This week in Medicare updates—4/13/2022

2023 Medicare Advantage and Part D Rate Announcement

On April 4, CMS published the 2023 Medicare Advantage and Part D Rate Announcement, which contains the capitation rates and Part C and D payment policies for 2023. CMS will continue to calculate 100% of the risk score using the 2020 CMS-HCC model. CMS is finalizing a 5.9% coding pattern adjustment for CY 2023, which is the minimum adjustment for coding pattern differences required by statute. CMS will also use the 2016-2020 fee-for-service risk scores to calculate the normalization factor for 2023 due to the possibility of skewed data from 2020 and 2021 due to the COVID-19 pandemic.

CMS published a Fact Sheet on the rate announcement on the same date.

 

Quarterly Medicare Provider Compliance Newsletter

On April 4, CMS published the April edition of the Quarterly Medicare Provider Compliance Newsletter. This issue of the newsletter contains a CERT review of hospice certification/recertification of terminal illness, a CERT review of refills of DMEPOS items provided on a recurring basis, and a Recovery Auditor review of total hip arthroplasties.

 

Comment Request: Medicare Current Beneficiary Survey; Application and Triennial Re-application to be a Qualified Entity to Receive Medicare Data for Performance Measurement

On April 4, CMS published a Comment Request in the Federal Register regarding the submission of the following information collections for OMB review:

• Medicare Current Beneficiary Survey
• Application and Triennial Re-application to be a Qualified Entity to Receive Medicare Data for Performance Measurement

Comments are due to the OMB desk officer by May 4, 2022.

 

Medicare to Cover Over-the-Counter COVID-19 Tests

On April 4, CMS published a Press Release to announce that it will cover up to eight COVID-19 tests per beneficiary per month at no cost to the beneficiary. Any beneficiary enrolled in Medicare Part B, including those enrolled in a Medicare Advantage plan, will be eligible for this program. Any health care provider who provides ambulatory health care services (such as vaccines, lab tests, or other clinic type visits to people with Medicare) may participate in the initiative. Medicare is not requiring participating eligible pharmacies and health care providers to go through any new Medicare enrollment process to participate in this program.

CMS published a Fact Sheet and an FAQ on this program on the same date.

 

Featured Topic: Telehealth

On April 5, the OIG published a Resource page on telehealth, which it spotlighted as a featured topic. The page includes information about ongoing OIG oversight of telehealth, as the service has expanded significantly since the start of the COVID-19 pandemic. The page includes recent audits as well as evaluations and inspections, and it also includes links to telehealth-related Work Plan items.

 

Guidance for Omnibus COVID-19 Health Care Staff Vaccination

On April 5, CMS revised three memorandums (QSO-22-07, QSO-22-09, QSO-22-11) regarding implementation of the Omnibus COVID-19 Health Care Staff Vaccination rule to add language to each memo stating that surveying for staff vaccination requirements is not required on Life Safety Code-only complaints or follow-up surveys. The memo also states that surveyors may modify the staff vaccination compliance review if the provider/supplier was in substantial compliance with the requirement within the previous six weeks.

 

ICD-10 and Other Coding Revisions to NCDs – July 2022

On April 6, CMS published One-Time Notification Transmittal 11342, which rescinds and replaces Transmittal 11264, dated February 10, 2022, to revise BR 12606.10 instructions for NCD 110.24, revise BR 12606.2 to fix a typo in the NCD 160.18 spreadsheet which had an incorrect ICD-10-CM code, and revise implementation verbiage. The original transmittal was published regarding the regular updates of ICD-10 conversions and other coding updates specific to NCDs. 

CMS revised MLN Matters 12606 on the same date to accompany the transmittal. 

Effective date: July 1, 2022 - unless otherwise specified in the individual requirements

Implementation date: March 12, 2022 - A/B MACs local edits; July 5, 2022 - Shared Systems edits

 

Comment Request: Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies—Revision of Medicare Coverage; more

On April 6, CMS published a Comment Request in the Federal Register regarding the following information collections:

• Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies—Revision of Medicare Coverage
• Data Collection to Support Eligibility Determinations for Insurance Affordability Programs and Enrollment through Health Insurance Marketplaces, Medicaid and Children’s Health Insurance Program Agencies

Comments are due by June 6.

