learn More:

American Health & Drug Benefits is available in print and online at www.AHDBonline.com. To view the current or past issues or download in PDF format, click here.

Kip Piper is health policy editor of American Health & Drug Benefits.

The Centers for Medicare and Medicaid Services' Office of the Actuary (CMS/OACT) has released its projections of U.S. health care spending for the ten years 2010 through 2019, with premliminary estimates of 2009 health spending. The projections, released each year around this time, offer a fascinating, detailed look at patterns and trends in public and private health spending across programs and provider types.

Health Care Spending in 2009:

In 2009, National Health Expenditures (NHE) is projected to have reached $2.5 trillion, up 5.7 percent from 2008. This compares to 1.1 percent GDP decline in 2009. Health spending grew by a slow rate of 4.4 percent in 2008.

The health care share of GDP is expected to jump from 16.2 percent of GDP in 2008 to 17.3 percent in 2009 - the largest one-year increase in history.

Medicare, Medicaid, and Private Health Insurance in 2009:

In 2009, Medicare was projected at $507.1 billion, a 8.1 percent increase over 2008. Medicaid spending is estimated at $378.3 billion (federal and state funds), an increase of 9.9 percent.

The fast grow in Medicare and Medicare compares to continued slow growth in spending on private health insurance premiums, again largely due to the poor economy and unemployment. CMS projects spending on private health insurance premiums at $808.7 billion in 2009, up 3.3 percent from 2008.

Hospital, Physician, and Prescription Drug Spending in 2009:

In 2009, hospital spending increased by 5.9 percent to $760.6 billion (inpatient and outpatient). Physician and clinical services spending is expected to have reached $527.6 billion or a 6.3 percent increase in 2009. Note that in 2008 hospital and physician spending increased at more moderate rates of 4.5 percent and 5.0 percent, respectively.

Prescription drug spending increased by an estimated 5.2 percent, for total of $246.3 billion in 2009. Part of this increase was driven by higher use of antiviral drugs. Political perceptions and grandstanding notwithstanding, drug spending continues to grow more slowly than other, much larger components of health spending and has declined as a proportion of total health costs.

Projected Health Care Spending in 2010:

Assuming that Congress stops the 21.3 percent cut in Medicare physician payment rates required under the Sustainable Growth Rate (SGR) provisions of current law, total U.S. health care spending is projected to increase by 4.7 percent in 2010. If Congress fails to stop the physician rate cuts, overall NEHs would grow by a more modest 3.9 percent. Fixing SGR could easily cost over $300 billion but a fix is likely, especially given the enormity of the cuts and fact this is an election year.

Private health care spending in 2010 is projected to grow by 2.8 percent because of declining private health insurance enrollment because of high unemployment and the expiration of federal subsidies for COBRA coverage.

Out-of-pocket spending is expected to have slowed from 2.8 percent in 2008 to 2.1 percent in 2009, reaching $283.5 billion in 2009. The recession slowed the ultization of medical services, thereby slowing growth in out-of-pocket spending on co-payments and deductibles.

Ten Year Projection Through 2019:

For 2010 through 2019, the CMS team of actuaries and economists project:

Not surprisingly, public sector spending on health care is projected grow faster on average than private spending for 2009 through 2019. Average annual growth rate of 7.0 percent for taxpayer financed health care versus 5.2 percent for private spending (by employers and individuals).

Public health care programs (Medicare, Medicaid, CHIP, VA, TRICARE, et al) will account for half of all health spending by 2012.

By 2019, CMS Office of the Actuary projects that U.S. health spending will reach $4.5 trillion or about 19.3% of the economy as measured by GDP. (Yikes!)

Learn More About Health Spending Projections:

The CMS Office of the Actuary projections for U.S. health spending are nicely summarized in a new article in Health Affairs. To read the article, click here (PDF).

To learn more, check out CMS' projections, historical tables, and methodology here.

Payment reform is an integral part of national and state-based health reform efforts. Indeed, payment reform is essential to moving from quantity-based reimbursement to a performance-based health care system. That is, moving from fee-for-service to fee-for-value. Payment innovations, such as global payment, are designed to reward efficiency and higher quality, while supporting providers as they invest in patient-centered models of care.

Massachusetts, a leader in health policy innovation, is exploring global payment concepts in an effort to rein in costs and improve care coordination and quality. The Massachusetts Medicaid Policy Institute (MMPI) has released a new report on global payment in the Medicaid context.

The report, prepared by Mark Heit of Sellers Dorsey and Kip Piper of Health Results Group, assesses global payment options while addressing the concerns of applying the innovative payment mechanism to MassHealth, the Massachusetts Medicaid program.

To read the report, click here (PDF).

Global payments have been recommended for public and private payors by the Commonwealth's Special Commission on Health System Payment and the Massachusetts Health Care Quality and Cost Council.

The MMPI report was funded through a grant from Blue Cross Blue Shield of Massachusetts (BCBSMA). BCBSMA is implementing global payments with select hospitals and physician groups.

The Massachusetts Medicaid Policy Institute is an independent and non-partisan source of information about the Massachusetts Medicaid program. Learn more at www.massmedicaid.org.

A series of new articles from the journal American Health and Drug Benefits address key issues in stroke prevention and management, with a special focus on transient ischemic attacks. A transient ischemic attack (TIA), a transient stroke that lasts only a few minutes, can be a warning sign that a person is at risk for a more serious, debilitating, and potentially deadly stroke.

Many strokes can be prevented by heeding the warning signs of TIAs, a carotid ultrasound test, and treating underlying risk factors (e.g., smoking, high blood pressure, obesity, and high cholesterol). Unfortunately, our health care system under diagnoses and under treats patients at risk for stroke, leading to preventable deaths and disabilities and significant costs, particularly for Medicare and Medicaid.

The articles are based on presentations given at a symposium earlier this year on stroke prevention and treatment strategies:

Epidemiology of Stroke:

Nirav R. Shah, MD, MPH discusses stroke as the third-leading cause of death in the U.S. and a crushing burden on patients, families, the healthcare system and the economy. Dr. Shah gives an overview of the two main types of stroke, ischemic and hemorrhagic, as well as describes typical patients. He highlights areas of stroke and TIA incidence throughout the U.S., as well as the average Medicare cost in per region. Dr. Shah is assistant professor of Medicine, New York University School of Medicine, and a researcher and clinical investigator, Geisinger Health System, Danville, PA.

TIA and Stroke: Pathophysiology, Management, and Prevention:

Mitchell S.V. Elkind, MD, MS explores the risk factors for both TIA and stroke as well as how advances in imaging techniques have enhanced the understanding of stroke and called into question the traditional definitions of the difference between TIA and stroke. These advances have also led to new concepts of managing stroke, and have, in turn, led to new advances in therapies, with several new compounds now in clinical trials. Dr. Elkind is associate professor of neurology, and associate chairman for research and training, Columbia University.

An Actuarial Analysis of TIA and Recurrent Stroke Costs to Commercial Payers and Employers:

Kathryn Fitch, RN, MEd, examines the link between TIA and stroke and the costs to health plans and employers. Ms. Fitch outlines the risk factors for key populations and underscores the overall costs to employers and insurers for both primary and secondary strokes and TIA. She concludes that educating patients about risk and implementing stroke prevention initiatives can dramatically reduce the exposure of employers and insurers to these conditions. Ms. Fitch is a principal and healthcare management consultant at Milliman and based in New York.

TIA and Recurrent Stroke Prevention Practices: Current and New Developments:

Robert J. Adams, MS, MD looks at the gaps in the U.S. healthcare system in its approach to TIA and ischemic stroke. Dr. Adams concludes that these gaps result in barriers to the delivery of proper stroke management and prevention. He examines the unresolved issues of stroke prevention and management, as well as the place of stroke in the disease pantheon in the U.S. Unlike diabetes or heart disease, stroke does not receive its due attention as the third largest killer despite its enormous financial and human toll. Dr. Adams is a professor of neuroscience; director, South Carolina Center of Economic Excellence; and director, MUSC Stroke Center, Medical University of South Carolina.

Care Management for TIA and Stroke Patients: Riding the Quality Improvement Wave:

Barbara Lennert, RN, BSN, CRRN, MAOM connects the quality improvement movement to the problem of stroke management and discusses how many quality-focused organizations still do not see stroke and stroke prevention as key concerns. Ms. Lennart asserts that while there is widespread agreement on the seriousness of stroke and TIA, there is also agreement that these diseases are not taken seriously enough by health plans and quality / safety groups leading to inadequate attention to prevention and care. Ms. Lennart is director of quality improvement at Xcenda, part of the AmerisourceBergen Specialty Group.

Healthcare Reform and Public Programs: Opportunities for TIA / Recurrent Stroke Prevention:

Kip Piper, MA, FACHE links stroke prevention and management to health policy changes underway as a result of health reform, particularly as they relate to Medicare and Medicaid. These two programs provide valuable models as to how to include stroke care in policy. As health reform moves forward there are risks that stroke prevention and management may be left out of the equation. Mr. Piper insists that it is critical to ensure that elements of health reform are aligned with stroke prevention, care, and management.

Integrating Patient-Centered Care and Clinical Support: A New Research Paradigm:

Nirav M. Shah, MD, MPH explains how a "smart" electronic health record (EHR) can increase efficiency and substantially improve outcomes in the prevention and care of stroke. Dr. Shah describes how EHRs can identify and target risk factors and help modify patient behavior by allowing shared decision-making, thus improving outcomes. Dr. Shah and his colleagues at the Geisinger Health System have developed one of the nation's most sophisticated and flexible health information platforms to support patient care and clinical research.

TIA and Recurrent Stroke: The Case for Prevention in Working Populations:

Alberto M. Colombi, MD, MPH addresses the importance of ensuring that working populations are included in programs that focus on prevention and management of cerebrovascular diseases. With more and more people delaying retirement, government and employers must find ways to confront stroke and TIA proactively through a broad range of health programs that will reduce costs and improve outcomes among older working populations. Dr. Colombi, a top thought leader in health and productivity management (HPM). is corporate medical director, PPG Industries

For all the articles in a single PDF, click here.

Kip Piper is health policy editor for American Health and Drug Benefits, a peer review journal with 30,000 subscribers. Issues are available at www.ahdbonline.com.

The Medicare Payment Advisory Commission (MedPAC) has updated its excellent series of reader-friendly primers on Medicare payment methodologies for hospitals, physicians, Medicare Advantage plans, prescription drug plans, and other health care providers. MedPAC is an advisory agency to Congress and is highly influential, particlarly on payment methods, delivery systems, and Medicare reforms.

Medicare Part A Reimbursement of Hospitals:

Medcare Part A Reimbursement of Post-Acute Providers:

Medicare Part B for Physician Services, Other Outpatient Services, Medical Equipment, ad Supplies:

Medicare Payment of Health Plans and Drug Plans:

At the last annual meeting of the Academy of Managed Care Pharmacy, several of us spoke on pharmaceutical research and development in the quickly emerging value-driven healthcare system. Topics focused on the impact of value-based benefit designs, comparative effectiveness research, and government policies on the development of new drugs and biologics:

Research and Development in the Current Healthcare System: An Overview
Thomas McCarter, MD, FACP

What Constitutes Medical Evidence in the Era of Comparative Effectiveness?
Nirav R. Shah, MD, MPH, FACP

New Government Policies: Opportunities for Supporting Research and Development
Kip Piper, MA, FACHE

Drug Discovery and Development in a Value-Driven Healthcare System
Matthew Sarnes, PharmD

A Hypothetical Case: Current Drug R&D Process
Michael F. Murphy, MD, PhD

Our presentations were published in a supplement issue of American Health & Drug Benefits, a peer-reviewed journal serving about 30,000 decision makers. To read the articles, which are approved for continuing education credit, click here.

The HHS Agency for Healthcare Research and Quality (AHRQ) has announced plans for spending its $300 million share of the $1.1 billion Congress appropriated for comparative effectiveness research (CER) under the American Recovery and Reinvestment Act of 2009 (ARRA or Recovery Act for short). AHRQ plans to solicit grant applications this fall and award grants and contracts by spring 2010. The $300 million must be encumbered by end of FFY 2010.

AHRQ Spending Plan for Comparative Effectiveness Research in 2010:

New Grants ($198.5 million):

$148 million for evidence generation, including prospective studies and patient registries:

• $100 million for the Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE), a new national effort to establish a series of prospective pragmatic clinical comparative effectiveness studies that measure the benefits treatments produce in routine clinical practice. This will include novel study designs focusing on real-world and under-represented populations (children, elderly, racial and ethnic minorities, and other understudied populations).
• $48 million for the establishment or enhancement of national patient registries that can be used for researching the longitudinal effects of different interventions and collecting data on under-represented populations.

$29.5 million to support innovative translation and dissemination grants.

$20 million to support training and career development.

$1 million for other grants.

New Contracts ($19.5 million):

$9.5 million to establish an infrastructure to identify new issues for comparative effectiveness research.

$10 million to establish a citizen's forum to engage stakeholders and to expand and standardize public involvement in the federal comparative effectiveness research program.

Expand Existing Contracts ($79 million):

$50 million for evidence synthesis.

$24 million for evidence generation.

$5 million for translation and dissemination.

Administration ($3 million):

$3 million for salary and benefits for new AHRQ staff to administer the CER program.

Health Conditions Selected for Comparative Effectiveness Research:

For the time being, AHRQ is going to use the same 14 priority conditions designated earlier by the HHS Secretary under the Medicare Modernization Act. The priority conditions were selected because of their high interest for Medicare, Medicaid, and the Children's Health Insurance Program (CHIP):

1. Arthritis and non-traumatic joint disorders
2. Cancer
3. Cardiovascular disease, including stroke and hypertension
4. Dementia and other brain and nerve conditions, including Alzheimer's Disease
5. Depression and other mental health disorders
6. Developmental delays, attention-deficit hyperactivity disorder, and autism
7. Diabetes mellitus
8. Functional limitations and disability
9. Infectious diseases including HIV/AIDS
10. Obesity
11. Digestive system conditions (peptic ulcer disease and dyspepsia)
12. Pregnancy including preterm birth
13. Pulmonary disease and asthma
14. Alcohol and drug abuse

For more information on AHRQ's CER program, visit effectivehealthcare.ahrq.gov.

Here are articles from the latest issue of American Health & Drug Benefits. AHDB is a peer-reviewed journal for 30,000 decision makers in health plans, PBMs, Medicare, Medicaid, and the pharma and biotech industries:

June - July 2009 Issue:

Applying Evidence for Medical Technologies: Closing the Gap between R&D and Decision Maker Need
Interview with Sean R. Tunis, MD, MSc

The Working Patient with Cancer: Implications for Payers and Employers
By Grant D. Lawless, BSPharm, MD, FACP

Lower Copay and Oral Administration: Predictors of First-Fill Adherence to New Asthma Prescriptions
By Zackary Berger, MD, PhD; William Kimbrough, MD; Colleen Gillespie, PhD; Joseph A. Boscarino, PhD, MPH; G. Craig Wood, MS; Zhengmin Qian, MD, PhD; J. B. Jones, PhD, MBA; and Nirav R. Shah, MD, MPH

Use Pattern and Off-Label Use of Atypical Antipsychotics in Adults with Bipolar Disorder, 1998-2002
Jeffery A. Demland, MS; Yonghua Jing, BPharm, PhD; Christina M. L. Kelton, PhD; Jeff J. Guo, BPharm, PhD; Hong Li, MPH, PhD; and Patricia R. Wigle, PharmD

Biosimilars Policy Forum: Perspectives on Safety and Efficacy of Future Products
By F. Randy Vogenberg, RPh, PhD

Payer Perspectives on Healthcare Reform
By Peyton Howell, MHA; Gene Reeder, RPh, PhD; and Timothy S. Regan, BPharm, RPh, CPh

Prioritizing Healthcare Resources to Keep the Baby Boomers Out of Nursing Homes
By Robert E. Henry

The View from Washington: Healthcare Reform
By John Gorman

Read Current and Past Issues:

American Health & Drug Benefits is available in print and online at www.AHDBonline.com. To view the current or past issues or download in PDF format, click here.

