May 6, 2010
On April 30, 2010, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum to all Medicare Part D Plan Sponsors outlining its draft guidance to implement the Medicare Coverage Gap Discount Program, beginning in 2011 (“Draft CGDP Guidance”). CMS will be accepting comments on the Draft CGDP Guidance via e-mail through May 14, 2010.
The Draft CGDP Guidance seeks to implement Section 3301 of the Patient Protection and Affordable Care Act (H.R. 3590) enacted on March 23, 2010, as amended by Section 1101 of the Health Care and Education Reconciliation Act of 2010 (H.R. 4872) enacted on March 30, 2010 (collectively, “PPACA”), otherwise known as the “Health Reform” law. The Part D Coverage Gap Discount Program and the Draft CGDP Guidance affect Part D Plans, drug manufacturers of Part D products, pharmacies, PBMs and all other companies and vendors involved in the chain of arrangements required to support the Part D program. We encourage all companies with Part D business and that contract to provide services to, or for the benefit of, Part D Plans to review the Draft CGDP Guidance and consider submitting comments to CMS by the May 14 deadline.
May 4, 2010
On April 21, 2010, the Council of Medical Specialty Societies (“CMSS“), a not-for-profit association of 32 member Societies[i] created to “provide an independent forum for the discussion by medical specialists of issues of national interest and mutual concern,” announced[ii] the release of the CMSS Code for Interactions with Companies(“Code“).[iii] This voluntary Code was developed by the CMSS Task Force on Professionalism and Conflicts of Interest and adopted by CMSS to “reinforce the core principles that help us maintain actual and perceived independence” and “to ensure that a Society’s transactions with Companies will be for the benefit of patients and members and for the improvement of care in our respective specialty fields.”[iv]
May 3, 2010
On April 27, 2010, a divided U.S. Supreme Court (5-3, with Sotomayor, J., recused) held that the Federal Arbitration Act, 9 U.S.C. §§ 1 et seq. (“FAA”), does not permit forcing unwilling parties to participate in a class arbitration to which they have not consented. This is a case of potentially great significance to entities whose contractual relationships include arbitration provisions and that generally oppose class-action treatment of cases against them—particularly employers of all kinds, but also health care providers and financial services companies, among others. Stolt-Nielsen S.A., et al. v. AnimalFeeds International Corp., No. 08-1198, 559 U.S. ____ (2010).
April 25, 2010
The Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010 (the “Act”) implements significant changes to the provision of health care and health coverage applicable to all aspects of health care delivery, operation and administration. The Act imposes many different requirements on employers that become effective over time. These requirements are discussed in more detail in our Client Alert of April 8, 2010, entitled “Health Care Reform: What Employers Need to Know.”
April 22, 2010
In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act and related amendments (“ACA”) to help achieve significant health reform in the United States. ACA authorized the creation of numerous advisory boards, commissions, councils and committees.
Each of these advisory bodies has its own purpose, membership, and composition, with different policies governing pay and reimbursement, applicable conflict of interest rules, effective dates and term limits. Several will operate consistent with the Federal Advisory Committee Act (5 U.S.C. App.) with the exception of section 14 of that Act (which addresses the termination, renewal and continuation of advisory committees).
April 21, 2010
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “Act”), significantly impacting the delivery of health care, also amends the Fair Labor Standards Act (“FLSA”). The FLSA amendments impose certain employer responsibilities in providing health care benefits, confer whistleblower protections and authorize the U.S. Department of Labor (“DOL”) to undertake increased enforcement related to health care. Employers have new requirements to learn, and to implement, under the FLSA, irrespective of their size or the number of employees in their workforce.
April 19, 2010
As we reported in our Client Alert of December 24, 2009 (“UPDATE: Cobra Subsidy: What it Means for Employers Now“), President Obama signed into law the Department of Defense Appropriations Act, 2010 (the “Defense Appropriations Act”), which, among other things, extended and expanded certain provisions of the American Recovery and Reinvestment Act of 2009 (“ARRA”) pertaining to premium assistance for benefits under the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”). The Defense Appropriations Act extended the COBRA premium subsidy for assistance-eligible individuals who became eligible for COBRA from the period that began September 1, 2008, and ended on December 31, 2009, to the period that ended on February 28, 2010.
April 19, 2010
In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“PPACA”) and related legislation which provide significant changes in the delivery of health care. One provision that impacts Medicare operations immediately is Section 6404 of PPACA. Section 6404 reduces the statutory timely filing deadline for Medicare fee-for-services claims under Medicare Parts A and B to one (1) year, effective for all Part A and B services furnished on or after January 1, 2010. This provision is self-executing.
April 15, 2010
On March 29, 2010, the U.S. Food and Drug Administration (“FDA“) published a proposed rule titled Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (“Proposed Rule“).[i] The Proposed Rule would require direct-to-consumer (“DTC“) television and radio advertisements to present the mandated “Major Statement” for major side effects and contraindications “in a clear, conspicuous, and neutral manner.” The FDA is accepting written comments on the Proposed Rule until June 28, 2010.