Health Care

On May 6, 2015, CMS issued interim final rules relating to Medicare Part D beneficiary access to Part D drugs. Through the rules, CMS announced updates regarding the impending prescriber enroll or opt-out effective date, provisional supplies, and “other authorized prescribers” (a newly defined term).

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers.

ML Strategies has 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.

The HHS Office of the National Coordinator for Health Information Technology (“ONC”) recently released a new and improved version 2.0 of their Guide to Privacy and Security of Electronic Health Information.

The Centers for Medicare & Medicaid Services (CMS) recently added to the trend toward greater health care data transparency by releasing data about the prescription drugs that physicians and other health care providers prescribed in 2013 under the Medicare Part D Prescription Drug Program.

Historically, the Center for Medicare and Medicaid Services ("CMS") issues all Medicare beneficiaries a paper card that includes the beneficiary's name, Medicare number and eligibility status.

In an April 22, 2015 letter to the New York State Department of Health, the Federal Trade Commission (FTC) cautioned that part of the state’s Medicaid reform program may sanction anticompetitive behavior.

Last week, new bi-partisan legislation was introduced to increase the number of graduate medical education (GME) slots over the next five years at teaching hospitals and academic medical centers.

On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA).

A tip from a local Denver news outlet lead to a compliance review, investigation and ultimately a resolution agreement between the Department of Health and Human Services' Office for Civil Rights ("OCR") and Denver-based Cornell Prescription Pharmacy ("CPP").

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.