CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their beneficiaries. CMS’s most recent guidance to Plans regarding the opioid epidemic was included in the Advance Notice and Call Letter.

In November of 2017, in the proposed Medicare Advantage and Part D regulations for CY 2019 CMS set out a framework for Part D plans to monitor and reduce the potential misuse of prescription opioids. Continue Reading CMS’s Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic

Congress is back in session and will begin its work in finalizing a final spending bill for fiscal year 2018. Both chambers are considering new ways to address the opioid crisis, and we should expect a renewed push around gun control and mental health. We cover this and more in this week’s health care preview.

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced a $100,000 settlement with a company that is no longer in business. Filefax, Inc. (Filefax) was an Illinois company that provided storage and delivery services for medical records held by covered entities. OCR had been investigating Filefax since 2015 for allegedly leaving medical records containing PHI of approximately 2,150 patients in an unlocked vehicle in a Filefax parking lot and/or allowing an unauthorized person to remove the files from the facility.

A court-ordered receiver liquidated Filefax’s assets in 2016.  As part of the settlement with OCR, the receiver agreed to pay $100,000 and properly dispose of all medical records and PHI remaining in Filefax’s possession. The settlement amount may be small, but the circumstances are striking. OCR’s pursuit of a settlement against a defunct company serves as a lesson to other health care companies that no one is off limits to HIPAA enforcement actions.

OCR’s press release about the settlement is available here.

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.  Earlier this month, the Department of Justice (DOJ) announced that a Michigan physician, Dr. Rodney Moret, was sentenced to 75 months in prison for his role in conspiracies to distribute prescription pills illegally and to defraud Medicare. The conduct alleged against Dr. Moret is particularly extreme, but nevertheless reflects the government’s commitment to ferreting out opioid-related misconduct. Continue Reading Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

Mintz Levin’s Antitrust & Federal Regulatory Practice recently published a Health Care Antitrust Alert on the DOJ Antitrust Division’s announced settlement with Henry Ford Allegiance Health (“Allegiance”). The settlement concludes nearly three years of litigation involving claims that Allegiance and rival hospitals unlawfully conspired to restrict the marketing of competing services in some South Central Michigan counties. We published an Alert when the claims were first filed in 2015. The new Alert outlines the terms of the proposed settlement agreement.

Today, the White House released its FY 2019 budget proposal, outlining its policy priorities for the fiscal year. In health care, the President’s budget focuses on prescription drug pricing and opioid funding. It included a number of legislation proposals relating to Medicare Part D, as well as the creation of a Medicaid demonstration allowing states to test new financing structures to cover prescription drugs. The proposal also discusses the future of the Affordable Care Act, including the Medicaid expansion, as well as appropriating cost-sharing reduction payments for FY 2018 through the end of calendar year 2019. Proposals in the budget that are regulatory in nature are certainly items worth monitoring since its likely they would be approved and implemented under this Administration.

We cover this and more in the budget analysis, which can be found here.



This week, the President’s FY 2019 budget will be released, and the Administration will spend the next couple of weeks touting its goals. How this activity is received in Congress will play out in various committee hearings, as will issues like drug pricing, which the Administration is closely examining.  On the regulatory side, is this the week that we finally see action on short-term limited duration insurance plans? We cover what that could mean and more in this week’s health care preview.

Based on the most up-to-date information on the budget deal, we have developed a new timeline for the major health care extenders. This new timeline is important because these provisions were once all tied together and now, they are not.

Click here for the health care extender timeline.

*Note this post assumes the budget deal will pass tonight and is based on information as of 4:00pm on February 8, 2018.

**Emma Zimmerman of ML Strategies contributed to this post.

Mintz Levin’s Health Care Enforcement Defense Group recently published its most recent Health Care Qui Tam Update. This Update analyzes the 47 health care-related qui tam cases unsealed in August and September 2017.  Highlights from this Update include:

  • a relatively high rate of intervention;
  • cases filed in 30 different courts;
  • cases brought against a variety of different health care providers;
  • almost half of the cases filed by current or former employees; and
  • faster times for unsealing cases.

Continue Reading Mintz Levin’s Health Care Enforcement Defense Group Releases New Qui Tam Update

Late last week, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (Advance Notice and Call Letter). The Advance Notice and Call Letter should be read hand-in-hand with the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for the Medicare Advantage (MA) CMS-HCC Risk Adjustment Model (2019 MA Risk Adjustment Changes) that CMS released on December 27, 2017.  Both documents request comments from interested parties and have a submission deadline of March 5, 2018. Continue Reading CMS Releases Advance Notice and Call Letter for Medicare Advantage and Part D