Health Care

On February 22, 2012, the Accreditation Council for Graduate Medical Education (ACGME) announced the roll-out of its “Next Accreditation System” (NAS) for all graduate medical education (residency and fellowship) programs that hold ACGME accreditation.

Thirteen months after over 500 comments were submitted in response to a CMS proposal, Medicare Part C (“Medicare Advantage”) plan sponsors and other stakeholders now know the methodology CMS will use in calculating payment errors through extrapolated estimates in audits based on risk adjustment data validation (“RADV”).

Last year, the Supreme Court limited the ability of states to regulate the sale of prescription data. In Sorrell v. IMS Health, the Supreme Court determined that a 2007 Vermont law that effectively banned the sale of prescription data for commercial marketing purposes unless the prescriber consented was an unconstitutional limitation on free speech.

On February 2, 2012, CMS issued proposed regulations that further refine and define how pharmaceutical manufacturers must calculate Medicaid drug rebates in the wake of health care reform (the Proposed Rule).

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise information on  implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform.

Health care providers and suppliers concerned about how the Centers for Medicare & Medicaid Services (CMS) plans to implement the 60-day deadline for returning Medicare and Medicaid overpayments enacted as part of the Affordable Care Act (ACA) now have a proposed rule that provides some insight.

The recent decision by a federal court judge in Mississippi to deny defendants’ motion for summary judgment in United States ex rel. Jamison v. McKesson rejected a well-established defense to claims that competitively procured arrangements for goods and services constituted “remuneration” for purposes of the Anti-Kickback Statute ("AKS").

The Massachusetts Board of Registration in Medicine recently released final revised physician licensing and discipline regulations, effective February 1, 2012.  The final regulations mark the end of a six-year process to overhaul these regulations.

Law360 recently published an interesting article examining the Seventh Circuit's recent opinion in Messner v. Northshore University HealthSystem.

CMS posted additional sub-regulatory guidance regarding the Medicare Loss Ratio (MLR) under Section 2718 of the Public Health Service Act, as added by the Affordable Care Act (ACA). 

An OIG Alert issued today reminds physicians who reassign their right to submit claims to and receive payment from Medicare may be liable for any false claims submitted to the government. The OIG linked this alert to recent settlements under the Civil Monetary Penalty Law with physicians whose Medicare payment reassignments resulted in false claims. 

It’s time for mandatory data breach reporting to the Office of Civil Rights (“OCR”) under The Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the interim/final breach notification rules.

ML Strategies has posted their weekly Health Care Reform Update.  This publication provides timely and concise information on implementation of the Affordable Care Act and other state and federal administrative and legislative activities related to health care reform.

Mintz Levin’s Health Care Enforcement Defense Group reviewed health care fraud enforcement activities in 2011 to offer a general snapshot of the environment in which health care providers and pharmaceutical and medical device manufacturers operate. 

The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule giving pharmaceutical and medical device manufacturers as well as group purchasing organizations some insight into how CMS intends to implement the Physician Payment Sunshine Act, which was enacted as part of health care reform.

Relators and their counsel are increasingly being held accountable for the misuse of qui tam defendants’ confidential and privileged documents in connection with lawsuits alleging violations of the False Claims Act (“FCA”). 

As discussed in a previous post, CMS recently issued a proposed rule implementing the Sunshine Act, but many pharmaceutical and medical device manufacturers are still trying to determine the scope of their continuing obligations under related state laws, such as the Massachusetts “gift ban” law. 

As discussed in a previous post published on December 21st, HHS recently released its Essential Health Benefits Bulletin, which outlines the intended regulatory approach to defining the essential health benefits required by section 1302 of the Affordable Care Act. 

CMS is soliciting comments from Medicare Advantage Organizations, Prescription Drug Plan Sponsors, and other interested parties on its Proposed Methodology for 2013 Plan Ratings (the “Proposed Methodology”).

The D.C. Court of Appeals gave Medicare providers and suppliers a holiday gift last week with the issuance of a rare jurisdictional ruling involving a challenge to the Stark Law regulations.