This week in Medicare updates—1/20/2021

January 20, 2021

Medicare Insider

CLIA Laboratories Surveyor Guidance for New and Modified CLIA Requirements Related to SARS-CoV-2 Test Result Reporting

On January 8, CMS published a Memorandum to state survey agency directors regarding updates to CLIA laboratory requirements to meet the SARS-CoV-2 test result reporting provisions. The memo includes expanded guidance which will provide information for CLIA surveyors to help consistently survey labs for full implementation of the CLIA SARS-CoV-2 reporting requirements.

Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state agency/CMS branch location training coordinators within 30 days of this memorandum.

CMS Responses to Questions Asked During the March 24 Call with the PACE Community

On January 8, CMS published an FAQ which updates a document originally released April 9, 2020, that compiled a list of questions and answers from a March 24, 2020 PACE call. Topics addressed include clinical concerns, staffing, eligibility/enrollment/recertification, telehealth, quality and reporting programs, billing and payment, and CMS communications. The guidance supplements previous guidance issued on March 17, 2020, to PACE organizations and a separate PACE FAQ that was issued on September 15, 2020.

CMS Pandemic Plan

On January 11, CMS published an updated and significantly redesigned Pandemic Plan, a 91-page document which outlines the steps CMS should take and the authorities CMS has to take action during a pandemic. CMS states Section 4: Policy Response, and Section 6: Operational Response are particularly important for readers to review.

CMS published a Press Release and an Administrator Letter from CMS Administrator Seema Verma on the same date. The letter introduces the pandemic plan and congratulates CMS for the work it has done during the COVID-19 PHE.

New Platform for Submissions of 1135 Waiver Requests and Inquiries - Go Live

On January 11, CMS published a Memorandum to state survey agency directors regarding a new web-based tool meant to help Medicare/Medicaid-participating providers and suppliers in submitting 1135 waiver requests and inquiries. Due to the heavy volume of 1135 waiver requests, CMS is encouraging providers and suppliers to use the new web-based submission tool starting January 11, 2021. The tool is available via the CMS PHE Emergency web portal. CMS is also reminding providers and suppliers that requests do not need to be submitted for anything covered by a blanket waiver. CMS published a YouTube video to provide training on using the tool and a Press Release on the same date.

Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the state/CMS location training coordinators immediately.

Enrollment for Administering COVID-19 Vaccine Shots

On January 12, CMS updated a COVID-19 Vaccine Enrollment webpage with new links to information on state government distribution of vaccines and COVID-19 vaccine progress. The page also includes helpful information on what providers should know about enrollment and vaccine administration.

Final Rule: Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”

On January 12, CMS published a draft copy of a Final Rule regarding a new Medicare coverage pathway, the Medicare Coverage of Innovative Technology (MCIT) pathway, which is designed to expedite access to new and innovative medical devices designated as breakthrough devices by the FDA. The pathway, the MCIT, will provide Medicare coverage for breakthrough devices on the same day as FDA market authorization. It also allows manufacturers flexibility to choose the start date for coverage on any date two years thereafter the market authorization. Regardless of start date, that coverage will last for four years from the date of the FDA market authorization.

The rule also states that the definition of “reasonable and necessary” will be codified to mean that an item or service is considered safe and effective; not experimental or investigational; and appropriate for Medicare patients. For NCDs and LCDs that have insufficient evidence to meet the appropriateness criteria, CMS will consider coverage based on what a majority of commercial insurers cover, and CMS will issue draft subregulatory guidance on which commercial insurers are considered relevant for that process within 12 months of this final rule.

CMS published a Press Release and Fact Sheet on the same date. The rule was published in the Federal Register on January 14. The final rule is effective on March 15.

2021 Therapy Code Update and Dispositions

On January 13, CMS published a Download Link to the 2021lists of codes that sometimes or always describe therapy services. The download contains a zipped file with an Excel sheet containing the 2021 therapy code list, another containing the 2021 therapy code dispositions, and an Excel file with both the code list and dispositions.

Federal COVID-19 Testing Report: Data Insights from Six Federal Health Programs

On January 14, the OIG published a Data Report on how six federal health care programs handled COVID-19 testing from February 1 - August 31, 2020. The federal agencies included HHS, the Office of Personnel Management (OPM), Department of Labor, Department of Veterans Affairs, Department of Defense, and Department of Justice. It looked at how many COVID-19 tests were administered (and when), who was tested, what types of tests were administered, how much each program paid for tests, which health care settings people used to access testing, and how long it took to return test results.

