This week in Medicare updates—11/10/2021

Comment Request: Survey Report Form for Clinical Laboratory Improvement Amendments (CLIA) and Supporting Regulations; ICF/IID Survey Report Form and Supporting Regulations

On November 1, CMS published a Comment Request in the Federal Register regarding the submission of the following information collections for OMB review:

• Survey Report Form for CLIA and Supporting Regulations
• ICF/IID Survey Report Form and Supporting Regulations

Comments are due to the OMB desk officer by December 1, 2021.

 

2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Prospective Payment System (ASC PPS) Final Rule

On November 2, CMS published a draft copy of the 2022 OPPS and ASC PPS Final Rule, which is scheduled to be published in the Federal Register on November 16. CMS finalized its decision to reverse course on the removal of the inpatient-only list, a process which was finalized in the 2021 OPPS final rule. CMS will add the services removed from the list in CY 2021 back into the inpatient-only list for CY 2022 with the exception of CPT codes 22630 (lumbar spine fusion), 23472 (shoulder joint reconstruction), 27702 (ankle arthroplasty), and their corresponding anesthesia codes. The rule also updates both OPPS and ASC PPS payment rates by 2% for 2022. Other policies finalized in the rule include:

• Increasing civil monetary penalties for failure to comply with price transparency requirements by using a scaled approach for the fines based on bed counts 
• Maintaining payment for 340B drugs at ASP minus 22.5%
• Reinstating criteria relating to patient safety for adding procedures to the ASC covered procedures list (CPL) and removing 255 of the 267 procedures from the list that had been added under the policy implemented via the 2021 OPPS final rule
• Adopting a nomination process to allow an external party to nominate a surgical procedure to be added to the CPL
• Approving three devices for pass-through payment status and continuing pass-through payment status in CY 2022 for 46 drugs and biologicals already receiving pass-through payments. 

CMS is soliciting comments on certain provisions in the rule, such as payment classifications assigned to interim APC assignments and status indicators of new or replacement Level II HCPCS codes. Comments are due 30 days after the rule’s publication in the Federal Register. 

CMS published a Fact Sheet and Press Release to accompany the rule. These policies will be effective January 1, 2022.

 

CY 2022 Medicare Physician Fee Schedule Final Rule

On November 2, CMS published a draft copy of the CY 2022 Medicare Physician Fee Schedule Final Rule, which is scheduled to be published in the Federal Register on November 19. The rule lowers the PFS conversion factor down to $33.59 for CY 2022, a decrease of $1.30 from the CY 2021 conversion factor. Other policies finalized in the rule include:

• Clarifying and refining policies pertaining to split/shared E/M visits and critical care services, including a new modifier for split/shared visits and adoption of CPT guidance for critical care services
• Allowing certain services added to the telehealth list during the COVID-19 PHE to stay on the telehealth list until December 31, 2023, and extending the inclusion of telehealth outpatient rehabilitation codes 93797 and 93798 along with HCPCS codes G0422 and G0423 to this list. 
• Beginning to make direct payment to physician assistants for professional services
• Delaying payment penalties for appropriate use criteria (AUC) further to January 1, 2023 or the January 1 following the declared end of the PHE

CMS is revising its proposal for the de minimis standard for physical therapist assistant/occupational therapist assistant (PTA/OTA) payment by finalizing a policy in which a 15-minute timed service can be billed without the CQ/CO modifier in cases when a PTA/OTA participates in providing care to a patient independent from the PT/OT. This exception will apply to cases where the PT/OT meets Medicare billing requirements for the timed service without the minutes furnished by the PTA/OTA by providing care for more than the 15-minute midpoint (8 minutes of the service or more).

CMS published a Press Release, Fact Sheet on the PFS rule as whole, Fact Sheet on the Quality Payment Program changes, and Fact Sheet on the Diabetes Prevention Program changes to accompany the rule. Policies are effective on January 1, 2022.

