Health Reform
The German pharmaceutical market still looks inviting to drug manufacturers. Germany has one of the highest levels of health care spending in the world and has the largest pharmaceutical market in Europe. (Source: United BioSource Corp. “Evidence Matters” Newsletter, Oct 2010)
The author reviews the pharmaceutical industry's patenting process as it has been impacted by the Hatch-Waxman and Medicare legislation which expedite review and approval for generic follow-on drugs. (Source: Jnl Corporation Law, Winter 2005, last revised Oct 2009)
In a series of 31 essays originally published in the Journal of Allied Health over a 20-year period, this book surveys the development of federal health policy as it relates to allied health.
One major change in the structure of the national health insurance started in 2002, when a Universal Coverage (UC) health insurance policy was launched. (Source:ISPOR Connections, Sept/Oct 2010, page 11)
One major change in the structure of the national health insurance started in 2002, when a Universal Coverage (UC) health insurance policy was launched. (Source:ISPOR Connections, Sept/Oct 2010, page 11)
Kaiser Health News staff writer Jordan Rau examines a new ad by a conservative advocacy group that warns that the health care bills now before Congress would hurt Medicare. He finds that the ad uses older Americans to exaggerate the impact of proposed Medicare cuts and ignores some improvements (11/4/2009).
So, how well will health reform work after it passes? (Source: Paul Krugman, NYT, Oct 25, 2009)
Nonpartisan, nonprofit group charged to help identify the roots of the nation's health care problems and the trade-offs posed by competing proposals for change. The group offers a full array of resources and viewpoints, in a number of formats, to elected officials and their staffs, journalists, policy analysts and advocates.
Faced with the prospect of lower reimbursement and new payment models called for by the reform law, some hospital systems are consolidating and bringing physicians on board as employees (Source AIS, Health Plan Week)
Web page aims to help health care practitioners in managed care pharmacy implement the new health care reform law. The web page, accessible to AMCP members only, contains the latest regulations, guidance, analysis and other documents needed to carry out the law’s various provisions. (Source: AMCP Press Release)
In the Oct. 22nd Federal Register, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule calling for a significant number of policy and technical changes to Medicare Advantage and stand-alone Part D prescription drug plans.
Part 1 of the video explains provisions related to the Medicare Part D drug benefit, while Part 2 explains other provisions relevant to managed care pharmacy.
Explains other provisions relevant to managed care pharmacy.
DB Wright comments on a recent editorial by Dr. Norbert Gleicher in The Wall Street Journal that roundly criticizes the proposed role of expert panels.(Source: D. Brad Wright, Huffinton Post, Oct 2009)
Each of the three major health care reform bills now before Congress contains a major section establishing the U.S.'s first comparative effectiveness research agency. (Source: GoozNews ~ 28 Sep 2009)
"...the administration considers Baucus’s bill the most promising vehicle for crafting a compromise, because it is less costly than the alternatives approved by four other congressional committees and is the most palatable to influential private stakeholders." (Source: Iglehart JK, NEJM, September 2009)
This article summarizes findings of a report funded by The Commonwealth Fund Commission on a High Performance Health System, including 15 federal policy options and their potential for lowering health spending are examined. (Source: Brian Ahier, Health IT & Healthcare Reform, Nov 21, 2009)
NEJM article by Oberlander, December 2010.
