Health Care

In a much anticipated appellate health care antitrust decision, the United States Court of Appeals for the Ninth Circuit upheld a district court’s finding that a consummated hospital-physician group merger violated Section 7 of the Clayton Act, despite the provider-defendants’ assertion of an efficiencies defense based on integrated care and risk-based reimbursement.

The Department of Justice (the “Department” or “DOJ”) continued its multi-pronged defense of standards-setting organizations (SSOs) who adopt patent policies to prevent hold-up during licensing negotiations.

2015 promises to be a big year for biosimilars.  Our colleague, Thomas Wintner, recently published an article in Law360 highlighting the biosimilar developments to expect in 2015 and potential areas for future litigation.

Last week, the Centers for Medicare & Medicaid Services (CMS) approved Indiana’s waiver under Section 1115 of the Social Security Act to implement Medicaid expansion, making it the 29th state (including the District of Columbia) to expand Medicaid.

Last week, the Texas Medical Board issued a proposed rule (the “Rule”) clarifying that physicians must perform a face-to-face or in-person physical examination of a patient prior to issuing a prescription or risk sanctions for unprofessional conduct.

One week prior to the unveiling of the President’s first budget under a completely Republican-controlled Congress, the Department of Health and Human Services (HHS) made its most formal announcement yet on the Obama Administration’s efforts to reduce total Medicare and Medicaid spending.

On February 24 and 25, 2015, the FTC and DOJ will host the second public workshop in their series entitled, “Examining Health Care Competition.” 

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.

January 28th is Data Privacy Day.  Given that privacy is the bedrock on which successful health care delivery is built, I would like to mark the occasion with a few thoughts for our health care industry clients and friends.

Last March, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) began a public workshop series entitled, “Examining Health Care Competition.”

The US Department of Justice (DOJ), the Department of Health and Human Services’ Office of Inspector General (OIG), and other federal and state agencies continued to focus on health care enforcement as a top priority in 2014. 

The Office of the Inspector General for the Department of Health and Human Services(“OIG”) responded to concerns expressed by the American Hospital Association (“AHA”) regarding the OIG’s hospital compliance reviews, particularly regarding Medicare Part A.

The Federal Trade Commission continues to analyze relevant products that have not yet been introduced into the market in its merger analysis and Medtronic's Deal Highlights FTC Focus On Future Competition.

Mintz Levin has prepared a chart of the proposed amendments to 42 C.F.R. Part 425 governing the Medicare Shared Savings Program. This chart provides a summary of each proposed amendment and its potential impact.

The Massachusetts Senate has created a Special Senate Committee on Marijuana to assess the Commonwealth’s medical marijuana implementation, to examine marijuana legalization issues in other states, and to make recommendations for the Senate regarding any legalization or ballot initiative on the subject.

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.

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome news for the mHealth community.

Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D billings resulted in falsely inflated claims to those programs.

The Supreme Court heard oral arguments on January 13, 2015 in a government contracts whistleblower case that could have a far-reaching impact on more than just federal contractors.

New York became the 22nd state to sign into law legislation that will require commercial and Medicaid plans to provide coverage of telehealth and telemedicine services. The law, originally intended to take effect on January 1, 2015, will become effective on January 1, 2016.