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Health Care Reform Implementation Update - May 15, 2013

Last week the Senate agreed to vote on Marilyn Tavenner’s nomination to lead the Centers for Medicare and Medicaid Services (CMS); the Department of Health and Human Services (HHS) announced an initiative that will give...more

Halbig, et al. v. Sebelius, et al.

Lawsuit Challenging IRS “Subsidy Expansion Rule” (Full Text Copy)

Lawsuit filed by a group of small business owners and individuals against the Internal Revenue Service over the agency’s “Subsidy Expansion Rule.” From the Blog of Legal Times: “Objecting to what they term an ‘Obamacare...more

New Kansas Abortion Law Among Most Restrictive in the Nation

Legislation signed into law in Kansas last week will sharply restrict women’s access to abortions, part of a nationwide assault on reproductive rights...more

Court Grants Unexpected Victory to Providers on Medicare DSH Adjustment

The United States District Court for the Eastern District of Pennsylvania’s opinion in Nazareth Hosp. v. Sebelius, slip op. no. 10-3513 furnished a surprising victory to two providers that challenged the calculation of the...more

Federal Court Orders FDA to Approve OTC Sales of “Morning-After Pill,” Finds Current Age and Point-of-Sale Restrictions to be...

On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”)...more

Counties in California Can Learn a Few Lessons from State on Inmate Health Care - BB&K Health Care Attorney Shares Tips on...

Inmates in the Riverside County jails served a federal class-action lawsuit last month, claiming the county is subjecting them to cruel and unusual punishment by depriving them of basic medical and mental health care. A...more

Employer Tax Considerations for Supreme Court’s Pending DOMA Decision

High Court considers the constitutionality of DOMA, which may create tax-refund opportunities for employers and employees before April 15....more

Religious Institutions Update: April 2013

Implementation of the Patient Protection and Affordable Care Act (PPACA) is in full swing. The law requires non-exempt religious organizations with fewer than 50 full-time employees to determine whether they are a large...more

Inmates Claim County is Depriving Them of Basic Medical and Mental Health Care - Similar Lawsuits Expected to be Filed as Counties...

Inmates in the Riverside County jails served a federal class-action lawsuit last week, claiming the county is subjecting them to cruel and unusual punishment by depriving them of basic medical and mental health care. Among...more

FDA Emphasizes Patient-Specific Prescriptions

On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

The Employment Law Authority - January/February 2013

In This Issue: - Email Request Does Not Constitute "Complaint" - Former NLRB Member Joins Ogletree Deakins - For Employers, Pay-Or-play Proposals Could Be Worse, Much Worse - The NLRB In 2013: More Controversy...more

Supreme Court Unanimously Rejects Antitrust Immunity in Hospital Merger Case

What you need to know: The Supreme Court issued a unanimous decision siding with the FTC against a hospital merger in Georgia. What you need to do: Companies should conduct careful analysis before investing...more

Supreme Court Limits State Action Immunity In FTC v. Phoebe Putney Health System, Inc.

On Tuesday, the United States Supreme Court reined in the state action immunity doctrine, which exempts municipalities from scrutiny under the federal antitrust laws when they act pursuant to a “clearly articulated state...more

White Collar Watch - February 2013

In This Issue: - New HIPAA “Megarule” Broadens Enforcement - Government Declines to Seek Rehearing of Landmark Off-Label Speech Decision - Seizure of Rothstein Ponzi Assets Highlights Tension Between...more

Supreme Court Hands FTC Victory on State Action Immunity

In a unanimous opinion, the U.S. Supreme Court this week tightened the standard for state action immunity under federal antitrust laws in a case involving a hospital merger. This decision arguably tightens the reins on the...more

Placing Limits on the State Action Doctrine, the Supreme Court Subjects Local Government Hospitals to Scrutiny under the Antitrust...

Recent major regulatory and technological developments have brought forth historic changes to the health care market. Health care providers have responded to these developments in several ways. One such mechanism, hospital...more

False Press Release Leads To Exclusion From Federal Programs

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

Proposed Regulations Released on Contraceptive Coverage Exemption and Accommodation for Nonprofit Religious Employers

On January 30, the Departments of Treasury, Labor, and Health and Human Services (the “Departments”) released proposed regulations regarding contraceptive coverage for employees of religious employers. This guidance is the...more

Stark Exception For ESRD Not Recognized In Florida

On January 10, 2013, the U.S. Court of Appeals for the Eleventh Circuit ruled in Fresenius Medical Care Holdings, Inc. v. Tucker, that an arrangement can violate Section 456.053 of the Florida Statutes, also known as...more

Expanded Exemption for Religious Employers Regarding Women's Contraceptive Services

The Patient Protection and Affordable Care Act requires non-grandfathered group health plans to cover preventive services at no cost. For women this includes all FDA-approved contraceptive methods, sterilization procedures,...more

Obama Administration Outlines Religious Accommodations for Contraception Coverage Mandate

Last week, federal regulators released a Proposed Rule outlining accommodations for religious employers that object to the Affordable Care Act’s contraception coverage mandate. The Proposed Rule expands the range of...more

Religious Institutions Update: February 2013

Last February, at the request of Senate Finance Committee member Charles Grassley (R-Iowa), the Commission on Accountability and Policy for Religious Organizations was formed to address tax-related policy questions of import...more

Health Reform + Related Health Policy News Update - February 6, 2013

In This Issue: - Top News ..CMS Announces Round 2 Competitive Bidding Single Payment Amounts ..CBO Lowers SGR Repeal Cost by $100 Billion ..Republicans Press HRSA on 340B Audits ..HHS Proposes...more