On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it had published a new Interim Final Rule with Comment Period (IFC) containing measures meant to remove regulatory barriers to ensure that Americans have access to affordable COVID-19 treatments and vaccines, when available. More specifically, FDA-approved COVID-19 vaccines will be covered for Medicare beneficiaries with no out-of-pocket costs. Private health plans (including non-grandfathered group health plans and health insurance carriers offering non-grandfathered group or individual health insurance coverage) must provide coverage, without cost-sharing, for qualifying coronavirus preventive services, including COVID-19 vaccines. Furthermore, the IFC includes enhanced payments for eligible inpatient cases that involve the use of certain new products authorized or approved to treat COVID-19. During the public health emergency, CMS will also pay for authorized or approved COVID-19 therapies separately from the Comprehensive Ambulatory Payment Classification to encourage the administration of these treatments in hospital outpatient settings.
On October 21, 2020, the Department of Health and Human Services (HHS) announced that it had authorized qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines (when available), and COVID-19 tests, subject to certain conditions. This guidance expands the HHS September 2020 authorization allowing pharmacists to administer childhood vaccines and COVID-19 vaccines. The requirements applicable to pharmacy technicians and authorized pharmacy interns include, among other things:
- The vaccination must be ordered by the supervising qualified pharmacist.
- The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
- The vaccine must be FDA-authorized or FDA-licensed.
- In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation(s).
- In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
- The qualified pharmacy technician or State-authorized pharmacy intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include a hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
- The qualified pharmacy technician or State-authorized pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
- The qualified pharmacy technician must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant State licensing period(s).
- The supervising qualified pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the State or local immunization information system (vaccine registry).
- The supervising pharmacist is responsible for complying with requirements related to reporting adverse events.
- The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or State-authorized pharmacy intern.
- The qualified pharmacy technician and State-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients when appropriate.
The supervising qualified pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
On October 22, 2020, the Department of Health and Human Services (HHS) announced that the Phase 3 Provider Relief Fund (PRF) application period has been expanded to include additional provider applicants, including residential treatment facilities, chiropractors, and eye and vision providers who have not yet received PRF distributions. Regardless of whether or not they accept Medicare and Medicaid, providers can apply for Phase 3 PRF distributions here until November 6, 2020.
On October 22, 2020, the Department of Health and Human Services (HHS) announced that it had updated its final reporting guidance originally published in September. The update includes clarification that, for purposes of relief payment for lost revenues attributable to COVID-19, recipients must submit information showing a negative change in year-over-year net patient care operating income. The updated FAQs on reporting can be found here and the HHS policy memorandum on the reasons for the change can be found here.
On October 20, 2020, the Office for Civil Rights (OCR) at the Department of Health and Human Services announced that it had resolved two religious discrimination complaints concerning clergy access to patients during the COVID-19 pandemic. More specifically, complainants alleged that hospitals had denied requests for clergy to have access to hospital patients to administer requested religious services. The Centers for Medicare & Medicaid Services has emphasized that facilities must ensure patients have adequate and lawful access to chaplains or clergy during the COVID-19 pandemic in conformance with the Religious Freedom Restoration Act and Religious Land Use and Institutionalized Persons Act. Acting with OCR, the named hospitals developed revised religious hospital visitation policies to ensure that patients can freely exercise their religious rights while remaining in conformance with hospital safety and care policies and practices necessary to prevent the transmission of COVID-19.
On October 16, 2020, the Kentucky Department of Public Health published a first draft vaccination plan for distribution of the COVID-19 vaccine to Kentucky’s local health departments and provider organizations as it becomes available in late 2020 or in 2021. The draft vaccination plan considers the phases of vaccination set out by the Centers for Disease Control and Prevention (CDC) and identifies targeted groups for each phase of equitable access to COVID-19 vaccinations in Kentucky:
Phase 1: Potentially limited supply of COVID-19 vaccine doses available—initial efforts will focus on critical populations of healthcare personnel and critical infrastructure workers and medically and situationally vulnerable populations, such as congregate care setting and correctional facility residents.