AHDB also published web exclusives, available for reading here.

Kip Piper is health policy editor of American Health & Drug Benefits.

The Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) created the Medicaid and CHIP Payment and Access Commission (MACPAC) to advise Congress on a wide range of Medicaid and CHIP issues. MACPAC will start operating in early 2010.

MACPAC Membership and Staff:

Modeled closely after the long standing and highly influential Medicare Payment Advisory Commission (MedPAC), MACPAC will be a Congressional agency like MedPAC, the Congressional Budget Office (CBO), and the Government Accountability Office (GAO). Like MedPAC, the 17-member MACPAC will include an executive director and a professional staff of ~25-40. MACPAC appoints the executive director.

The 17 Commission members will be appointed for three-year, staggered terms, by the Comptroller General (head of the GAO), with representation from health financing experts, physicians, health professionals, employers, third-party payors, consumers, and current or former state Medicaid / CHIP officials. Non-health care providers must constitute a majority of the MACPAC membership. MACPAC appointments must be made by January 1, 2010.

Qualifications for MACPAC Membership:

In general, MACPAC's membership must include individuals with direct experience as:

• Medicaid / CHIP beneficiaries or parents of beneficiaries.
• Individuals with national recognition for expertise in Medicaid, CHIP, health finance and economics, actuarial science, health plans, integrated health systems, reimbursement, health information technology, or health care providers (e.g., pediatricians, dentists).

In particular, the MACPAC membership must include physicians and other health professionals, employers, third-party payors, and individuals with expertise in the delivery of health services. This must include:

• Members representing children, pregnant women, the elderly, and individuals with disabilities
• Current or former state Medicaid agency officials.
• Current or former State CHIP agency officials.

Congress seeks a mix of different professionals, broad geographic representations, and a balance between urban and rural representatives.

Role and Duties of MACPAC in Advising Congress on Medicaid and Children's Health Insurance Program:

Starting in 2010, MACPAC will:

• Review Medicaid and CHIP policies affecting children's access to covered services and make recommendations to Congress, with a report due by March 1 each year.
• More broadly examine issues affecting Medicaid and CHIP, including implications of changes in care delivery and the marketplace. Make recommendations to Congress, with report due by June each year.

More specifically, Congress directs MACPAC to regularly review and assess:

• Medicaid and CHIP payment policies, including state payment methodologies and factors affecting expenditures in different sectors, including the process for updating reimbursement rates for hospitals, nursing facilities, physicians, and community health centers.
• The relationship of payment policies to access and quality of care for Medicaid and CHIP beneficiaries.
• Interaction of Medicaid and CHIP payment policies with health care delivery.
• Implications of health care delivery changes and other marketplace changes on access to care for Medicaid and CHIP beneficiaries.
• The effect of other Medicaid and CHIP policies on access to covered health care services, including transportation and language barriers.

MACPAC must also:

• Create an early warning system to identify provider shortage areas or any other problems that threaten access to care or the health care status of Medicaid and CHIP beneficiaries.
• Review and comment to Medicaid and CHIP related reports to Congress by HHS.
• Upon request of committee chairs or ranking members, conduct studies, produce special reports, and make recommendations to Congress on Medicaid and CHIP issues.
• Periodically consult with Congressional leadership (committee chairs and ranking members), make its reports available to the HHS Secretary and the public, record and report votes on all recommendations, and examine the budget consequences of recommendations.
• Before making any recommendations, MACPAC must consider the budget consequences of such recommendations, directly or through consultation with experts.

CHIPRA also contains provisions on MACPAC operations, data collection and access, authority, funding and staffing. Again, these closely align with existing policies governing MACPAC's sister agency MedPAC.

Committee Jurisdictions in Congress:

MACPAC will be accountable to the Congressional committees with jurisdiction for Medicaid and CHIP, namely:

• House Energy and Commerce Committee and its Subcommittee on Health.
• Senate Finance Committee.

Federal agencies are busy implementing the new program for comparative effectiveness research. The Federal Coordinating Council for Comparative Effectiveness Research (CER) has released, for public comment, a draft definition of CER and draft prioritization criteria for making research selections. The definition and criteria are intended to help guide, albeit at a high level, federal use of the $1.1 billion appropriated for comparative effectiveness research in FY 2009 and FY 2010 in the American Recovery and Reinvestment Act (ARRA).

Draft Definition of Comparative Effectiveness Research for the Federal Coordinating Council:

Comparative effectiveness research is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations. Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, behavioral change strategies, and delivery system interventions. This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness.

Draft Prioritization Criteria for Comparative Effectiveness Research:

Threshold Minimal Criteria (i.e. must meet these to be considered):

Prioritization Criteria:

The criteria for scientifically meritorious research and investments are:

To comment on the draft definition and criteria, click here.

Plans for Implementing Comparative Effectiveness Research:

Of the $1.1 billion Congress appropriated for comparative effectiveness research, the Agency for Healthcare Research and Quality (AHRQ) received $300 million, the National Institutes of Health (NIH) received $400 million, and the HHS Office of the Secretary (OS) received $400 million. They have each developed plans for implementing their parts of the federal CER initiative:

Lessons from Comparative Effectiveness Research in Other Countries:

Meanwhile, an interesting new report from the Deloitte Center for Health Solutions profiles comparative effectiveness programs in the United Kingdom, Australia, Canada, and Germany. The report nicely lays out the complexity, challenges, and usefulness of comparative effectiveness. It also gives a helpful history of CER in the U.S. To read the report, click here (PDF).

Here are articles from the latest issue of American Health & Drug Benefits. AHDB is the peer-reviewed journal for 30,000 decision makers in health plans, PBMs, Medicare, Medicaid, and the pharma and biotech industries:

May 2009 Issue:

The Paradox of Public Policy Reform: Change or Continuum?
By Robert E. Henry

Are You Kidding Me? Clinical Comparative Effectiveness or Evidence-Based Medicine
By Thomas Kaye RPh, MBA, FASHP

MIPPA: First Broad Changes to Medicare Part D Plan Operations
By Jean D. LeMasurier and Babette Edgar, PharmD, MBA
Stakeholder Perspective by Mark Newsom, MSc

ProvenCare: Geisinger's Model for Care Transformation through Innovative Clinical Initiatives and Value Creation
Interview with Ronald A. Paulus, MD, MBA

Perspective: The Integrated Patient-Centered Medical Home: Tools for Transforming Our Healthcare Delivery System
By Matias A. Klein

Increased Patient Cost-Sharing, Weak US Economy, and Poor Health Habits: Implications for Employers and Insurers
By Melinda C. Haren, RN; Kirk McConnell; Arthur F. Shinn, PharmD, FASCP
Stakeholder Perspective by Paul Anthony Polansky, BSPharm, MBA

New Legislations on Generics and Biosimilars Brewing in Congress
By Dalia Buffery, MA, ABD

Paying for Cancer Care: Economic Models Start to Emerge, Dovetailing Healthcare Reform
By Caroline Helwick

Read Current and Past Issues:

American Health & Drug Benefits (AHDB) is available in print and online at www.AHDBonline.com. To view the current or past issues, click here.

AHDB also published web exclusives, available for reading here.

Kip Piper is health policy editor of American Health & Drug Benefits.

The incoming leadership at the U.S. Department of Health and Human Services (HHS) face a number of serious management challenges. These challenges, recently identified by the Office of the Inspector General (OIG), will require close, sustained attention by the Secretary's Office and the agency heads, particularly at CMS and FDA.

The nominees for Secretary and Deputy Secretary - Tom Daschle and Bill Corr, respectively - are wise choices, especially given President-elect Obama's policy perspective and strong interest in national health reform. They are smart, seasoned policy gurus with strong relationships on the Hill. However, as the Obama Administration populates the agencies with appointees, the White House and HHS leadership should seriously consider the need for strong executives and senior management types for top positions at agencies like CMS, FDA, CDC, and NIH. Yes, they will need requisite policy and technical expertise, but at the agency level management savvy should be a priority.

The reason is simple. The existing management challenges certainly require attention. Further, the ultimate success of the Obama Administration's health care agenda may well depend on fixing these problems. Also, the HHS Secretary's Office and the new White House Office of Health Reform will have their hands full with health reform legislation, Medicare fixes, and FDA legislation. And the White House and HHS leadership will need strong executives to effectively implement the range of major, complex new policies expected in 2009 and 2010. The Democrats have a fairly deep bench when it comes to policy wonks, researchers, and academics generally. Their bench for executives and managers is relatively thin - but they could look within the agencies themselves and in state government for management talent friendly to the Administration's policy views.

Here is the OIG's list of top management challenges at HHS:

Oversight of Medicare Part D Prescription Drug Benefit:

Medicare Program Integrity:

Integrity of Medicaid and State Children's Health Insurance Program:

Quality of Care:

Emergency Preparedness and Response:

Oversight of Food, Drugs, and Medical Devices by FDA:

Grants Management:

Integrity of Information Systems and the Implementation of Health Information Technology:

Ethics Program Oversight and Enforcement:

The Institute of Medicine (IOM) has identified 20 key indicators that together "reflect the overall health of the nation and the efficiency and efficacy of U.S. health systems."

Each of the 20 indicators can be readily measured over time using existing, publicly collected, reasonably high quality data. In addition to supporting nationwide snapshots, they permit drill-down views based on geography, population subgroups, and socioeconomic status.

Here are the IOM's key indicators:

Health Outcomes:

1. Life Expectancy at Birth (number of years that a newborn is expected to live if current mortality rates continue to apply).

2. Infant Mortality (deaths of infants aged under 1 year per 1,000 live births).

3. Life Expectancy at Age 65 (number of years of life remaining to a person at age 65 if current mortality rates continue to apply).

4. Injury Related Mortality (age-adjusted mortality rates due to intentional and unintentional injuries).

5. Self-Reported Health Status (percentage of adults reporting fair or poor health).

6. Unhealthy Days Physical and Mental (mean number of physically or mentally unhealthy days in past 30 days).

7. Chronic Disease Prevalence (percentage of adults reporting one or more of six chronic diseases [diabetes, cardiovascular disease, chronic obstructive pulmonary disease, asthma, cancer, and arthritis]).

8. Serious Psychological Distress (percentage of adults with serious psychological distress as indicated by a score of > 13 on the K6 scale, with scores ranging from 0-24).

Health Related Behaviors:

9. Smoking (percentage of adults who have smoked > 100 cigarettes in their lifetime and who currently smoke some days or every day).

10. Physical Activity (percentage of adults meeting the recommendation for moderate physical activity [at least 5 days a week for 30 minutes a day of moderate intensity activity or at least 3 days a week for 20 minutes a day of vigorous intensity activity]).

11. Excessive Drinking (percentage of adults consuming four [women] or five [men] or more drinks on one occasion and/or consuming more than an average of one [women] or two [men] drinks per day during the past 30 days)

12. Nutrition (percentage of adults with a good diet [conformance to federal dietary guidance] as indicated by a score of > 80 on the Healthy Eating Index)

13. Obesity (percentage of adults with a body mass index > 30).

14. Condom Use (proportion of youth in grades 9-12 who are sexually active and do not use condoms, placing them at risk for sexually transmitted infections).

Health Systems:

15. Health Care Expenditures (per capita health care spending).

16. Insurance Coverage (percentage of adults without health coverage via insurance or entitlement).

17. Unmet Medical, Dental, and Prescription Drug Needs (percentage of [non-institutionalized] people who did not receive or delayed receiving needed medical services, dental services, or prescription drugs during the previous year).

18. Preventive Services (percentage of adults who are up-to-date with age-appropriate screening services and flu vaccination).

19. Childhood Immunization (percentage of children aged 19-35 months who are up-to-date with recommended immunizations).

20. Preventable Hospitalizations (hospitalization rate for ambulatory care-sensitive conditions).

State of the USA - a new non-profit endeavor developed under the auspices of The National Academy of Sciences and funded by several major foundations - sponsored the IOM project to identify the indicators. The IOM committee of experts was asked to (a) select indicators that, taken together, give "a broad view of health in America, covering health care, health status, and health determinants" and (b) choose only 20 indicators to ensure "maximum clarity and focus."

Historically, traditional payment policies - coupled with lax oversight by regulators, weak leadership from many corners of the hospital and physician communities, and an uninformed, reverential public - have served to perpetuate (sometimes even reward) the use of unsafe practices and antiquated technologies in the hospital industry. This, in turn, resulted in a frightening number of adverse events - instances where patients are harmed by medical care. The consequences are tens of thousands of deaths and millions of injuries - the vast majority quite avoidable.

Fortunately, reduction of adverse events is now a priority. This is led by new payment and reporting policies by Medicare and some state Medicaid programs, influential players like IHI and the Leapfrog Group, the Hospital Quality Alliance, and a growing demand for disclosure of hospital and physician performance. Through realigned payment policies, public reporting of adverse events, and readily available best practices, hospitals are being given powerful new incentives to use safer practices.

Key Issues in Adverse Event Reporting by Hospitals:

The HHS Office of the Inspector General (OIG) has identified key issues affecting reporting of adverse events in hospitals:

The OIG believes we are finally "on the threshold of accelerated progress" in reducing the incidence of adverse events in hospitals. Yeah, their optimism is heavily couched but there has been some genuine progress. The OIG identifies a series of strategies that could hasten this.

For the OIG report on key issues in reporting and reducing adverse events in hospitals, click here (PDF).

State Requirements for Reporting Adverse Events:

Today, 26 states now have adverse event reporting programs. The Institute of Medicine (IOM), which supports mandated reporting, says reporting helps hold individual hospitals accountable for performance while providing information to improve patient safety and save lives. States vary somewhat by the list of reportable events and criteria for identifying reportable events. Most of the 26 state systems focus on adverse events in hospitals but some also require or support reporting in other care settings.

Most states told the OIG that "hospitals do not always report when adverse events occur." Underreporting is apparently common and probably substantial. To encourage better reporting, states have implemented various strategies. For example:

For the OIG report on state reporting programs, click here (PDF).

To aid the incoming 111th Congress and Obama Administration, the Congressional Budget Office (CBO) released a 235-page report outlining 115 budget options for health care reform. The report catalogs most of the hottest legislative ideas on Capitol Hill, with useful background information and scores of costs and savings. Here's the list of reform ideas in the report:

The Private Health Insurance Market:

The Tax Treatment of Health Insurance:

Changing the Availability of Health Insurance Through Existing Federal Programs:

The Quality and Efficiency of Health Care:

Geographic Variation in Spending for Medicare:

Paying for Medicare Services:

Financing and Paying for Services in Medicaid and State Children's Health Insurance Program:

Premiums and Cost Sharing in Federal Health Programs:

Long-Term Care:

Health Behavior and Health Promotion:

Medicare reimbursement policies are highly complex. Yes, that could be the litotes of the decade. Thankfully, the outstanding staff at the Medicare Payment Advisory Commission (MedPAC) produce and routinely update a series of basic primers on Medicare payment methodologies for hospitals, physicians, other providers, Medicare Advantage plans, and Part D prescription drug plans.

MedPAC's primers are reader friendly and crafted for a general audience. Typically 2 to 4 pages in length, they summarize the basic elements of each given payment methodology, with some history, policy context, and a flow chart(s) diagramming how payments are generally calculated.

Here are the latest primers on the basics of Medicare payment methods:

Medicare Hospital Services:

Medicare Outpatient Services:

Medicare Post-Acute and Related Services:

Medicare Health Plans and Prescription Drug Plans:

The next President and Congress will face many fiscal and policy challenges from the $436 billion Medicare program. Following my earlier quick primers on Medicaid policy making and Medicare and Medicaid waivers, here is a similar briefing on the primary vehicles of Medicare policy making.

