This week in Medicare updates—2/22/2023

Billing Medicare Part B for Insulin with New Limits on Patient Monthly Coinsurance

On February 13, CMS published an MLN Fact Sheet regarding billing procedures for insulin following the new regulation that limits the Part B coinsurance for a month’s supply of insulin at $35. CMS is instructing providers not to bill for supplies for insulin for July 2023 or subsequent months in advance of July 2023 to ensure patients aren’t charged more than the $35 maximum allowed for that month. 

CMS is also adding two modifiers to the April 2023 HCPCS file: JK (one-month supply or less of drug/biological) and JL (three-month supply of drug/biological). Providers are instructed not to bill a three-month supply of insulin in May or June 2023 and should bill a one-month supply instead using the JK modifier. Starting in July, providers should bill a three-month supply of insulin with the JL modifier and a one-month supply with the JK modifier. 

On February 16, CMS published Medicare Claims Processing Transmittal 11834 regarding implementation of the system changes necessary to accommodate the changes to insulin pricing and provider/supplier payments. 

Effective date: July 1, 2023

Implementation date: July 3, 2023

 

Proposed Rule: Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities (SNF) and Nursing Facilities (NF)

On February 13, CMS published a draft version of a Proposed Rule regarding implementation of a section in the Affordable Care Act which requires disclosure of certain ownership, managerial, and other information regarding SNFs and NFs. The rule would require SNFs and NFs to disclose data upon initial enrollment and revalidation. SNFs would also have to report information as part of any change of ownership within specific timeframes. The rule also provides definitions of private equity companies and real estate investment trusts, which would then allow SNFs to disclose whether each direct and indirect owning or managing entity is a private equity company or real estate investment trust.

CMS published a Press Release and Fact Sheet on the rule on the same date. Comments on the rule are due by April 14. The rule was published in the Federal Register on February 15.

 

CMS Rolls Out Three New Drug Pricing Models in Response to Biden Administration’s Executive Order on Drug Prices

On February 14, CMS published a Press Release to announce that it has selected three new drug pricing models for testing by the CMS Innovation Center in an attempt to help lower prescription drug prices. This action is in response to the Biden Administration’s Executive Order directing HHS to consider additional actions to further drive down prescription drug costs. The three drug models include:

• The Medicare $2 Drug List: Also referred to as the Medicare High-Value Drug List, this model encourages Part D plans to offer a low, fixed copayment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs.
• The Cell & Gene Therapy Access Model: This Medicaid model would have state Medicaid agencies assign CMS to coordinate and administer multi-state outcomes-based agreements with manufacturers for certain cell and gene therapies.
• The Accelerating Clinical Evidence Model: This Part B Model involves having CMS develop payment methods for drugs approved under accelerated approval to encourage timely confirmatory trial completion and improve access to post-market safety and efficacy data.

CMS published a Fact Sheet and FAQ on these three models. It also published a Report regarding the response to the Executive Order.

 

Comparison of Average Sales Prices (ASP) and Average Manufacturer Prices (AMP): Results for the Third Quarter of 2022

On February 14, the OIG published a Report regarding drugs for which the ASP exceeds the AMP by 5% or more for two consecutive quarters or three of the previous four quarters. When this happens, CMS substitutes 103% of the AMP for the ASP-based reimbursement. In the third quarter of 2022, 15 drug codes met this price substitution criteria. Eight additional drug codes exceeded the 5% threshold but were identified as being in short supply. Another 18 drug codes had ASPs exceeding the AMPs by at least 5% in the third quarter of 2022 but didn’t meet other price substitution criteria. The OIG will provide these results to CMS for review.

 

Updated OIG Work Plan

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

• Bridging Data and Practice: A Resource Guide for Medicare's Enrollment Race and Ethnicity Data
• In-Depth Review of Nursing Home Citations Related to the Use of Antipsychotic Drugs
• Securing Medicaid and Medicare Payments to Providers

 

Proposed Decision Memo: Seat Elevation Systems as an Accessory to Power Wheelchairs (Group 3)

On February 15, CMS posted a Proposed Decision Memo regarding coverage of seat elevation systems as an accessory for Group 3 power wheelchairs. CMS has determined that coverage of this equipment within the benefit category for DME is reasonable and necessary under the following conditions:

• The individual performs weight-bearing transfers to/from the wheelchair at home using either their upper extremities during a non-level sitting transfer and/or their lower extremities during a sit-to-stand transfer with or without caregiver assistance and/or the use of assistive equipment
• The individual has undergone a specialty evaluation by a practitioner who has specific training experience in rehabilitation wheelchair evaluations

CMS is seeking comment both on the proposed decision and whether power seat evaluation equipment on Group 2 power wheelchairs would also fit into the benefit category. Comments are due by March 17. CMS published a Press Release to accompany the proposed decision memo.

 

Omnibus CR to Implement Policy Updates in the CY 2023 Physician Fee Schedule (PFS) Final Rule

On February 16, CMS published Medicare Benefit Policy Transmittal 11865, Medicare National Coverage Determinations Transmittal 11865, and Medicare Claims Processing Transmittal 11865, which rescind replace Medicare Benefit Policy Transmittal 11824, Medicare National Coverage Determinations Transmittal 11824, and Medicare Claims Processing Transmittal 11824, all dated January 27, to add the Spanish version of MSN Message 18.29 to the IOM for the Claims Processing Manual. The original transmittal was issued regarding the implementation of changes from the 2023 PFS Final Rule. 

CMS revised MLN Matters 13017 on the same date to update the web addresses of the transmittals.

Effective date: January 1, 2023

Implementation date: February 27, 2023 - requirements implementation date; April 3, 2023 - for release tracking purposes only