Health Care

Earlier this week, ML Strategies posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees and provide operational and management services to a related psychiatric hospital.

One of the most frequently asked questions posed to healthcare lawyers is whether State X has a prohibition on the corporate practice of medicine, nursing or other profession, and if so, whether the prohibition is enforced.

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market.

Mintz Levin's Communications Practice recently released a Communications Advisory discussing a Declaratory Ruling and Order released by the Federal Communications Commission (FCC).

In yet another data breach affecting millions of individuals, UCLA Health System ("UCLA") reported on July 17, 2015, that hackers had accessed portions of its health network that contained personal information, including names, addresses, dates of birth, social security numbers, medical record numbers, Medicare or health plan ID numbers, and some medical information.

Biosimilars continue to be a topic to watch in 2015 as the law around biosimilar products evolves. In March 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products, shortly after the FDA’s approval of a biosimilar version of Amgen’s drug Neupogen®.

Mintz Levin’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, analyzing overall trends in 36 recently unsealed health care related whistleblower cases.

In a set of rules published last week, the government finalized a July 2010 interim final rule (“IFR”) related to coverage of certain preventive services and an August 2014 IFR regarding the definition of an eligible organization and the process by which an eligible organization can provide notice of its religious objection to the coverage of contraceptive services.

New York State Attorney General Eric Schneiderman recently announced that his office had reached a $2.5 million settlement in a federal False Claims Act (FCA) case with Trinity HomeCare and its related entities. 

On June 29, 2015, the American Academy of Pediatrics (AAP) published a policy statement supporting the use of telemedicine in the practice of pediatrics as long as telemedicine technologies are used “in support of and integrated with” the patient-centered medical home (PCMH) – not in place of it.

On July 7th, the House introduced much anticipated bipartisan telehealth legislation.

On July 6, 2015, the Federal Communications Commission (“FCC”) adopted a Memorandum Opinion and Order modifying its rules covering Experimental Radio Service (“ERS”) licenses, which permit research and testing of radio equipment. 

For some health care providers, a pair of recent announcements made by the Obama Administration to implement mandatory alternative payment models (APMs) for home health value-based purchasing and bundled payments for hip and knee episodes of care will come as a shock.

Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological products to FDA.

On June 30, 2015, the Department of Health and Human Services' Office of Inspector General (OIG) announced that it would be staffing a new specialty litigation unit whose sole focus will be on levying civil monetary penalties (CMPs) and excluding individuals and entities from participation in Medicare and Medicaid.

Recently, South Carolina U.S. District Judge Joseph Anderson, Jr. issued an opinion in which he struggled with how to handle a non-intervened qui tam brought under the Federal False Claims Act (FCA).

On June 23, 2015, the OIG issued two reports focusing on fraud, waste, and abuse in the Part D program, the first “Ensuring the Integrity of Medicare Part D” and the second “Questionable Billing Practices and Geographic Hotspots Point to Potential Fraud and Abuse in  Medicare Part D.”

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until November 1, 2015 (Compliance Policy).

Late last week, the United States Department of Justice (DOJ) and the Michigan Attorney General (AG) filed suit against four southern Michigan hospitals, alleging that they secretly agreed not to compete with each other in violation of Section 1 of the Sherman Act and Section 2 of the Michigan Antitrust Reform Act.