This week in Medicare updates—1/5/2022

January 5, 2022

Medicare Insider

April 2022 Update of ICD-10-CM

On December 17, the CDC published the April 2022 Update files for the ICD-10-CM code set. These codes are for use from April 1, 2022, through September 30, 2022. Changes include new status codes for underimmunization for COVID-19.

Hospital Provider Compliance Audit: St. Joseph’s Hospital Health Center

On December 20, the OIG published a Review of whether St. Joseph’s Hospital Health Center complied with Medicare requirements for billing inpatient and outpatient services for certain claims that were potentially at risk for billing errors. The OIG determined that St. Joseph’s did not comply with requirements on six of the 100 claims reviewed, with five errors pertaining to inpatient claims and one error involving an outpatient claim. The OIG said the five inpatient claims billed in error should have been billed as outpatient or outpatient with observation, as they did not meet Medicare criteria for inpatient status. Two of the inpatient claims also had incorrect coding which led to incorrect DRG payments. The outpatient claim error involved an incorrect HCPCS code. These errors resulted in an estimated $389,000 in overpayments for the audit period.

The OIG recommends St. Joseph’s refund the $389,000 in estimated overpayments; exercise reasonable diligence to identify, report, and return overpayments in accordance with the 60-day rule; and strengthen controls to ensure compliance with Medicare requirements. The hospital challenged the OIG’s findings for three of the six claims found in error and partially disagreed with the OIG’s recommendations. The OIG maintained its original findings and recommendations.

DMEPOS Accreditation

On December 20, CMS revised an MLN Fact Sheet regarding DMEPOS Accreditation to note that, beginning January 3, 2022, DMEPOS suppliers will receive informational messaging on remit advice if the supplier is billing for products and services without the appropriate accreditation.

Rural Health Clinic

On December 20, CMS revised an MLN Booklet regarding rural health clinics to update it with information on payment amounts for 2022, mental health visits furnished via telehealth, payments for hospice attending physician services, and more.

Original Medicare vs. Medicare Advantage

On December 20, CMS published an MLN Fact Sheet regarding what providers should know about how coverage via Original Medicare differs from coverage under Medicare Advantage. The fact sheet addresses the way coverage affects seeing patients, processing claims, and filing appeals.

Clinical Laboratory Fee Schedule (CLFS)

On December 20, CMS revised an MLN Fact Sheet regarding how Medicare pays for lab tests under the CLFS. The revisions address changes to Medicare payment rules to pay independent labs for specimen collection from homebound patients and inpatients.

ETC Managing Clinician PPA and KCF PBA Implementation

On December 21, CMS published Demonstrations Transmittal 11167, which rescinds and replaces Transmittal 11108, dated November 5, 2021, to update the policy section, update requirements 12404.35 and 12404.38, and to add testing requirements 12404.36.1, 12404.48, 12404.49, 12404.50, 12404.51 and 12404.52. The original transmittal was published regarding implementation of payment adjustments for the ESRD Treatment Choices (ETC) Model and the Kidney Care Choices (KCC) Model.

Effective date: January 1, 2022

Implementation date: January 3, 2022 - Implement all BRs related to ETC Managing Clinician Performance Payment Adjustment (PPA); April 4, 2022 - Implement all BRs related to KCF Performance Based Adjustment (PBA)

Trends in Genetic Tests Provided Under Medicare Part B Indicate Areas of Possible Concern

On December 21, the OIG published a Data Brief regarding nationwide trends in performance and payment of genetic tests from 2016-2019. The OIG found that Medicare payments for genetic tests quadrupled during this time period. The number of genetic tests that Medicare paid for increased by 230%. The average amount Medicare paid per beneficiary who received at least one genetic test increased by 75%, while the average number of genetic tests paid per beneficiary increased by 43%. The OIG highlighted a concern where the number of laboratories that received more than $1 million in Medicare payments per year for genetics tests tripled, and the number of providers ordering these tests more than doubled from 2016-2019.

The OIG said there may be legitimate reasons for these increases, but it is also concerned about the possibility of excessive and/or fraudulent genetic testing. It also noted that Medicare requirements and guidance related to coverage of genetic testing have been limited and vary among MAC jurisdictions. The OIG said this data brief may serve as a source of insight for CMS and other stakeholders into trends and areas of possible concern about these tests.