As a federal health program operating nationwide, Medicare policies are made through:

Federal Medicare Statutes:

Title XVIII of the Social Security Act sets forth the bulk of federal Medicare laws. Given the political importance and visibility of Medicare, Medicare statutes are extremely specific, especially on provider reimbursement, benefits, cost sharing, managed care, and provider conditions of participation. Therefore, CMS' rulemaking discretion is often limited.

In the House, the Ways and Means Committee has primary jurisdiction over Medicare but often shares jurisdiction on certain issues with the Energy and Commerce Committee. In the Senate, the Finance Committee has primary jurisdiction for Medicare. The Medicare Payment Advisory Commission (MedPAC) advises Congress on Medicare issues and often proposes major policy changes. Like with Medicaid, Medicare legislative changes are typically accomplished through budget reconciliation bills rather than separate stand-alone legislation.

Federal Medicare Rules:

Most federal Medicare rules are promulgated by CMS (42 CFR Part 400 through 429). CMS must follow the same rulemaking and clearance processes for federal Medicaid rules. Medicare rules are developed by the relevant operating center or office with CMS, such as the Center for Medicare Management (CMM) for fee-for-service Part A and Part B issues and the Center for Drug and Health Plan Choice (CDHPC) for Part D and Medicare Advantage issues. Legal advice comes from the HHS Office of General Counsel (OGC).

Before publication in the Federal Register, all proposed and final rules require approval of the HHS Secretary and the White House Office of Management and Budget (OMB). OMB's Medicare rule reviews are conducted primarily by the Medicare Branch in OMB's Health Division.

Federal Medicare Guidance:

CMS uses numerous vehicles to convey Medicare guidance, including tens of thousands of pages of manuals, instructions, and program transmittals to contractors, providers, suppliers, health plans, and drug plans. Within the framework of the statutes and rules, considerable operational and technical policy is also set through the Medicare Advantage and Part D drug benefit applications, bids, and contracts.

Unlike in Medicaid - where CMS is often criticized for setting substantive policy through sub-regulatory guidance - Medicare guidance is more a product of a layering effect of highly specific statutes and regulations. Therefore, the Medicare administrative guidance focuses on execution issues, operational details (e.g., coding), and clarifications within and across the four complex, sometime conflicting parts of Medicare.

Under a new Executive Order, OMB now has the right to prior review and approval of CMS guidance, particularly any sub-regulatory guidance involving issues about $100 million, which is virtually anything in Medicare or Medicaid. To learn more, read my earlier post on expansion of OMB's review authority and implications for policy making by CMS and the FDA.

Many of my clients ask me how Medicaid policy is made, particularly for coverage, reimbursement, and managed care and other delivery systems. The $360 billion Medicaid program is highly complex and there are many nuances and exceptions, but here is a high-level primer on the basics.

Given the Medicaid program's shared federal-state funding and governance, underlying complexity, and variability across the respective states, Medicaid policy is set through several distinct vehicles, some federal and some state.

Medicaid Policy Making by Federal Government:

The primary federal policy making vehicles are:

Federal Medicaid Statutes:

Title XIX of the Social Security Act provides the federal statutory framework for Medicaid nationwide. Like its Medicare counterpart, Title XIX is extraordinarily complex and frequently amended by Congress. The federal Medicaid statutes are a mix of mandates and options for states. Medicaid legislative changes are often accomplished through budget reconciliation bills rather than separate stand-alone legislation. Short-term fixes may be made through appropriations bills.

Federal Medicaid Rules:

The vast bulk of federal Medicaid rules are promulgated by the Centers for Medicare and Medicaid Services (CMS). As with Medicare rules, CMS must follow the rulemaking process required by federal Administrative Procedures Act (APA) and the same clearance process. Most proposed and final rules affecting Medicaid are drafted by staff in CMS' Center for Medicaid and State Operations (CMSO), with legal advice from the HHS Office of General Counsel (OGC). Before publication in the Federal Register, proposed and final rules require approval of the HHS Secretary and White House Office of Management and Budget (OMB). OMB's Medicaid rule reviews are conducted primarily by the Medicaid Branch in OMB's Health Division but coordinated through OMB's Office of Information and Regulatory Affairs.

Federal Medicaid Guidance:

CMS uses several mechanisms to make or clarify Medicaid policy through "sub-regulatory guidance." This includes CMS' State Medicaid Manual and an important and influential ad hoc series of letters to State Medicaid directors - both issued by CMSO.

Federal law requires formal rulemaking for most substantive policy making, including interpretations of federal statutes. However, CMS often sets policy administratively, either in lieu of or far in advance of formal rule making. For example, if Congress makes significant changes to Title XIX with a tight deadline for implementation, CMS often issue a guidance letter or directive months in advance of issuing necessary conforming regulations. CMS must perform a balancing act to comply with the intent of APA and still implement frequent changes enacted by Congress or expected by the White House or HHS Secretary.

Officially, letters to State Medicaid directors (SMDs) are not intended to make policy per se but many states and experts believe some of these SMD letters make policy that requires formal rulemaking. Under a new Executive Order, OMB now has the authority to review and approve CMS guidance. This is consistent with its longstanding authority to review rules and waivers and a response to growing use of sub-regulatory issuances by agencies across the Executive Branch. OMB's new role continues to evolve.

Federal Medicaid Waivers:

Under sections 1115 and 1915 of the Social Security Act, the HHS Secretary may waive a variety of federal statutes and rules to permit state Medicaid programs to change benefit packages, eligibility, cost sharing, and care delivery in ways not permitted by current law. For my recent primer on federal Medicaid and Medicare waivers, click here.

Medicaid Policy Making by States:

The state-level policy making mechanisms in Medicaid are:

Medicaid State Plan:

Each state Medicaid program has its own "State Plan," which serves as the funding agreement between the state Medicaid agency and CMS. The State Plan specifies all of the state's key policies on Medicaid eligibility, benefits, cost sharing, reimbursement, managed care, quality assurance, utilization management, and program integrity. Here's an example of a Medicaid State Plan.

State Plans are highly detailed (typically 1000-2000 or more pages in length) and subject to frequent revision to reflect changes in federal law or rules, CMS guidance, state policy choices, and court rulings. State Plan Amendments (SPAs) are drafted by the state Medicaid agency and submitted to CMS for approval. Many SPAs are routine, following "preprints" - boilerplate checklists that allow states to propose SPAs needed to conform the State Plan to federal mandatory policies or common practices already approved for other states. States don't have to follow the preprints but it makes routine SPAs much easier. The state publishes a prior public notice for each SPA.

Routine SPAs are handled by the CMS regional offices but CMSO's central office staff in Baltimore handles all major and controversial SPAs. CMS may ask questions and may deny SPAs that it determines fail to comply with federal requirements. If an SPA rejected, the state may appeal CMS' decision to the HHS Departmental Appeals Board (DAB) and thereafter to the federal courts.

State Statutes and Administrative Rules:

Each state also sets some degree of Medicaid policy through state statutes and administrative rules. States vary widely in the degree to which state Medicaid policies are set forth in statutes or rules. Most states set eligibility, benefit packages, and cost sharing in statute and/or rules. Other policies, such as specific reimbursement methodologies and rates, are sometimes set administratively by the state Medicaid agency through manuals and instructions to providers. The basic parameters of hospital and nursing home payment formulars are often set in state statute. Still other policies are made through the state budget process or contracting mechanisms, such as managed care RFPs and Medicaid health plan contracts.

However, some states, specify a considerable amount of Medicaid policy through rules. While state Medicaid rules are drafted and promulgated by the state Medicaid agency, some states require legislative committee review and approval of all rules. (Note that regardless what is addressed in state statutes or rules, the State Plan must reflect the latest policies.)

Serious and costly performance problems riddle U.S. health care. Because of overuse, under use, and misuse of health care, researchers at the Juran Institute and elsewhere estimate that about 30 percent of health care costs are generated by poor quality. Therefore, poor quality medical care will cost about $720 billion in 2008 (30% of $2.4 trillion).

Poor quality also reduces productivity. For every dollar of health care spending caused by poor quality, poor care costs an estimated 50 cents in lost productivity. When applied to the $822 billion in care provided through employer-sponsored insurance, this translates to an additional $123 billion in costs.

A recent study by the Health Research Institute at PricewaterhouseCoopers estimates that wasteful health care spending costs $1.2 trillion annually. Analyzing findings from a wealth of published studies, the PwC researchers looked at the cost of waste from clinically inappropriate care and overt errors, individual behaviors leading to costly health problems, and antiquated operational processes that add costs without providing any value.

Making matters worse, research on the care patients receive from physicians, hospitals, and other providers paints a frustrating, even scary picture. For example, studies conducted by the respected RAND Corporation show that Americans receive clinically inadequate or inappropriate care at shockingly high rates.

Specifically, RAND's research shows that acute care for insured adults is appropriate only 53.5 percent of the time on average. In other words, about 46 percent of acute care is clinically incorrect. Similarly, about 43.9 percent of chronic care and 45.1 percent of preventive care is inappropriate according to accepted medical standards. Children receive 68 percent of recommended care for acute medical problems, 53 percent of recommended care for chronic medical conditions, and 41 percent of recommended preventive care.

The bottom line is health care - whether for adults or children - is inappropriate or unnecessary about half the time. Basically, it's a coin flip.

Root Causes of Poor Quality, High Costs:

Ultimately, three immutable laws of economics explain the underlying causes of this poor performance:

1. Price is what you pay but value is what you get:

Taking a page from Warren Buffet's playbook, buyers of health benefits must focus on value, not price. Price is an important part of the equation but meaningless if you don't know the value of what you are receiving for that price. Unfortunately, in health care we obsess on unit prices. In no other marketplace or domain of life do Americans - corporations, consumers, federal and state policymakers, news media - pay so much attention to price and so little to value.

2. You get what you pay for:

Today, we pay for quantity, not quality. Poor performers are sustained and rewarded. The best performers are financially penalized and professionally demoralized. The consequences are all too obvious.

3. You can't fix what you can't see:

In sharp contrast to virtually every other industry, health care is highly opaque. American health care is full of decision makers - consumers, physicians, and other providers, health plans, public officials - who lack the information needed to make decisions.

Five Steps to Higher Performance:

The problems are daunting but solvable. To improve the quality and cost effectiveness of health care delivery, purchasers and payors must tightly focus on strategies to expect, measure, disclose, reward, and support results:

1. Expect Results:

2. Measure Results:

3. Disclose Results:

4. Reward Results:

5. Support Results:

Support the infrastructure and processes essential to results-driven health care. These include:

The Medicare Payment Advisory Commission (MedPAC) - the influential independent Congressional agency charged with advising Congress on a wide range of Medicare policy issues - has released its Medicare payment policy recommendations for 2009. The 355-page report includes a weath of information for those tracking Medicare provider or health plan issues, particularly annual provider payment updates, reforms to Medicare Advantage, and quality incentives.

In summary, here are MedPAC's recommendations to Congress:

Hospital Inpatient and Outpatient Services:

Physician Services:

Outpatient Dialysis Services:

Skilled Nursing Facility Services:

Home Health Services:

Inpatient Rehabilitation Facility Services:

Long-Term Care Hospital Services:

Medicare Advantage Special Needs Plans:

Part D Enrollment, Benefit Offerings, and Drug Plan Payments:

Medicare Savings Programs and Part D Low-Income Drug Subsidy:

To read the full MedPAC report, click here (large PDF file).

More purchasers and payors are moving away from simplistic cost-driven drug benefit designs to formularies and cost sharing based on value. The impact of value-based drug benefit designs on manufacturers will depend on how quickly individual firms adapt their business thinking and communications strategies.

Until recently, the path to success for a drug manufacturer was based largely on product novelty, physician-centric marketing, and revenue strategies balancing unit prices and concessions against formulary position.

To maximize market share and margins in the world of value-based drug benefit designs, drug manufacturers will need to:

(1) Demonstrate the clinical and economic case for each product and each therapeutic class with an indication,

(2) Build absolute and comparative evidence on a continuous basis,

(3) Develop new value-based pricing models and market partnerships, and

(4) Communicate far more effectively with public and private payors.

For many firms, this will require a significant, even scary change in thinking and tactics; payor-centric communications; comfort with a massive increase in transparency; and a greater willingness to partner. Therefore, while the financial risks of moving to a value-based world are daunting, ultimately the greatest challenges are intellectual.

Value-based drug benefit designs will pose the greatest challenges to manufacturers with product lines (or pipelines) dominated "me too" drugs; rigid, risk-adverse organizational silos; and out-dated, prescriber-centric communications.

The latest issue of the American Journal of Managed Care has several interesting articles on diabetes, demonstrating several opportunities to improve outcomes and reduce costs:

How Managed Care Organizations Contribute to Improved Diabetes Outcomes: Patricia Salber, MD, chief medical officer and SVP at Universal American, a large Medicare health and drug plan, outlines how MCOs are improving outcomes for patients with diabetes.

Diabetes Complications Severity Index and Risk of Mortality, Hospitalization, and Healthcare Utilization: This study show that the Diabetes Complications Severity Index (DCSI) performs better than complication counts and is a useful tool to predict mortality and hospitalization risk.

Lower Severe Hypoglycemia Risk: Insulin Glargine Versus NPH Insulin in Type 2 Diabetes: Findings shows cost savings and lower incidence of hypoglycemia with insulin glargine.

Diabetes Diagnosis, Resource Utilization, and Health Outcomes: Article highlights the clinical and economic case for much earlier detection of hyperglycemia.

Do Diabetes Group Visits Lead to Lower Medical Care Charges?: Findings show that group visits (shared medical appointments) significantly reduce outpatient costs of diabetes care, primarily by substituting group visits for more expensive individual specialty care visits.

To read or download all the articles in the January 2008 issue of AJMC, click here.

The journal Medical Care has published series of outstanding articles on emerging methods and tools to compare the effectiveness of medical therapies, prescription drugs, and devices. The peer-reviewed articles are an outgrowth from a symposium on comparative effectiveness research sponsored by the Agency for Healthcare Research and Quality (AHRQ).

Here are links to the individual articles in PDF format:

The Medicare Payment Advisory Commission (MedPAC), the savvy nonpartisan shop that advises Congress on Medicare program issues, has updated its excellent series of primers. Extremely complex and changing constantly, Medicare payment policy will drive $479 billion in health spending in 2008. MedPAC's primers, typically four crisply-written pages, explain the basic steps and methodologies Medicare uses to reimburse fee-for-service providers, Medicare Advantage plans, and Medicare prescription drug plans.

Here are MedPAC's updated primers on the basics of Medicare reimbursement policy (click on links to open in PDF format):

Medicare Hospital Reimbursement:

Medicare Post-Acute Provider Reimbursement:

Medicare Physician Reimbursement:

Medicare Managed Care (Part C and Part D):

Other Medicare Reimbursement Policies:

The well-regarded industry trade journal Biotechnology Healthcare has an excellent article by Patrick Mullen on The Arrival of Average Sales Price. In it, Mr. Mullen interviews several top industry experts (yes, including me) on the rationale for and impact of Average Sales Price (ASP) and how health plans are following Medicare's lead:

Health plans are beginning to adopt the average sales price method of paying oncologists and other specialists for office-administered drugs. ASP is more transparent and has a smaller markup than its much maligned predecessor, average wholesale price. The speed of ASP uptake will affect everyone who makes, sells, prescribes, and takes these medications.

Average Sales Price and Drug Reimbursement:

In 2005, as part of the Medicare Modernization Act (MMA), the way Medicare Part B reimbursed physicians and clinics for biologics and other physician-administered injectable drugs changed fundamentally. Medicare Part B, the nation's largest payor of injectable drugs, started using Average Sales Price (ASP) to base payments for most drug products covered by Part B fee-for-service.

Using a new, tighter, and more accurate definition of ASP, drug manufacturers must report the Average Sales Price of each of their products. CMS, through its Part B claims processing contractors, reimburses physicians for covered drug products administered to Medicare benies at 106% of ASP, adjusted for volume.

