Legal Insights and Perspectives for the Healthcare Industry

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the healthcare industry and a trio of district court decisions halting enforcement of the public charge rule, FDA draft guidance on clinical decision support software, and federal recommendations for avoiding medical events involving radioactive material overflowed from our trick or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.

Several lawyers from our healthcare industry team recently attended HLTH in Las Vegas. HLTH provided a showcase for innovative ideas, platforms, and programs embracing the concept of “patient-centered care.”

This year’s event offered particular focus on innovations addressing the social determinants of care, elements of daily life that create barriers to receiving health services. As one executive of a large hospital system mentioned, they were reframing the institution’s vision around “health” and not “healthcare.” From programs in states partnering with ride-share apps to ensure Medicaid beneficiaries made their appointments, to highly integrated medical record and patient communication platforms designed to meet patients in their own space, there were numerous examples of business opportunities and legal challenges.

In Part 2 of a two-part Morgan Lewis series for Bloomberg Law on the proposed Stark Law and anti-kickback statute (AKS) rules, Kathleen McDermott, Matt Hogan, and Jacob Harper examine the safe harbors and exceptions aimed at empowering patients to manage their healthcare. Noting that value-based care can only be achieved when patients no longer sit on the sidelines, the authors ask whether the proposed AKS safe harbors are bold enough, and conclude there may be more that the Office of the Inspector General and the Centers for Medicare & Medicaid Services could do.

Read the full Bloomberg Law article >>

The US House of Representatives unanimously voted to approve HR 647, the Palliative Care and Hospice Education and Training Act (PCHETA), on October 28. This legislation would amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited medical, nursing, and social work schools and other programs (including physician assistant education programs); promote education and research in palliative care and hospice; and support the development of faculty careers in academic palliative medicine. PCHETA now moves to the Senate where a similar measure, S 2080, has been referred to the Committee on Health, Education, Labor, and Pensions. However, given the fast approaching deadlines for Congress to fund the government and reauthorize expiring programs, this legislation may not receive attention in the near term. We will continue to monitor the bill’s progress and keep you apprised of any new developments.

Law clerk Ariel Landa-Seiersen contributed to this blog post.

With bipartisan bills introduced in both the US House of Representatives and the US Senate on October 30, Congress appears ready to expand access to telehealth benefits for Medicare beneficiaries. The Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2019 (CONNECT Act) may eliminate significant barriers Medicare beneficiaries currently face in accessing and utilizing telemedicine. The CONNECT Act acknowledges the potential for telehealth services to promote the “three pillars” of healthcare—expanding access, improving quality, and reducing spending—particularly at a time where healthcare workforce shortages make it difficult for many Medicare beneficiaries to access the care they need.

The Office of the Inspector General and the Centers for Medicare and Medicaid Services recently published a pair of proposed rules aimed at encouraging the adoption of value-based payment and care. In Part 1 of a two-part Morgan Lewis series for Bloomberg Law, Al Shay, Donna Clark, and Banee Pachuca unpack the proposed Stark Law exceptions and anti-kickback statute safe harbors that share similarities but differ in design when it comes to protecting physician compensation arrangements that advance value-based care. Potential challenges presented by the proposed rules with respect to obtaining safe harbor protection, encouraging payor participation, and absorbing downside financial risk are also addressed.

In addition, Al and Donna will be joining Jake Harper to talk about the Stark Law changes in more detail during our October 30 Fast Break—make sure to register!

Read the full Bloomberg Law article >>

The FTC announced on October 21, 2019, that its Commissioners voted 5–0 in support of issuing orders requesting information from five health insurance companies and two health systems to study the effects of Certificate of Public Advantage laws (COPAs) on price, quality, access, and innovation in the healthcare sector. The FTC has demanded an extensive amount of data from the targeted entities by January 21, 2020. Also notable in the FTC’s announcement is that the agency will study the impact of hospital consolidation on employee wages.

We invite you to join us on Wednesday, October 30, for Part 1 of our two-part Fast Break: Regulatory Sprint webinar. In a recent Health Law Scan post, we highlighted two rules proposed 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 calls the “Regulatory Sprint to Coordinated Care Initiative.” In Part 1 of this Fast Break, Donna Clark, Albert Shay, and Jacob Harper will discuss the CMS’s proposed rule on Stark Law changes. Stay tuned for Part 2 when we discuss the OIG’s proposed rule on Anti-Kickback Statute and Civil Money Penalty changes.

Register for the webinar now.