 

Updated EUAs for Pfizer, Moderna Vaccines

On April 6, CMS updated its COVID-19 Toolkit to note that the FDA revised the Emergency Use Authorizations (EUA) for the Pfizer and Moderna COVID-19 vaccines on March 29, 2022, to add second booster doses for all patients 50 years and older and any immunocompromised patients 12 years and older.  

CMS added information about payment rates for the second booster doses to its Medicare COVID-19 Vaccine Shot Payment page. Payment remains the same ($40 per dose) for the second booster as it does for other doses. CMS noted on its Billing for COVID-19 Vaccine Shot Administration page that providers should bill for these doses using the booster shot codes.  

CMS published a News Alert about the second boosters on the same date.

 

Laboratory Tests Subject to Exceptions from Laboratory DOS Policy

On April 6, CMS published an updated Download Link for the latest list of laboratory tests subject to exceptions to the Laboratory DOS Policy defined at 42 CFR §414.510(b)(5) to reflect the April updates.

 

Updated Civil Monetary Penalties and Affirmative Exclusions

On April 7, the OIG published an updated List of Fraud Self-Disclosures, including:

• On March 15, Advanced Dermatology & Skin Cancer Center (ADSCC), of Ohio, reached a $50,000 settlement agreement with the OIG to resolve allegations that offered and provided remuneration to a dermatology practice in the form of a printer cartridge, payment for holiday party expenses, and payment to a dermatology employee to prepare, pack, and complete related paperwork for specimens to be delivered to ADSCC.
• On March 21, AltheaDX, of California, reached a $72,083.57 settlement agreement with the OIG to resolve allegations that it violated civil monetary penalties law by submitting claims for payment for pharmacogenic tests that were not ordered by a physician.
• On March 30, National Medical Services II, of Florida, reached a $932,660 settlement agreement with the OIG to resolve claims that its mid-level providers fraudulently recorded personally performed services as if the services were performed by an employed physician, then improperly submitted claims for those services.

The list also included settlements to resolve allegations of violating civil monetary penalties law by employing individuals an organization knew or should have known were excluded from participation in federal health care programs. Those entities include: 

• River Hospital, of New York
• Heritage Health of Danville, of Illinois
• Harney County Health District, of Oregon

 

Updated Civil Monetary Penalties and Affirmative Exclusions

On April 7, the OIG published an updated List of Civil Monetary Penalties and Affirmative Exclusions, including:

• On March 2, Metroplex Pain Consultants and Dr. Steven Casey, of Dallas, TX, reached a $110,748.12 settlement agreement with the OIG to resolve allegations that it submitted claims for services rendered by Dr. Casey during a time when Dr. Casey was not at his office. Metroplex and Dr. Casey also submitted claims to Medicare for spinal facet joint injections beyond the injection limit in a rolling 12-month period.

 

Corrections to Home Health Billing for Denial Notices and Calculation of 60-Day Gaps in Services

On April 7, CMS published Medicare Claims Processing Transmittal 11341 regarding the removal of the requirement to submit a Notice of Admission before billing for home health denial notices. It also revises the counting method used for identifying Low-Utilization Payment Adjustment (LUPA) add-ons to ensure the Medicare systems calculate 60-day gaps in service consistently. 

Effective date: October 1, 2022 - Claims processed on or after this date

Implementation date: October 3, 2022

 

Electronic Transmission of MAC Provider Enrollment Recommendations of Approval

On April 7, CMS published One-Time Notification Transmittal 11337 regarding instructions to the contractors on the upcoming implementation of a new process for sending provider enrollment recommendations of approval to state agencies, accrediting organizations, and/or SOG locations as applicable. 

Effective date: April 15, 2022

Implementation date: April 15, 2022

 

FYs 2021-2022 Updates for MS-DRGs Subject to IPPS Replaced Devices Offered Without Cost of With a Credit Policy

On April 7, CMS published One-Time Notification Transmittal 11346 regarding the addition of five MS-DRGs to the list of DRGs subject to the IPPS payment policy for the reimbursement of replaced devices offered without cost or with a credit. It also includes the termination of two MS-DRGs from the list. 