Wide Ranging Impact of ASP in Marketplace:

Physician offices, particularly oncologists, have seen significant drops in Medicare revenue. While the impact on drug makers is mixed, overall the switch to ASP has tightened profit margins and required many manufacturers to revise projections.

Also, like the move of Medicaid to a new and publicly reported version of Average Manufacturer Price (AMP), the ASP reforms are another way drug prices are becoming transparent and flatter or less variable. The transformative effect on business practices and strategy should not be underestimated.

For Medicare Part B, the switch to ASP-based payment has saved billions of dollars and dramatically slowed the growth in Part B prescription drug spending. Beneficiaries have benefited as well, since they are paying the 20% Part B copay on lower prices. However, there is some evidence that some docs are switching drug therapies (which may or may not be clinically optimal for patients) or forcing patients to receive injections from other settings, such as outpatient hospitals. The behavioral effect on physician practices is still hard to discern beyond the realm of anecdote but is something worth monitoring closely, especially in light of low Medicare rates for professional fees.

To Learn More About ASP:

In addition to the article in Biotechnology Healthcare mentioned above, here are some MedPAC resources to understand ASP, Medicare spending on drugs and biologics, and Medicare reimbursement of physician services:

Kerry Weems, Secretary Mike Leavitt's deputy chief of staff and President Bush's nominee to head the Centers for Medicare and Medicaid Services (CMS), faces tough Senate confirmation hearings in July. A savvy, career HHS insider with a wealth of experience in the fiscal and organizational mechanics of federal health programs, Mr. Weems is a good choice for an administrator to steer CMS in the last 18 months of the Bush Administration. But he nonetheless faces several serious challenges during the confirmation process. A few examples:

1. Efforts to Hold Confirmation Hostage to Policy Commitments:

Senators, trade groups, and advocates of all flavors have long policy wish lists. As FDA Commissioner Andrew C. von Eschenbach, M.D. can attest, the confirmation process - in committee and on the Senate floor - is a unique opportunity for Democrats and even some Republicans to hold up confirmation until the nominee or Department concedes to certain policy demands. And the wish lists for the FDA are nothing compared to what many want from CMS.

2. A Maze of Medicare and Medicaid Controversies:

For better or worse, a wide range of delicate issues at CMS were left unexamined during Republican control of Congress. The Democrats now in charge of the Hill are eager to make political hay with health issues, reshape policy, and give their core constituencies a crack, albeit by proxy, at challenging CMS actions in a public forum.

Regardless of the Administration or the party running the Executive Branch, Medicare and Medicaid are full of dirty little secrets, some real and some imagined, intertwined within a massive level of complexity prone to misconception and manipulation by political foes and those of varying motivations eager for a larger slice of an $800 billion+ pie. Many critics of CMS see the Weems nomination hearings and floor debate as a unique opportunity.

3. Nomination of a Non-Wonk:

While Kerry Weems has a lot going for him and CMS would likely benefit from leadership by a career insider, he is not a health policy wonk. That is, he is not a academic, researcher, health policy maker, or lobbyist (not that most lobbyists are mavens but they like playing them on TV). He's a budget and finance guy and a career one at that. Not a bad thing at all, but a potential problem in a town that grossly overvalues what MD's and PhD's typically know about health policy or finance and sees "budget guys" in health programs as somehow being on a first name basis with the devil.

Some advocacy groups, who naturally have the ear of Dems in the Senate, are concerned that Mr. Weems lacks the requisite substantive expertise in Medicare or Medicaid policy (well, make that Medicare, since unfortunately few inside the Beltway understand or track Medicaid). When a Republican is in charge of the White House, Dems and advocates are much more comfortable with an academic running CMS. And when a Democrat is in charge, they virtually insist on it. In its 30-year history, CMS (formerly named HCFA) has had nearly as many administrators and acting administrators. Add to this extremely high turnover the fact that CMS is rather unique in having a tiny number of political appointees.

There are notable exceptions. Gail Wilensky, Ph.D., one of the nation's most talented health policy experts, turned out to be an excellent administrator in the early 1990's. And there have been times where the agency was led by a budget guy, most notably Leonard Schaeffer, who ran HCFA is its early days. He came to HCFA from managing health budgets for the State of Illinois and later was the founding chairman and CEO of WellPoint.

Kerry Weems will have his hands full next month. But he's a smart fellow, with a keen sense for detail, and HHS and CMS staffs are briefing him around the clock in preparation. He'll do well before the Senate if given a fair shake.

Of the 45 million Medicare beneficiaries, 19 percent are enrolled in a Medicare Advantage health plan. The other 81 percent choose to remain in traditional fee-for-service Medicare for Part A and Part B services. Governed under Part C of Medicare, Medicare Advantage health plans come in several flavors, most notably HMOs, PPOs, special needs plans (SNPs), and private fee-for-service plans.

While only about 16% of Medicare Advantage enrollees and about 3 percent of all Medicare beneficiaries are in private fee-for-service plans, these PFFS plans are receiving considerable attention by Congress and Wall Street. To help you understand the unusual dynamics at play, here are some helpful resources:

An Examination of Medicare Private Fee-for-Service Plans: This paper by Jonathan Blum, et al from Avalere Health, covers the history, features, trends, and policy and market implications of PFFS plans.

The Medicare Advantage Program: Trends and Options: Congressional Budget Office (CBO) report, with CBO's projections for Medicare managed care enrollment.

Private Fee-For-Service Plans in Medicare Advantage: Testimony by Mark E. Miller, Ph.D., executive director of the Medicare Payment Advisory Commission (MedPAC) on MedPAC's observations and recommendations.

Private Fee-For-Service Plans In Medicare: Rapid Growth and Future Implications: In testimony before the House Ways and Means Committee, Patricia Neuman, Ph.D, a Kaiser Family Foundation vice president, offered a thoughtful overview of many of the key issues.

The Impact of Reductions in Medicare Advantage Funding on Beneficiaries: This study, by Adam J. Atherly, Ph.D. and Kenneth E. Thorpe, Ph.D. of Emory University, shows financial savings Medicare Advantage enrollees receive and therefore the adverse impact on benies of proposed cuts to Medicare Advantage plans.

Medicare Advantage Program Payment System: An excellent 4-page primer by MedPAC on how CMS sets Medicare Advantage plan payments.

Normally, $15 million a year doesn't buy you much in the federal government. A notable exception is the Effective Health Care Program at the Agency for Healthcare Research and Quality (AHRQ). Drug manufacturers, device makers, health plans, state Medicaid agencies, Wall Street analysts, physicians, and patient groups should all follow it closely.

The Medicare Modernization Act of 2003 (MMA) authorized AHRQ to conduct and support research on outcomes, comparative clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services. With a modest budget, a tiny but dedicated staff, and partnerships with top research institutions, AHRQ's Effective Health Care Program involves three approaches to research the comparative effectiveness of different medical treatments, drug therapies, and clinical practices:

1. Review and Synthesize Knowledge: AHRQ's network of 12 Evidence-based Practice Centers systematically review published and unpublished scientific evidence on what is known. Given the huge volume of studies and journal articles produced every year, it is next to impossible for providers, payors, and other key decision makers to keep up and even harder for them to thoughtfully weigh the evidence. AHRQ and its research partners synthesize the science and build a meaningful evidence base.

2. Promote and Generate New Knowledge: The DEcIDE Research Network studies new scientific evidence and analytic tools in an accelerated and practical format. DEcIDE stands for "Developing Evidence to Inform Decisions about Effectiveness." Comprised of 13 university research centers and think tanks, the DEcIDE network conducts accelerated practical studies about the comparative clinical effectiveness, safety, and appropriateness of specific health care services, drugs, and devices. In other words, what works best for patients.

3. Compile Findings and Translate and Disseminate Knowledge to Decision Makers: AHRQ's John M. Eisenberg Clinical Decisions and Communications Science Center takes the research results and transform them into into a variety of useful, actionable formats for stakeholders (e.g., providers, payors, purchasers, patients, manufacturers). Specifically, these include (a) consumer guides (short summaries of health care research that can help with decisions about treatments), (b) clinician guides (brief evidence summaries to assist clinical decision making), (c) policymaker guides (short reports of research evidence for use in health care policy making), and (d) white papers on state-of-the-art concepts in health communication.

The past couple years, the initiative has focused on ten priority health care conditions, selected because of their high impact on Medicare, Medicaid, SCHIP, and other federal health programs:

Later this year, AHRQ will entertain nominations for other priority conditions.

Here's a sampling of the excellent work already generated. For a directory of these reports, with free access in PDF format, click here:

The Effective Health Care Program has 40 other reports in the works, covering a wide range of topics. These include more comparative effectiveness reviews of specific drugs as well as tools to measure quality, reduce errors, and monitor therapies. To get notified when new research becomes available, sign up for AHRQ's email list.

Under a new Executive Order, President Bush has significantly expanded the authority of the White House Office of Management and Budget (OMB) over policymaking by the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA).

Specifically, OMB now has the authority to review and approve a vast array of written guidance issued day-to-day by CMS and FDA. The expansion of OMB's oversight authority has far-reaching implications for Medicare and Medicaid policy and the regulation of the drug and device industries.

In recent years, an increasing amount of agency policymaking has come in the form of "sub-regulatory guidance." That is, written guidance that does not go through the formal rulemaking process. In the case of CMS, this written guidance shows up, for example, as memorandums to health plans, letters to state officials, and manuals or other instructions. In its role administering the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has its own system of guidance documents.

While the FDA approach to sub-regulatory guidance has its own critics and limitations, the FDA approach is better organized and managed than CMS' approach. FDA has been at it longer than CMS but also has (relatively speaking) a narrower, more explicit scope of work. The FDCA and all its amendments is no walk in the park, but Titles 18, 19, and 21 of the Social Security Act are exercises in pure legislative surrealism.

President Bush's new Executive Order means that much of this written guidance is now subject to prior review and approval by OMB. While OMB has always been a key player, particularly in Medicare and Medicaid policy, the E.O. greatly increases OMB's influence and may result in a substantial power shift in many day-to-day issues affecting providers, health plans, drug manufacturers, states, and other stakeholders. (In the interest of full disclosure, my career includes service on OMB's Medicare and Medicaid team.)

For those interested in more background, below is a quick overview of the rulemaking process and the increasing role of written guidance in lieu of rules.

Background on OMB Regulatory Review:

Virtually all CMS and FDA proposed and final rules are subject to prior review and approval of the Office of Management and Budget (OMB), the powerful policy management arm of the White House. (It's important to note that OMB also reviews Medicare and Medicaid waivers, agency budget requests and legislative proposals, and written testimony to Congress.) OMB's regulatory oversight was created by Presidential Executive Order in the Reagan Administration and modified but retained by the Clinton Administration.

The basic idea is to help ensure that agency rulemaking activities follow the sitting President's policy objectives to the extent possible under the laws passed by Congress. OMB oversight also allows for a more thoughtful and disciplined approach to regulations, to keep track of the impact of agency rules on individuals, businesses, and states and guard against such things as unnecessary or excessive regulations and conflicting rules across different federal agencies.

In principle, the rulemaking process is designed to (1) inform the public of planned rules in detail; (2) give the public, including stakeholders and experts, an opportunity to comment, provide new information, and suggest alternatives; (3) ensure the rulemaking agency considers and responds to public comments before issuing final rules; (4) ensure that all federal rules can be found in a central publication (published in the Federal Register and formally codified in the Code of Federal Regulations); and (5) provide a comprehensive public record for use by the courts, Congress, and the news media in overseeing an agency's use of power and interpretation of statutes.

Written Guidance Instead of Formal Rules:

In other words, the formal rulemaking process provides for far more thoughtful, documented, and transparent policymaking than the so-called sub-regulatory guidance. However, developing proposed and final rules is a laborious process taking months and sometimes even years. And CMS faces the imperatives of implementing massive pieces of legislation, such as the Deficit Reduction Act (DRA) and the Medicare Modernization Act (MMA). Even if CMS always had the necessary staff, expertise, systems, and budget to implement the avalanche of Medicare and Medicaid legislation on time (it never does, unfortunately), there are just not enough hours in the day to promulgate all the necessary rules to meet statutory deadlines.

Therefore, much of CMS policymaking is done through written guidance, letters, memos, and memos - and not regulations. While it's easy to understand the practical pressures, many legal observers seriously question CMS's compliance with the Administrative Procedures Act (APA). The APA, originally enacted in 1946, governs when and how agencies must go through the formal rulemaking process.

Privately, several players have told me how CMS's informal approach to many Medicare and Medicaid policies would likely not stand up in federal court. However, trade groups, states, and other stakeholders don't want to anger the increasingly powerful agency - and, in many cases, written guidance today is better than waiting months or even years for a rule.

Like its sister agency CMS, the FDA is increasingly using sub-regulatory guidance in lieu of formal rules. Given the demands facing the FDA, including a variety of reforms and pending legislative changes, this is expected to increase. To get a flavor, check out the list of guidance documents from the FDA's Center for Drug Evaluation and Research (CDRR). You'll see it includes various backgrounders mixed with policy statements and instructions.

The federal False Claims Act has been an effective tool in combating fraud and abuse in government programs, particularly Medicare. Several states have their own state versions of false claims legislation. The federal Deficit Reduction Act (DRA), enacted last February, gives states a powerful new financial incentive to enact state false claims acts modeled after the federal version and directed at fighting Medicaid fraud and abuse.

Specifically, states with state false claims acts that meet certain federal standards are able to keep more of whatever is recovered from fraudulent Medicaid providers or suppliers. The incentive amounts to ten percentage points of any recovery. For example, if a state has a 50% federal Medicaid match, it would normally have to return to the feds 50% of anything recovered. However, if the state has a federally compliant false claims act, the state gets to keep 60% or a 10 percentage point jump in its share. For most states, this could easily result in millions of dollars kept in the state.

OIG Review of State False Claims Acts:

Under the DRA, the HHS Office of the Inspector General (OIG) is responsible for looking at state false claims laws (whether new, existing, or amended) to see if they meet the federal standard and therefore if the state gets the incentive. To read the OIG's review guidelines, click here.

So far, at the request of state officials, the OIG has looked at existing statutes in ten states: California, Florida, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, Tennessee, and Texas. According to the OIG, the state false claims statutes in Illinois, Massachusetts, and Tennessee meet the DRA requirements and therefore these states' Medicaid programs may keep more of any Medicaid recoveries. The other states will need to amend their statutes if they wish to qualify for financial incentive.

Background on Federal False Claims Act:

Since the nation's founding, federal law has permitted private citizens to sue on behalf of the government to combat fraud in public programs. If the fraud or false claim is proven in court, the citizen bringing the suit gets to keep a portion of the funds recovered as an incentive.

Today, fraud fighters and whistleblowers use the federal False Claims Act, which was enacted in 1863 to stop fraud by military suppliers to the Union Army. Revised several times by Congress, the federal False Claims Act (FCA) has been increasingly used to bring lawsuits against health care providers and suppliers.

Of course, federal prosecutors may also bring criminal charges but in criminal cases they must prove guilt beyond a reasonable doubt. Civil cases are much easier to win in the complex world of health care claims since the standard is a preponderance of the evidence.

How the False Claims Act Works:

Under the False Claims Act, a person with knowledge of fraud against the U.S. government may file a civil suit on behalf of the government against the person or business that allegedly committed the fraud. These are referred to qui tam cases. "Qui tam" (pronounced "key tam" or "kwee tam" and Latin for "who as well") is used in short for longer Latin phrase meaning "he who (sues) for the king as well as for himself." (Okay, for Latin buffs, it's qui tam pro domino rege quam pro seipse. Now you know why everybody just says Qui Tam.)

Qui tam lawsuits are first filed with the federal district court in secret, to give the U.S. Justice Department time to decide whether to intervene and take over prosecuting the case itself. DOJ takes on about a quarter of these cases. If DOJ decides not to take the case, the qui tam plaintiff or "relator" - who is often an internal whistleblower since they need to be the source of information in the case - may pursue the case on behalf of the federal government but at his or her own expense. However, unlike other civil actions where a person can represent themselves (unwise but possible), the relator must hire an attorney to represent them.