 

CY 2022 Home Health Prospective Payment System (HH PPS) Final Rule

On November 2, CMS published a draft version of the CY 2022 HH PPS Final Rule, which is scheduled to be published in the Federal Register on November 9. The rule finalizes the nationwide expansion of the Home Health Value-Based Purchasing (HHVBP) Model nationwide beginning January 1, 2023. It also makes permanent certain regulatory blanket waivers that were issued during the PHE, including allowing the 14-day on-site supervisory visit requirement to be performed virtually in rare circumstances and updating the home health Conditions of Participation to allow an occupational therapist to conduct an initial assessment visit and complete the comprehensive assessment when OT is on the home health plan of care with either PT or ST, and skilled nursing services are not originally on the plan of care. 

Other changes affect PDGM case-mix weights, LUPA add-on factor calculations, home infusion therapy payment, and more. CMS estimates that the aggregate home health payment update will be 3.2% for CY 2022. 

CMS published a Press Release and Fact Sheet to accompany the final rule. These regulations are effective January 1, 2022.

 

Opioid Treatment Programs: CY 2022 Methadone Payment Exception

On November 2, CMS published a draft copy of an Interim Final Rule with Comment, which is scheduled to be published in the Federal Register on November 19, regarding payment to Opioid Treatment Programs (OTP) for methadone for CY 2022. CMS found that, during the process of gathering manufacturer-reported ASP data for the annual update to OTP drug pricing for CY 2022, the volume-weighted ASP for methadone had decreased by just over 50% from the 2021 rate. CMS has questions as to whether the current ASP data is representative of utilization of the two forms of oral methadone for Medicare beneficiaries receiving treatment from OTPs. Due to the questions about the ASP data and the effects of the COVID-19 PHE on people with substance use disorders, CMS is freezing the payment rate for methadone furnished via OTPs in 2022 at the 2021 payment amount.

Effective date: These regulations are effective on January 1, 2022. 

Comment date: Comments are due no later than 5 p.m. on January 3, 2022. 

 

Therapy Code List and Dispositions

On November 2, CMS published a Download Link for the 2022 Therapy Code List and Dispositions files, which contain the list of codes indicating whether they are sometimes or always therapy services. 

 

Updated Pfizer COVID-19 Vaccine Emergency Use Authorization (EUA)

On November 3, CMS published a link to the Updated Pfizer COVID-19 Vaccine EUA, which was modified on October 29 to allow it to be used for children ages 5-11 years old. CMS also updated information about the Pfizer vaccine on its COVID-19 Vaccine Shot Payment webpage and added a table to better display Medicare payment rates for COVID-19 vaccines. CMS posted the coding information for these vaccines on its COVID-19 Vaccines and Monoclonal Antibodies page. 

CMS published a Press Release on the same date to accompany the updated EUA.

 

COVID-19 Vaccine and Monoclonal Antibody Changes for Medicare Advantage

On November 3, CMS updated its Medicare Billing for COVID-19 Vaccine Shot Administration webpage and its Monoclonal Antibody COVID-19 Infusion webpage to note a change in billing for COVID-19 vaccines and monoclonal antibodies. Original Medicare will no longer pay claims for Medicare Advantage patients treated with monoclonal antibody products or COVID-19 vaccines on or after January 1, 2022. These claims should be billed to the Medicare Advantage plan instead. 

 

CLIA Certification for COVID-19 Testing in the Work Place

On November 4, CMS published a CLIA COVID Quick Start Guide and a CLIA COVID Fact Sheet regarding certification processes under CLIA for conducting COVID-19 testing in the work place. The fact sheet provides Q&As about why CLIA certification for this testing is necessary and how employers can apply for and use the certification. The quick start guide provides a step-by-step process for applying for CLIA certification. 

 

Arkansas Man Charged in $100 Million COVID-19 Health Care Fraud Scheme

On November 4, the OIG published a COVID Enforcement Action regarding an Arkansas man who owned or managed numerous diagnostic testing laboratories. Billy Joe Taylor, of Lavaca, Arkansas, was charged with 16 counts of health care fraud and one count of engaging in a monetary transaction in criminally derived property. He is accused of misusing private medical and personal information for Medicare beneficiaries to submit claims to Medicare for diagnostic tests that were not ordered by medical providers and were not performed by laboratories. This included over $100 million in false billings for urine drug testing, COVID-19 testing, and other clinical lab services. 

