Federal Updates
HHS Releases Interim Final Rule on COVID-19 Vaccine Coverage, Other Flexibilities
On October 28th, the Department of Health and Human Services (HHS), alongside the Department of Labor and the Treasury Department, released an interim final rule with request for comments (IFC) (available here) in response to COVID-19, with particular emphasis on establishing coverage policies for potential COVID-19 vaccines. HHS is also issuing three toolkits aimed at state Medicaid agencies (available here), vaccine providers (available here), and insurers (available here) to address issues related to access, billing and payment, and coverage.
Vaccine Coverage
- The rule directs the Medicare fee-for-service (FFS) program to cover any vaccine that receives Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) at no cost to beneficiaries.
- The rule mandates that Medicaid programs, Children’s Health Insurance Program (CHIP) plans, Medicare Advantage (MA) and cost plans, and non-grandfathered private group and individual health insurance plans cover “qualifying coronavirus preventive services” (including COVID-19 vaccinations). If applicable, the coverage must be provided without cost sharing and without regard to whether the vaccine provider is in-network or not. The rule also mandates that non-grandfathered group or individual health plans establish such coverage within 15 business days of an applicable recommendation from federal public health agencies.
- For MA plans, if the cost of a new mandated benefit is “significant” (greater than 0.1 percent of national average per capita costs, or about $13 per beneficiary per year), the Medicare FFS program will provide coverage for MA enrollees. In the MA toolkit, HHS states that this policy will be implemented in 2020 and 2021.
Medicaid
- CMS is reinterpreting the federal requirement that states maintain all Medicaid beneficiaries’ enrollment in order to receive an enhanced Federal Medical Assistance Percentage (FMAP) of 6.2 percent. Previously, CMS required states to maintain every beneficiary’s original eligibility group. Under the new rule, states may move enrollees between eligibility groups as long as they remain within the same (or a higher) “tier” of coverage. The three tiers are: (1) coverage that qualifies as minimum essential coverage (MEC); (2) coverage that does not qualify as MEC but still covers both testing and treatment for COVID-19; and (3) other coverage (e.g., family planning only). States may make programmatic changes to coverage, cost sharing, and beneficiary liability, subject to certain individual beneficiary protections.
Medicare
- The rule establishes Medicare add-on payments for new COVID-19 treatments (e.g., convalescent plasma or remdesivir).
- For inpatient services, the add-on payment under the Inpatient Prospective Payment System (IPPS) would be the lesser of (1) 65% of the operating outlier threshold for a COVID-19 hospitalization claim or (2) 65% of the cost of a COVID-19 stay beyond the operating Medicare payment, including the 20% add-on payment for COVID-19 hospitalizations authorized by the CARES Act.
- Under the Outpatient Prospective Payment System (OPPS), for the remainder of the PHE, new treatments will be paid separately even when provided on the same claim as a service packaged into a Comprehensive Ambulatory Payment Classification (C-APC) service. As a result, the new treatment will be paid separately and come with an additional copayment of 20% of the cost of the new COVID-19 treatment, up to the amount of the inpatient deductible. Currently, however, there are no qualifying products.
Other
- The rule allows states to request modifications to the public notice and post-award public participation requirements for Section 1332 State Innovation Waivers during the COVID-19 PHE.
- The rule modifies the Comprehensive Care for Joint Replacement model by extending Performance Year (PY) 5 by adding six months, creating an episode-based extreme and uncontrollable circumstances COVID-19 policy, providing two reconciliation periods for PY 5, and adding Diagnosis-Related Groups 521 and 522 for hip and knee procedures.
HHS Updates Provider Relief Fund FAQs
- HHS will allow providers that submitted data as part of the COVID-19 High Impact Area Distribution and/or the Nursing Home Infection Control/Quality Incentive Payment Distribution an opportunity to submit corrected data with justification for up to 5 business days after the submission deadline.
- Providers who return PRF payments to HHS must also return any accrued interest on the payments if they were held in interest-bearing accounts.
- PRF payments may be used to support distribution of a COVID-19 vaccine licensed or approved by the FDA.
- PRF funds cannot be used to pay for vaccination, including doses and administration fees, for Medicare, Medicaid, or CHIP beneficiaries.
The FAQs are available here.
CMS Updates FAQs with Billing Guidance for Monoclonal Antibodies
On October 28th, the Centers for Medicare and Medicaid Services (CMS) updated their Medicare fee-for-service COVID-19 FAQ document (available here) with information on how hospitals may bill for monoclonal antibody products. CMS will issue a new code for such products after they are available for use and authorized by the FDA. If hospitals utilize such products before then, they may use existing drug administration codes as well as the code C9399 for unclassified drugs or biologics. If the hospital receives the product for free, it will not receive payment for the product. If billed under the hospital outpatient department, this entails billing a nominal charge along with the C9399 code. Such administration may be billed on site, in the patient’s home, or in a temporary expansion site, in line with COVID-19 flexibilities.
State Updates
DOH Ends COVID-19 Flexibility for Health Homes to Accept Verbal Consents
On October 26th, the New York State Department of Health (DOH) issued a notice (available here) to update requirements for Health Homes on obtaining verbal and written consents during the COVID-19 emergency. In previous guidance for Health Homes (available here), DOH allowed providers to use verbal consent for Health Home services when signed consent (wet or electronic) is unobtainable due to the COVID-19 emergency. However, this verbal consent only authorizes the care manager to enroll the member in the Health Home program, not to share Protected Health Information (PHI), receive hospital notifications or RHIO alerts, or communicate with other providers in the care team.
In the new notice, DOH directs Health Homes to begin the process of obtaining signed consents (wet or electronic) within 45 days for all members who have only a verbal consent in place. All attempts to contact the member to obtain proper signed consent must be clearly documented. If the signed consent cannot be obtained within the required timeline, the care manager must document the reason and disenroll the member from the program. A signature must also be obtained from the member for any changes to Health Home consent (e.g. adding or removing providers) that were provided verbally.
This requirement is applicable to all Health Homes, including adult Health Homes, Health Homes serving children, and Care Coordination Organizations (CCOs) for individuals with intellectual or developmental disabilities (IDD).
Governor Cuomo Announces Counties Can Mandate Masks in Schools and Other COVID-19 Updates
On October 27th, Governor Cuomo announced that the State will allow counties and local governments to impose a mandate on schools requiring students to wear masks at all times. On October 27th the Governor also announced (available here) that California has been added to New York State’s COVID-19 travel advisory requiring individuals returning to New York to quarantine for 14 days. Massachusetts now also meets the criteria for the travel advisory; however, similar to other neighboring states that meet the advisory (Connecticut, New Jersey, and Pennsylvania), the quarantine restrictions for Massachusetts will not be feasible. New York State nevertheless discourages non-essential travel between Massachusetts and other neighboring states while they meet the travel advisory criteria.
OPWDD Releases Interim Visitation Guidance for Supportive Residential Facilities
On October 28th, the Office for People with Developmental Disabilities (OPWDD) issued visitation guidance (available here) for residential facilities that provide less than 24-hour staff support to residents, including Supportive Community Residences and non-24/7 (supervised) Individualized Residential Alternatives (IRAs). Because the provider’s staff is not always present, the guidance lays out the provider’s responsibility to ensure that the individual resident is aware of COVID-19 protocols and to facilitate the protocols (e.g., by providing masks and other supplies, instructing the resident to self-conduct a health screening, and maintain a log of visitors for contact tracing).