FWK Brown, in MDDI Online, thinks so but lays out who will be the winners and why. (Source: July 18, 2011 Frederick W.K. Brown)
Only 32% of medication studies published in top medical journals compared the effectiveness of existing treatments, and active-comparator trials were less likely than trials with inactive controls to report positive results. (Source: Michael Hochman, MD; Danny McCormick, MD, MPH, JAMA, 2010;303(10):951-958)
Only 32% of medication studies published in top medical journals compared the effectiveness of existing treatments, and active-comparator trials were less likely than trials with inactive controls to report positive results. (Source: Michael Hochman, MD; Danny McCormick, MD, MPH, JAMA, 2010;303(10):951-958)
Only 32% of medication studies published in top medical journals compared the effectiveness of existing treatments, and active-comparator trials were less likely than trials with inactive controls to report positive results. (Source: Michael Hochman, MD; Danny McCormick, MD, MPH, JAMA, 2010;303(10):951-958)
As the US healthcare system transitions from a pay-for-service model to pay-for-value through new arrangements including bundled payments and the Accountable Care Organization (ACO), healthcare organizations will require advanced analytics solutions to track, analyze and report on quality and cost across every care setting.(Source: Healthcare Technology News)
Douglas W. Elmendorf, director of the Congressional Budget Office, offered a skeptical view Friday of the cost savings that could result from preventive care. (Source: Jake Tapper, ABC News, Aug. 9, 2009)
High U.S. health care spending has been characterized not only as a barrier to affordable insurance but also as the preeminent long-term threat to the economy and the competitiveness of American business. The current policy discussion in Congress does not address this problem.
The US Council of Economic Advisors has released a report stating that slowing the growth in healthcare spending from 6% to 4.5% per year would create 500,000 jobs a year and increase annual income for a family of 4 by $2,600/year over the next decade. By covering the 46M who lack healthcare benefits, they say this coverage would improve the federal budget, allow job mobility, and increase the economic well-being of the US by $100B/year.
A group of 29 organizations released a set of five recommendation to protect public health and prevent direct-to-consumer advertising. (Source: Epha.org, March 15, 2010)
Critics say the industry is trying to establish a higher price base before Congress passes legislation that tries to curb drug spending in coming years. (Source: Duff Wilson, NYT, Nov. 15, 2009)
The shift is occurring, policy analysts and others say, as employers feel more pressure from the weak economy and the threat of even more expensive coverage under the new health care law. In contrast to past practices of absorbing higher prices, some companies chose this year to keep their costs the same by passing the entire increase in premiums for family coverage onto their workers, according to a new survey released on Thursday by the Kaiser Family Foundation, a nonprofit research group.(Source: NYT, 9/2/2010, Reed Abelson)
Dave A. Chokshi, M.D. In the current political environment, forging consensus on health care reform has proven challenging. Yet the value of a strengthened primary care infrastructure is one apparent zone of agreement among policymakers. Read more
IOM recommends HHS base essential benefits on typical small business plans. Costs for plans to be offered in exchanges would be lower than basing benefits on large employers, but premiums are still likely to increase because of benefits.
Dr. Norbert Gleicher in The Wall Street Journal roundly criticizes the proposed role of expert panels that would make determinations about what treatments to cover by using comparative-effectiveness research. (Source: Gleicher,Wall Street Journal, Oct. 18, 2009)
To help meet the information needs of health care reform, and to inform our own work, the Agency for Healthcare Research and Quality (AHRQ) convened a small group of policymakers, researchers, and producers of health care data. The purpose of the meeting was to begin developing a strategy to optimize the availability of information and data for enactment and implementation of health care reform. (Source: AHRQ, July 2009)
Prospects for the enactment of some reform look good, but comprehensive, sustainable reform of the health care system must wait for another day. (Source: Victor Fuchs, NEJM, oct 2009)
This book examines the advantages and disadvantages of funding arrangements currently in use across Europe. Adopting a cross-national, cross-disciplinary perspective, it assesses the relative merits of the main methods of raising resources including taxation; social, voluntary and supplemental forms of insurance; and self-pay including co-payments. There is a cost to purchase this book. (Source: New Jersey Long Term Care Insurance, July 27, 2010)
In January 2011, Germany introduced price controls for new prescription drugs through its AMNOG legislation. AMNOG has created a lot of uncertainty for regulators and affected the industry alike, as many of its elements have not been clearly defined. The jury is still out as to how the system works , let alone its ultimate impact.(Source:Julian Upton, Editor of Pharm Exec Global Digest)
