- Samantak Ghosh, The Taking of Human Biological Products, SSRN/Calif L. Rev
- Mark Rothstein & Abigail Shoben, Does Consent Bias Research? SSRN/Am.J.Bioethics
- David Hyman, Why Did Law Professors Misunderestimate the Lawsuits against PPACA? SSRN/U. Ill. L. Rev.
- Aaron S. Kesselheim, et al, Distributions of Industry Payments to Massachusetts Physicians, NEJM
Author Archives: npterry
Worth Reading This Week
- Stephanie Morain & Michelle Mello, Survey Finds Public Support For Legal Interventions Directed At Health Behavior To Fight Noncommunicable Disease, Health Affairs
- J.D. Boudreau, M.A. Somerville, & N. Biller-Andorno, Physician-Assisted Suicide, NEJM
- Thomas Frieden, Government’s Role in Protecting Health and Safety, NEJM
- Susan Dentzer, The ‘Triple Aim’ Goes Global, And Not A Minute Too Soon, Health Affairs
Worth Reading This Week
- Dan Burk, Edifying Thoughts of a Patent Watcher: The Nature of DNA, SSRN/UCLA Law Review Discourse
- Wendy Mariner, The Affordable Care Act and Health Promotion: The Role of Insurance in Defining Responsibility for Health Risks and Costs, SSRN/Duquesne L.Rev.
- Benjamin Eidelson, Kidney Allocation and the Limits of the Age Discrimination Act, SSRN/Yale LJ
- Wendy Mariner & George Annas, Limiting “Sugary Drinks” to Reduce Obesity — Who Decides? NEJM
Worth Reading This Week
- Jason Kanter & Robin Feldman, Understanding and Incentivizing Biosimilars, SSRN/Hastings LJ
- Eric Stecker, The Oregon ACO Experiment — Bold Design, Challenging Execution, NEJM
- Sharon Silow-Carroll & Jennifer N. Edwards, Early Adopters of the Accountable Care Model: A Field Report on Improvements in Health Care Delivery, Commonwealth Fund
- Scott Burris & Evan Anderson, Legal Regulation of Health-Related Behavior: A Half-Century of Public Health Law Research, SSRN/Ann. Rev. Law & Social Science
Worth Reading This Week
- David Hyman & Bernard Black, Public Reporting of Hospital Infection Rates: Not All Change is Progress, SSRN/Jurimetrics
- Jonathan Adler, The Future of Health Care Reform Remains in Federal Court, SSRN
- David Shern & Wayne Lindstrom, After Newtown: Mental Illness And Violence, Health Affairs
- Allison Hoffman & Howell Jackson, Retiree Out-of-Pocket Healthcare Spending: A Study of Consumer Expectations and Policy Implications, SSRN/AJLM
Worth Reading This Week
- Eric Stecker,The Oregon ACO Experiment — Bold Design, Challenging Execution, NEJM
- Nicole Huberfeld, Heed Not the Umpire (Justice Ginsburg Called NFIB), SSRN/U. Pa. J. Const. L. Height. Scrutiny.
- Lance Gable, Evading Emergency: Strengthening Emergency Responses through Integrated Pluralistic Governance, SSRN/Oregon L.Rev.
- Susan Wolf, The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the Environment, SSRN/JLME
Final Tally on Insurance Marketplaces
- State-run: 17 plus DC
- State-federal partnership: 7
- Federally-facilitated: 26
Worth Reading This Week
- Max Mehlman, Professional Power and the Standard of Care in Medicine, SSRN/Arizona State L.J.
- Mark Rothstein, HIPAA Privacy Rule 2.0, SSRN/JLME
- Benjamin Sommers & Arnold Epstein, Governors and the Medicaid Expansion — No Quick Resolution in Sight, NEJM
- Thad Pope, Clinicians May Not Administer Life-Sustaining Treatment Without Consent: Civil, Criminal, and Disciplinary Sanctions, SSRN/J.Health & Biomedical L.
Worth Reading This Week
- Maxwell Mehlman, Patrick Lin & Keith Abney, Enhanced Warfighters: Risk, Ethics, and Policy, SSRN
- Evelyn Tenenbaum, Revitalizing Informed Consent and Protecting Patient Autonomy: An Appeal to Abandon Objective Causation, SSRN/Oklahoma L.Rev.