The False Claims Act provides for treble damages. Therefore, if fraud is proven through the civil case, the defendant(s) are liable for three times the original cost of the fraud to the taxpayers - plus civil fines of $5,000 to $10,000 for each instance of fraud or false claim.

The amount received by a successful qui tam plaintiff depends on whether the DOJ took the case. If the Justice Department takes the case, the qui tam plaintiff gets between 15% and 25% of the recovery. If the Justice Department declines to take the case and the relator pursues the civil suit on their own, the qui tam plaintiff receives 25% to 30% of the recovery.

Given the size of some of these incentives, the Justice Department often balks and tries to get them reduced, arguing that the plaintiff lacked the direct knowledge required to qualify. Therefore, the payouts to successful whistleblowers often lead to legal battles long after the fraud is proven and defendants pay up.

Earlier this month, the U.S. Supreme Court heard oral arguments in just such a case where the federal government was challenging the right of a successful qui tam plaintiff to collect a portion of recoveries. The ruling, expected by this summer, could have a major impact on future qui tam suits.

Please check out my previous posts on Medicaid program integrity issues.

With far-reaching implications for states, providers, and health plans, the Deficit Reduction Act (DRA) dramatically increased the role of the federal government to combat Medicaid fraud and abuse. Together with a substantial increase in funding for federal contractors and staff, the DRA gives the Centers for Medicare and Medicaid Services (CMS) new, potentially massive authority in areas previously managed exclusively by state Medicaid agencies.

New Federal Authority in Medicaid:

Under the DRA, Congress mandates that "States must comply with any requirements determined by the Secretary (of Health and Human Services) to be necessary for carrying out the Medicaid Integrity Program...." This new, open-ended authority to impose directives on state Medicaid agencies - and, via states, on health plans, health care providers, and Medicaid fiscal agents - will be implemented by CMS through new rules and instructions.

Key Components of Medicaid Integrity Program:

The Medicaid Integrity Program (MIP) includes:

CMS, after consulting with the National Association of State Medicaid Directors (NASMD), developed a 37-page plan detailing the initiative.

The DRA also boosts Medicaid anti-fraud funding for the HHS Office of the Inspector General and the Program Integrity Group in CMS' Office of Financial Management (OFM). The OIG gets an additional $25 million a year from FY 2006 through 2010. The DRA also created a new position of Medicaid chief financial officer within CMS.

The Medicaid Integrity Program is in addition to the Medicaid Payment Error Rate Measurement (PERM) initiative I reported on last week.

Perspective:

Overall, the Medicaid Integrity Program holds the promise of saving taxpayer dollars. Like much of American health care, Medicaid is certainly rife with waste, fraud, and abuse. And it's reasonable for the federal government, which covers about 55% of Medicaid costs nationally, to take a more hands on role in combating Medicaid fraud and abuse. However, the MIP creates many challenges for CMS and states, with a high risk of conflict, confusion, overlapping bureaucracy, and worse. This is especially so if CMS fails to work with states as genuine partners and leverage the expertise of state staff.

Learn More:

The Kaiser Commission on Medicaid and the Uninsured recently released an excellent report on key issues raised by the Medicaid Integrity Program. This report, which will be followed by a more detailed study later this year, does a good job describing many of the challenges, conflicts, and potential unintended consequences of the MIP.

The Government Accountability Office (GAO) has long been critical of both CMS and states on issues involving Medicaid financial management. After passage of the DRA, the GAO released its ideas for how CMS should implement the Medicaid Integrity Program and make best use of staff and contractors. A June 2006 GAO report assessed CMS' ability to "identify and address emerging issues that put federal Medicaid dollars at risk."

As part of a larger, federal government-wide congressionally mandated initiative to reduce inappropriate payments, CMS has published its final rule on Medicaid / SCHIP payment error rate measurement. As expected, it represents a significant expansion of federal oversight of day-to-day state Medicaid operations and of the lives of Medicaid providers and Medicaid managed care organizations.

Medicaid Payment Error Rate Measurement:

The Medicaid Payment Error Rate Measurement (PERM) initiative is a complicated process but means that every state will undergo a detailed examination of paid claims, capitation payments, reimbursement and premium policies, coding, and more. States must turn over vast amounts of data every quarter, plus virtually everything else on rates, policies, and claims processing edits and audits.

CMS will hire a series of new contractors to examine all this, run samples, and identify errors. CMS will then set maximum acceptable error rates (based on what it or its contractors determine is an "error") and then state must take corrective action. These corrective actions could include recovering payments, changing reimbursement policies, and revising claims processing requirements.

States Targeted for Federal Review:

States will rotate, with each state going through the entire process every three years. The states selected for the first round (FY 2006) are Pennsylvania, Ohio, Illinois, Michigan, Missouri, Minnesota, Arkansas, Connecticut, New Mexico, Virginia, Wisconsin, Oklahoma, North Dakota, Wyoming, Kansas, Idaho, Delaware.

Second round states (FY 2007) are North Carolina, Georgia, California, Massachusetts, Tennessee, New Jersey, Kentucky, West Virginia, Maryland, Alabama, South Carolina, Colorado, Utah, Vermont, Nebraska, New Hampshire, Rhode Island. Third round states (FY 2008) are New York, Florida, Texas, Louisiana, Indiana, Mississippi, Iowa, Maine, Oregon, Arizona, Washington, District of Columbia, Alaska, Hawaii, Montana, South Dakota, Nevada.

Opportunities and Challenges:

If CMS manages the process well and works cooperatively with states, the PERM may help (1) save taxpayer dollars, (2) improve the operations of the less sophisticated state Medicaid programs, (3) showcase the best run Medicaid shops and best fiscal agents, (4) help CMS develop greater respect for the hard work of states, (5) identify inappropriate provider practices across state lines, (6) facilitate comparative research and analysis of Medicaid, and (6) allow CMS and states identify, build, and share best practices.

However, PERM raises many practical concerns, especially given the enormous complexity of Medicaid and wide technical and programmatic variation among state Medicaid programs. Even if a state has a low error rate, the administrative burden could be intense, with a steep learning curve for CMS and the new federal contractors and endless arguments among the parties on what is or is not a genuine error. For states with high error rates, the implications include need to update systems, modernize procedures, redirect or replace fiscal agents, change payment and claims procedures, and much more. And add to this, controversial recoveries of federal dollars from states and providers.

In the Deficit Reduction Act (DRA), Congress authorized the new $150 million Medicaid Transformation Grant Program to help states design and implement reforms to increase quality and efficiency of Medicaid. This is a unique opportunity to help states restructure and modernize Medicaid, save taxpayer dollars, and improve services. But states must act fast to take advantage.

State Medicaid agencies may submit grant proposals to CMS by September 15, 2006. For grants, CMS has a total budget of $75 million in FFY 2007 and another $75 million in FFY 2008. The amount of each grant will vary and will depend on the number of applications received. State matching funds are not required.

While states have wide discretion in proposing projects and may propose multiple projects in a single grant application, CMS is encouraging states to look at ways to improve Medicaid program operations and efficiency.

In the area of improving Medicaid program efficiency, CMS is particularly interested in grant projects to:

CMS is also interested in projects to improve the effectiveness of Medicaid. Examples include projects on:

In the arena of improved care delivery, CMS is particularly interested in grant proposals to:

This is a unique, one-time opportunity for states but, with grant applications due in six weeks, the timeline is tight. States needing help or advice in writing an application may contact me or my friends at Sellers Feinberg for assistance.

Patient-centered care - one of the new buzz phrases in health care - is all about aligning the delivery of medical care with the needs and preferences of patients. Research shows that the practices and tools of patient-centered care result in:

Unfortunately, despite overwhelming support of the medical community and patient advocates, only 22 percent of physicians practice patient-centered care.

Patient-Centered Care Defined:

Patient-centered care is one of the six essential components of high quality medical care, according to the Institute of Medicine (IOM), the respected healthcare arm of the National Academy of Sciences. The IOM defines patient-centered care as:

Health care that establishes a partnership among practitioners, patients, and their families (when appropriate) to ensure that decisions respect patients' wants, needs, and preferences and that patients have the education and support they need to make decisions and participate in their own care.

Key Components of Patent-Centered Care:

At its core, patient-centered care is all about improved patient-provider communication, where patients and providers collaborate for the benefit of the patient. Ideally, patient-centered care delivery involves an array of tools and practices, including:

To learn more, check out these resources:

The Commonwealth Fund's excellent initiatives on patient-centered care.

Report from the Economic and Social Research Institute on the key components of patient-centered care that are unique to underserved populations.

Tools from the HHS Agency for Healthcare Research and Quality (AHRQ).

Using new flexibility created by the Deficit Reduction Act (DRA), states may restructure Medicaid benefits. States may now customize Medicaid health care benefits to specific populations, model some benefit package after commercial-like health plans, and offer additional benefits as incentives to reward healthier patient behavior.

Based on the concept of benchmark benefit packages first used in the State Children's Health Insurance Program (SCHIP), the new restructuring options are expected to save $11 billion over the next ten years (about $6 billion federal savings, $5 billion state savings) and ultimately affect 1.6 million Medicaid beneficiaries.

Kentucky, West Virginia, and Idaho are the first states to use the new options. With help from leading consultants, other states are exploring ways to use DRA flexibility to reform some benefit packages and section 1115 waivers to modernize Medicaid, contain costs, and expand coverage.

Here is a quick briefing on Medicaid benchmark coverage permitted under the DRA:

1. Through the state plan amendment (SPA) process, states may provide Medicaid benefits through benchmark or benchmark equivalent packages for children and some non-disabled adults. The benchmark packages would replace existing Medicaid benefits for the targeted populations.

2. The newly designed benefit packages may include wrap-around services or additional benefits not now covered by the state's Medicaid program. Every benchmark benefit package must cover Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) services for children under 19, federally qualified health center (FQHC) services, and rural health clinic services.

3. Benchmark coverage means the same health benefit package offered by (a) the state for state employees, (b) standard Blue Cross Blue Shield Plan offered under the Federal Employee Health Benefits Plan (FEHBP), (c) the state’s largest commercial HMO, or (d) other models approved by the HHS Secretary.

4. Benchmark-equivalent coverage means a package with the same actuarial value as one of the benchmark plans. If a state uses this route, benchmark-equivalent coverage must include (a) inpatient and outpatient hospital services, (b) physician services, (c) lab and x-ray services, (d) well child care and immunizations, and (e) other preventive services designated by the Secretary. For prescription drugs, mental health services, and hearing and vision services, a benchmark-equivalent package must provide at least 75 percent of the actuarial value of coverage. States must use generally accepted actuarial principles and methodologies.

5. States may only use benchmark or benchmark-equivalent packages to beneficiary groups already covered under the state Medicaid plan. Therefore, by itself, the DRA benchmark package option cannot be used to expand health coverage to new populations.

6. In addition, many beneficiary groups are exempt from benchmark coverage, including (a) dual eligibles, (b) persons with disabilities or special health care needs, (c) beneficiaries needing long-term care services, (d) foster care children, (d) pregnant women with federally mandated coverage, and (e) individuals eligible for Medicaid via the TANF welfare reform law.

The world's leading guru of competitive strategy, Michael Porter, Ph.D., has turned his sights on explaining the fundamental cause of high costs, poor quality, consumer dissatisfaction, uneven access, and skyrocketing premiums in American health care.

In Redefining Health Care, Porter and innovation expert Elizabeth Teisberg, Ph.D. provide a thoughtful, groundbreaking framework to use competition to drive dramatic increases in quality and efficiency.

Unlike many wonks who foolishly believe that health care is not a market, Drs. Porter and Teisberg see competition " of a sort " in operation. They show us that the current competitive environment in health care is designed to "shift costs, accumulate bargaining power, and restrict services." That is, what we have now is dysfunctional, zero-sum competition serving to limit, even reduce value for patients. And they see all this taking place "...at the wrong level-among health plans, networks, and hospitals " rather than where it matters most, in the diagnosis, treatment, and prevention of specific health conditions."

Focusing on how to move American health care to positive-sum competition based on economic and clinical value for patients, Redefining Health Care provides a series of specific recommendations for the key players " including physicians, hospitals, health plans, employers, Medicare, and Medicaid.

To learn about the Massachusetts health care reform initiative, here are two podcasts on this groundbreaking new program to cover virtually all the uninsured in the Commonwealth.

For Sellers, Feinberg and Associates, the lead consultants on the Massachusetts reform project, I host a biweekly podcast on hot issues in Medicaid. These concise audio briefings help state leaders and business executives keep tabs with Medicaid on Capitol Hill and CMS.

In Part 1 of the special audio briefing on the Massachusetts health reform initiative, Marty Sellers, President and founder of Sellers Feinberg, describes the key components of the Massachusetts initiative, how it was developed, and implications for other states and the healthcare market.

In Part 2, Peggy Handrich, the former Wisconsin Medicaid director and now leader of Sellers Feinberg's strategic Medicaid consulting practice, describes the key financial and programmatic characteristics of the Massachusetts health reform.

To listen directly on your computer, click here for Part 1 and here for Part 2. The podcasts are in the popular MP3 format, so you may also right-click to save and upload them to your iPod or other MP3 player for listening on the road.

For a useful two-page fact sheet on the Massachusetts health care reform plan, click here (PDF).

To subscribe to receive the free podcasts on Medicaid, please contact Sellers Feinberg. The folks there are working with a number of other states on health reform and Medicaid restructuring initiatives.

Medical errors are rampant in American health care, particularly in physician and hospitals services. The human and economic costs are extraordinary. And because these mistakes are virtually 100 percent avoidable, so are the deaths, injuries, pain, and cost.

A diverse range of players - policy makers, thought leaders, researchers, consumer groups, purchasers, and clinicians - are working to reduce error rates and promote the use of safer systems and practices. However, reformers continue to hit the great blue wall of medical secrecy. Physicians, hospital administrators, and other health professionals are extremely reluctant to disclose or discuss a harm-causing mistake.

This is not surprising, of course. No one likes to talk about his or her mistakes, especially mistakes that result in injury or death. These conversations are awkward and painful for all concerned. What's more, disclosuring the truth can lead to lawsuits, disciplinary action, embarrassment, self-doubt, and diminished status in society and among peers. But ethically, all this is beside the point. Patients and their surviving family have a right to the unvarnished truth, something they rarely get absent costly and protracted lawsuits. And the health care system cannot fix what it cannot see.

Medical Errors and Medical Narcissism - a groundbreaking book by John Banja, PhD, assistant director of health services and clinical ethics at Emory University - examines the concept of "medical narcissism." Specifically, Dr. Banja explains why a health professional's need to preserve his or her self-esteem often robs patients and their families of the truth and perpetuates high-error medicine. He describes the "common psychological reactions of healthcare professionals to the commission of a serious harm-causing error and the variety of obstacles that can compromise ethically sound, truthful disclosure."

In Medical Errors and Medical Narcissism, Dr. Banja explains how and why talented, hard working medical professionals often fall into narcissistic traps. Living in a world of intense stress, long hours, and high, often unfair expectations, the "medical narcissist" works hard to maintain the respect of patients and colleagues. As Dr. Banja says:

When a medical error occurs, that world of competence, adequacy, and ability is turned upside-down. It is no wonder that even when such persons want to do the right thing and disclose error, they might do it clumsily and make an already bad situation worse.

This fascinating, thoughtfully researched book includes detailed recommendations, including advice on how to:

It is an immutable truth of economics. Transparency is an essential ingredient for a market to function with any semblance of efficiency or effectiveness. Lack of transparency - what economists call asynchronous information - leads to rapid inflation, gross inefficiency, gaming and abuse, ignorant consumers, poor quality, rampant error rates, and misaligned resources. In other words, you get America's $1.9 trillion health care system.