Phase 2: Large number of vaccine doses available—supplement supply to unvaccinated critical populations (see Phase 1) and expand to essential workers and workers in high public contact jobs, including social service support workers, education personnel, grocery workers, and transportation workers.
Phase 3: Sufficient supply of vaccine doses for entire population—administer vaccines to vulnerable general population (e.g., age 60+, comorbidities), high-risk children, pregnant women, and other high-risk adults, and critical infrastructure workers not included in previous phases.
Phase 4: General population.
On October 16, 2020, CMS announced that it will allow Medicare-enrolled immunizers, including, but not limited to, U.S. pharmacies, to bill and receive direct reimbursement from the Medicare program for vaccinating Medicare beneficiaries residing in skilled nursing facilities (SNFs). In absence of the exercise of such discretion, the Social Security Act’s Consolidated Billing Provisions would have required SNFs to bill for COVID-19 vaccine administration even when SNFs rely on an outside vendor to perform the service. CMS stated that the U.S. is facing an unprecedented challenge in meeting the urgent need to vaccinate the most vulnerable citizens in SNFs where about 30 percent of U.S. COVID-19 deaths have occurred. CMS stated, “Outside immunizers can help fill that urgent need and provide onsite vaccinations at SNFs [but] to do so during this global emergency, Medicare-enrolled vaccinators must be able to bill directly and receive direct reimbursement from the Medicare program.”
The ability of immunizers to directly bill and receive direct reimbursement will be in effect until the latter of: (1) the last day of the calendar quarter in which the last day of the emergency period occurs; or (2) so long as CMS determines that there is a public health need for mass COVID-19 vaccinations in congregate care settings.
On October 14, 2020, the Centers for Medicare and Medicaid Services (CMS) announced the release of a new supplement to its State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth, COVID-19 Version. This toolkit contains helpful examples and insights into lessons learned from various states that have implemented telehealth changes. While this toolkit is aimed at State Medicaid and CHIP agencies, it may also prove helpful to providers.
On October 14, 2020, the Centers for Medicare and Medicaid Services (CMS) announced the addition of 11 new telehealth services that Medicare Fee-For-Service will pay for during the COVID-19 public health emergency, including cardiac and pulmonary rehabilitation services. Medicare will begin immediately paying practitioners who furnish these newly added telehealth services and will continue during the public health emergency. A complete list of services payable under the Medicare Physician Fee Schedule when furnished via telehealth is available here.
In our September 25 post titled “HHS Publishes Reporting Requirements for Provider Relief Fund Recipients and Changes Lost Revenue Calculation,” we reported on the Department of Health and Human Services (HHS) new Post-Payment Reporting Requirements applicable to providers who received payments of more than $10,000 from the Provider Relief Fund and changes to the lost revenue calculation. Concerns have been expressed about these changes. On September 25, 2020, the American Hospital Association (AHA) wrote a letter to HHS asking it to reinstate the COVID-19 Provider Relief Fund (PRF) reporting requirements outlined in HHS’s June 19 frequently asked question that defined both expenses and lost revenues attributable to COVID-19. The June guidance defines “lost revenue” as any revenue lost to COVID-19, while the September formula for lost revenue is significantly narrower. On October 9, 2020, the AHA reported that a bipartisan group of 32 senators signed a letter to HHS expressing concerns about changes to the COVID-19 Provider Relief Fund reporting requirements: “We have grave concerns this change in reporting requirements for funds received from the Provider Relief Fund (PRF) will create uncertainty and financial hardship for hospitals in our states, particularly in rural areas. In the midst of the COVID19 pandemic, our health care providers need more certainty, not less.” In a separate letter, 22 Senate Democrats urged HHS to reinstate the original June reporting requirements: “We are concerned that this change in reporting requirements changes the terms of the relief as providers initially understood them based on the initial June guidelines—further exacerbating the financial challenges and uncertainty that these systems continue to grapple with as a result of the pandemic. Therefore, we respectfully request that you reinstate the original June requirements for determining lost revenue in order to prevent unnecessary financial uncertainty for hospitals and health care providers and to prevent them from being forced to return PRF funds that they have already received.”