Top 10 Pharmaceutical, Healthcare & Life Sciences Headlines from North America Failing to comply with various federal group health plan mandates, including COBRA and HIPAA portability, just got riskier and costlier for employers. On October 9, 2009, CMS issued a proposed rule, Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Proposed Rule), which establishes new and revised rules for Medicare managed care (Part C), Medicare Advantage (MA), and Medicare prescription drug plans (Part D). CMS will accept comments on the Proposed Rule until December 8, 2009. The Office for Civil Rights of the Department of Health and Human Services (HHS) recently issued a proposed regulation implementing certain provisions of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA) that clarifies the status of genetic information as protected health information under the HIPAA Privacy Rule. Competition authorities continue to examine various aspects of the pharmaceutical industry. HITECH Act Greatly Expands Scope of HIPAA'sApplicability and Enforcement and Increases Civil MonetaryPenalties for Violations. Hospitals that look to health reform initiatives for a reduction in their burden of uncompensated care may find that declining compensation for related costs offsets any expected gains. In whatever form biosimilar legislation might take, patent holders will need to review their patent portfolios carefully. The next chapter in the ongoing effort by the federal government to narrow the permissible uses of personal health information by entities engaged in the health care industry has arrived. This HIPAA Update provides a detailed description of the new breach notification requirements for HIPAA covered entities and business associates as required by interim final rule issued pursuant to the HITECH Act of 2009. The Massachusetts Health Care Reform Act (the Act) requires employers with 11 or more employees at Massachusetts locations to (among other things) make a “fair and reasonable” contribution to the health care premium costs of its employees or, alternatively, pay an annual “fair share contribution” (FSC) to the Commonwealth of $295 per employee. |