After years of behind the scenes work by top health care thought leaders, the White House and key Congressional leaders are jumping on board and calling for reforms to ensure transparency (read public reporting) of health care provider prices. While prices are only part of the information needs of patients, purchasers, and payors, nationwide transparency of medical prices is essential. Health Savings Accounts and other consumer-driven health reforms such as Medicaid Health Opportunity Accounts are largely pointless in a health care system otherwise rooted in incomplete, inaccurate, and inaccessible information.

As leaders contemplate specific measures to promote transparency of prices, they should also consider sending every Medicaid and Medicare beneficiary a quarterly report on the cost of their care. (I am not talking about Explanation of Benefits [EOB] notices. EOBs don't give a picture of their overall costs or utilization and offer no comparative, trend, or historical information.)

Using simple, colorful charts and tables and an emphasis on decision relevant information, a well-designed report would show them what care they received, what providers charged, what public programs paid, how much they paid in cost sharing, and how their medical costs compare to their peers (age group, sex, health status, and geography).

For Medicare beneficiaries, the reports could help bust a core myth of Medicare financing by showing what Medicare has paid for their care compared to what as an individual they paid in Medicare taxes and cost-sharing to date. In Medicaid, the reports would be invaluable to state efforts to move toward consumer-directed models where chronically ill or disabled patients and their families take active control of their medical lives. It would also help low-income families better understand the health care system. For dual eligibles - the 6.3 million Americans with annual health costs of a quarter trillion dollars - these personalized reports would be truly eye opening for patients and their families.

Over time, the reports could help Medicaid and Medicare beneficiaries see how their providers, health plans, and drug plans compare on measures of quality, errors, and cost effectiveness. And they could include simple health reminders.

Of course, not every benie would read the reports much less change their behavior based on the information. But the vary act of creating the reports would require Medicare and Medicaid to modernize information systems, turn transaction data into genuine decision-relevant information, and begin thinking of program beneficiaries as consumers in need of more than monstrously dull doorstops masquerading as handbooks.

Americans, including Medicaid and Medicare beneficiaries, are not stupid. But when it comes to health care costs, they are too often ignorant or oblivious. That must stop. Yes, there is a learning curve and some people prefer the bliss of ignorance to the dilemmas of judgment. Nonetheless, as consumers, as Americans, as human beings we are entitled to the information we need to make decisions. Keeping Medicare and Medicaid beneficiaries and their families in the dark is as costly as it is insulting.

Coming on the heels of Medicare Part D and the new Part B drug-pricing schema based on Average Sales Price (ASP), the new Competitive Acquisition Program (CAP) for Medicare Part B drugs and biologics represents yet another major change to the pharmaceutical supply chain. While it is too early to reliably predict the impact or even viability of CAP, it's critical for players to understand the initiative. Ultimately, CAP may have a dramatic impact on drug manufacturers, distributors, physicians, and beneficiaries.

Road to Average Sales Price (ASP):

While Medicare Part B drug coverage is complex, generally speaking Part B drug coverage is limited to physician-administered drugs and therefore primarily injectibles. Prior to the Medicare Modernization Act of 2003, Medicare reimbursed physician offices for Part B drugs based on percentages of Average Wholesale Price (AWP). Physicians would buy what they need, administer drugs to patients as necessary, charge beneficiaries for their deductible and 20% Part B co-payment, and bill Medicare for the drug and the office visit.

This approach was widely criticized by MedPAC, GAO, and the OIG as well as outside experts. Under the AWP-based system, Medicare drug payments were far higher than other payors. It also meant higher patient co-payments. However, in fairness to physicians, in many ways the higher drug reimbursement helped make up for Medicare's below-market office visit rates.

Under MMA, Congress changed that way Medicare reimburses physicians for drugs and biologics covered under Medicare Part B. Since January 2005, Medicare reimburses physicians using a new formula based on Average Sales Price (ASP). For most Part B drugs, physician offices are now paid 106% of ASP.

In brief, ASP is what a pharma or biotechnology company makes on a given product, net of rebates and other price concessions. The Centers for Medicare and Medicaid Services (CMS) calculates ASP using net sales data provided by drug makers. Medicare adds 6% to help cover physicians' costs of buying, storing, and billing. The new ASP-based payment system results in substantial savings to Medicare but of course also lower revenues for physicians.

Basics of the Competitive Acquisition Program (CAP):

Starting in July 2006, physicians will have an alternative to buying and billing for Part B drugs and ASP-based payment. The upcoming Competitive Acquisition Program (CAP) will give physicians the option of obtaining most Part B drugs needed by Medicare patients from vendors selected by CMS. Medicare physicians may elect to participate in CAP on an annual basis.

The CMS-approved vendors, selected through competitive bidding, will negotiate with manufacturers, buy and distribute supplies to physicians, bill beneficiaries for any applicable deductible and coinsurance, and bill Medicare's designated national carrier for drug costs. The carrier will pay the CAP vendor after verifying that the physician administered the drug. To do this, the carrier will match the CAP vendor's claim for the drug with the corresponding physician claim for drug administration. Following this verification, the CAP vendor will bill the beneficiary (or the beneficiary's Medigap policy or other third party insurance) for applicable cost sharing.

For the Part B drug categories they have selected, physicians opting for CAP will receive all of those drugs (used for Medicare patients) from the approved CAP vendor. Physician offices participating in CAP will continue to bill Medicare as usual for the drug administration fee and other office fees.

Under certain conditions, a participating CAP physician may provide a drug to a Medicare beneficiary from his or her own stock and obtain the replacement drug from the CAP vendor. There is also an exception for "furnish as written" situations when the physician specifies that a certain brand of a drug is medically necessary and that drug is not available from the CAP vendor. In those cases, the participating CAP physician may buy the drug, administer it to the beneficiary, and bill Medicare using the ASP system.

CAP Bidding and Contracting:

Every three years, CMS will solicit bids from qualifying vendors - primarily major distributors and specialty pharmacy shops. MMA gives CMS the authority to select drugs or categories of drugs that will be included in the program. Drugs may be excluded from the CAP if competition will not result in significant savings compared to the ASP system or when necessary to avoid disruption in access to a drug.

In April, CMS is expected to announce the CAP vendors for the program's July 1, 2006 start.

Market Implications of CAP:

In an upcoming story, I will comment on the implications of CAP for drug manufacturers, drug distributors, and physicians.

Since Medicaid is administered by the states, traditionally virtually all Medicaid anti-fraud efforts were managed by state Medicaid agencies, with civil enforcement and payment recoveries by the Medicaid agency and criminal prosecutions by the state attorney general and the AG's Medicaid fraud control unit (MFCU). States vary widely in their approaches, the relative sophistication of tools used, and staff resources dedicated. For example, Northern and Western states tend to focus on provider fraud and Southern states tend to focus more on beneficiary fraud.

The recently enacted Deficit Reduction Act of 2005 (DRA) significantly expands the federal government's role in combating Medicaid fraud and abuse. The new provisions have far-reaching implications for states, providers, and health plans as well as for the federal-state relationship. If managed well and in close coordination with the states, it could save taxpayers billions of dollars. If not, it could easily result in chaos and confusion for Medicaid providers and health plans and a time sink for state Medicaid agencies.

It also creates (1) significant new business opportunities for anti-fraud contractors and systems vendors, (2) new financial incentives for states to beef up their own systems and staff, and (3) new opportunities for whistleblowers and for qui tam suits.

The DRA creates a federal Medicaid Integrity Program, including new contractors, additional federal staff, and financial incentives for states to increase their own efforts at fraud detection and payment recovery. Congress is giving the Centers for Medicare & Medicaid Services (CMS) an additional 100 staff plus $50-$75 million a year for outside contractors. If a state enacts its own false claims act, it will be able to retain a larger share of any payment recoveries. (Only 15 states and DC now have some form of state false claims act.) The effect is that compliant states could increase their savings from anti-fraud efforts by as much as 20 percent.

The new law also requires organizations with more than $5 million in annual Medicaid payments to regularly train employees on Medicaid fraud laws and reporting. Across the country, this will apply to thousands of hospitals, nursing homes, home care providers, Medicaid managed care organizations, and counties, as well as many chain pharmacies, clinics, other providers, and the Medicaid fiscal agents like EDS and ACS.

For outpatient prescription drugs, Medicare has two distinct programs with a maze of complex policies. Physicians, Medicare patients, retail pharmacies, Medicare drug plans, Medicare Advantage health plans, nursing homes, and long-term care pharmacies are all struggling with how to navigate Medicare drug coverage under Part B and Part D. To help you, here's an overview:

Basics of Medicare Part B Drug Coverage:

Drug coverage applies under Part B under this basic situations:

1. Drugs billed by physicians and provided incident to physician service for that patient (e.g., chemotherapy drugs).

2. Drugs billed by pharmacy suppliers and administered through durable medical equipment (DME) benefit (e.g., respiratory drugs given via nebulizer).

3. Some drugs billed by pharmacy suppliers and self-administered by the patient (e.g., immunosuppressive drugs, some oral anti-cancer drugs).

4. Separately billable drugs provided in hospital outpatient departments. Increasingly, Medicare is bundling drug costs within outpatient hospital payment rates.

5. Separately billable End Stage Renal Disease (ESRD) drugs (e.g., erythropoietin). Increasingly, Medicare is bundling ESRD drug costs within ESRD facility payment rates.

Medicare Part B Drug Coverage in Physician Offices:

For Medicare Part B drug coverage in a physician's office, here are the basics:

1. Must be furnished "incident to" a physician service. Normally, this means the drug is physician prescribed and dispensed or physician prescribed and administered during a patient office visit.

2. As a result, Medicare Part B drug coverage is usually limited to drugs or biologicals administered by injection or infusion.

3. If the injection is generally self-administered it is not covered under Part B (e.g., Imitrex). That is, in most cases Part B coverage of a specific drug stops if more than half of Medicare beneficiaries on the drug self-administer it.

4. Medicare uses mix of local and national coverage decisions. Therefore, in absence of a national coverage decision by CMS, local coverage decisions are made my individual Medicare contractors (Part B claims processors, commonly called "carriers"). Therefore, regional differences can and do occur. That is, a specific drug could be covered in one state and not another.

Formulary Basics in Medicare Part D Drug Benefit:

1. While Medicare drug plan formularies are subject to CMS review during the annual bidding process, the Medicare Modernization Act (MMA) gives Medicare prescription drug plans (PDPs and MA-PDs) wide latitude.

2. There is no national drug formulary or mandated formulary. Most Medicare drug plans use commercial-like drug formularies.

3. Regarding therapeutic classes or categories used to structure a formulary, Medicare drug plans may use USP model guidelines or use their own structure. The USP model is not a formulary and not mandated.

4. Medicare drug plans must use P&T committees for formulary decisions.

5. For most drug classes, PDPs and MA-PDs must cover at least two drugs. CMS reviews each formulary to make sure Part D plans are not cherry picking or otherwise discriminating against certain kinds of patients.

6. Plans must cover "all or substantially all" of the drugs in six classes: Antidepressant, Antipsychotic, Anticonvulsant, Anticancer, Immunosuppressant, and HIV / AIDS.

7. Step therapy, prior authorization and cost tiers are allowed. Many Medicare drug plans are using four tiers in their benefit designs.

Coverage of Non-Formulary Drugs Under Medicare Part D:

1. The Medicare Modernization Act (MMA) requires Medicare drugs plans to ultimately cover any drug (not otherwise excluded under Part D) if "medically necessary" and "medically accepted", regardless of formularies.

2. Drug plans are not required to list off-label on formularies, but physicians may still prescribe off-label drugs for medically accepted indications. Physicians must justify off-label use and the indication must be listed one of four compendiums accepted by CMS (e.g., DRUGDEX, USP).

3. To justify off-label coverage for a medically necessary, medically accepted drug, the physician must determine that all drugs on plan's formulary for the treatment of the same condition (a) would not be as effective and/or (b) have adverse effects for patient. The same applies to justify an exception from a higher tier co-payment.

4. A multi-step appeal process is available to beneficiary to seek coverage of a non-formulary drug or an exception from a tier. Steps include drug plan review, independent review, administrative law judge, HHS department appeals board, and the federal courts. The exceptions and appeals process may be initiated by the beneficiary, their physician, or another person designated by the patient.

Prescription Drugs Excluded from Medicare Part D:

1. The following kinds of drugs are not covered under Part D:

- Weight-related, fertility, cosmetic, symptomatic relief cough or colds, vitamins (except prenatal), barbiturates, and benzodiazepines.

- Over-the-counter (OTC) drugs, unless through a CMS-approved step therapy program and then only if free using the drug plan's non-benefit dollars. Few Medicare plans are covering OTCs this year.

- Drugs covered by Medicare Part A or Part B for that individual in that instance.

2. For dual eligibles, Medicaid may cover drugs not covered by Part D. State Medicaid programs must cover if drug is covered for non-dual Medicaid population (e.g., OTCs). This means dual eligibles will obtain drugs through multiple programs.

Naturally, this is a high-level overview and is neither comprehensive or an official statement of federal policy. For more details, click here to read CMS' draft guidance explaining differences between Part B and Part D drug coverage. There are many nuances, twists and turns. So please be careful and closely monitor guidance from CMS and OIG.

While the feds work to fix a series of technical problems plaguing the new Medicare Part D drug benefit, governors are stepping in to help ensure dual eligibles and other vulnerable beneficiaries have access to prescription drugs. As a result, states are incurring millions of dollars of costs. They shouldn't have to - by federal law, drug coverage for these patients is now the sole responsibility of CMS and the prescription drug plans. However, governors of both parties are doing the right and necessary thing. Of course, Congress should be the one doing this. But Congress is too distracted to act quickly and the Bush Administration has been adamant in opposing changes to Part D until well after implementation.

The crisis creates a great opportunity for the pharmaceutical industry to step in and help make Part D work. As I've pointed out before, drug makers have a lot riding on the success of Part D. No, it's not that they will make more money. In fact, it's more likely that most brand manufacturers will see lower margins under Medicare. It's because failure of Part D - whether real or imagined - will undoubtedly lead to more government regulation of the industry and a new push for price controls. And the much-maligned industry needs all the good will it can get.

Pharma manufacturers should act immediately to offer to make states whole for the cost of temporary drug coverage for dual eligibles. Specifically, drug makers should work with the National Governors Association (NGA), National Association of State Medicaid Directors (NASMD), and the HHS Office of the Inspector General (HHS) to create a private trust fund that reimburses states for all of their costs associated will filling the gaps while CMS and the drug plans get things fixed. The trust fund can be set up through a non-profit and be totally neutral as to the drug products being reimbursed. The point is to step in, help make it work, create good will, and avoid further pain and frustration.

After an avalanche of federal money the past ten years, the National Institutes of Health (NIH) is under pressure to show results. This is no small feat given the enormous scientific challenges of cancer, heart disease, HIV, and other killers and disablers. And even though NIH's budget more than doubled in recent years, less than five percent of government health spending goes to research into causes, treatments, and cures.

In areas where NIH and the private research community is successful, we face another challenge - getting the results or evidence into practice. According to the Institute of Medicine, it takes an average of 17 years before a proven best practice is in wide spread use for the benefit of patients. In other words, patient care in 2005 is more often based on the best science as of 1988.

Our nation's investment in health services research - which covers how to get evidence to practice and improve access, quality, and cost effectiveness of our $1.8 trillion health system - is worse. It hovers around one percent of what we spend on NIH. Medicare and Medicaid waste more in a single day than what we spend in a year on trying to improve program performance for patients and taxpayers.

As the NIH works to demonstrate results for the taxpayers, we all need to recognize the symbiotic relationship between (a) basic and clinical research that creates new evidence and (b) health services research that shows us how to bring the evidence to the physician and patient. Right now our research system is like a auto manufacturer who spends all its money on engineering and testing new vehicles and virtually nothing on design, quality control, financing, cost management, distribution, training, sales, or marketing.

