This week in Medicare updates—12/1/2021

December 1, 2021
Medicare Insider

Ordering External Breast Prostheses & Supplies

On November 22, CMS revised an MLN Fact Sheet regarding Medicare coverage and documentation requirements for breast prostheses and supplies. Revisions were made to almost the entirety of the fact sheet and affect coding, provider documentation, supplier replacements, and more.


Medicare Provider Enrollment

On November 22, CMS updated an MLN Educational Tool on Medicare provider enrollment to include the 2022 enrollment application fee ($631) and to note that effective January 1, 2022, CMS no longer requires enrolling Medicare Diabetes Prevention Program suppliers to pay the provider enrollment application fee.


Advisory Opinion 21-18

On November 22, the OIG published an Advisory Opinion regarding whether an arrangement involving a proposed joint venture for providing therapy services would be grounds for the imposition of sanctions under civil monetary penalties and exclusion authorities related to the anti-kickback statute. The requestor, a contract therapy services company providing management of day-to-day operations and therapy staffing for rehab programs in various facilities, would enter into a joint venture with a company that owns certain facilities, and the joint venture entity would provide contract therapy services to rehab programs in those facilities. The company entering into the agreement with the requestor would purchase a 40% interest in the joint venture entity. While the company partnering with the requestor would not be obligated to contract with or make direct referrals to the joint venture entity, the requestor would expect that the company would do so and would terminate its current therapy service contracts with others.

The OIG said that this arrangement would implicate the federal anti-kickback statute, and the OIG noted it has longstanding concerns about these types of joint venture arrangements, especially when all or most of the business from the joint venture is derived from one of the joint venture investors. The OIG said the arrangement presents a host of concerns, which are detailed in the Opinion, and the arrangement would constitute grounds for the imposition of sanctions under the anti-kickback statute. 


Facility Initiated Discharges in Nursing Homes Require Further Attention

On November 22, the OIG published a Review of facility-initiated discharges in nursing homes. The OIG had trouble identifying facility-initiated discharges and discovering ways for CMS and the Administration for Community Living (ACL) to address inappropriate facility-initiated discharges due to a lack of data, perspectives on regulations and enforcement of facility-initiated discharges, and weak safeguards to protect against such discharges. The OIG recommends CMS provide training to nursing homes, assess the effectiveness of its enforcement of inappropriate facility-initiated discharges, and implement initiatives to address inappropriate facility-initiated discharges. It also recommends ACL and CMS coordinate to strengthen safeguards to protect nursing home residents.


Comment Request: Payment Collections Operations Contingency Plan

On November 22, CMS published a Comment Request in the Federal Register regarding an information collection titled “Payment Collections Operations Contingency Plan.” 

Comments are due by January 21, 2022.


Over-the-Counter (OTC) Home Testing and CLIA Applicability FAQ

On November 22, CMS published an FAQ regarding OTC tests for home COVID testing and CLIA certification requirements. The FAQ covers which settings these tests can be used in, whether these settings need CLIA certificates, and more.


Reduced Payment for Physical Therapy and Occupational Therapy Services Furnished In Whole or In Part by a Physical Therapist Assistant (PTA) or Occupational Therapy Assistant (OTA)

On November 22, CMS published Medicare Claims Processing Transmittal 11129, which rescinds and replaces Transmittal 10934, dated August 13, 2021, to update the background/policy section. This transmittal is no longer sensitive and may now be posted to the internet. The original transmittal was published regarding implementation of the policy which reduces payment down to 85% of the part B payment for PT or OT when furnished in whole or in part by a PTA or OTA on dates of service on or after January 1, 2022. 

Effective date: January 1, 2022

Implementation date: January 3, 2022


Ground Ambulance and Patient Billing Advisory Committee

On November 23, CMS published a Notice in the Federal Register regarding the establishment of an advisory committee, named the Advisory Committee on Ground Ambulance and Patient Billing (GAPB Advisory Committee) as required by The No Surprises Act. The notice solicits nominations for members of the committee. These nominations are due by December 13, 2021.

CMS published a Press Release regarding the GAPB Advisory Committee on the same date.


Revisions to Certified Provider/Supplier Model Letters and Instructions for Processing Initial SNF Enrollment Applications

On November 23, CMS published Medicare Program Integrity Transmittal 11139, which rescinds and replaces Transmittal 11040, dated October 14, 2021, to delay the implementation date to January 3, 2022. The original transmittal was published regarding revisions to model letters MACs use when processing provider/supplier enrollment applications and updates to MAC processing instructions for initial SNF enrollment applications.

Effective date: October 15, 2021

Implementation date: January 3, 2022


CMS Should Strengthen its Prescription Drug Event Guidance to Clarify Reporting of Sponsor Margin for Medicare Part D Bids

On November 24, the OIG published a Review of whether a Part D sponsor complied with federal requirements for reporting prescription drug event (PDE) information during CY 2015 that supported cost information in its 2017 Part D bid. The OIG found that the sponsor complied with CMS’ PDE reporting requirements, but those requirements don’t adequately address sponsor service delivery models in which a sponsor owns the pharmacy it uses and does not have a negotiated contract with the pharmacy. This makes it difficult to identify and separate the sponsor margin in the PDE record from the pharmacy costs. This then prevents CMS from being able to readily identify and evaluate all margin that accrues to sponsors in future years’ Part D bids, and CMS cannot readily determine whether the amounts included in those Part D bids are reasonable. 

The OIG recommends CMS update its PDE guidance to address margin under sponsor delivery models where a sponsor owns a pharmacy. CMS did not concur with the recommendation but agreed that it is important for sponsor-owned pharmacies’ margins to be clearly reported, and CMS said it is open to exploring other avenues to achieve this. 


Updated COVID-19 Vaccine Emergency Use Authorizations (EUA)

On November 24, CMS published links to updated EUAs for the Janssen, Pfizer-BioNTech, and Moderna COVID-19 vaccines to include the amended versions which authorize the use of a single booster dose for all patients 18 years or older. CMS also updated its Medicare COVID-19 Vaccine Shot Payment webpage to note the Medicare payment rate for boosters is $40 as it is for every other dose of the vaccine.  


Comment Request: Review Choice Demonstration for Home Health Services; Continuation of Data Collection to Support QHP Certification and Other Financial Management and Exchange Operations; more

On November 26, CMS published a Comment Request in the Federal Register regarding the following information collections:

  • Review Choice Demonstration for Home Health Services
  • Continuation of Data Collection to Support QHP Certification and Other Financial Management and Exchange Operations
  • Notice of Rescission of Coverage and Disclosure Requirements for Patient Protection under the Affordable Care Act
  • Requirements Related to Surprise Billing: Qualifying Payment Amount, Notice and Consent, and Disclosure on Patient Protections Against Balance Billing, and State Law Opt-in

Comments are due by January 25, 2022.