Health Care

On March 23, 2012, the Department of Health and Human Services (HHS) issued its statutorily required report to Congress (Report) describing the implementation of the Medicare Physician Self-Referral Disclosure Protocol (SRDP) and the status of disclosures under the SRDP to date. 

Officials from the Department of Health and Human Services Office for Civil Rights (OCR) announced March 26 that the long-awaited rule updating Health Insurance Portability and Accountability Act (HIPAA) regulations has been sent to the Office of Management and Budget (OMB).

In Advisory Opinion 12-01, the Office of Inspector General for the Department of Health and Human Services (OIG) analyzed a proposal from a nonprofit health system (the “System”) to form a group purchasing organization (the “Proposed GPO”) for the benefit of the System’s affiliates and subsidiaries. 

Mintz Levin has issued a Client Alert:  The False Claims Act: The Impact in 2012 - Part II in a Continuing Series on Health Care Enforcement. 

No one wants to be the first, especially not in this case. The Department of Health and Human Services' Office of Civil Rights (OCR) announced its first settlement with a covered entity stemming from a report submitted pursuant to the Health Information Technology for Economic and Clinical Health Act's (HITECH) Breach Notification Rule (the "Rule").

On February 22, 2012, a New York State Court held for the first time that a provider may bring a claim against a health insurer under the State’s prompt pay law (PPL). 

Starting today, March 7, 2012, clinical research consent forms for certain FDA-regulated clinical trials must contain a specific statement advising participants that clinical trial information will be entered into the ClinicalTrials.gov database. 

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.

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.