From 2011 onwards new medicines will have to undergo a benefit assessment. The GBA will commission this to IQWIG or other third parties. Prices can be freely set for the first six month, if no additional benefit can be demonstrated the drug will thereafter automatically be part of the therapeutic reference price system. If an additional therapeutic benefit is established manufacturers will negotiate prices with the statutory health insurance funds, if no agreement can be reached prices will be fixed by an independent arbitrary commission taking into consideration the EU price level.(Source: Health Economics Blog)
Editorial by Paul B. Ginsburg, NEJM, Nov. 2009
Experts believe that comparative-effectiveness research can substantially reduce future health care spending and improve the quality of care. (Source: NEJM, Feb.3,2010)
The government has unveiled its plans for a new outcomes framework to underpin the revamped National Health Service and establish accountability at a national level “in an open and transparent way”. The NHS Outcomes Framework will consist of a set of national outcome goals to help give an indication of the overall performance of the Service, as well as provide a mechanism by which the Health Secretary can hold the new independent NHS Commissioning Board to account for securing improved health outcomes. (Source: Pharma Times July 20, 2010)
From modest beginnings in the late 19th century, government's role in paying for health care has expanded greatly in every high-income country. Today, most of these countries have some form of national health insurance - that is, all or virtually all of the population is eligible for health care that is paid for in full or in large part by a government-organized insurance system.(Source: NEJM, December 1, 2010)
Growing Application of Pharmacoeconomics and Outcomes Research in Health-Care Decision-Making in the Asia-Pacific Region. (Source: Bong-min Yang, PhD, and Kenneth Lee, PhD, Values in Health, Vol. 12, 2009)
Buried within the 2400 pages of the landmark health care reform bill passed by the House of Representatives this week and signed by President Barack Obama are several provisions that touch on clinical research. Two are aimed at determining which therapies work best and identifying researchers' financial conflicts. A third, which has flown under the radar until now, would fund a new push in drug development at the National Institutes of Health.
(Source: Science 26 March 2010)
in Britain with a £20bn black hole opening up in NHS budgets, a group of top performing trusts are seeking to profit from paying patients and use the money to fund public healthcare in Britain.
As the health reform debate has heated up, editorial cartoonists have sharpened their pencils and gotten to work. Click thumbnails to enlarge.
The use of the budget-reconciliation process continues to be raised as a possibility. The attraction of this approach is that if a reform package were cast as a budget bill, it would require only a simple majority for passage in the Senate, the time allowed for debate would be limited, and the bill would not be subject to filibuster. (Source: NEJM, March 3rd, 2010)
NEJM edition dedicated to covering the Health Care Reform debate. (Source: NEJM, 2009)
Health care reform will eventually pit the goal of expanding health insurance coverage against strong pressure to reduce the growth in health care costs. If left to measures in the proposed reform legislation, cost containment will be driven primarily by marketplace incentives, programmatic initiatives, and organizational changes that would partially offset the costs of expanding coverage.1
This article looks at the current health care reform legislation, espeically in terms of personal privacy and choice. (Source: The Health & Wellness Institute, PC, Juice Plus+ Healthnews, Nov. 23, 2009)
The new law requires the Department of Health and Human Services (HHS) to develop national priorities for quality performance improvements and to develop new quality measures and metrics for providers of health care services.
For AMCP members to help with health reform regulations, guidance,analysis and other documents needed to carry out the law’s various provisions.
Comparative effectiveness research (CER) stands out as the intriguing wild card of health care reform. CER compares competing treatments against each other to determine which interventions work best, supplying critical information for medical decision-making and health policy. If CER works as planned, it may be one of the few reform measures to survive into the final health care legislation that has a chance of flattening the cost curve while also improving quality.(Source: University of North Carolina (Chapel Hill) School of Law; University of North Carolina (UNC) at Chapel Hill, Richard S. Saver)
As the politics of the US continues to grind on around providing all Americans with the basics of health care, the government of Singapore has put together a panel of some of the world’s top designers to reshape it’s already terrific medical system so that it attracts people from all over the world to its facilities—and makes high value medicine a 21st century industry. (Source: Bruce Nussbaum, Busienss Week, November 22, 2009)
A heavy reliance on emergency rooms care is seen as a sign of weaknesses in the primary health care system.
