Legal Insights and Perspectives for the Healthcare Industry

The Morgan Lewis healthcare team continues to monitor the developments surrounding the coronavirus (COVID-19) pandemic. We are acutely aware of what the healthcare service provider community is currently facing and are here to help. We are hosting two webinars a week to address the evolving unprecedented legal issues that arise from pandemic. The webinars will be held on Tuesdays and Thursdays. Below we provide the webinars we have previously hosted, and we will keep our COVID-19 Healthcare Provider Update Webinars page updated with the latest webinars.

UPCOMING SESSIONS

PREP Act and Other Considerations for Hospitals Experimenting with COVID Treatments – 4.7.20

COVID-19 Healthcare Provider Update Webinars – 4.9.20

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.

CMS issued program instructions on March 17 (through a Fact Sheet and FAQ) to implement the Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA), which was enacted on March 6 in response to the coronavirus (COVID-19) crisis. Telehealth and other healthcare stakeholders have been waiting for these program instructions to be released to determine how CMS will fully implement the Medicare telehealth waiver.

Traditionally, under the Medicare program, professional telehealth services are restricted by statute to originating site locations (defined generally as healthcare facilities and physician offices) that are located in rural areas or outside of Metropolitan Statistical Areas (MSAs). Medicare beneficiaries generally would not be allowed to receive telehealth services in their home. CPRSAA waived both of these requirements, enabling Medicare beneficiaries across the country (regardless of urban or rural location) to receive telehealth services, including in their home, from a doctor in a remote location directly through their smart phone or computer.

As part of emergency funding to combat the threat of the 2019 Novel Coronavirus (COVID-19), last week Congress waived many of the telehealth restrictions for Medicare services in certain situations. This monumental change could—depending on how it is implemented—radically alter how telehealth is performed in connection with the government’s most ubiquitous healthcare program. In a win for telehealth advocates, Congress waived the originating site and geographic limitations for coverage of Medicare telehealth services, which heretofore have prevented most commercial forms of telehealth from reaching Medicare beneficiaries. Specifically, Congress allowed the secretary of HHS to waive the originating site and geographic restrictions in Social Security Act § 1834(m) in “emergency areas.” However, only practitioners (or their group practice partners) who have seen a particular patient and billed Medicare for such service within a three-year period are eligible to take advantage of this waiver. In other words, only a practitioner’s established patients who have received Medicare services in the past (and who are in a designated emergency area) are eligible for this program.

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.

It’s October 1, and that means this month is the deadline for the US Drug Enforcement Agency (DEA) to issue its final rules on special registration for telemedicine. The SUPPORT Act, signed into law on October 24, 2018, gave the DEA one year to promulgate regulations specifying the circumstances under which special registration may be obtained and the procedure for doing so. When finalized, special registration should give telehealth providers significantly more flexibility to prescribe controlled substances without first performing in-person exams.

We hope you were able to join us for last month's Fast Break on the Physician Fee Schedule proposed rule. If not, you missed a great session featuring Eric Knickrehm discussing the important changes the proposed rule would have on Medicare Part B. 

Eric provided an overview of the most important aspects of the proposed rule, which was published on August 4, 2019. A number of these changes highlight CMS's increasing emphasis on preventive and low acuity care. For instance, CMS has continued to incentivize Transitional Care Management services and Chronic Care Management services to ensure that patients who were either recently hospitalized or are very likely to be hospitalized have effective care management to avoid further hospitalization.

Coming on the heels of the FCC’s recently proposed $100 million Connected Care Program to fund telehealth-based connections between healthcare providers and patients, and continuing its recognition of the critical role telehealth plays in the healthcare industry, the FCC recently voted to adopt an extensive order overhauling the Rural Health Care (RHC) Program. The RHC Program has been supportive of telehealth services for some time, providing subsidies to rural healthcare providers to lower the expense of their broadband services, including monthly telecom and broadband recurring costs, and funding for special construction and network equipment where the healthcare provider otherwise lacks access to telecom or broadband facilities. (Read our prior blog on the FCC’s proposal.

The RHC Program has significant funding—over $571 million—and this reform is designed to streamline certain procedures, provide priority to rural healthcare in areas that are medically underserved, simplify the calculation of amounts that healthcare providers pay and service providers receive, reform the competitive bidding process, and improve the application process. The FCC intends for these comprehensive program changes to support vital telemedicine and telehealth services in rural communities while promoting efficiency and transparency and avoiding waste, fraud, and abuse.