CMS Pub. 100-02, ch. 13, § 80.1

RHCs are required to file a cost report annually in order to determine their payment rate

and reconcile interim payments, including adjustments for GME payments, bad debt,

influenza, pneumococcal, hepatitis B and COVID-19 vaccines, and covered monoclonal

antibody products used as pre-exposure prophylaxis prevention of COVID-19 and their

administration. If in its initial reporting period, the RHC submits a budget that estimates

the allowable costs and number of visits expected during the reporting period. The A/B

MAC calculates an interim rate based on a percentage of the per-visit limit, which is then

adjusted when the cost report is filed.

FQHCs are required to file a cost report annually and are paid for the costs of GME, bad

debt, influenza, pneumococcal, hepatitis B and COVID-19 vaccines, and covered

monoclonal antibody products used as pre-exposure prophylaxis prevention of COVID-

19 and their administration through the cost report. All FQHCs, including an FQHC that

does not have GME costs, bad debt, or costs associated with influenza, pneumococcal,

hepatitis B and COVID-19 vaccines, or covered monoclonal antibody products used as

pre-exposure prophylaxis prevention of COVID-19 and their administration, must file a

cost report.

The RHC and FQHC cost reports were updated to reflect costs related to COVID-19

shots and COVID-19 monoclonal antibody products and their administration, and to

include hepatitis B vaccines with the other Part B vaccines (influenza, pneumococcal and

COVID-19).

Effective for dates of service on or after July 1, 2025, RHCs and FQHCs, shall report all

Part B preventive vaccines and their administration – pneumococcal, influenza, hepatitis

B and COVID-19 -- on the claim at the time of service. Although paid at the time of

service, payments for these services must be annually reconciled with the RHC or

FQHC’s actual vaccine and vaccine administration costs, to ensure these services are

ultimately reimbursed at 100% of reasonable costs through the cost report. This includes

any in-home additional costs, if applicable. See section 220.1 and 220.3 of this Chapter

for more information.

Note: Until the end of the calendar year in which the Emergency Use Authorization

(EUA) declaration for drugs and biological products with respect to COVID-19 ends,

CMS covers and pays for these infusions or injections the same way it covers and pays

for COVID-19 vaccines when furnished consistent with the EUA. That is, for RHCs and

FQHCs COVID-19 monoclonal antibody products (when purchased from the

manufacturer) and their administration are paid at 100 percent of reasonable cost through

the cost report. Effective January 1 of the year following the year in which the EUA

declaration ends, CMS will cover and pay for monoclonal antibody products used for the

treatment or for post-exposure prophylaxis of COVID-19 in the same way we pay for

other Part B drugs and biological products. For RHCs, payment is through the All-Inclusive Rate and for FQHCs payment is through the FQHC Prospective Payment

System.

RHCs and FQHCs must maintain and provide adequate cost data based on financial and

statistical records that can be verified by qualified auditors.

RHCs and FQHCs are allowed to claim bad debts in accordance with 42 CFR 413.89.

RHCs may claim unpaid coinsurance and deductible, and FQHCs may claim unpaid

coinsurance. RHCs and FQHCs that claim bad debt must establish that reasonable efforts

were made to collect these amounts Coinsurance or deductibles that are waived, either

due to a statutory waiver or a sliding fee scale, may not be claimed.