Home Health Change of Care Notice

On December 22, CMS published an updated Home Health Change of Care Notice and form instructions for download. The renewed form, which has an expiration date of 12/31/2024, will be required for use starting on April 30, 2022.

Correction Notice: CY 2022 Home Health Prospective Payment System Final Rule

On December 22, CMS published a Correction Notice in the Federal Register to correct technical errors and typos in the CY 2022 Home Health Prospective Payment System Final Rule, which was published on November 9. The errors include incorrect website addresses, an omitted note from a table, and more.

This correcting document is effective January 1, 2022.

April 2022 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

On December 22, CMS published Medicare Claims Processing Transmittal 11169 regarding the quarterly updates to the ASP and NOC drug pricing files for Part B drugs.

Effective date: April 1, 2022

Implementation date: April 4, 2022

Changes to the Laboratory NCD Edit Software for April 2022

On December 22, CMS published Medicare Claims Processing Transmittal 11170 regarding the April 2022 updates to the clinical diagnostic laboratory services edit module.

CMS published MLN Matters 12575 on the same date to accompany the transmittal.

Effective date: April 1, 2022 - unless noted differently in requirements

Implementation date: April 4, 2022

Nursing Home Visitation FAQs

On December 23, CMS published an FAQ regarding nursing home visitation guidance during the COVID-19 PHE. The FAQ was issued to clarify information provided in a Memorandum, dated November 12, which noted that visitation is now allowed for all nursing home residents at all times. The FAQ states that CMS is committed to continuing to allow visitation at all times except in very limited and rare exceptions, but it addresses various scenarios to discuss how visitation should work in greater detail.

Geographically-Adjusted Payment Rate Files for COVID-19 Vaccine Administration, Monoclonal Antibody Administration

On December 23, CMS published download links to the 2022 Geographically-Adjusted Payment Rates for COVID-19 Vaccine Administration and the 2022 Geographically-Adjusted Payment Rates for Monoclonal Antibody Administration to its COVID-19 Vaccines and Monoclonal Antibodies webpage. CMS also updated the May - December 2021 monoclonal antibody payment rate file to account for new codes for tixagevimab packaged with cilgavimab.

FDA Issues EUA for Tixagevimab Co-Packaged with Cilgavimab

On December 23, CMS updated its Monoclonal Antibody COVID-19 Infusion webpage with information regarding a new monoclonal antibody product, tixagevimab co-packaged with cilgavimab, which received an EUA from the FDA on December 8, 2021. The webpage includes coding and billing information for the product.

Final Rule with Comment Period: IPPS Changes to Medicare Graduate Medical Education (GME) Payments for Teaching Hospitals; Changes to Organ Acquisition Payment Policies

On December 27, CMS published a Final Rule with Comment Period in the Federal Register to finalize certain provisions regarding GME payments and policies for teaching hospitals as well as provisions pertaining to organ acquisition payments and organ procurement policies from the FY 2022 IPPS Proposed Rule. The rule finalizes distribution of Medicare funding for 1,000 medical residency positions phased in beginning in FY 2023, implementation of a funding opportunity to allow rural teaching hospitals participating in an accredited rural training track to receive increases to their FTE caps, and a provision allowing qualifying hospitals that begin a new medical residency training program to receive additional residency positions and increased per resident amounts (PRA). These policies were all mandated through the Consolidated Appropriations Act, 2021. The rule also includes the codification and clarification of certain organ acquisition payment policies and finalized with modification some of the policies for billing organ procurement organizations.

CMS is seeking comment on how to account for health care provided outside of a HPSA to HPSA residents, feasible alternatives to HPSA scores as a proxy for health disparities in the prioritization of additional FTE cap slots, and the review process to determine eligibility for PRAs or FTE cap resets in situations where a hospital disagrees with the information on cost reports that are no longer within the three-year reopening period.

CMS published a Fact Sheet on the rule on December 17. Comments are due by February 25, 2022.

Effective date: This final rule is effective February 25, 2022.

