CMS Finalizes Physician Fee Schedule That Expands Telehealth Services
Centers for Medicare & Medicaid Services (“CMS”) has released its final rule for the Medicare physician fee schedule (“PFS”), effective January 1, 2021. Under the final rule, the PFS conversion factor for 2021 is $32.41, which is down 10 percent from $36.09 in 2020.
The final rule expands the list of Category 1 and 2 telehealth services covered by Medicare to include services such as group psychotherapy, neurobehavioral status exams, and domiciliary or rest home services for established patients. CMS has also finalized a third temporary category of criteria of telehealth services during the COVID‑19 pandemic – those for which there is a likely clinical benefit outside of the public health emergency (“PHE”) when furnished via telehealth, but for which there is not yet sufficient evidence available to consider the services as permanent additions under Category 1 or 2. The final rule adds nearly 60 services to the Category 3 list, which will be covered by Medicare through the end of the calendar year in which the PHE ends.
The final rule also makes permanent the policy allowing non‑physician practitioners, i.e. nurse practitioners, clinical nurse specialists, and physicians assistants, to supervise diagnostic tests if state law allows. Moreover, direct supervision, which, in response to the PHE, CMS revised to include the virtual presence of a supervising physician or practitioner, can continue to be provided virtually until the latter of end of the calendar year in which the PHE ends or December 31, 2021.
In addition, the final rule makes changes to evaluation and management services and codes, including increasing payments for such services. According to CMS Administrator Seema Verma, this final rule “marks the most significant updates to E/M codes in 30 years . . . by rewarding time spent evaluating and managing their patients' care.”
The PFS will be published in the Federal Register on December 28, 2020. Comments, which are due February 1, 2021, will be accepted/considered only on the interim final rules for Coding and Payment of Virtual Check-in Services and Personal Protective Equipment (PPE).
In addition, as many practitioners already know, the United States Department of Health and Human Services (“HHS”), through the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), allowed providers to provide telehealth services across state lines for covered services, including diagnostic tests, to combat the spread of COVID-19. On December 3, HHS amended this Declaration to allow healthcare providers to order or administer "covered countermeasures" to COVID‑19, such as diagnostic tests that received emergency use authorization from the FDA across state lines. Interestingly, HHS has taken the position that the Declaration preempts any state law that would inhibit the Declaration.
CMS Issues New Proposed Rule to Simplify Prior Authorizations
CMS issued a proposed rule with the intent to streamline prior authorizations. The proposed new rule would require payers in Medicaid, Children's Health Insurance Program, and Qualified Health Plan programs to build application programming interfaces (“APIs”) to support data exchange and prior authorization. Payers will have a maximum of 72 hours to issue a decision, and will be required to provide a specific reason for any denial, which will allow providers some transparency into the process. To add transparency, the rule would require plans to make public certain metrics that demonstrate how many procedures they are authorizing. Comments are due by January 4, 2021.
HHS Proposes New Rule Expanding Access to PHI
HHS issued a proposed rule with the intent to strengthen an individual’s access to their own protected health information (“PHI”) while simultaneously facilitating greater and easier exchange of PHI. First, the rule permits individuals to inspect their PHI in person, including take notes or use other resources to view, capture, and retain their own records. Second, the response time for HIPAA covered entities to provide an individual with access to their PHI would be shortened from 30 days to 15 days. Third, the rule would lay the foundation to allow individuals to directly share their PHI and electronic health records (“EHR”) among covered health care providers and plans. Fourth, the proposed new rule sets forth specifications for when electronic PHI must be provided to individuals at no charge and requires covered entities to post estimated fee schedules on their websites for both PHI access and disclosures as well as provide individualized estimates of fees for an individual's request for copies of PHI.
The National Cybersecurity Center of Excellence Issues New Guidance on Telehealth & Remote Patient Monitoring
The National Cybersecurity Center of Excellence (“NCCoE”), part of the National Institute of Standards and Technology (“NIST”) recently published guidance entitled “Securing Telehealth Remote Patient Monitoring Ecosystems.” NCCoE recognized that since the onset of the COVID-19 pandemic, telehealth and remote patient monitoring has grown exponentially while adequate privacy and cybersecurity measures have not kept up. The NCCoE, in collaboration with commercial industry partners, built a laboratory environment and tested and demonstrated how healthcare providers privacy and cybersecurity controls enhance telehealth and remote patient monitoring. To that end, as part of its guidance, NCCoE offers its best practices to implement cybersecurity and privacy controls and policies for remote patient monitoring and telehealth.
HHS Finalizes Rules on Guidance Documents
HHS finalized its rule governing the agency's release and maintenance of guidance documents. The regulations are intended to ensure that the public receives appropriate notice of new guidance and that the Department's guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them. The final rule is also designed to increase accountability, improve the fairness of guidance issued by the Department, guard against unlawful regulation through guidance, and safeguard the important principles underlying the United States administrative law system.