Erin Hoefligner, of Anthem Blue Cross / Blue Sheild -- Ohio, presents the case that insurance profits are slim and insurers should not be the target for reductions to national health care spending. (Source: Erin Hoeflinger, Cincinnati.com, Nov. 22, 2009)
NPR’s short, animated movie explains Health Care Reform: the problems with the current health care system, the changes that are happening now, and the big changes coming in 2014. (Source: Health Reform Source)
Comparative Effectiveness Research (CER) has been a primary topic of both discussion and legislative debate for the past four Congressional sessions, with both House and Senate resolutions and bills drafted, debated, amended, and ultimately tabled as members tried to arrive at a meaningful way to cultivate the CER-derived evidence base within the U.S.
A new set of NHS "quality standards" will improve patient care, the Health Secretary said today as he insisted he was not creating new targets for the health service.
This house believes that the widespread use of comparative effectiveness reviews and cost/benefit analyses will stifle medical innovation and lead to an unacceptable rationing of health care. (Source: The Economist, October 2009)
HHS Secretary Kathleen Sebelius today announced three sets of grants and cooperative agreements totaling nearly $17 million for patient-centered outcomes research (PCOR), or research that compares treatments and strategies to improve health outcomes for patients (Source: US Department of Health and Human Services).
HHS' Agency for Healthcare Research and Quality (AHRQ) today announced the award of $473 million in grants and contracts to support projects that will help people make health care decisions based on the best evidence of effectiveness. The funding announced today covers all of AHRQ's allocation and $173 million administered for the HHS Secretary by AHRQ (Source:AHRQ).
HHS State Report includes statistics on health care cost and quality for each of the 50 states in US. Examples include % increase in health premiums, costs of care for uninsured, % of state residents without health insurance, and quality ratings.
In his Policy Address delivered recently, the Chief Executive has proposed to promote the development of Chinese medicine and facilitate its development by introducing new certification services, making Hong Kong a stage for promoting Chinese medicine to the world. (Source: Webnewswire, Nov. 18, 2009)
HarvardBusiness.Org article provides excellent graphics and comparators re health reform: How to Think Constructively About Healthcare. (Source: Umair Hague, HBR Guest Edition, Aug. 5, 2009)
Bruce Goodman of Humana forecasts the impact of ICD-10, real-time claim adjudication, and role of health insurers in health reform. (Source: WSJ, Nov. 16, 2009)
Your complimentary copy from Xcenda delivers analysis of the major principles underpinning healthcare reform and how its implementation will impact patients’ access to affordable, quality cancer treatment.
Turn understanding into action as the Administration and federal agencies move forward with healthcare reform implementation. Xcenda's complimentary Executive Briefing provides manufacturers with a line of sight on the regulatory guidance, as well as the early and anticipated market response to the implementation actions to date.
Little attention has been paid to the actual language of the Senate bill with regards to comparative effectiveness research. It is notable to report that the bill repeats several times that the findings from government-funded research into the comparative effectiveness of various treatments will not be used to determine coverage or reimbursement under government health programs. (Source: Ken Terry, BNET, Dec. 7, 2009)
Further investment in and analysis of comparative effectiveness is required for health care reform.
Commentary in JMCP March 2010 issue discussing most of the recent evidence from controlled studies suggests that chronic disease management is not delivering on the promise of lowered costs through improved population health.
Leela Barham explores whether pharma firms can use value-based pricing (VBP) to improve market access.
Fairman and Curtiss review the recently published studies of copay waivers and discusses the implications for payers, both private and public. (JMCP, Kathleen Fairman, Fred Curtiss)
This article addresses the influence of growing interest in humanism and comparative effectiveness on health care reform.
