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Enforcing Medicaid’s entitlement still uncertain in the wake of the Supreme Court’s Douglas decision
  • Foley Hoag LLP
  • USA
  • March 6 2012

The Medicaid statute begins with seven words: “A state plan for medical assistance must,” and the statute then proceeds to list 83 requirements that a state Medicaid plan is required to meet.


HHS-DOL-Treasury summary of benefits and coverage and uniform glossary final rule
  • Foley Hoag LLP
  • USA
  • February 10 2012

Section 2715 of the Public Health Service Act (PHS Act), which was enacted as part of the Patient Protection and Affordable Care Act (also referred to as PPACA, the Affordable Care Act, or the ACA), requires health insurers and group health plans offering health care coverage to enrollees and beneficiaries in the plan to provide a “Summary of Benefits and Coverage” (SBC) and Uniform Glossary to insured individuals and plan enrollees.


HHS proposed major changes to HIPAA privacy, security and enforcement rules
  • Foley Hoag LLP
  • USA
  • July 12 2010

On July 8, 2010, the Department of Health and Human Services ("HHS") issued a notice of proposed rulemaking ("NPRM" or "proposed rule") modifying the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") Privacy, Security, and Enforcement Rules pursuant to the Health Information Technology for Economic and Clinical Health Act ("HITECH"), which was enacted February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009.


ONC Establishes Temporary Certification Program for EHR Technology
  • Foley Hoag LLP
  • USA
  • June 22 2010

ONC Establishes Temporary Certification Program for EHR Technology On June 18, 2010, the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule establishing a temporary certification program to test and certify health information technology (HIT), including electronic health records (EHRs).


Medical device tax provisions in health care reform legislation
  • Foley Hoag LLP
  • USA
  • March 25 2010

The Patient Protection and Affordable Care Act of 2009 (Pub. L. No. 111-148),1 which President Obama signed into law on March 23, 2010 imposes an annual fee on medical device manufacturers and importers.


FDA releases initial draft guidance on risk evaluation and mitigation strategies (REMS): seeking input from stakeholders
  • Foley Hoag LLP
  • USA
  • October 1 2009

The Food and Drug Administration (FDA) announced on September 30 that it has released a draft guidance for industry, titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.”


Awaiting further guidance from CMS, hospitals seeking to craft on-call physician compensation policies may look to OIG Advisory Opinion for guidance
  • Foley Hoag LLP
  • USA
  • July 24 2009

In a recent opinion issued by the Health and Human Services (HHS) Office of Inspector General (OIG) on May 14, 2009, Advisory Opinion No. 09-05, the OIG concluded that there are circumstances under which a hospital may compensate physicians for taking on-call coverage in the emergency department without running afoul of the federal Anti-Kickback statute.