- Richard Frank, Using Shared Savings to Foster Coordinated Care for Dual Eligibles, N Engl J Med
- Seth A. Seabury et al, On Average, Physicians Spend Nearly 11 Percent Of Their 40-Year Careers With An Open, Unresolved Malpractice Claim, Health Affairs
Worth Reading This Week
- Douglas L. Rogers, After Prometheus, Are Human Genes Patentable Subject Matter? SSRN
- Douglas McCarthy et al, Recasting Readmissions by Placing the Hospital Role in Community Context, JAMA/Commonwealth Fund
- John Robertson, Paid Organ Donation and the Constitutionality Of the National Organ Transplant Act, SSRN/Hastings Const. L.Q.
Worth Reading This Week
- David Orentlicher & William David, Concussion and Football: Failures to Respond by the NFL and the Medical Profession, SSRN/FIU L.Rev.
- Benjamin Sommers & Arnold Epstein, U.S. Governors and the Medicaid Expansion — No Quick Resolution in Sight, NEJM
- Jonathan Kahn, The Troubling Persistence of Race in Pharmacogenomics, SSRN/JLME
- Alicia Ouellette, Health Reform and the Supreme Court: The ACA Survives the Battle of the Broccoli and Fortifies Itself Against Future Fatal Attack, SSRN/Alb. L. Rev.
Worth Reading This Week
- Barbara Evans, Why the Common Rule is Hard to Amend, SSRN
- Ann Marie Marciarille, Let Fifty Flowers Bloom: Health Care Federalism after National Federation of Independent Business V. Sebelius, SSRN/UMKC L.Rev.
- Tim Jost, Religious Freedom and Women’s Health — The Litigation on Contraception, NEJM
- Elizabeth Sepper, Taking Conscience Seriously, SSRN/Va L Rev
Cross-posted at HealthLawProfs
Worth Reading This Week
- Efthimios Parasidis, Justice and Beneficence in Military Medicine and Research, SSRN/Ohio State LJ
- Sara Rosenbaum, Threading the Needle — Medicaid and the 113th Congress, NEJM
- David Orentlicher, NFIB v. Sibelius: Proportionality in the Exercise of Congressional Power, SSRN
- Karen Rothenberg & Lynn Wein Bush, Manipulating Fate: Medical Innovations, Ethical Implications, Theatrical Illuminations, SSRN/Houston J.Health L. P’cy
- Sallie Thieme Sanford, Designing Model Homes for the Changing Medical Neighborhood: A Multi-Payer Pilot Offers Lessons for ACO and PCMH Construction, SSRN/Seton Hall L. Rev.
Cross-posted at HealthLawProfs
Worth Reading This Week
- Jessica Mantel, Accountable Care Organizations: Can We Have Our Cake and Eat it Too? SSRN
- Kieran Healy & Kimberly Krawiec, Custom, Contract, and Kidney Exchange, SSRN/Duke L.J.
- Eliott Fisher et al, A framework for evaluating the formation, implementation, and performance of accountable care organizations, Health Affairs
- Ronald Bayer et al, Repackaging Cigarettes — Will the Courts Thwart the FDA? NEJM
- Vicki Girard, Reducing Unlawful Prescription Drug Promotion: Is the Public Health Being Served by an Enforcement Approach that Focuses on Punishment? SSRN/FDLI Food & Drug Forum
Cross-posted at HealthLawProfs
Meaningful Scrutiny for Meaningful Use
Today the Office of the Inspector General (OIG) in the Department of Health and Human Services released a report, here, that is decidedly critical of CMS and ONC oversight of the Electronic Health Record (EHR) subsidy program.
Over the last couple of years there have been growing criticisms of the Meaningful Use program and its disbursement of potentially $30 billion in ARRA funds. I have detailed many of these concerns, such as the overall effectiveness of electronic records, my doubts as to the robustness of the first two Stages of Meaningful Use requirements, the safety record of the technologies, their ability to actually save money, their real-world interoperability, and their general usability in the healthcare workflow, here.
Recently, additional questions have been raised that go to the very heart of the subsidy program. First, the Center for Public Integrity, here, and the New York Times, here, set off a firestorm with allegations of EHR use leading to extensive upcoding. This led to a scolding letter to the healthcare industry from Secretary Sebelius and the Attorney-General, here, and combative words back from some of the addressees, here.
Questions have also been raised about the apparent laxity of CMS in approving payment to providers claiming subsidy funds, leading to CMS announcing a hastily designed audit process, here.
