We had a great time last Thursday celebrating the American Health Lawyers Association's AHLA Day 2019. Each April, AHLA hosts receptions in multiple cities to bring together the health lawyer community. This year, Morgan Lewis came out in force at the Washington, DC, reception held at McCormick and Schmick's. Michele Buenafe, Joyce Cowan, Ryan Kantor, Amanda Robinson, Jonelle Saunders, and Jake Harper had the opportunity to catch up with colleagues and friends new and old.
We're excited to introduce Tele-Tuesdays, a new feature on Health Law Scan where we'll bring you the latest updates in the world of telehealth legal issues. From new regulations and legislation to enforcement actions and changes in the telehealth landscape, we'll cover it all.
Federally, telehealth continues to be a central feature of the government’s efforts to expand access and control soaring healthcare costs. Just last week, CMS finalized its rules implementing the Bipartisan Budget Act of 2018, which will increase flexibility for Medicare Advantage (MA) plans offering telehealth services irrespective of whether a patient is in a rural or urban area. Right now, MA plans are working feverishly to redesign their telehealth benefits in anticipation of plan year 2020. Providers interested in offering telehealth services should assess their current MA contracts and consider engaging with plans to make sure their telehealth services are covered. According to Kaiser Family Foundation, MA plans now cover 34% of Medicare beneficiaries, so this will be a momentous occasion in the expansion of telehealth coverage. And should the results of this expansion be as favorable as anticipated, expect future legislation that will expand telehealth to all Medicare beneficiaries, whether enrolled in MA plans or in Original Medicare.
Daniel Levinson, the HHS Inspector General (IG), tendered his resignation to President Donald Trump on April 2, effective May 31. Mr. Levinson was the longest serving HHS-IG and under his leadership, the watchdog managed a wide array of oversight, including checks on the implementation of the Affordable Care Act. The HHS-OIG is the largest inspector general office among federal agencies helping to police over 200 HHS programs as well as the massive Medicare and Medicaid programs. The current Principal Deputy Inspector General Joanne Chiedi will become the acting IG on June 1.
Undoubtedly the next HHS-IG appointee will be a staunch advocate of fraud and abuse enforcement, and likely will have years of government audit or enforcement experience, as was the case with previous HHS IGs. It remains to be seen, however, if the appointee will also have private industry experience and will bring to bear deep knowledge of an evolving healthcare delivery system.
In a March 19 letter to CMS and HHS-OIG, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) continued their oversight efforts regarding physician-owned distributorship (POD) relationships by raising questions about US Sunshine compliance by PODs. PODs involve the ownership of medical device distributorships by surgeons who use or recommend those products in their surgical procedures. The senators are critical of CMS and OIG efforts to expose and deter POD arrangements, citing long-held concerns that POD arrangements are, as the OIG has suggested in a prior Fraud Bulletin, "inherently suspect” and abusive arrangements that promote medically unnecessary services. The March letter raises an often debated question regarding POD compliance with Physician Sunshine Rules and whether CMS or the OIG have taken sufficient steps to assure transparency compliance with these particular arrangements.
The cool winds of March blew red-hot for the Health Law Scan beginning with a new Senate inquiry into tax-exempt hospitals and ending with an announcement by the US Department of Justice that the Affordable Care Act should be invalidated. In between, we filled out this month’s March Madness bracket with a rundown of important provisions from the proposed interoperability rule, how divided government impacts the healthcare industry, a recap from a very interesting Fast Break on radioactive materials in hospitals, insights for FCA practitioners from the Justice Department, and much more. No worries if you missed anything, we have all for you right here:
- Medicare for All – Fault Lines, Tradeoffs, and Potential for Disruption
- In a Surprise Turn, DOJ Asks Fifth Circuit to Invalidate ACA
- Recap on Fast Break: Radioactive Materials
- Assistant AG Discusses Transparency in DOJ’s Decisionmaking Process
- Interoperability and Patient Access to Health Data Proposed Rules Are Here: Comments Due May 3
- The 116th Congress – How Divided Government May Impact the Healthcare Industry
- DOJ Offers Insight for FCA Practitioners at Qui Tam Conference
- Immigration Update: Spouse Work Authorization and Application to Extend/Change Nonimmigrant Status
- US Supreme Court Signals Interest in FCA Pleading Requirement and the Appointments Clause
- Senate Finance Committee Sends Inquiry to IRS on Tax-Exempt Hospitals
“Medicare for All” has appeared in the nation’s political dialogue as we head into the next election cycle, with a number of plans being proposed by Democratic lawmakers. Recent public opinion polls show a growing surge in popularity for expanding the federal program that currently insures older Americans. Yet the polls also show a decline in favorability for Medicare for All when respondents are asked about the details of the plans. While there appears to be general agreement that Americans should have access to affordable coverage, the Democratic plans differ over options for reforming the health insurance system. To that end, the Medicare for All plans can be divided into one of two categories: a single payor or a public option plan. From there, the proposals diverge over a mix of fault lines, tradeoffs, and potential for disruption.
In a tersely worded letter to the US Court of Appeals for the Fifth Circuit, the US Department of Justice (DOJ) announced on Monday that it “has determined that the district court’s judgment in Texas v. U.S. should be affirmed” and “is not urging that any portion of the district court’s judgment be reversed.” In December 2018, Judge Reed O’Connor of the US District Court for the Northern District of Texas reignited the simmering debate over the Affordable Care Act’s (ACA’s) ultimate survival when he ruled the entire law unconstitutional in Texas v. U.S. In a surprising reversal of its previously stated position that only certain provisions of the ACA (such as the ban on preexisting condition protections) should be severed from the statute, the DOJ is now asking the Fifth Circuit to invalidate the entire law. Even before yesterday’s abrupt change of course by the DOJ, the US Department of Health and Human Services has said that it will continue to administer and enforce the ACA during the appeals period.
We had a really enjoyable Fast Break yesterday on a non-traditional health law topic: radioactive material regulation. As it turns out, nearly all hospitals and larger provider groups, particularly those doing imaging, oncology, or neurosurgery, routinely use or come into contact with regulated radioactive material. PET scans, for instance, which are operated by a significant number of hospitals, rely on radioactive isotopes as the basis of the imaging procedure. Morgan Lewis partner Lewis Csedrik and associate Roland Backhaus explained that providers are regulated by the Nuclear Regulatory Commission (NRC) and/or similar state-based agencies (called Agreement States). Each provider has to secure a specific license for use of radioactive materials, which entails designating a radiation safety officer and establishing a radiation safety plan.
In recent remarks, Assistant US Attorney General Brian A. Benczkowski emphasized that the US Department of Justice remains serious about fighting corporate fraud and corruption, and noted that transparency in its criteria for prosecution is a key tool for both DOJ and private sector companies. Stressing the importance of effective compliance programs, he noted that companies are more likely to implement such programs when it is clear what conduct DOJ will credit or penalize.
The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on March 4 to help patients more easily access their complete health information in interoperable forms across programs that CMS administers (the Interoperability Rule). In the rule’s preamble, CMS lays out a vision of an environment in which a patient’s health information can move seamlessly between health plans, providers, and post-acute care settings. CMS observes that while adoption of electronic health records (EHRs) by healthcare providers has been significant, progress on interoperability needs to be accelerated. The Interoperability Rule fact sheet is available here. While there are several new proposals and requests for information in the 71-page document, this post provides an overview of two of the Interoperability Rule’s proposals.