The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

  • Regulatory Developments. The OIG has published a major proposed rule to amend the safe harbors to the Anti-Kickback Statute and the Civil Monetary Penalty rule. CMS regulations and notices have addressed home health conditions of participation, amount in controversy thresholds for Medicare appeals, and corrections to the final FY 2015 Medicare IPPS/LTCH rule. The ONC has issued a final rule on electronic health record certification criteria, and the DEA published a final rule on secure disposal of controlled substances.
  • Other HHS Developments. CMS has announced changes to the Nursing Home Five Star Quality Rating System; launched the “Open Payments” public database; requested input on delivery innovations in Medicare Part D, Medicare Advantage, and other programs; released new Medicare Recovery Auditors statistics; and posted updated Medicare Part B drug pricing files. HHS has released guidance on the HIPAA Privacy Rule and same-sex marriage. Draft FDA guidance documents address laboratory developed test regulatory oversight and medical device cybersecurity).
  • OIG & GAO Developments.  The OIG has issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons, along with a report on this topic. Other recent OIG reports have focused on state standards for access to care in Medicaid managed care, CMS enforcement of rural health clinic location criteria, and Part B drug dispensing and supplying fees. The OIG also has highlighted state Medicaid policies that inflate federal costs.  The GAO has called for improvements to information security and privacy controls.
  • Legislative Developments. President Obama has signed into law the Improving Medicare Post-Acute Care Transformation Act; Reed Smith has prepared a client alert summarizing the new law.  President Obama also signed bills addressing muscular dystrophy research, emergency medical care for children, and autism research and intervention.
  • Health Industry Events. CMS is hosting calls on hospital appeals settlements and transitioning to ICD-10. HHS is holding a workshop on “Integrating Plans for Long-Term Services and Supports and Health Care Delivery through Health Information Technology.” MedPAC is meeting to discuss various Medicare policy issues.
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