Health Care

On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the "SaMD Draft Guidance"). The draft guidance was prepared by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF), chaired by Bakul Patel, Associate Director for Digital Health at CDRH, and was endorsed by the IMDRF Management Committee in September 2016.

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate obligations for EpiPen. 

Earlier this week my colleagues, Bruce Sokler and Farrah Short published an alert detailing the FTC's creative solution to permit a presumptively anticompetitive merger for a financially failing medical practice.

Just last month the “Improving Transparency and Accuracy in Medicare Part D Spending Act” was introduced in the Senate to amend the Social Security Act. The bill seeks to prohibit Part D plans (and their contracted pharmacy benefit managers (PBMs)) from retroactively reducing payments to pharmacies for clean claims.

Please join Mintz Levin for a webinar discussing health care fraud enforcement in the pharmacy and pharmaceutical industry on October 26, 2016 at 1 pm (ET). My colleagues Theresa Carnegie, Larry Freedman, and Ellyn Sternfield, members of Mintz Levin’s Health Law and Health Care Enforcement Defense practices, will discuss enforcement trends facing the industry.

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”).

On Friday, Robert Kidwell and Bruce Sokler, members of the Firm’s Antitrust and Federal Regulatory practice group, presented a webinar on the Third Circuit’s hotly anticipated decision on the FTC’s appeal of the District Court’s denial of its request for a preliminary injunction on the merger of Penn State Hershey Medical Center and Pinnacle Health System.

As we've previously reported, the Massachusetts Department of Public Health (DPH) has recently proposed a number of amended regulations in connection with the regulatory review and overhaul mandated by Governor Baker’s Executive Order 562. Senior DPH staff presented these proposed regulations at a Public Health Council Meeting on September 14 (the “PHC Meeting”). 

Join us this Friday at 1:30 pm EDT for a webinar with two of our Antitrust colleagues, Robert Kidwell and Bruce Sokler. They will discuss recent events in the Hershey Hospital merger and their impact on FTC's hospital merger enforcement program. Learn more about these recent updates from the comfort of your computer in our one-hour webinar.

In an unprecedented administrative action, the U.S. Department of Health & Human Services Office of the Inspector General (“HHS-OIG”) penalized a medical billing company for preparing and submitting claims to Medicare for diagnostic tests that were never conducted.

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the global centers of life sciences regulations, including the United States, the European Union (both the unified government and the individual countries), Brazil, Mexico, China, Japan, and other regions.

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to enable the regulations to meet a number of goals, among them ensuring a high quality of care, industry standardization and strong consumer protection for hospital patients.

The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”). 

Lawmakers are again eyeing ways to modernize the Medicare system, including a revamping of the identification cards used by Medicare beneficiaries. On Wednesday, the House Ways and Means' health subcommittee held a hearing on spurring innovation in the health care system. In the meeting, Rep. Peter Roskam (R-Ill.)  said that he will revive legislation that will replace traditional Medicare identification cards with electronically readable cards.

Last month the California legislature passed AB-72, which amends the Health & Safety Code to address reimbursement for out of network (OON) providers who provide services at in-network facilities, such as hospitals and laboratories.

This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products (HCT/P) as well as on the scope of the “same surgical procedure” exception under 21 CFR § 1271.15.

Earlier this week, the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) filed an amicus brief with the Fifth Circuit stating that the Texas Medical Board's (the “Board”) appeal was inappropriate and the Court does not have jurisdiction over the appeal.