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

Senate

Administration

Proposed Rules

Final Rules/Guidance

Reports

Senate

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.

Administration

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 [email protected].

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.

Proposed Rules

FDA Issues Draft Guide on Proprietary Naming of Non-Rx Drugs

On Dec. 11, the Food and Drug Administration (FDA) published a draft guidance that details how sponsors should select and screen proprietary names for nonprescription drugs. The new draft guidance, Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products, makes naming recommendations for drugs that are switched from full-prescription and partial-prescription to nonprescription status. In the draft guide, FDA says drugs that switch from full-prescription to nonprescription status likely can keep the same name. However, drugs that are switched from partial-prescription to nonprescription status may need to have their names changed to avoid causing confusion among consumers.

Find the draft guidance here. Public comments are due by Feb. 8, 2021.

Final Rules/Guidance

CMS Issues Contract Year 2022 Medicare Advantage and Part D Final Rule

On Jan. 15, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring Part D plans to offer a real-time benefit comparison tool starting Jan. 1, 2023, so enrollees can obtain information about lower-cost alternative therapies under their prescription drug benefit plan. Under the final rule, CMS is allowing Part D plans to have a second, “preferred” specialty tier with a lower cost-sharing level than their other specialty tier. This change is meant to give Part D plans more tools to negotiate prices on highest-cost drugs and lower out-of-pocket costs for enrollees in exchange for placing these products on the “preferred” specialty tier. The final rule also requires Part D plans to disclose pharmacy performance measures to CMS, and CMS will be able to report pharmacy performance measures publicly to increase transparency on the process.

Find the final rule here.

CMS Finalizes Rule on Prior Authorization Process

On Jan. 15, the Centers for Medicare and Medicaid Services (CMS) finalized the CMS Interoperability and Prior Authorization rule, requiring the payers regulated under this rule (Medicaid and CHIP managed care plans, state Medicaid and CHIP fee-for-service programs (FFS) and issuers of individual market Qualified Health Plans (QHPs) on the Federally-facilitated exchanges (FFEs)) to implement application programing interfaces (APIs).

The final rule also requires Medicaid and CHIP (FFS) programs, Medicaid and CHIP managed care plans, and issuers of individual market QHPs on the FFEs to include, as part of the already established Patient Access API, claims and encounter data, including laboratory results, and information about the patient’s pending and active prior authorization decisions. These payers are also required to share this data directly with patients’ providers if they ask for it and with other payers as the patient moves from one payer to another.

Find the final rule here.

CMS: Notice of Benefit and Payment Parameters for 2022 Final Rule

On Jan. 14, the Centers for Medicare and Medicaid Services (CMS) finalized the Notice of Benefit and Payment Parameters for 2022, including reducing the exchange user fee from 3 percent to 2.25 percent of premiums for carriers in federal exchange and from 2.25 percent to 1.75 percent of premiums for state-based exchanges that use the federal platform. The final rule also codifies the Trump administration’s revised 1332 waiver and clarifies that insurers must accept payments from health reimbursement accounts. It also ends network adequacy requirements for plans that do not have networks and lets states rely on web-brokers and other entities for enrollment.

Find the final rule here.

CMS: Medicare Coverage of Innovative Technology (MCIT)

On Jan. 12, the Centers for Medicare and Medicaid Services (CMS) finalized the Medicare Coverage of Innovative Technology (MCIT) rule that will eliminate lag time for both seniors and innovators in access to new technology. The final rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems “breakthrough,” which FDA approves on an expedited basis and could include devices harnessing new technologies like implants or gene-based tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions like cancer and heart disease.

Under the MCIT rule, Medicare can provide national coverage simultaneously with FDA approval, up to a period of four years. After the coverage period is over, CMS will reevaluate the device based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries to determine more permanent coverage. Upon manufacturer request, Medicare may cover through MCIT eligible breakthrough devices the FDA has approved, including breakthrough devices that received FDA marketing authorization approval within two calendar years prior to the final rule’s effective date, giving Medicare beneficiaries access to these devices.

In addition, the MCIT final rule will clarify the standard CMS uses to determine whether Medicare should cover items and services, like devices and surgical procedures. This final rule will codify CMS’s definition of reasonable and necessary in regulation.

Find the final rule here.

Courts

Find a comprehensive look at “Courts and Healthcare Policy in 2020” here.

Reports

GAO: Prescription Drugs - Department of Veterans Affairs Paid About Half as Much as Medicare Part D for Selected Drugs in 2017

On Jan. 14, the Government Accountability Office (GAO) released a report on the Medicare and the Department of Veterans Affairs coverage of prescription drugs for about 52 million people in 2017. In a GAO sample of 399 brand-name and generic prescription drugs, the VA paid an average of 54 percent less per unit than Medicare, even after taking into account rebates and discounts. The programs pay for drugs differently. Medicare reimburses the Part D plan sponsors to pay pharmacies, but the VA buys drugs directly from manufacturers. According to GAO, the VA may be able to get lower prices because it can negotiate as a single health system with a unified list of covered drugs and use discounts defined by law that Medicare does not have.

Find the full report here.

GAO: Medicaid - Data Completeness and Accuracy Have Improved, Though Not All Standards Have Been Met

On Jan. 14, the Government Accountability Office (GAO) released a report on state-reported data that helps the federal government oversee the Medicaid program. GAO’s prior work found issues with the completeness and accuracy of the qdata in the federal repository and made recommendations. Since then, federal Medicaid administrators have improved that data. For example, GAO found that all states provided at least some data in nearly all of the Medicaid-related topic areas, and that the data was generally of acceptable quality. Yet, GAO also highlighted data on services, payments and more that did not meet standards. GAO suggests implementing their open recommendations.

Find the full report here.