Of course, the researchers must deliver. To do this, NIH and ARHQ in particular should support more actionable research. To be actionable, research must be:

1. Timely: Better to have a good answer today than a perfect answer in a few years. All too often we allow analysis to be the enemy of action.

2. Decision Relevant: Enough of preaching to the choir and hunting for tenure. Researchers must connect with real-world decision makers and answer their questions. Other than the Nobel Prize, virtually all other forms of recognition for research have little or nothing to do with work that is actionable.

3. Translated: It's all about reaching decision makers and unfortunately most researchers are horrible communicators. What do you think, what do you know, what can you prove, what do you suspect? Say it in the context of decision makers and their challenges.

4. Disseminated: Peer reviewed journals are great. I enjoy reading many of them. But most decision makers do not. You're lucky if they read the abstract. Disseminate findings in new ways to reach decision makers. Multiple mediums must be used and, if necessary, created.

NIH's new Institutional Clinical and Translational Science Awards program is a great start in the right direction.

Sophisticated health care purchasers and health plans know the value of prescription drug data. When analyzed with paid claims data from physicians and hospitals, data from pharmacy claims can be used to identify, understand, and track a wide range of issues.

Starting January 2006, when the 6.5 million dual eligibles move from Medicaid to Medicare for their prescription drug benefits, state Medicaid agencies will no longer have access to data on drug use by these extremely expensive, at-risk beneficiaries - patients who drive over 40 percent of Medicaid costs. As a result, Medicaid managers will lose an invaluable source of information, severely handicapping the ability of states to monitor quality, access, and costs and catch waste, fraud, and abuse.

The Centers for Medicare and Medicaid Services (CMS) lacks the legal authority to require Medicare prescription drug plans (PDPs and MA-PDs) share data with Medicaid. However, nothing precludes voluntary Rx data sharing between Medicare drug plans and states.

Voluntary data sharing would be an easy, inexpensive way for Medicare drug plans to gain goodwill among states and advocates, generate positive publicity, and differentiate themselves from the mass of competitor plans. In addition, because dual eligibles may switch plans any time and multiple times each year, two-way data exchanges with states would aide drug therapy transitions, utilization review, and medication therapy management. Stand-alone PDPs, which are at risk only for drug costs and therefore will not have access to any non-drug data, could greatly benefit from data from state Medicaid programs (e.g., diagnoses, prescription history, providers seen)

To help make this happen:

- A major pharmaceutical manufacturer should offer to fund a national initiative to show the business and clinical case for information exchange, develop data sharing agreements, iron out any technical obstacles (e.g., data safeguards), and cover the modest start-up costs (e.g., systems changes). In addition to generating goodwill, this would help minimize disruption in drug therapy, quality problems, and errors - and reduce lost revenue and bad publicity that will inevitably result if duals have problems accessing vital medications.

- In their standards for a Medicare drug plan to be designated as a preferred plan for low-income beneficiaries, State Pharmaceutical Assistance Programs (SPAPs) should require that preferred drug plans to exchange duals' Rx data with states.

Once the Food and Drug Administration (FDA) approves a new prescription drug for one medical indication, physicians are free to prescribe it for virtually any condition. While there are downsides of prescribing drugs "off-label," it allows patients and payors to benefit as physicians test drugs under real-world conditions and identify new applications.

Because formal clinical trials and the FDA review process can take years, valuable new uses of a drug may be validated by studies in peer-reviewed medical journals years before the new indication becomes officially approved. And because of research and regulatory costs, drug makers cannot justify pursuing FDA approval for new indications, even when a new indication is highly cost-effective for purchasers, plans, and patients. Indeed, some diagnoses have no "on-label" drugs and are treated entirely on an off-label basis.

With the new Medicare drug benefit (Medicare Part D), the federal government will become the world's largest buyer of prescription drugs. In Part D, a prescription drug is coverable by a Medicare drug plan (PDP or MA-PD) only if it is prescribed for a medically accepted indication as defined under federal Medicaid law. This includes uses that are approved by the FDA or supported by a citation in one of four drug compendia:

· American Medical Association Drug Evaluations
· American Hospital Formulary Service Drug Information
· DRUGDEX Information System
· United States Pharmacopeia Drug Information

Because of this restriction in the Medicare Modernization Act, indications that are supported in peer-reviewed medical literature but not yet approved by the FDA or accepted in one of the compendia are not "medically accepted" by Medicare. In such cases, the Medicare drug plans may not pay for the drug.

While this helps Medicare drug plans manage their financial exposure and allows them to crack down on inappropriate drug therapy, it also means that it'll be harder for physicians to identify valuable new uses of medications. As we loose this critically important path to expanding our evidence base, patients and the economy will suffer.

This is yet another reason why we need a comprehensive approach to post-market surveillance and assessment of prescription drugs, continuous improvement of the evidence base of what works, and more effective ways to bring that evidence to day-to-day clinical practice.

Regardless where you come down on the issue of contraception and availability of the new Plan B "morning after" pill, the Food and Drug Administration's handing of Plan B provides ample evidence against expanded regulation of the pharmaceutical industry.

Plan B, an emergency contraction drug, was approved for sale by prescription in 1999 "indicated to prevent pregnancy following unprotected intercourse, a known or suspected contraceptive failure, or in cases of sexual assault." When taken within 72 hours of unprotected intercourse, it reduces the chance of pregnancy by 84 percent. Plan B is not RU-486, the so-called abortion pill. It doesn't not work if the woman is already pregnant, although reportedly it sometimes prevents a fertilized egg from implanting in the uterus.

Because Plan B is more effective the sooner it is taken, an FDA advisory panel voted overwhelmingly to recommend the drug for sale over the counter (OTC). Concerned that women under 16 may not understand the label instructions, the FDA rejected the committee's recommendation.

To accommodate the FDA's concerns, the drug's maker, Barr Pharmaceuticals (NYSE: BRL), asked the FDA to allow OTC access to Plan B for women age 16 and older. A prescription would still be required for those 15 and younger. For many, that seemed like a reasonable approach, although of course it wouldn't satisfy radicals on the Left or the Right. Now, contrary to the statutes governing the FDA and the FDA's own rules, the matter is again on hold.

Plan B is a political football to be sure and the FDA Commissioner, Lester M. Crawford, is in a tough spot. Any discussion of contraception " particularly an entirely new method designed to help reduce the chance of a pregnancy after intercourse " brings out both sides, particularly the Far Left and the Far Right.

However, the FDA's job is not to make the nation's social policy or, for that matter, the nation's health policy. Its sole job " and therefore sole authority " is to determine whether Plan B is safe and effective. It already made that decision in the affirmative. Federal law " and the FDA commissioner's promises to Congress " dictates that Barr's request for OTC status be approved. If elected lawmakers are concerned about women's or girls' access to contraceptives (either because they see it as too restrictive or too loose), then they are free to debate it to their heart's content and the rest of us can watch them on C-SPAN. However, the FDA is an administrative agency charged with a specific scientific mission.

The FDA's mishandling of Plan B does have a positive aspect. It provides an excellent case study in why we must guard against over regulation of health care, whether of pharmaceuticals or medical services. Just as it's important to make sure our courts not legislate, it's also important that executive branch agencies stick to their knitting.

With the new Medicare drug benefit, the federal government will soon become the world's largest buyer of prescription drugs. Taxpayer-funded programs " notably Medicaid and Medicare " already account for just under half of the nation's health spending. With more and more medical dollars in the hands of the government (gulp), lawmakers will be overcome with an urge to legislate and regulate. We must guard against this terribly perverse, inherently counterproductive instinct.

With so much public money in the mix, it is not realistic to assume a complete separation of science and politics. But that's why we have a system of laws, due process, transparent decision-making, and limited, precise delegation of authority. The situation of Plan B and the FDA shows how this can quickly brake down if we are not watching.

In response to criticism from major drug distributors and lackluster response to a request for bids, the Centers for Medicare and Medicaid Services (CMS) is delaying implementation of the Competitive Acquisition Program (CAP) for physician-administered drugs paid under Medicare Part B. Originally scheduled to launch January 2006, CAP will now start July 2006 " provided CMS modifies the proposed requirements to make the program workable and sufficiently profitable for distributors.

Part of the series of reforms enacted by Congress in the Medicare Modernization Act (MMA) of 2003, the Competitive Acquisition Program is designed to help Medicare leverage its market share to reduce prices for injectable drugs and save money for taxpayers and beneficiaries. However, both CMS and the major drug distributors face huge, albeit different learning curves.

The feds are learning the complex, less than transparent ways and means of the pharmaceutical supply chain ' all while also trying to implement the massive new Medicare Part D outpatient drug benefit. Moreover, given the politics of Medicare, historically it has been tough for CMS to introduce competition to the program.

Meanwhile, the prospective players in CAP ' likely including the four big drug distributors ' are learning about their own complex new world ' the often-inscrutable, always Byzantine domain of Medicare, CMS, federal rulemaking, and government procurements.

And physicians ' who will need to decide whether to participate in CAP and select among wholesalers under contract with CMS ' are none too happy these days. Earlier, MMA reduced what Medicare reimburses docs for Part B drugs. While the new pricing is defensible and more in line with the market, it reduced physician office revenues, particularly for oncologists. In addition, unless Congress acts this fall, physicians face unsupportable fee cuts of 5 percent a year for several years.

The Part B Competitive Acquisition Program is a major change to Medicare and the multi-billion dollar market for physician-administered, injectable drugs. It'll be interesting to watch if Medicare can make it work.

By Michael H. Bailit, MBA
President of Bailit Health Purchasing, LLC

Introduction

The serious problems in our health care system have been more than adequately documented in this journal and many others over the two past decades. Rates of uninsurance rise with a steadiness fueled by costs that seemingly know no bound. Quality varies with little or any relationship to cost, and ill-informed consumers cannot be confident that they are receiving the care that they need.

It initially appears astounding that that these problems are not getting resolved despite the well-intended efforts of many, many people. In fact with respect to cost growth and insurance coverage, the problems with our health care system are getting worse. Much worse. We who work in the field of health policy have failed.

Yet, the reasons for this failure are not difficult to understand. The health care industry represents a whopping 14.9% of the GDP (Levit, Smith, Cowan, Sensenig, and Catlin, 2004). It is an economic monolith, that becomes larger and, hence, more difficult to change every day. There are two sectors which foot the growing health care bill, neither of which is up to the challenge of curbing the expansion: government and employers.

Government

"One person's waste is another person's income.' (Wasson, 2004)

Federal and state government pay the largest share of the health care bill. They fight valiantly to control health expenditure growth, but rarely, if ever, by addressing the problem. Instead government purchasers often end up shifting costs to private payers. States and the federal government also reduce covered health care services in times of profound economic hardship. Finally, state and federal government assume loans (especially the federal government) and cut other service expenditures to meet the growing demand for health care dollars.

Ultimately, however, government fails to manage the growth of health care costs for two primary reasons. First, constituting a large economic sector, health care employs many Americans, thus creating a mission conflict for those elected and appointed to serve us. Reductions in healthcare expenditures result in lower income and potentially reduced employment for many Americans, including some who are politically influential. Second, most Americans don't want health cost growth restricted since the impact of costs is not directly visible to most Americans. That is, American taxpayers don't appear to appreciate how growing health care costs reduce available funds for other government programs and contribute to government debt.

To continue reading, click here.

The Medicare prescription drug benefit (aka, Medicare Part D) is biggest thing to hit American health care in decades. The massive, costly, and extraordinarily complex new program will likely realign the entire pharmaceutical supply chain and create a raft of new winners and losers in the marketplace. Looking into my crystal ball, here are some likely winners:

● Low-Income Medicare Beneficiaries Without Prescription Drug Coverage: Over two-thirds of the 41 million Medicare beneficiaries already have prescription drug coverage and many of those without drug coverage are wealthy or healthy enough to not worry. However, several million beneficiaries will benefit from the heavy subsidies offered for low-income, low-asset enrollees in Part D. Countless thousands will live longer, healthy, happier lives as a result. In addition, the process of enrolling in the Part D low-income sudsidy will likely increase the number of beneficiaries taking advantage of the Medicare savings programs. This is where state Medicaid programs pick up some or all of Medicare cost sharing.

● Employers Offering Retiree Drug Coverage: With nearly $100 billion in new taxpayer subsidies and a range of new options to cost shift retiree drug coverage to taxpayers, public and private employers are big winners over the long run.

● Generic Drug Manufacturers: Under Medicare Part D, drug benefits will be delivered by private drug plans at risk for drug spending. Most Part D enrollees will be served by a totally new creature in the marketplace - stand-alone prescription drug plans (PDPs) at risk only for unit cost and utilization. Using their relatively wide discretion in setting formularies and benefit designs, drug plans will work hard to drive patients to low-cost generic versions of medications.

● Beneficiaries in Medicare Advantage Health Plans: The new Medicare Advantage health plans are a boon to beneficiaries. Compared to the often dysfunctional and perpetually outdated Medicare fee-for-service system, Medicare Advantage (aka, Medicare Part C) offers seniors a range of voluntary HMO and PPO plans, lower cost sharing, higher quality, less paperwork, and often more benefits.

● Large, National Insurers: To successfully compete as a Medicare drug plan and establish a strong beachhead, players need deep pockets to manage risk, a sophisticated and scalable infrastructure, Medicare-savvy marketing, a stomach for the government contracting, and a recognized, positive brand. While many players are seriously overconfident and dangerously naive about the Part D business (sorry, guys), large national players have a shot at winning early on. If they play it smart, the large insurers can leverage the new market opportunities of both Medicare Part D and Medicare Part C. Of course, the federal government is not the most reliable purchaser and Congressional action can change winners to losers darn quick.

● Administrative Services Contractors: To survive and ultimately succeed in the Medicare drug benefit business, players will need a range of new or expanded capacities, including call centers, claims processing, drug utilization review systems, decision support tools, and medication therapy management (MTM) programs.

● Consultants, Actuaries, and Lobbyists: Last but not least, demand for consultants and actuaries is already through the roof. Right now, the biggest demand is for specialists who help drug plans prepare bids to Medicare. Later this fall, demand will grow for experts in marketing to and managing the complex Medicare population, including dual eligibles - who will ultimately make or break many drug plans in 2006 and 2007. Moreover, the business of pharma industry consultants, Medicare/Medicaid gurus, and public affairs specialists will undoubtedly rise dramatically as drug manufacturers begin to realize that strategically and tactically Part D is a whole new ballgame.

What about the losers, you ask? There are plenty. Stay tuned for my list of the likely losers under the brave new world of Medicare Part D.

Quality of care in the federal Medicare program remains poor. New evidence shows a wide range of serious, often worsening problems in the physician and hospital care received by America’s 41 million Medicare beneficiaries.

The bad news includes (1) increases in preventable medical mistakes; (2) inadequate screening and treatment of colorectal cancer, hypertension, depression, high cholesterol, and urinary incontinence; and (3) wide, unjustified geographic and racial disparities in quality of care received.

There is some good news, including more preventive services and modest improvements in inpatient care of heart attacks and outpatient care of diabetes.

Medicare, of course, does not operate in a vacuum. Medicare beneficiaries suffer from the consequences of poor quality, inefficiency, and outdated systems just like the rest of us. The costs – in lost lives, suffering, and wasted dollars – are staggering. And while progress is slow, Medicare has begin several initiatives to improve care.

New evidence on the high incidence of preventable, often deadly drug errors in nursing homes raises serious implications for the new Medicare prescription drug benefit.

Each month, one in ten nursing home residents suffer a medication-related injury, according to a new study in the American Journal of Medicine. The lead author, Jerry H. Gurwitz, MD from the University of Massachusetts Medical School, is a top expert on the safe use of drugs by seniors.

Extrapolating to the 1.6 million nursing home residents, the study suggests a staggering 1.9 million medication errors each year - including over 86,000 fatal or life-threatening mistakes. These scary new figures, still considered conservative, indicate the problem is five times worse than previously believed. To read the study, click here (PDF).