Today’s OIG report elaborates on the same basic issue of lax payment safeguards. First, the report finds that CMS has not implemented strong pre-payment safeguards (either by verifying self-reported data or requiring supporting documentation). Second, it suggests that CMS’s proposed post-payment audit program is limited and potentially flawed. Fortunately, CMS/ONC are in broad agreement with the OIG that the EHR technology itself must step up and meaningfully test for meaningful use. In the meantime increased Congressional scrutiny seems a less elegant but likely surrogate.
The Readmission Penalty Begins to Bite
As is well known ACA § 3025 (§1886(q) Social Security Act) established the Hospital Readmissions Reduction program. This is operationalized through deductions built into the Hospital IPPS (Inpatient Prospective Payment Systems) Rule which sets the Medicare reimbursement amounts, here. The excess readmissions ratio initially only applies to readmissions based on MI, Heart Failure, and Pneumonia. Initially the maximum deduction is 1% but that rises to 2% in October 2013 and 3% in October 2015.
A parallel program for Medicaid designed to reduce hospital-acquired infections was introduced in the 2005 Deficit Reduction Act, here. However, Lee and colleagues, here, found no change in infection rates. Nevertheless, the dollars associated with readmissions reduction may give that program greater traction.
Jordan Rau in the New York Times, here, notes that 307 hospitals are already facing the maximum reduction involving many millions of dollars. Not surprisingly some hospitals view the penalties as a distraction while others blame their patients for everything from their level of sickness and poverty to non-compliance. Overall, however, Rau’s article and Amy Boutwell’s recent post at Health Affairs, here, suggest that CMS is succeeding in getting the industry’s attention.
Worth Reading This Week
- Richard Epstein & David Hyman, Fixing Obamacare: The Virtues of Choice, Competition and Deregulation, SSRN/NYU Annual Survey of American Law
- Brendan Maher & Radha Pathak, Enough about the Constitution: How States Can Regulate Health Insurance under the ACA, SSRN/Yale Law & Policy Rev.
- Mark Rothstein, The Case Against Precipitous, Population-Wide, Whole-Genome Sequencing, SSRN/JLME
- J. Oberlander, The Future of Obamacare, NEJM
Cross-posted at HealthLawProfs
Worth Reading This Week
- Kevin Outterson, Regulating Compounding Pharmacies after NECC, NEJM\
- Katherine Pratt, A Constructive Critique of Public Health Arguments for Anti-Obesity Soda Taxes and Food Taxes, SSRN/Tulane L.Rev.
- Ronald Bayer, Lawrence Gostin, & Daniel Marcus-Toll, Repackaging Cigarettes — Will the Courts Thwart the FDA? NEJM
- Richard Saver, Is It Really All about the Money? Reconsidering Non-Financial Interests in Medical Research, SSRN/JLME
Cross-posted at HealthLawProfs
Worth Reading This Week
- Sam Bagenstos, Federalism by Waiver after the Health Care Case, SSRN
- Thomas Lambert, Why the Affordable Care Act, as Construed by the U.S. Supreme Court, Will Fail, SSRN/Regulation
- Brietta Clark, Medicaid Access, Rate Setting and Payment Suits: How the Obama Administration is Undermining Its Own Health Reform Goals, SSRN/Howard LJ
- Peter Neumann and James Chambers, Medicare’s Enduring Struggle to Define “Reasonable and Necessary” Care, NEJM
- Barak Richman, Concentration in Health Care Markets: Chronic Problems and Better Solutions, SSRN/American Enterprise Institute
Cross-posted at HealthLawProfs
Bending the Cost Curve, Not Just Talking About It
When the 2012 history of health care is written, which date will have the largest entry, November 5 or 6? Of course, many (but not that many) provisions of the Affordable Care Act will live or die depending on how the election affects control of the White House and Senate. But, November 5 may end up having more significance because that is the date Massachusetts’s new health care spending legislation, here, takes effect.
Signed into law by Governor Patrick on August 6, 2012, the new law now has its own website, here, the promise of a a ton of data, here, and in Brandeis University economist Stuart Altman, here, a chair for its Health Policy Commission (HPC).
Thomas Lee, here, notes “the 349-page law that was just passed in Massachusetts created 25 new boards, task forces, and commissions, and 266 new appointees are going to be enlisted to monitor and enforce compliance with spending caps, oversee provider performance improvement plans, and certify Accountable Care Organizations (ACOs).”