Health Law Advisor

On November 1, 2018, the Office of the Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published an audit report finding that the U.S. Food and Drug Administration’s (“FDA”) policies and procedures were “deficient for addressing medical device cybersecurity compromises.” (A copy of OIG’s complete report is available here and Report in Brief is available here.) Specifically, the OIG found that FDA’s policies and procedures were “insufficient for handling postmarket medical device cybersecurity events” and ...

While the opioid crisis has inspired a wave of new legislation by Congress, the U.S. Department of Justice (“DOJ”) has continued to increase its own response to the prevalent rate of opioid-related drug crimes with a number of new initiatives.  On October 17^th, Deputy Attorney General Rod Rosenstein recently delivered remarks at the America’s Health Insurance Plans 2018 National Conference on Medicaid and highlighted the Department’s continued determination to tackle the opioid crisis. Rosenstein’s remarks reiterated Attorney General Jeff Sessions’ recent ...

On November 2, 2018 CMS announced the finalization of the 2019 OPPS and ASC payment rules which were initially proposed in July of 2018.[1] [2] While the final document will not be officially published until November 21st, an Inspection Copy is available for the public to review on the Federal Register website. These new payment rules in many ways expand the range of services that CMS will reimburse when performed at Ambulatory Surgical Centers (ASCs), most notably, by including certain cardiac catheterization procedures on the approved list, and by lowering the threshold that ...

Massachusetts employers with six or more employees are required to annually submit the new Health Insurance Responsibility Disclosure (“HIRD”) form, regardless of whether they offer health insurance to their employees or not. The Massachusetts Department of Revenue (DOR) recently issued guidance on the new HIRD reporting requirements. An individual is considered to be an employee if the employer has included such individual in the quarterly wage report to the Department of Unemployment Assistance during the past 12 months. The new HIRD form only consists of a single ...

On October 24, 2018, President Trump signed sweeping bipartisan legislation to combat the opioid epidemic. The Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act (“H.R. 6” or “the Law”), aims to “reduce access to the supply of opioids by expanding access to prevention, treatment, and recovery services.”[1] Congress has already appropriated $8.5 billion to implement this “landmark legislation” in 2018 and 2019.

In a series of Client Alerts, Epstein ...

On October 26, 2018, the Federal Trade Commission (FTC) announced that it will hold four days of hearings between December of 2018 and February of 2019 to examine the FTC’s authority to deter unfair and deceptive conduct in data security and privacy matters.[1] The two days of December hearings will focus on data security, while the two days of February hearings will focus on consumer privacy. This announcement comes as part of the agencies Hearings on Competition and Consumer Protection in the 21^st Century, an initiative that has already scheduled hearings on closely related ...

On October 25, 2018, the Centers for Medicare and Medicaid Services (CMS) released an advance notice of proposed rulemaking (ANPRM) to solicit feedback on its newly proposed International Pricing Index (IPI) model for Medicare Part B drug reimbursement.  The IPI model will be tested by the CMS Innovation Center as a potential means to dismantle and replace the current buy-and-bill model and advance the Trump Administration’s agenda for drug pricing reform, as described in its May 2018 Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.  The framework of the IPI model is ...

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, D.C., on October 4-5, 2018. The purpose of this and other public meetings of MedPAC is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. These meetings offer a comprehensive perspective on the current state of Medicare as well as future outlooks for the program.

As thought leaders in health care law, Epstein Becker ...

Recent comments by the Federal Trade Commission (FTC) Commissioner Rohit Chopra should have companies on notice for increased enforcement actions across the board. During the “Privacy. Security. Risk.” Conference in Texas last week, Chopra made comments regarding his views on increasing enforcement, including the imposition of greater civil monetary penalties. “I’ve already raised concerns about settlements we do with no monetary penalties. I want to see monetary consequences for egregious breaking of the law” said Chopra as reported by the IAPP during a live ...

On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude ...