Trump Administration Releases Final "Rebate Rule"
to Address Drug Pricing
The Trump Administration has released the final “Rebate Rule” which modifies the current rebate system, which hides the true costs of prescription drugs, to deliver rebates to patients at the point of sale. HHS is moving forward under the Executive Order released in July directing the agency to revive this rule with explicit restrictions by the President not to increase costs to the government or premiums for Part D patients. This rule would take effect January 1, 2022 and applies to Part D. Unfortunately, the Administration chose not to address any policies impacting pharmacy DIR fees in the rule. NCPA will be providing a detailed summary of the rule in the future including impacts on community pharmacy.
HHS Finalized Anti-Kickback Statute (AKS)
Safe Harbor Revisions Final Rule
HHS has released the final rule on revisions to the Anti-Kickback Statute (AKS) to better align with a focus on value based coordinated care for patients and delivering financial incentives by reducing legal barriers for healthcare providers. After the release of the proposed rule, NCPA met with the HHS OIG office to advocate on behalf of independent pharmacy community. As a result of those discussions and earlier comments , under the new safe harbors, most pharmacies are a protected entity under the AKS and are not subject to any limitations. However, under these changes, compounding pharmacies are not eligible for these protections. For purposes of this rule, a compounding pharmacy is a pharmacy which primarily compounds or dispenses compounded drugs. This rule will take effect on January 19, 2021. Additionally, NCPA will be releasing a more detailed summary of the revisions and the impacts on membership in the coming days.
Most Favored Nation Drug Pricing Initiative Released
CMS announced on November 20 a new payment model, the Most Favored Nation (MFN) Model for Medicare Part B Drugs and Biologicals and issued a corresponding Interim Final Rule with Comment Period (IFC). The MFN will, according to CMS, lower prescription drug costs by paying no more for high-cost Medicare Part B drugs and biologicals than the lowest price that drug manufacturers receive in other countries that have a comparable per-capita gross domestic product (GDP) and is a member of the Organization for Economic Co-operation and Development (OECD). The MFN Model will also pay providers a flat add-on amount for each dose of an MFN drug instead of a percentage of each drug’s cost. The MFN Model will require participation of Medicare providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions, beginning January 1, 2021 and will operate for seven years until December 31, 2027. NCPA will share more info on potential member impact soon.
CMS Releases Final Medicaid Managed Care Rule
CMS issued a final rule with changes to the Medicaid managed care program. CMS made it easier for states to require managed care organizations to reimburse providers at rates established in the fee-for-service program. Under the new rule, states will no longer need to obtain CMS approval to establish such a benchmark in the managed care program. The rule requires MCOs to report the amount paid to a provider and, in response to NCPA’s comments, CMS clarified that this reporting requirement applies to MCO subcontractors, such as PBMs. Over NCPA’s objection, CMS also changed network adequacy standards by replacing existing time/distance network requirements with state-established standards that may allow states to minimize the importance of patient access to community pharmacy services.
FDA Authorization of First At-Home
Prescription COVID-19 Test
This week, the Food and Drug Administration (FDA) approved an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider.
North Dakota Asks the United States Supreme Court
to Hear PBM Case
The state of North Dakota filed a petition for a writ of certiorari, which means it is asking the Supreme Court to review the 8th U.S. Circuit Court of Appeals judgment in PCMA v. Tufte. Now known as Wilke v. PCMA, this case is similar to Rutledge v. PCMA, which the court heard in October. In both cases, the Supreme Court is asked to consider whether ERISA preempts a state’s authority to regulate PBMs. Should the court find in favor of the state of Arkansas in Rutledge and reverse the 8th Circuit, it should then grant North Dakota’s petition, vacate the 8th Circuit’s judgment, and send North Dakota’s case back to the 8th Circuit for reconsideration in light of the Supreme Court’s ruling in Rutledge. Should the Supreme Court find in favor of PCMA in Rutledge, there are issues in North Dakota’s case that were not before the Supreme Court in Rutledge, where there could be an opportunity for the court to decide those outstanding issues. Here’s how we reported the 8th Circuit decision in August.
NCPA Joins Coalition Letters
on the Paycheck Protection Program
This week, NCPA joined on two coalition efforts surrounding the Paycheck Protection Program (PPP). In the first letter addressed to House and Senate leadership, NCPA joined over 110 other small business organizations in urging Congress to streamline the PPP loan forgiveness process before the end of the year, which would inject the equivalent of $7 billion into the economy.
Secondly, NCPA joined over 80 other organizations on letters to Congressional leadership and the Small Business Administration and Department of the Treasury urging prompt action to address the concerns raised by the signatories regarding the PPP Loan Necessity Questionnaire.
NCPA Comments on CMS’ RFI on Home and
Community Based Services (HCBS)
This week, NCPA submitted comments to CMS in response to the recent request for information. NCPA encouraged CMS to adopt data driven metrics for HCBS and utilizing pharmacy metrics developed by PQA. NCPA continues to advocate for CMS to recognize Medical At Home pharmacy services, in which patients are entitled to long term care pharmacy services in their home setting. NCPA has engaged CMS on this topic and will continue to do so as these patients are deserving of the proper care and services no matter where they live.
Democrats and Republicans Elect House Leaders
for Next Congress
This week, House Democrats and Republicans selected their leaders for next Congress, and there will be no change in the top leadership ranks. Democrats voted to retain Reps. Nancy Pelosi (D-Calif.) as Speaker, Steny Hoyer (D-Md.) as Majority Leader, and James Clyburn (D-S.C.) as Majority Whip. Republicans voted to retain Minority Leader Kevin McCarthy (R-Calif.), Minority Whip Steve Scalise (R-La.), and Conference Chair Liz Cheney (R-Wyo.). Pelosi will still have to win a majority vote on the House floor when the new Congress convenes in January, and it remains to be seen if some Democrats will again refuse to vote for her.
NCPA Summary of CMS Transparency in Coverage Rule
for ERISA and ACA Plans
NCPA has released a brief summary of the recent Transparency in Coverage rule released by CMS. The rule will require most health plans and insurers to make available personalized out of pocket cost information and underlying rates for all covered health care items and services, including prescription drugs, through an internet based tool by January 1, 2024. Most plans offering coverage will have to make machine readable files containing detailed pricing information showing all negotiated rates for all covered items and services between the plan and in-network providers, a separate file for out-of-network provides, and a third file detailing historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level. All of this data must be available by January 1, 2022.
Follow Up on Recent FDA Actions on Compounding
Following up on mentions in previous communications to membership, NCPA is releasing summaries of the Memorandum of Understanding between the States and the FDA on interstate shipments of compounded drugs and the Insanitary Conditions Guidance issued by the FDA. The MOU was released on October 27, 2020 and States will have 365 days to make the determination if they wish to sign the compact. Despite NCPA’s comments, the Insanitary Conditions Guidance, while not legally binding, is a non-exhaustive list of potential events and remedies which conflict with current USP language and any reported violations will put a compounding pharmacy on the FDA’s disciplinary radar. NCPA will continue to monitor the legal challenges to the MOU as well as any changes made by the FDA to the Guidance.
Oregon Board of Pharmacy Moves
to Implement Senate Bill 698
Senate Bill 698 which passed in 2019 requires pharmacies to have special prescription container labels in both English and at least 14 readable languages for patients with limited English proficiency (LEP) starting January 1, 2021. It is the Board’s responsibility to implement rules pursuant to SB 698 and they have requested public comment on options to be considered for achieving SB 698’s requirements while limiting the negative economic impact of the rule on businesses. NCPA plans to submit comments to the board bringing to their attention the high cost of compliance, the need to delay implementation, and the need to phase in implementation over the next 2 years to ensure feasibility and compliance.
NCPA State Legislative Activity Update
NCPA tracks state legislation related to our top three state priorities: Medicaid reform, scope of practice and compensation for services, and PBM reform and regulation. Click each issue for a report of bills that have been introduced so far this session specifically dealing with these three issue areas. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the attached report. Bills that have moved this week are listed at the top in the “Recently Updated” section.
Due to the holiday, there will not be an Advocacy Center Update on November 27. It will resume on December 4.
NCPA’s Advocacy Center Update provides a weekly detailed summary of recent and breaking legislative, regulatory, and state developments impacting independent community pharmacy and NCPA’s efforts to affect policies benefitting its membership and the industry. The weekly update is distributed to NCPA leadership, steering committees, allied organizations/stakeholders and major contributors to the NCPA LDF and PAC.