The realization that meaningful medical liability reform is critical to controlling health care costs and optimizing quality of care is spreading beyond traditional supporters, as evidenced by Peter Orszag's column.(Source: NYT Opinion Pages)
The realization that meaningful medical liability reform is critical to controlling health care costs and optimizing quality of care is spreading beyond traditional supporters, as evidenced by Peter Orszag's column.(Source: NYT Opinion Pages)
NYT Columnist, David Leonardt, poses one of the more disturbing questions of the health care debate: "If politicians cannot fix America's fragmented, ailing health care system, who will?" (Source: NYT Magazine, David Leonhardt, Nov 3, 2009)
With increasing frequency in Europe, and now starting to show up in the US, biopharma companies and payers are entering into agreements to provide some form of risk sharing or price protection as new drugs are adopted into formularies. (Source: eyeforpharma, August 10, 2010)
It is worth asking “Why Medicaid?” Why not simply subsidize all poor people who do not qualify for Medicaid under current standards and enroll them in health insurance exchanges? (Source: Sara Rosenbaum, J.D., NEJM, Oct. 14, 2009)
A health minister has confirmed Nice will be "moved" from it's current central role in health technology assessment to make way for value-based pricing of medicines. (Source: InPharm, October 26, 2010)
A pioneering scheme designed by government to impose a money-back guarantee on pharmaceutical companies if their drugs did not adequately treat patients has failed to provide any clear conclusions more than seven years after it was launched.
Article on the early formation of NICE
The NHS could use incentives to help people quit unhealthy habits if proposals from the National Institute for Health and Clinical Excellence (NICE) are adopted (Source: infaonline.co.uk)
The democratization of the health system in the UK has been discussed within the last three to four years, and will now be implemented in line with the government's decision of disempowering the National Institute for Health and Clinical Excellence who has previously been in charge of medication regulation. (Source:Top News)
The 'Equity and Excellence: Liberating the NHS' White Paper unveiled by the Health Secretary Andrew Lansley has, as would be expected, generated a wide variety of responses on both sides of the argument, ranging from "a serious attempt at major and lasting reform" to an "expensive Trojan Horse in political dogma". (Source:www.Public Service.co.uk, July 13, 2010)
The OHE’s Annual Lecture for 2010 features Dr Alan Garber, Director both of Stanford University’s Center for Health Policy and its Center for Primary Care and Outcomes Research at the School of Medicine. Source: OHE News, May 2010
Coverage, performance data, policy updates, etc.
The Affordable Care Act broadly outlines a pathway for biosimilars approval, but many details are still undefined. Our complimentary white paper delivers an executive analysis of the key policy issues related to bringing a biologic to market as well as the reimbursement and safety considerations that are critical to maximizing product uptake.
With discussions about U.S. health care reform focused heavily on insurance reforms, relatively little attention has been paid to the delivery-system reforms that will be required to improve the quality and coordination of health care and slow the growth of spending.
Ponemon Institute published their study surveying American opinions on privacy of their health information. They found: 71% of Americans trust their providers with their medical information much more than they trust payers (43%), state and local government (31%), private information technology companies (27%) or the federal government (27%). (Source: Health Care Technology News, Feb. 1, 2010)
Presentation at ISPOR Europe, Nov. 2011
The statement's provocative recommendations include the imposition of requirements that (a) the off-label drug should be "irreplaceable for treatment of the patient," that is, no drug labeled for the indication is available; (b) the off-label use must be "submitted and approved by the hospital's pharmacotherapy committee and hospital ethics committee" except in emergency situations; and (c) informed consent for off-label use must be obtained from the patient or a legal representative.
(Source: JMCP October 2010 Volume 16 Issue 8, Authors: Kathleen A. Fairman, MA, and Frederic R. Curtiss, PhD, RPh, CEBS)
This article provides a summary of testimony that Donna Sweet, MD, MACP to the Subcommittee on Health of the House Energy and Commerce Committee. She addresses the recent breast cancer screening guidlines. (Source: ACP - American College of Physicians, Dec. 2009)
This side-by-side compares the leading comprehensive reform proposals across a number of key characteristics and plan components. (Source: The Henry J. Kaiser Family Foundation, Oct. 15, 2009)
Pay for view article by Sculpher in PharmacoEconomics.(Source: PharmacoEconomics, 2010, vol. 28, issue 5, pages 347-349)
Pay for view article by Sculpher in PharmacoEconomics.(Source: PharmacoEconomics, 2010, vol. 28, issue 5, pages 347-349)
Pay for view article by Sculpher in PharmacoEconomics.(Source: PharmacoEconomics, 2010, vol. 28, issue 5, pages 347-349)
This editorial raises ethical issues related to findings that trauma patients without insurance are 80 percent more likely to die than those with insurance. (Source: DR. PETER MAHR, My Oregon, Nov 24, 2009)
The program created to provide Medicare recipients with prescription drug benefits exceeded expectations during its first two years, extending pharmacy coverage to most seniors while reducing their overall spending on drugs, according to a new RAND Corporation study. (Source: RAND, Aug. 2009)
The program created to provide Medicare recipients with prescription drug benefits exceeded expectations during its first two years, extending pharmacy coverage to most seniors while reducing their overall spending on drugs, according to a new RAND Corporation study. (Source: RAND, Aug. 2009)
What are the basic details of the 2012 Medicare Part D Program? Which governmental agency is responsible for the Medicare Part D program? How many Medicare Part D plans are currently available? Where did the Medicare Part D prescription drug program come from?