Reprocessing Payment for Outpatient Clinic Visit Services at Excepted Off-Campus Provider-Based Departments

On January 14, CMS published a Notice in MLN Connects regarding claims reprocessing due to a U.S. Court of Appeals ruling on the provider-based department site-neutrality policy. The CY 2019 OPPS final rule finalized payment for outpatient clinic visits provided at excepted off-campus provider-based departments at the same rate as payment for the clinic visit in a hospital outpatient setting. In 2019, a district court ruling invalidated that policy, and in the first six months of 2020, CMS reprocessed claims paid at a reduced rate to restore payment to the full rate. However, last July, the U.S. Court of Appeals struck down the district court ruling, which reverts payment back to the reduced rate. By July 1, 2021, CMS will begin reprocessing affected claims (dates of service between January 1 and December 31, 2019) to bring payment for those claims back down to the reduced rate. This process will happen automatically.

Updated OIG Work Plan

On January 15, the OIG updated its Work Plan with the following new items:

Contract Year (CY) 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program

On January 15, CMS published a draft copy of the CY 2022 Medicare Advantage and Part D Final Rule, which is scheduled to be published in the Federal Register on January 19. While the rule is technically published for the 2022 CY, the rule addresses remaining policies from the February 2020 proposed rule that were not originally addressed in the CY 2021 Final Rule (published June 2, 2020), as only the most immediate policies were adopted at that point. Those provisions from the February 2020 proposed rule will be in effect during CY 2021. Policies finalized in the rule include:

Offering a Beneficiary Real Time Benefit Tool (RTBT) which will require Part D plans to offer real-time comparison tools to enrollees starting January 1, 2023
Allowing Part D plans to have a second, “preferred” specialty tier with a lower cost-sharing amount than the other specialty tier effective January 1, 2022
Requiring Part D plans to disclose pharmacy performance measures to CMS starting January 1, 2022
Codifying existing policy regarding supplemental benefits, including the expanded definition of “primarily health related,” the Medicare Managed Care Manual’s criteria for a supplemental benefit, and the reinterpreted uniformity requirements which state that reductions in cost-sharing are an allowable supplemental benefit

CMS published a Press Release and Fact Sheet on the rule on the same date.

Effective date: These regulations are effective 60 days after the date of publication in the Federal Register.

Applicability date: Most provisions will be applicable to coverage beginning January 1, 2022, except for specific provisions mentioned in the applicability section of the final rule.

Final Rule: Improving Prior Authorization Processes and Promoting Patients’ Electronic Access to Health Information

On January 15, CMS published a draft copy of a Final Rule regarding improved processes related to prior authorization and the electronic exchange of health care data for Medicaid and CHIP managed care plans, state Medicaid and CHIP FFS programs, and Qualified Health Plans. The rule requires payers to implement and utilize APIs at higher standards. It also finalizes policies that are designed to make the prior authorization process more efficient and transparent, including implementing a documentation requirements lookup service API, prior authorization support API, required denial reasons, shorter prior authorization timeframes, and payor public reporting on prior authorization metrics.

CMS noted that payers with multiple lines of business may choose to implement the policies for Medicare Advantage lines of business to streamline processes, but CMS is not proposing or finalizing any changes for Medicare Advantage at this time. CMS stated in the proposed rule that was issued in December that it may consider implementing these changes for Medicare Advantage at a future time. Despite describing prior authorization in this rule as burdensome for providers, CMS expanded prior authorization requirements for Medicare under the 2021 Outpatient Prospective Payment System final rule.

CMS published a Fact Sheet and Press Release on the same date.

Dates: These regulations are effective 60 days after the date of publication in the Federal Register.

Implementation dates: The provisions of this regulation will be implemented on January 1, 2023, with the exception of amendatory instructions 5, 22, and 28, which will be implemented on January 1, 2024.

Home Health Agency Provider Compliance Audit: Southeastern Home Health Services

On January 15, the OIG published a Review of whether Southeastern Home Health Services complied with Medicare requirements for billing home health services. The OIG found that Southeastern billed Medicare incorrectly for 18 of the 100 home health claims reviewed. These issues pertained to services provided to beneficiaries who were not homebound, did not require skilled services, or to claims with incorrect HIPPS codes. The OIG originally stated in a draft report that 29 of the 100 claims did not meet Medicare requirements, and Southeastern challenged those findings, stating that the OIG’s review contractor misapplied and misinterpreted Medicare’s homebound and skilled requirements. After review, the OIG determined 11 of the 29 claims originally questioned were fully compliant with Medicare regulations and adjusted findings for five additional claims.

The OIG estimated that Southeastern received overpayments of at least $1.8 million for the remaining noncompliant claims within the audit period, which is now outside of the 4-year reopening period. The OIG recommends Southeastern identify, report, and return any overpayments in accordance with the 60-day rule and strengthen procedures to ensure full compliance with home health billing requirements.