Legal Insights and Perspectives for the Healthcare Industry

As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the coronavirus (COVID-19) crisis. We noted that the Office of Inspector General (OIG) and the Office for Civil Rights (OCR) at HHS simultaneously issued policy statements with respect to their exercise of enforcement discretion regarding, respectively, telehealth-related copay waivers and HIPAA violations. These coordinated policy announcements represent a concerted effort by federal government agencies to broaden telehealth flexibility to immediately promote and expand the use of technology to help Medicare beneficiaries follow guidance from the CDC, including practicing social distancing, thereby enabling vulnerable beneficiaries and beneficiaries with mild symptoms to access the care they need from their homes. Not only will this help protect Medicare beneficiaries who are particularly vulnerable to COVID-19 infection, it presumably will help deter the spread of the virus and ease the burden on already over-stressed emergency departments, doctor’s offices, and other healthcare facilities.

In the face of the coronavirus (COVID-19) pandemic, the US president’s National Emergency Declaration, issued on March 13, set in motion several actions required of other agencies to provide the regulatory relief needed to ensure that healthcare providers have flexibility in responding quickly to the growing need in the United States.

First, the secretary of the US Department of Health and Human Services (HHS) issued a Waiver or Modification of Requirements under Section 1135 of the Social Security Act on March 13, with a retroactive effective date of March 1, 2020 (1135 Waiver). The 1135 Waiver suspends certain Medicare, Medicaid, and Children’s Health Insurance Program requirements “only to the extent necessary, as determined by the Centers for Medicare & Medicaid Services” to meet the needs of those programs’ participants and to assure that providers furnishing care to such participants in good faith are reimbursed.

Healthcare industry lawyers Eric Knickrehm and Jake Harper recently authored a LawFlash analyzing medical licensure waivers issued in connection with the coronavirus (COVID-19) emergency that permit healthcare professionals to receive federal healthcare program reimbursement for telehealth services in states where they do not hold a license.

Noting that such waivers are limited in scope to conditions of participation and payment for federal healthcare programs such as Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP), Knickrehm cautions that “these waivers alone do not waive the requirement for physicians and other healthcare providers to maintain licensure in states where they are practicing a licensed profession, including via telehealth.” Waivers by state medical boards to implement emergency changes to licensure requirements are also addressed.

Read the full LawFLash.

Partner Reece Hirsch recently attended and spoke at the 2020 Health Datapalooza held in Washington, DC. This year, Health Datapalooza was co-located with the National Health Policy Conference, providing attendees with an opportunity to participate in both events and hear the latest developments in digital health and health policy innovation.

The US Department of Health and Human Services (HHS) Office of General Counsel (OGC) offered the healthcare industry the benefit of its legal analysis of the recent US Supreme Court opinion in Azar v. Allina Health Services (Allina) with respect to its impact on Medicare payment rules, sharing its Memorandum to the Principal Deputy Administrator & Director of the Center for Medicare dated October 31, 2019 (OGC Memo) with the public. The OGC recognized at the outset the primary directive of the decision –“The Supreme Court made clear that Congress has imposed more stringent procedural requirements for certain Medicare rules than the framework that otherwise would apply under the Administrative Procedure Act (APA).”

The OGC then offered its advice as to the legal implications associated with that directive. If HHS or CMS “issued guidance that, under Allina, should have been promulgated through notice-and-comment rulemaking, the Department's ability to bring enforcement actions predicated on violations of those payment policies is restricted.” This concept works in concert with elements of the Department of Justice's Brand memorandum, which was also referenced in the OGC Memo. The OGC Memo then attempted to draw a distinction between guidance documents that do not require notice-and-comment rulemaking versus those that do. According to the OGC Memo, the principal inquiry in distinguishing between the two is the closeness of the guidance to the relative statutory or regulatory terms.

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.”

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.

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.

Highlighting the US Department of Health and Human Services’ (HHS) efforts to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) have issued two proposed rules that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what HHS calls the “Regulatory Sprint to Coordinated Care Initiative.”

The HHS Regulatory Sprint identifies four lanes to better coordinate care:

  • Improving a patient’s ability to understand his/her treatment plans and be empowered to make decisions
  • Increasing providers’ alignment on end-to-end treatment
  • Providing incentives for providers to coordinate and collaborate care with their patients
  • Encouraging information sharing among providers, facilities, and other stakeholders in a manner that facilitates efficient care while preserving and protecting patient access to data

The US Department of Health and Human Services (HHS) recently announced more than $1.8 billion in funding to support the prevention and treatment of opioid addiction. This latest round of funding, authorized in conjunction with the continuing implementation of the 2018 SUPPORT Act, will be awarded by the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) to states and local communities.

The CDC will provide more than $900 million to help state and local governments track overdose data “as closely to real-time as possible.” Packaged as a three-year cooperative agreement “to scale-up prevention and response activities,” the CDC will distribute $301 million in funding for the first year to states, localities, and some territories beginning in September 2019.