Health Care

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the prescribed biological product.

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post, payment provisions and offsets in our April 21st post, and provisions relating to program integrity and fraud and abuse in our April 23rd post.

On Thursday April 16th, President Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). Pub.L. 114-10. In two previous posts, we discussed MACRA’s repeal of the Sustainable Growth Rate formula (the “SGR”) and physician payment reform, and the payment provisions and offsets established by MACRA.

Yesterday the HHS OIG, in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association (AHLA), and the Health Care Compliance Association, released a guidance document entitled Practical Guidance for Health Care Governing Boards on Compliance Oversight (the Guidance).

This is the second post in our continuing series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No: 114-10. In addition to repealing the Sustainable Growth Rate (SGR), which was covered in our April 20th post, MACRA includes several other payment provisions and offsets totaling $39.5 billion in savings over ten years.

On April 16, 2015, President Obama signed into law, the “Medicare Access and CHIP Reauthorization Act of 2015” (MACRA), ending annual temporary patches and massive lobbying efforts since the late 1990s to prevent significant reimbursement cuts for physicians serving Medicare beneficiaries caused by the so-called Sustainable Growth Rate (SGR) formula.

Next Thursday April 23rd at 12pm EST, Mintz Levin attorneys Dionne Lomax and Steve Weiner will be presenting a webinar, moderated by Bruce Sokler, on trends in antitrust enforcement in health care.

As states attempt to control increasing healthcare costs, many Medicaid programs are seeking approval from the Centers for Medicare & Medicaid Services (CMS) to implement Medicaid managed care programs. 

The spring of 2015 is shaping up to be a busy time in the field of food and nutrition. Issues relating to food labeling, food safety, dietary guidelines, dietary supplements, child nutrition, and nutrition education in medical schools are being examined by the FDA, Congress, the Obama administration, and some states.

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products.  The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar version of the reference cancer drug Neupogen.

At today’s Massachusetts Public Health Council meeting, Department of Public Health Commissioner Monica Bharel, MD, MPH, announced sweeping changes to the Medical Marijuana Dispensary Program in Massachusetts.

On March 19, 2015, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) issued their annual Health Care Fraud and Abuse Control (HCFAC) Program report highlighting that the HCFAC Program obtained $3.3 billion in health care fraud judgments and settlements in FY 2014.

On April 8th I will be presenting in a Health Care Compliance Association webinar entitled "Hot Topics in Laboratory Compliance."

On March 20, 2015, the Center for Medicare and Medicaid Services ("CMS") and the Office of the National Coordinator for Health Information Technology ("ONC") each released their much-anticipated proposed rules for Stage 3 of the Meaningful Use program and the 2015 Certification Criteria for EHR Vendors, respectively.

Last week I attended the American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues in Baltimore, Maryland. Taking a comprehensive approach to reimbursement issues, the program offered a variety of sessions ranging from Medicare and Medicaid program fundamentals to areas of highly-specific technical expertise.

New York’s Emergency Medical Services and Surprise Bills law went into effect yesterday, which means consumers who receive out of network (OON) emergency services will no longer have to pay more than their usual in-network obligations, regardless of the network status of the treating physician, and any disputed portions of the bill must be settled by the physician and the health plan.

A divided Supreme Court ruled by a 5-4 margin on March 31st that providers may not sue in federal court over the adequacy of state Medicaid rates. The decision in Armstrong v. Exceptional Child Ctr., Inc. has important implications well beyond the narrow group of providers of “habilitation” services for the mentally retarded in the state of Idaho.

ML Strategies has posted its weekly Health Care Update.  This week’s Health Care Update focuses on the latest Congressional developments on the repeal of the Medicare Sustainable Growth Rate (“SGR”), commonly known as the “Doc-Fix” and the Children's Health Insurance Program (“CHIP”) reauthorization.

A small regional hospital’s antitrust suit alleging illegal exclusive dealing and attempted monopolization against its largest competitor will move forward following a district court’s denial of the defendant hospital’s motion for judgment on the pleadings.

Yesterday the Office of Inspector General for the Department of Health and Human Services  (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory and a physician practice could potentially generate prohibited remuneration under the Anti-Kickback Statute.