This week in Washington: The 117th Congress will be in session on Jan. 21.

Senate Finance Issues Bipartisan Report on Rising Insulin Prices

On Jan. 14, the Senate Finance Committee released a bipartisan report on rising insulin prices over the past decade. In the course of its investigation, the committee reviewed the three largest insulin manufacturers (Sanofi, Novo Nordisk and Eli Lilly) and the three largest PBMs (CVS Caremark, Express Scripts and OptumRx) in the U.S. The investigation found that insulin manufacturers raised the list price of their insulin products absent significant advances in the efficacy of the drugs. The report also said there was little attempt by PBMs to discourage manufacturers from increasing the list price of their products. Find the full report here.

CMS Releases an Informational Bulletin on the Extension of Grace Period Related to the Four Walls Requirement for IHS/Tribal Facilities

On Jan. 15, the Centers for Medicare and Medicaid Services (CMS) released a Center Informational Bulletin that extends the grace period previously granted to Indian Health Service (IHS) facilities, and facilities operated by Tribes and Tribal organizations under the Indian Self-Determination and Education Assistance Act (ISDEAA). This ISDEAA permits IHS and Tribal facilities to claim Medicaid reimbursement under the clinic services benefit at 42 C.F.R. § 440.90 (including at the IHS All Inclusive Rate) for services provided outside the “four walls” of the facility.

The grace period is extended to Oct. 31, 2021, and the bulletin explains the steps Tribal facilities and states will need to take before the extended grace period expires in order for these facilities to continue to be reimbursed for services provided outside the four walls of the facility after Oct. 31. Find more information here.

CMS Updates Opioid Prescribing Mapping Tools with 2018 Data

On Jan. 15, the Centers for Medicare and Medicaid Services (CMS) released an update to the Medicare Part D Opioid Prescribing Mapping Tool and the Medicaid Opioid Prescribing Mapping Tool with data for 2018. The Opioid Prescribing Mapping Tools are web-based visualization resources that present geographic comparisons of opioid prescribing rates. The Medicare Part D Opioid Prescribing Mapping Tool presents opioid prescribing rates at the state, county and ZIP Code levels and the Medicaid Opioid Prescribing Mapping Tool presents opioid prescribing rates at the state level. In both the Medicare Part D and Medicaid programs, overall opioid prescribing rates continue to decrease. In Medicare Part D, the opioid prescribing rate had decreased from 5.1 percent in 2017 to 4.7 percent in 2018. In the Medicaid program, the opioid prescribing rate decreased from 4.6 percent in 2017 to 3.7 percent in 2018. The Opioid Prescribing Mapping Tools are available here.

CMS: Geographic Direct Contracting Model Request for Applications (RFA) Now Available

On Jan. 15, the Centers for Medicare and Medicaid Services (CMS) announced that the Geographic Direct Contracting Model (Geo) Request for Applications (RFA) is now available. The Model will test a geographic-based approach to improve health and reduce costs in selected regions across the country. CMS expects to accept applications for Geo from March 1-April 2, 2021, via an online portal. Further details will be available on the Geo webpage in the coming month.

The RFA lists full details on the Model, including:

  • Eligibility and participation requirements;
  • Model design elements, such as beneficiary eligibility and alignment, beneficiary outreach and education requirements, financial methodology, model overlap, benefit enhancements, beneficiary engagement incentives, capitation payment mechanisms, payment integrity and medical review;
  • Application questions, scoring and selection, including the proposed discount review process.

Find more information here.

CMS: Part D Senior Savings Model – CY 2022 Pharmaceutical Manufacturer RFA Released

On Jan. 15, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2022 Part D Senior Savings Model Request for Applications (RFA) for Pharmaceutical Manufacturers for Plan Year 2022. The Part D Senior Savings Model tests a change that enables participating Part D enhanced alternative plans to lower Medicare beneficiaries’ out-of-pocket costs for insulin to a maximum $35 copay per one-month supply in the deductible, initial coverage and coverage gap phases of the benefit. CMS intends to subsequently release the CY 2022 Request for Applications for Part D Sponsors after it completes its review and approval of CY 2022 manufacturer participation, and is currently targeting March 2021 to start these activities.

Manufacturers of Model Drugs who are not currently participating in the Part D Senior Savings Model that wish to participate in the Model for the 2022 Plan Year must submit an executed Addendum to the Medicare Coverage Gap Discount Program Agreement for Participation in the Part D Senior Savings Model to CMS by 11:59 p.m. ET on Jan. 27, 2021.  Signed materials should be submitted to CMS via PartDSavingsModel@cms.hhs.gov. Find more information here.

CMS: Applications for MIPS Exceptions Due to COVID-19 Now Due Feb. 1

On Dec. 17, the Centers for Medicare and Medicaid Services (CMS) pushed back the deadline to Feb. 1 for doctors to apply for extreme and uncontrollable circumstances exceptions from the Merit-based Incentive Payment System. CMS is reminding providers that that process can include a request to leave out one or more performance categories from their score due to the COVID-19 pandemic. However, the hardship application for the interoperability category would still have a Dec. 31 deadline. Find more information here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.