How SCOTUS could kick the can on the ACA – Jennifer Haberkorn – POLITICO.com

September 30, 2011

While the Supreme Court appears likely to hear the case against President Barack Obama’s health reform in this term, that doesn’t mean the court will actually decide soon whether it is constitutional.

The court has an “out” that’s gotten a lot more attention from appellate courts in recent weeks.

When the Justice Department asked the Supreme Court on Wednesday to hear a lawsuit filed by 26 states and the National Federation of Independent Business, it also suggested the court look at whether a federal tax law could prevent a ruling until well after 2014.

The tax law, called the Anti-Injunction Act, requires Americans to pay a tax before they can challenge it in court. That could be a factor in the centerpiece of the legal challenge — the individual mandate — since people who don’t get coverage will have to pay a tax penalty. But the mandate doesn’t go into effect until 2014, and people who get fined wouldn’t have to pay it until 2015.

via How SCOTUS could kick the can on the ACA – Jennifer Haberkorn – POLITICO.com.


The FDA and ABCs: The Unintended Consequences of Antidepressant Warnings on Human Capital by Susan Busch, Ezra Golberstein, Ellen Meara :: SSRN

September 29, 2011

Using annual cross-sectional data on over 100,000 adolescents aged 12-17, we studied academic and behavioral outcomes among those who were and were not likely affected by FDA warnings regarding the safety of antidepressants. Just before the FDA warnings, adolescents with probable depression had grade point averages 0.14 points higher than adolescents with depression just after the warnings. The FDA warnings also coincided with increased delinquency, use of tobacco and illicit drugs. Together, our results stress the importance of mental health and its treatment as an input into cognitive and non-cognitive aspects of human capital.

via The FDA and ABCs: The Unintended Consequences of Antidepressant Warnings on Human Capital by Susan Busch, Ezra Golberstein, Ellen Meara :: SSRN.


The Constitutional Protection of Trade Secrets and Patents Under the Biologics Price Competition and Innovation Act of 2009 by Richard Epstein :: SSRN

September 29, 2011

The Biologics Price Competition and Innovation Act of 2009 (“Biosimilars Act”) 1 is for the field of pharmaceutical products the single most important legislative development since passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”),2 on which portions of the Biosimilars Act are clearly patterned. Congress revised section 351 of the Public Health Service Act (PHSA) to create a pathway for FDA approval of “biosimilar” biological products. Each biosimilar applicant is required to cite in its application a “reference product” that was approved on the basis of a full application containing testing data and manufacturing information, which is owned and was submitted by another company and much of which constitutes trade secret information subject to constitutional protection. Because the Biosimilars Act authorizes biosimilar applicants to cite these previously approved applications, the implementation of the new legislative scheme raises critical issues under the Fifth Amendment of the Constitution, pursuant to which private property – trade secrets included – may not be taken for public use, without “just compensation.” FDA must confront those issues as it implements the scheme set out in the Biosimilars Act. This article will discuss these issues, after providing a brief overview of the Biosimilars Act and a more detailed examination of the law of trade secrets.

via The Constitutional Protection of Trade Secrets and Patents Under the Biologics Price Competition and Innovation Act of 2009 by Richard Epstein :: SSRN.


The Patient-Centered Outcomes Research Institute — Promoting Better Information, Decisions, and Health — NEJM

September 29, 2011

Within the 2000 pages of the 2010 Patient Protection and Affordable Care Act (ACA) is a short section authorizing the creation of the Patient-Centered Outcomes Research Institute (PCORI) — a research organization dedicated to the support and promotion of comparative clinical effectiveness research. The establishment of PCORI represents the culmination of long-standing interest in comparative effectiveness research, a lengthy legislative gestation, and compromise among varied congressional perspectives and priorities.1 PCORI responds to a widespread concern that, in many cases, patients and their health care providers, families, and caregivers do not have the information they need to make choices aligned with their desired health outcomes.

via The Patient-Centered Outcomes Research Institute — Promoting Better Information, Decisions, and Health — NEJM.


Holtz-Eakin Amicus Brief Central to U.S. Appeals Court Ruling

September 29, 2011

In August, the 11th U.S. Circuit Court of Appeals ruled against the provision in President Obama’s health law requiring Americans to buy health insurance or face tax penalties. It was the first appellate decision to find the Patient Protection and Affordable Care Act’s (PPACA) individual mandate provision unconstitutional. It now seems that the case will be headed to the Supreme Court next summer.
Central to this constitutional debate is the Obama Administration’s claim that the voluntarily uninsured (The Young, Healthy, Uninsured) impose large uncompensated costs on society.
This claim was refuted by Douglas Holtz-Eakin and 105 Amicus Brief signers who evaluated the federal Medical Expenditure Survey Data (MEPS). The moral hazard of the voluntarily uninsured—the only segment of the uninsured that the individual mandate would apply to—it turns out is grossly exaggerated.

More at OHC_WeeklyCheckup_092811.pdf (application/pdf Object).


What’s Behind The Rise In Premiums For Employer Coverage? – Health Affairs Blog

September 29, 2011

Dentzer said that rising underlying health care costs were a bigger influence than insurer price increases. Firms that “self-insure” – that pay health care costs out of their own pockets – saw costs go up just as fast as firms with traditional insurance policies. “So that’s what tells you that it’s really not insurance that is driving most of this increase right now,” she said.

via What’s Behind The Rise In Premiums For Employer Coverage? – Health Affairs Blog.


Employers interested in joining hospitals in ACOs – FierceHealthFinance – Health Finance, Healthcare Finance

September 29, 2011

Accountable care organizations (ACOs) could prove a popular option with employer groups looking to keep their workers insured while controlling costs, concludes a new study by consulting firms Aon Hewitt and Polakoff Boland. This ultimately could prove beneficial to hospitals, which have been moving toward forming ACOs but are still unsure of what market demand for such arrangements would be.

via Employers interested in joining hospitals in ACOs – FierceHealthFinance – Health Finance, Healthcare Finance.