Video of Roundtable: President Barack Obama has argued that health care reform is essential to the future economic health of the United States. But the economics of both health care and reform are daunting. Is it possible to pay for health care coverage for all Americans without moderating our rapidly rising health care costs?
Excellent report containing great metrics and trends on health care costs
HHS State Report has recently been issued, including statistics on health care cost and quality for each of the 50 states in US. Examples include % increase in health premiums, costs of care for uninsured, % of state residents without health insurance, and quality ratings.
This report provides a summary of the health care reform issues that have emerged as important to related industries. For life sciences companies in particular, the implications of those issues are examined and a new approach in addressing the government as a key stakeholder is explored.(Source: Capgemini Consulting)
Hard hitting article: Obama's agreement with Big Pharma may help healthcare reform pass, but it may also mean higher drug prices for you. (Source: Robert Reich, Salon.com, Aug. 10, 2009)
The passage of the Affordable Care Act (ACA) in March 2010 promised to put an end to the "doughnut hole," the gap in prescription-drug coverage that is the most controversial component of the Medicare Part D benefit.(Source: NEJM)
AHRQ Report, prepared August 2009, to help inform CMS if there is a causal relationship between the timing of initiating coverage for new technology and beneficiary participation in clinical trials to provide evidence of effectiveness.
The pioneering and influential National Institute for Health and Clinical Excellence (NICE) in London currently assesses drugs and decides whether they are cost-effective and should be available through the country's National Health Service (NHS). But the coalition government is making plans to pay drug companies only what a medicine is worth, promising to shake up the industry — and it is not yet clear what part NICE will play in the new system.(Source: Naturenews)
Health and life sciences are among the areas targeted by chancellor George Osborne and business secretary Vince Cable in a package of proposed tax reforms which includes the introduction of a patent box. (Source:InPharm)
Undertakes economic and social policy research.
HIQA has published new guidelines for the economic evaluation of health technologies in Ireland, which will standardise how evaluations are produced.The guidelines will apply to all healthcare treatments, including medications, procedures, medical devices and broader public health initiatives, and according to Dr Ryan, they are relevant to the assessment of both new and existing healthcare technologies.(Source:Irish Medical Times)
In December 2010, the Government launched its consultation on its plans to change the way medicines are priced in the UK. By 2014, a system of ‘value-based pricing’ (VBP) will replace the current Pharmaceutical Price Regulation Scheme (PPRS), which is a voluntary agreement between the Department of Health (DH) and the pharmaceutical industry whereby companies negotiate profit rates from drug sales to the National Health Service (NHS) every 5 years utilising price and profit controls.
The new value-based pricing strategy will radically overhaul the way medicines are paid for. Once the PPRS scheme has run its course by 2014, grug prices will be set according to the value the medicines provide. The White Paper also proposes changes to the role of NICE (National Institute of Clinical Excellence) and structural shifts in the way that budgets are managed – with 80% of control being handed over to GP’s. (Source: InPharm.)
Pricing, reimbursements, and coverage decisions for medical innovations and services are complex. In many countries, valuing medical technologies is the responsibility of national health-care systems that strive for distributive efficiency under fiscal constraints on medical spending (Source: Wiley On-Line Library).
Health Economics Tools for Financial Management of Public Hospitals Networks. (Source: WHO Collaborating Centre on Health Economics and Pharmaceutical Policies, www.who.int)
