Legal Insights and Perspectives for the Healthcare Industry

In what has become the new “normal” in Washington, DC, these days, hospitals and their associations filed a lawsuit today against the US Secretary of Health and Human Services (Secretary) challenging the recent Final Rule issued by the Centers for Medicare and Medicaid Services (CMS) on November 27, 2019, addressing hospital pricing disclosures.

In its complaint, the American Hospital Association, joined by the Association of American Medical Colleges, the Federation of American Hospitals, the National Association of Children’s Hospitals, Inc. (d/b/a Children’s Hospital Association), and three representative hospitals in Missouri, California, and Nebraska (collectively, Plaintiffs), argue that the Secretary issued a Final Rule that (1) is unlawful and in excess of his statutory authority; (2) is a violation of the First Amendment by unlawfully compelling speech; and (3) is arbitrary and capricious, an abuse of discretion, and contrary to law, citing the Administrative Procedures Act (APA).

US government–funded academic medical centers and other research institutions are caught between traditional values of academic freedom, collaboration, and nondiscrimination and their obligations to comply with US law and enforcement authorities. So far, academic medical centers and other research institutions have avoided prosecution by cooperating with the US government, but they are well advised to review their vetting and disclosure policies with respect to visiting non-US or dual national scholars and students while not targeting specific ethnic groups. From a practical standpoint, US academic medical centers and other research institutions conducting federally funded research need to be careful to address both export and deemed export control issues, as well as potential conflicts of interest in applying for and using the results of US government–funded research. Academic medical centers and other research institutions should follow closely the increased enforcement activities of the US government and recent congressional recommendations for further changes to safeguard US government–funded research, which are detailed below.

The government watchdog agencies continue to focus their attention on Medicare oversight of hospice providers, with two recent reports from the US Government Accountability Office (GAO) and the HHS Office of Inspector General (OIG) focused in large part on ways to improve hospice surveys and nursing care oversight deficiencies. These reports, along with a portfolio of other OIG hospice reports, are giving way to renewed focus by the Centers for Medicare and Medicaid Services (CMS) on hospice surveys as well as by Congress, where legislation in the Senate (and soon the House) has focused on providing CMS with additional hospice survey tools. Proactive hospice providers will do more than take notice of these watchdog agency reports—they will also compare their practices with the critical findings in these OIG and GAO reports to prepare for what will likely be the future focus of Medicare hospice surveys, whether by state agency surveyors or accreditation organizations.

Price transparency rules impacting hospitals, health plans and third-party payers released by the Trump administration promise to substantially change how health plans, consumers, and providers will interact over the coming years. In this LawFlash, our healthcare industry team unpacks the final rule requiring hospitals to make standard charges public and the proposed transparency in coverage rule requiring group health plans and health insurance issuers to disclose negotiated rates with providers and out-of-network estimates for consumers. Across the industry as a whole, plans and providers alike will have to undertake additional costs to update their current programs, technology, and web pages to comply with the price transparency rules and take on or train personnel to maintain that programming and technology.

Read the LawFlash >

Healthcare is the largest labor market in the United States, employing over 18 million workers. Our labor, employment, and benefits team has compiled a list of hot topics and trends in employee benefits to watch in 2020. Key takeaways addressed in this important presentation include health and welfare preventative care services, fringe benefits, taxpayer identity theft, part-timers and 401k plans, and more.

Read the presentation >>

Healthcare providers dedicate approximately $39 billion per year to administrative activities related to regulatory compliance, according to research conducted by the American Hospital Association, which found the pace of regulatory changes “has begun to exceed many providers’ ability to absorb them.” To that end, understanding the federal rulemaking process and knowing when and how to get involved is critical for the healthcare industry.

In a recent webinar, Susan Harthill, Jonathan Snare, and Timothy Lynch addressed the ins and outs of the federal rulemaking process, including:

  • The differences between rules, policy statements, and other types of guidance
  • Why submitting comments is more critical now than ever

CMS has released a pair of rules “that take historic steps to increase price transparency to empower patients and increase competition among all hospitals, group health plans and health insurance issuers in the individual and group markets.” To that end, health plans would be required to disclose their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers on a public website, according to the proposed rule. CMS also finalized its proposed hospital price transparency program released as part of the CY 2020 proposed outpatient prospective payment system (OPPS) rule last August.

Morgan Lewis is reviewing these rules more fully and will provide additional analyses on the proposed health plan rule and the final hospital transparency rule in the coming days.

We invite you to join us on Wednesday, November 20, for our second installment of the Fast Break: Regulatory Sprint series. In a recent Health Law Scan post, we discussed the two proposed rules by the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what the US Department of Health and Human Services (HHS) calls the “Regulatory Sprint to Coordinated Care Initiative.”

Last month, we held Part 1 of the series, which highlighted CMS’s proposed rule on Stark Law Changes. This month, Katie McDermott, Matthew Hogan, and Jake Harper will discuss the OIG’s proposed rule on the Anti-kickback and beneficiary inducement Civil Money Penalty changes.

Register for the webinar now.

You can also check out a recent Bloomberg Law article the presenters wrote on “OIG Proposed AKS Safe Harbors For Patient Incentives – Getting Patients Involved.”

October might be known traditionally for pumpkin patches, fall festivals, creative costumes, and haunted houses, but Health Law Scan will remember it as the month when proposed rules on Stark exceptions and AKS safe harbors were unveiled. In between stocking up on candy corn and picking out gourds for autumnal décor, Health Law Scan posted continuing coverage on the proposed rules, unpacking the detail and assessing what they mean for the healthcare industry.

Additional developments that lit up our Jack-o’-lanterns included new bipartisan legislation to expand telehealth benefits for Medicare beneficiaries, the FTC’s decision to study the Certificate of Public Advantage laws and their effect on healthcare, and takeaways for assessing privacy compliance under the New York SHIELD Act. An update on visa requirements affecting the healthcare industry and a trio of district court decisions halting enforcement of the public charge rule, FDA draft guidance on clinical decision support software, and federal recommendations for avoiding medical events involving radioactive material overflowed from our trick or treat bag.

So if you missed any of Health Law Scan’s memorable Okoberfest—given the distraction from all that candy, funnel cake, and brat and wurst—look no further, it’s all right here!

The US District Court for the District of Oregon on November 2 issued a temporary restraining order (TRO) to block the new health insurance requirement for immigrant visa applicants from taking effect on November 3, 2019. As discussed in an earlier alert, the White House issued a presidential proclamation that sought to deny admission to the United States of “immigrant” foreign nationals that will “financially burden the United States healthcare system.” The proclamation effectively deems aliens seeking to immigrate permanently to the United States inadmissible unless they will be covered by “approved” health insurance within 30 days of their entry into the United States or have the financial resources to pay for “reasonably foreseeable” medical costs.