 

Updated Civil Monetary Penalties and Affirmative Exclusions

On November 4, the OIG published an updated List of Civil Monetary Penalties and Affirmative Exclusions, including:

• On October 21, Raquel Paragas and DR Home Healthcare, of Lemont, Illinois, reached a $112,000 settlement with the OIG to resolve allegations that Paragas paid improper remuneration to a doctor in exchange for Medicare beneficiary referrals to the DR Home Healthcare agency. 
• On October 27, Carolina Behavioral Care, of Durham, North Carolina, reached a $23,816.94 settlement with the OIG to resolve allegations that it submitted claims to Medicare for specimen validity testing (a noncovered service) in conjunction with claims for urine drug testing.  
• On October 29, Targol Boostani, of Los Angeles, California, agreed to a 20-year exclusion for offering and paying improper remuneration to bariatric patients in order to induce patients to purchase, order, and/or arrange for purchasing or ordering of certain prescription drugs. 
• On October 29, Farah Rodefshalom Kohan, of Los Angeles, California, agreed to a 20-year exclusion for offering and paying improper remuneration to bariatric patients in order to induce patients to purchase, order, and/or arrange for purchasing or ordering of certain prescription drugs. 
• On October 29, Afrooz Javanford, of Beverly Hills, California, agreed to a 20-year exclusion for offering and paying improper remuneration to bariatric patients in order to induce patients to purchase, order, and/or arrange for purchasing or ordering of certain prescription drugs.

 

SNF Claims Processing Updates

On November 4, CMS published Medicare Claims Processing Transmittal 11109, which rescinds and replaces Transmittal 10904, dated August 10, 2021, to add a note to business requirement 12344.1. The original transmittal was issued regarding updates to SNF edits to bypass services related to an emergency room encounter when there is a 250 revenue code on the same claim. It also makes changes to the FISS and CWF edits for overlapping claims when there is a no-pay hospital claim during an interrupted stay. 

CMS revised MLN Matters 12344 on the same date to accompany the transmittal. 

Effective date: January 1, 2022

Implementation date: January 3, 2022

 

Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule with Comment

On November 5, CMS published an Interim Final Rule with Comment in the Federal Register regarding vaccination requirements for Medicare and Medicaid-certified providers and suppliers. The emergency regulation requires that all facilities covered by the rule establish a policy ensuring all eligible staff have received the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by December 5, 2021, prior to providing any care, treatment, or other services. All staff must be fully vaccinated by January 4, 2022. CMS will enforce these requirements through survey and enforcement processes.

CMS published a Q&A document and a Press Release on the rule on the same date. Comments are due no later than 5 p.m. on January 4, 2022.  

Effective date: These regulations are effective November 5, 2021

Implementation date: The regulations included in Phase 1 (specific citations are in the final rule document) must be implemented by December 6, 2021. The regulations included in Phase 2 must be implemented by January 4, 2022. Staff who have completed a primary vaccination series by this date are considered to have met these requirements even if they have not yet completed the 14-day waiting period required for full vaccination. 

 

ETC Managing Clinician PPA and KCF PBA Implementation

On November 5, CMS published Demonstrations Transmittal 11108, which rescinds and replaces Transmittal 11017, dated September 21, 2021, to revise sections of the KCC Interface Control document,  revise business requirements 12404.18 and 12404.21, and to add new business requirement 12404.47. 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)

 

2022 Annual Update of Per-Beneficiary Threshold Amounts

On November 5, CMS published Medicare Claims Processing Transmittal 11107 regarding updates to the annual per-beneficiary incurred expenses amounts (KX modifier thresholds). The CY 2022 outpatient per-beneficiary therapy amounts are $2,150 for physical therapy and speech-language pathology combined. The occupational therapy amount is $2,150.

Effective date: January 1, 2022

Implementation date: January 3, 2022