On January 8, 2013, the Obama Administration published its latest semiannual regulatory agenda, outlining planned regulatory initiatives in a number of policy areas. The Federal Register version of the agenda includes only a portion of the regulations in the pipeline, however; the full agenda has been posted on the Office of Management and Budget (OMB) web site. Major Department of Health and Human Services (HHS) regulations are highlighted after the jump.

  • An HHS Office of Inspector General (OIG) proposed rule that would add new/modify existing safe harbors under the anti-kickback statute; add new/revise existing regulations governing OIG’s authority to impose civil money penalties and assessments; add new/revise existing regulations governing OIG’s exclusion authority; and codify new exceptions to the beneficiary inducement prohibition (expected July 2013);
  • A final Centers for Medicare & Medicaid Services (CMS) rule implementing Affordable Care Act (ACA) provisions related to Medicaid reimbursement for covered outpatient drugs (expected in August 2013);
  • A CMS proposed rule to establish Medicare payment safeguards to prevent providers and suppliers that do not meet Medicare requirements from remaining enrolled in or submitting claims to Medicare (expected May 2013);
  • Proposed emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers (expected in July 2013);
  • A final CMS rule establishing requirements for disclosure of skilled nursing facilities’ ownership (expected May 2013);
  • A final rule on long-term care facility agreements with hospice agencies (expected October 2013);
  • A proposed rule to establish a prospective payment system for Federally Qualified Health Centers (expected June 2013);
  • Annual Medicare payment update rules (various dates);
  • Various rules implementing insurance-related provisions of the ACA (various dates);
  • A final rule modifying HIPAA privacy, security, enforcement, and breach notification rules (expected but not released in December 2012);
  • An advance notice of proposed rulemaking to establish a methodology allowing an individual harmed by an offense punishable under HIPAA to receive a percentage of any civil money penalty or monetary settlement collected (expected March 2013);
  • A final rule to enhance human subjects research protections (expected April 2013); and
  • A Food and Drug Administration (FDA) final rule establishing a unique device identification system for medical devices (expected May 2013).

There are also some surprises on the Administration’s list of “long-term actions” – including the long-overdue final ACA “Sunshine Act” rule requiring applicable manufacturers of drugs, devices, biologicals, or medical supplies to annually report certain payments to physicians or teaching hospitals (“final action” listed as December 2014). Other long-term actions include a final rule implementing ACA requirements related to reporting and returning of overpayments (February 2015); a variety of rules dealing with the 340B discount drug program (timing listed as “to be determined”); and a final HIPAA privacy rule on accounting for disclosures under the Health Information Technology for Economic and Clinical Health Act (TBD).