Health Care

The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31, 2015.

Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss.

Earlier this month, HHS Secretary Silvia Burwell made a game-changing announcement about the Obama Administration’s most significant alternative payment model (APM). 

In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and expeditious flow of information about drugs and medical devices from industry to the Agency.

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

On May 13, 2015, the House Energy and Commerce Committee released the latest draft of its 21st Century Cures Legislation.

Earlier this week, ML Strategies (MLS) 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.

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.”

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.

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").