Correction Notice: CY 2022 Medicare Physician Fee Schedule (MPFS) Final Rule

On December 27, CMS published a Correction Notice in the Federal Register to correct technical errors from the CY 2022 MPFS Final Rule, which was published on November 19. Corrections apply to typos in dollar amounts, typos in references to the phrase “pre-hypertensive,” typos in tables, and more.

This correction is effective January 1, 2022.

Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination

On December 28, CMS published a Memorandum to state survey agency directors regarding the Omnibus COVID-19 Health Care Staff Vaccination interim final rule. Following court actions, the rule was enjoined in 25 states, and Medicare and Medicaid-certified providers in those states (which are listed in the memorandum) do not need to comply with the rule. The memorandum provides guidance for surveyors in the states who are required to comply with the rule as to how to assess and maintain compliance with the regulatory requirements. CMS also provided provider-type guidance for download to accompany the memorandum. Those files are accessible via this link.

CMS published a number of other resources related to the rule on the same date, including:

Effective date: This policy should be communicated with all survey and certification staff, their managers, and the State/CMS Location training coordinators immediately. The effective date of the specific actions are specified in the memorandum.

Prior Authorization for Certain Hospital Outpatient Department Services

On December 28, CMS published a Notice on its prior authorization webpage to note that, effective for dates of service on or after January 7, 2022, CMS will be removing CPT code 67911 from the list of codes that require prior authorization. CMS said this change is because the procedure is not likely to be cosmetic in nature and commonly occurs secondary to another service. CMS also noted that it is revising the exemption process for hospital outpatient department providers and is extending the exemption cycle. Details are available in the Operational Guide and FAQ documents available for download on the prior authorization webpage.

DMEPOS Final Rule

On December 28, CMS published a Final Rule in the Federal Register regarding changes to the DMEPOS fee schedule and related provisions. The rule establishes methodologies for adjusting the fee schedule payment amounts for DMEPOS items furnished in a non-competitive bidding area on or after the effective date of the rule or the date immediately following the end of the COVID-19 PHE (whichever is later) using information from the DMEPOS competitive bidding program. CMS will continue paying suppliers the 50/50 blend of adjusted and unadjusted fee schedule rates for items and services in rural and non-contiguous areas.

The rule classifies adjunctive continuous glucose monitors as DME under Part B. It also establishes methodologies for adjusting fee schedule amounts and procedures to make benefit category and payment determinations for new items and services that are DMEPOS, therapeutic shoes and inserts, surgical dressings, or devices used for reductions of fractures and dislocations under Part B.

CMS published a Fact Sheet on the rule on December 21. These regulations are effective on February 28, 2022.

Most Favored Nation (MFN) Model Final Rule Rescinded

On December 29, CMS published a Final Rule in the Federal Register to rescind the Most Favored Nation interim final rule, dated November 27, 2020. The rule was supposed to have gone into effect January 1, 2021, but it was never implemented due to a nationwide preliminary injunction issued by the U.S. District Court for the Northern District of California on December 28, 2020. CMS finalized rescinding the rule and any associated regulatory text in its entirety.

This final rule is effective February 28, 2022.

Medicare and Beneficiaries Pay More for Preadmission Services at Affiliated Hospitals Than at Wholly Owned Settings

On December 30, the OIG published an Issue Brief regarding Medicare’s DRG window policy and the possible extension of that policy to affiliated settings. While the window policy covers all settings wholly owned or operated by the admitting hospital, it does not currently apply to affiliated settings, which the OIG defined as health care settings that are owned by the same affiliated group. The OIG found that in 2019, Medicare paid $168 million and beneficiaries paid approximately $77 million for admission-related outpatient services provided during the DRG-window at hospitals affiliated with the admitting hospital. This is more than five times the amount Medicare and beneficiaries paid when the OIG examined this issue back in 2011. The situation was particularly egregious at affiliated CAHs, where beneficiaries paid approximately six times as much as beneficiaries who received similar services at other affiliated hospitals. The OIG therefore recommends CMS evaluate the potential impact of updating the DRG window policy to include affiliated hospitals and seek the legislative authority to do so.