Under the new Medicare prescription drug benefit, most nursing home residents face dramatic changes to their drug benefits starting January 1, 2006. While some aspects of the Medicare drug benefit may ultimately help improve care, the highly complex Medicare program will likely exacerbate the problem of medication errors.

Some key factors to consider:

1. More restrictive formularies: The drug formularies offered by the Medicare drug plans will be far more restrictive than state Medicaid formularies. For many nursing home residents, this will mean changes to drug therapy regimens.

2. More complex drug management: It's unlikely that all of a facility's residents will be enrolled in the same drug plan. Therefore, nursing homes face the challenge of navigating multiple formularies and benefit procedures. In addition, the Medicare drug plans will likely force significant changes to nursing home?s long-established relationships with the specialty pharmacies that know and serve this market.

3. Misaligned financial incentives: Most Medicare beneficiaries in nursing homes will be enrolled in brand-new kind of creature, i.e., stand-alone drug plans that are at financial risk only for the drugs. This is in sharp contrast to health plans (HMOs, PPOs) which are at risk for all care and therefore have a built-in incentive to maintain a safe, therapeutically sound drug benefit to guard against hospitalizations and other more costly events. Because of the serious misalignment of incentives and the potential for cost-shifting and other gaming, no employer or Medicaid program would ever consider a similar at-risk carve out of drug benefits.

A new breed of physician is coming to a hospital near you: the hospitalist. And they hold tremendous promise for improving quality and lowering costs.

Hospitalists, who specialize in caring for hospitalized patients, are specially trained to effectively diagnose and treat high-acuity patients. Assuming primary responsibility for managing medical and surgical patients, hospitalists also help determine admissions from emergency departments and keep the patient's office-based docs in the loop.

While traditional office-based physicians visit hospitalized patients before or after office hours, hospitalists are onsite and immediately accessible to patients and their families. A fulltime hospitalist can care for ten times the number of inpatients than an office-based physician.

Supported by an array of new information management technologies, evidenced-driven protocols, and a team-based approach to care, the hospitalist model dramatically improves clinical decision-making. When done right, this translates to fewer medical errors, better patient outcomes, and lower costs from shorter stays and fewer re-admissions.

The hospitalist model is gaining attention among cost and quality conscious employers, health plans, and hospitals. Hospital services represent some 40 percent of health spending and physician decisions direct more than 80 percent of hospital services.

An excellent new study by the Center for Studying Health System Change says "Mounting financial pressures, increasing problems with patient flow in hospitals, a growing focus on patient safety, and rising malpractice costs..." are increasing use of the hospitalist model.

The number of hospitals increased from a few hundred in the mid-1990s to more than 8,000 in 2003, according to the Society for Hospital Medicine, the professional society of hospitalists.

Adjusted for cost-of-living differences, rural physicians have 13 percent more purchasing power than urban physicians. And while there are fewer physicians per capita in rural areas, the overall urban-rural disparity is likely due to an over supply of physicians (particularly specialists) in urban areas.

So says a new study by the Center for Studying Health System Change, a respected nonpartisan policy research shop funded primarily by The Robert Wood Johnson Foundation. Their findings dispel the widely held myth that low pay is an obstacle to recruiting docs to serve rural areas. The authors acknowledge that this higher purchasing power may be "needed to compensate physicians for other disadvantages of rural practice, including less control over work hours, professional isolation and a lack of amenities associated with urban areas."

Some implications to consider:

● Future Medicare and Medicaid rate increases for rural docs should target those specific areas with inadequate patient access.

● Policy makers should invest in innovative ways to reduce the professional isolation and inflexibility of rural medical practice.

To read the full report, click here (PDF).

The pay-for-performance (P4P) movement continues to grow:

1. The Medicare Payment Assessment Commission (MedPAC) is calling on Congress to incorporate quality incentives in Medicare payments to hospitals, physicians, and home health agencies. In 2003, MedPAC released similar P4P recommendations for Medicare managed care plans and dialysis facilities. MedPAC says the Centers for Medicare & Medicaid Services (CMS) should earmark between 1% and 2% of Medicare payments to pay bonuses to providers that meet specific quality measures. The quality incentives would into account the severity of patients' illnesses.

2. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) released principles for constructing pay-for-performance programs to align provider reimbursement with quality of care.

3. The American Medical Association released a new report to get physicians ready for pay-for-performance. The report says pay-for-performance is a "tsunami building offshore in a sea of stakeholder unrest, threatening those who are not prepared."

Under the new Medicare prescription drug benefit, drug plans will have a fair amount of discretion in setting formularies. The idea is to encourage competition among drug plans and offer Medicare beneficiaries choice. The Centers for Medicare & Medicaid Services (CMS) will review the benefit designs of drug plan bidders to ensure the beneficiaries have appropriate access to needed drugs.

CMS has released draft guidelines for reviewing prescription drug plan formularies. CMS' strategy for drug benefit review is designed to promote "appropriate operation of beneficiary protections and formulary oversight that includes access to all Part D covered drugs, while providing flexibility in plan design as expected under the Medicare Modernization Act (MMA)." Public comments are due by Thursday, December 30, 2004.

CMS also released a helpful fact sheet that summarizes the formulary review process.

In an excellent new piece for HealthLeaders, E. Preston Gee asks an fascinating question with wide ranging implications for health care: "What if the mass merchandising giants like Wal-Mart or Target got into the healthcare delivery business in a big way?"

Highly efficient, consumer friendly, and tech-savvy companies like Wal-Mart and Target stand in sharp contrast to health care delivery. Many health strategists, including myself, have noodled on what it would take for hospitals and clinics to adopt consumer-focused, competitor-savvy practices of high performing industries like these "big box" retailers.

As Mr. Gee notes, the big retailers may never enter health care but that is beside the point. Health care providers must adapt to the new market realities. Employers and other demand-side players expect an end to the inefficiency, poor quality, and high error rates that plague much of health care delivery. After providing thoughtful advice on how they can adapt, Mr. Gee calls on health care executives to "lead their organizations into and through this new era of heightened expectations and emerging market-driven dynamics."

Preston Gee has written widely on market-driven, consumer-oriented strategies in health care. His latest book is Service Line Success: Eight Essential Rules. It shows how provider execs can apply the principles of service line management to meet tough market challenges. Service line / product line management is proven and often profitable in other sectors but rare in health care.

There is ample evidence America has a serious problem with poor quality health care and high rates of preventable medical mistakes.

Thankfully, there is no shortage of caring professionals motivated to improve care and the problems are solvable. As with any effort to improve performance, measurement is the first step to improving care and reducing medical mistakes. As I often remind clients and colleagues: you can't fix what you can't see.

However, measuring hospital and physician quality is complex. And too often efforts to measure quality get bogged down - perfect becomes the enemy of good and analysis becomes the enemy of action.

Quality Health Care: A Guide to Developing and Using Indicators serves as an excellent, up-to-date guide on how to design and implement an effective quality measurement program, particularly in hospitals. While paying close attention to the importance of clinically sound measurement, this guide focuses on providing practical and actionable advice. Specifically, the book provides:

1. Helpful overview on quality measurement, the increasing demands of consumers and purchasers for public disclosure of provider quality, and the information consumers find most valuable in their decision making.

2. Practical advice on how to select quality indicators, collect and organize data, and create a dashboard to monitor progress.

3. Technical guidance on how to analyze data effectively, including how and when to accept limitations and variations.

4. Cases studies on how to use quality measurement to improve both clinical and operational performance.

The author, Robert Lloyd, PhD, is executive director of performance improvement at the Institute for Healthcare Improvement and a highly regarded expert in quality measurement.

Escape Fire is collection of compelling speeches by one of America's leading crusaders for health care quality and patient safety - Don Berwick, MD, founder and president of the Boston-based Institute for Healthcare Improvement.

Each year, IHI hosts the National Forum on Quality Improvement in Health Care. The influential annual event draws 4,000 health care leaders from around the world in person and 6,000 via satellite.

In many ways, Dr. Berwick's keynote lectures set the tone for quality improvement efforts across the US. With an effective blend of common sense, real-life stories, persuasive metaphors, and out-of-the-box thinking, Dr. Berwick's presentations make for fascinating reading for anyone interested in improving America's $1.7 trillion health care system.

For example, in his 1999 keynote, Dr. Berwick recounts the 1949 Montana wildfire that killed thirteen young men and applies lessons learned from the catastrophe to today's health care system.

In the typical hospital, nurses spend only about 30 percent of their time on patient care. The remaining 70 percent of their long days are spent largely on paperwork. This lopsided situation is seen as a major cause of poor quality, patient dissatisfaction, nurse turnover, and operating inefficiency.

Thanks to the ideas of the Institute for Healthcare Improvement and funding from The Robert Wood Johnson Foundation, a dozen of the nation's most innovative hospitals are studying ways for nurses to spend the bulk of their time taking care of patients.

Transforming Care at the Bedside, a two-year pilot program, is designed to improve the patient-caregiver relationship. The effort will look at practical ways to reduce paperwork, improve teamwork among nurses and physicians, reduce medication errors, increase the quality of bedside care, and increase job satisfaction and retention.

Health insurers, whether commercial health plans or public programs like Medicaid and Medicare, only wish to pay for care that is necessary. Every day they make decisions on what is and is not "medically necessary."

Gov. Phil Bredesen has proposed a new definition of medical necessity for TennCare, Tennessee's long-troubled Medicaid program. To be covered by TennCare, a health care service must be (1) required to diagnose and treat an enrollee's medical condition, (2) safe and effective, (3) the least costly alternative course of treatment adequate to address the enrollee's medical condition, and (4) not experimental or investigational.

Beneficiary advocates, who have a long and effective history of challenging TennCare in federal court, are concerned that the new definition is vague and overly restrictive. The Governor has promised to further refine it in regulations to minimize unintended consequences.

All this reminded me of the definition of medical necessaity I wrote for the Wisconsin Medicaid program in the 1990's. While no definition is perfect, you might find this one interesting:

“Medically necessary” means service or item that is:

(a) Required to prevent, identify or treat a recipient’s illness, injury or disability; and

(b) Meets the following standards:

1. Is consistent with the recipient’s symptoms or with prevention, diagnosis or treatment of the recipient’s illness, injury or disability;

2. Is provided consistent with standards of acceptable quality of care applicable to the type of service, the type of provider and the setting in which the service is provided;

3. Is appropriate with regard to generally accepted standards of medical practice;

4. Is not medically contraindicated with regard to the recipient’s diagnoses, the recipient’s symptoms or other medically necessary services being provided to the recipient;

5. Is of proven medical value or usefulness and is not experimental in nature;

6. Is not duplicative with respect to other services being provided to the recipient;

7. Is not solely for the convenience of the recipient, the recipient’s family or a provider;

8. With respect to prior authorization of a service and to other prospective coverage determinations made by the department, is cost–effective compared to an alternative medically necessary service which is reasonably accessible to the recipient; and

9. Is the most appropriate supply or level of service that can safely and effectively be provided to the recipient.

To address the enormous deficiencies in quality of health care, health care organizations need to make a business care for improvement. That is, they need to demonstrate a compelling rationale for the significant financial investments necessary to improve quality and reduce medical errors.

To make decisions, businesses traditionally look at the potential return on investment (ROI). However, ROI projections are tough to make in health care. Data sources are limited and decision support tools are often outdated or nonexistent. Most health services research is purely academic, offering no actionable or timely advice to decision makers. The fragmented delivery system means that organizations that invest in performance improvement benefit other players more than themselves. Finally and most critically, incentives are terribly misaligned. Providers are paid for how much they do, not how well they do it. When patient care improves and medical mistakes decline, provider revenues can drop like a stone.

The savvy folks at Bailit Health Purchasing LLC offer a new framework for building a business care to invest in quality improvement. In an excellent new issue brief published by The Commonwealth Fund, Michael Bailit, MBA and Mary Beth Dyer, MPP provide “a mechanism for an organization to consider a broad set of factors affecting a business case for quality.”

Taking into account key financial, strategic, and organization factors, they offer 10 practical business care arguments. By looking beyond bankable dollars, hospitals, clinics, and other providers can create compelling business cases to improve their performance.

In Consumer-Driven Health Care, Regina E. Herzlinger, a leading health care thought leader and a professor at the Harvard Business School, provides a thought-provoking look inside a new, powerful force transforming America's dysfunctional health care industry. Consumer-Driven Health Care builds on her popular 1997 book Market-Driven Health Care: Who Wins, Who Loses in the Transformation of America's Largest Service Industry.

In the first part of her new 900-page book, Dr. Herzlinger makes a convincing case about how and why health care is broken and why market-based solutions - which empower consumers - are best. She restates the case she made in Market-Driven Health Care for putting consumers directly in charge of their own decisions (picking insurance plans, making medical decisions).

Through transparency of information, a realignment of incentives, and new tools to support decision-making, the consumer-driven model gives individuals a clear stake in their own health care. While not unique to other parts of the US economy, the approach is a radical departure for the $1.7 trillion health care market. As Dr. Herzlinger makes clear in her energetic analysis, the absence of these proven market-based tools goes a long to explain how health care became our most inefficient, outdated, and error-prone industry.

The second part – 80 percent of the book - is a collection of 73 think pieces written by 92 other experts. With short introductions by Dr. Herzlinger, these articles serve as a useful initial knowledge base for a growing field with an uncertain future.

Consumer-Driven Health Care has its limitations. For example, Dr. Herzlinger's case for the consumer-driven model fails to address the Medicare and Medicaid systems. It also leaves a variety of practical transition and execution issues unaddressed, although these are beyond the purpose of this volume. Because articles were written several years ago as part of a conference and most of the writers lack purchaser-side experience, the book also does not deal with the growing list of market-based reforms underway by large employers and innovative health plans.

In addition, since the field is still in its infancy, Dr. Herzlinger is a business researcher, and the contributors are largely wide-eyed entrepreneurs, the book will likely frustrate health policy wonks and others stuck in the technical minutia and ideological fights that characterize most health care discussions. But then, that’s just as well. Too often analysts forget that health care is a business and operates as a market, albeit a flawed one insulated from tools proven to drive quality and efficiency.

Dr. Herzlinger also has her detractors. It reminds me of the old joke that there are two kinds of people in the world – people who like Wayne Newton and people who don’t. Well, it seems that health care wonkdom is divided by those who like Reggie Herzlinger’s ideas and those who don’t. However, given the massive problems in American health care, her contributions remain as useful as they are provocative.

For a primer on consumer-driven health care, I recommend Let's Put Consumers in Charge of Health Care, a concise article by Dr. Herzlinger in Harvard Business Review (July 2002 issue).

A South Carolina surgeon has asked the American Medical Association to approve a national policy permitting physicians to deny medical treatment to malpractice attorneys, according to NPR's Morning Edition.

This is the latest in a series of controversial steps by some physicians to blacklist patients and trial lawyers.

If the doctors cure
then the sun sees it.
If the doctors kill
then the earth hides it.
The doctors should fear arrogance
more than cardiac arrest.

The June 2004 issue of the Harvard Business Review contains an outstanding article on Redefining Competition in Health Care by Michael E. Porter, Ph.D. of the Harvard Business School and Elizabeth Olmsted Teisberg, Ph.D. of the University of Virginia's Darden School of Business.

Their carefully researched, well-argued, actionable recommendations include:

- Standardized information about individual diseases and treatments should be collected and disseminated widely so patients can make informed choices.

- Purchasers, providers, and health plans should establish transparent billing and pricing to reduce cost shifting, confusion, pricing discrimination, and a host of other inefficiencies.

- Providers should be experts in specific conditions and treatments rather than try to be all things to all patients.

Canada's Socialized health care system may result in cheaper drugs but far more dead patients.

The first major study of patient safety in Canadian hospitals has found an extremely high number of preventable medical errors.

Preventable medical mistakes and inappropriate, outdated medical care is the third leading cause of death in America, according to the Institute of Medicine and other experts.