Effective date: October 1, 2020

Implementation date: October 3, 2022

 

Update to COVID-19 Emergency Declaration Blanket Waivers for Specific Providers

On April 7, CMS published a Memorandum to state survey agency directors regarding the end of certain COVID-19 emergency declaration blanket waivers for the following provider types:

• Skilled nursing facilities/nursing facilities (SNF/NF)
• Inpatient hospices
• Intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs)
• End-stage renal disease (ESRD)   

The memo does not apply to waivers in effect for hospitals and critical access hospitals. CMS is rescinding a variety of waivers pertaining to things such as in-person physician visits, physician delegation of tasks in SNF that allowed physicians to delegate certain tasks to other provider types, waived requirements for on-time fire inspections, training for feeding assistants for LTC facilities, and more. Waivers will end in two stages, with some ending 30 days from issuance of the memo while others will end 60 days after the issuance of the memo.

CMS said it is rescinding these waivers due to findings from onsite surveys that have revealed significant concerns about resident care that are not related to infection control, and it is concerned that the waivers issued for the PHE may have contributed to some of these issues or raise the risk of certain issues. CMS said it is still concerned about the likelihood of COVID-19 transmission in certain facilities, but it feels it must balance infection control with the need for certain regulatory requirements to protect resident health and safety. 

CMS published a Press Release about the waivers on the same date. 

Effective date: The emergency declaration blanket waivers identified will end according to the timeframes described in the memorandum.

 

Decision Memo: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

On April 7, CMS published a Decision Memo to announce it will cover FDA-approved monoclonal antibodies directed against amyloid as a treatment for Alzheimer’s disease under Coverage with Evidence Development (CED). If the FDA determines a clinical benefit for drugs within this class, CMS will also provide enhanced coverage for people with Medicare participating in CMS-approved studies or for these antibodies when furnished according to an FDA-approved indication in NIH-supported trials. CMS did not finalize a restriction from the proposed decision that would require all trials to be conducted in a hospital-based outpatient center. 

The only monoclonal antibody currently approved by the FDA for this purpose is Aduhelm. CMS stated coverage for this monoclonal antibody treatment is limited to clinical trials because there currently is not enough evidence of demonstrating improved health outcomes to say that this treatment is reasonable and necessary for people with Medicare. CMS will therefore do what it can to support continued studies into this treatment, and it said it structured the NCD in a way that provides CMS the flexibility to respond quickly should any new drugs in this class demonstrate a clinical benefit. 

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

 

Post-Hospital Skilled Nursing Facility Care Provided to Dually Eligible Beneficiaries in Indiana Generally Met Medicare Level-of-Care Requirements

On April 8, the OIG published a Review of whether post-hospital SNF care provided to dually eligible beneficiaries in Indiana was associated with potentially avoidable hospitalizations and whether it met Medicare level-of-care requirements. The OIG found that 98 of the 100 beneficiaries reviewed did not have potentially avoidable hospitalizations and the level of care provided to them met Medicare requirements. The OIG noted that records from the hospitals where 33 beneficiaries had a qualifying inpatient stay did not contain a clear and definitive hospital physician discharge order for SNF care, as the hospital physicians discharged the beneficiaries “back to nursing facility” without specifying the level of care. In these cases, the SNF physicians certified the SNF level of care. 

Because the review showed that Indiana generally met Medicare level-of-care requirements, the OIG did not have recommendations in this case. However, the OIG stated that it remains concerned about quality of care in nursing facilities and will conduct more of these types of reviews to monitor this issue.

 

Proposed Rule: Radiation Oncology (RO) Model Delay

On April 8, CMS published a Proposed Rule in the Federal Register to propose the delay of the start of the RO Model to a date to be determined through future rulemaking and to modify the definition of the model performance period so that the start and end dates will be decided by future rulemaking. Although CMS said it continues to believe that the RO Model would address long-standing concerns related to these services, it noted that the RO Model has now been delayed by Congress twice and the concern about the resources involved in preparing to implement the model as well as comments received by stakeholders throughout this process necessitate an indefinite delay to the model. 

Comments on the proposed delay are due by June 7.