NCPA Sues HHS Over Pharmacy DIR Fees

Today, NCPA sued HHS Secretary Alex Azar (NCPA v. Azar) to put an end to pharmacy DIR fees. This has been a top priority for NCPA since 2014 and we have worked tirelessly with the current administration to adopt new rules. Having exhausted every effort to work through the legislative and regulatory processes, community pharmacies can wait no longer.

On behalf of our members and the more than 21,000 community pharmacies that we represent, we are now taking our fight to the courts. NCPA created a one pager on the case and you can click here for more information on the lawsuit.

Sens. Grassley and Wyden Release Insulin Pricing Report

This week, Senate Finance Committee Chairman Charles Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Ore.) released a report on their bipartisan investigation into the skyrocketing costs of Insulin. The report calls out the role PBMs played in the rising costs and noted that there appeared to be little, if any, attempt by PBMs to discourage manufacturers from increasing the list price of their products. The investigation found that PBMs used their size and aggressive negotiating tactics, like the threat of excluding drugs from formularies, to extract more generous rebates, discounts and fees from insulin manufacturers.

Republicans Name New Members of E&C Committee

This week, House Republicans named new members to the Energy and Commerce (E&C) Committee to replace retiring members and fill new slots created as a result of the elections. The E&C Committee is the main committee of jurisdiction for NCPA’s pharmacy priorities. If your Representative is one of the new members, we urge you to get to know them and their staff as they will be crucial to NCPA’s legislative efforts. Hosting them for a pharmacy visit, either in person or virtually, is a great way to showcase your pharmacy. Contact Michael Rule at mrule@ncpa.org with any questions on arranging or hosting such a visit. The new Republican members are:

• Representative John Curtis (Utah-3)
• Representative John Joyce (Pa.-13)
• Representative Kelly Armstrong (N.D.- At Large)
• Representative Dan Crenshaw (Texas-2)
• Representative Debbie Lesko (Ariz.-8)
• Representative Gary Palmer (Ala.-6)
• Representative Greg Pence (Ind.-6)
• Representative Neal Dunn (Fla.-2)

President Trump Signs Law Removing Federal
Antitrust Protection for Health Insurance Companies

This week, President Trump signed H.R. 1418, the Competitive Health Insurance Reform Act of 2020. This bipartisan, bicameral legislation removes the exemption for health insurers from federal antitrust jurisdiction – permitting Federal law enforcement authorities to pursue violations of anticompetitive statutes. The Act continues to exempt certain activities related to actuarial data collection and sharing and creation of common-use forms. NCPA will continue to encourage the federal government to pursue all available avenues to eliminate anticompetitive and anti-patient behavior in the healthcare industry.

New NCPA One Pager Highlights Pitfalls
of Mandatory Mail Order Medications

NCPA has a new one pager available that highlights the negative aspects of mandatory mail order medications. This resource shows that mail order prescriptions are more expensive, create problems for patients, such as delays in delivery, and lead to waste in the system.

CDC Chart on Pharmacy COVID Program

CDC has developed a resource (CDC Pharmacy Partnership Programs Chart – Snapshot) that explains the currently available program(s) for pharmacy engagement and how the federal and state processes work together. This captures some of the key elements to help you understand the differences and operations of the programs.

CMS Releases Final Rule for 2022 with Changes
to Medicare Part D Pharmacy Performance

Today, CMS released the final rule for the “Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” to address the remaining proposals from the February 2020 proposed rule. Most changes will take effect on January 1, 2022. Of important note to pharmacy, CMS will be requiring Part D plans to disclose pharmacy measures to CMS – in response to concerns from “pharmacies that the measures plans use to assess their performance are unattainable or otherwise unfair”. In comments, NCPA advocated for the inclusion of standardized pharmacy performance measures in the rule as currently Part D plans do not have disclose such information. By taking the steps necessary to increase transparency in the process, CMS can better understand how these measures affect pharmacy reimbursements and inform development of standard measures.

NCPA Member Summary on Midnight Rulemaking

NCPA is providing members with a summary on midnight rulemaking and the avenues the incoming President, Congress, and third-party stakeholders have available to delay, change, or repeal rules finalized in the closing days of the Trump Administration. NCPA expects the Biden Administration to put a moratorium on rules not yet finalized, as well as potentially delay rules not yet implemented, to review policy outcomes - which could impact newly promulgated rules effecting community pharmacy.

PCMA Files Lawsuit Over the Rebate Rule

This week, the Pharmaceutical Care Management Association (PCMA), which represents PBMs, filed a lawsuit in the District Court of D.C. challenging the legitimacy of the “rebate rule.” The rule, which was finalized on November 30, 2020, would create a safe harbor mechanism under the antikickback statute to pass along drug manufacturer rebates to Medicare Part D patients at the point of sale. As of today, no hearings have been scheduled by the Court.

Both Sides Agree: North Dakota PBM Lawsuit
Should be Reconsidered

After the Eighth Circuit struck down its PBM regulations due to ERISA preemption issues, North Dakota petitioned the U.S. Supreme Court to vacate the unfavorable ruling. Since the Supreme Court’s subsequent ruling in Rutledge v. PCMA, even PCMA, the PBM lobbying group that brought the suit against North Dakota, has conceded that the court should vacate the Eighth Circuit’s decision and send it back for reconsideration. Although PCMA has not conceded that it should lose under the Rutledge precedent, both parties to the lawsuit agree that the Eighth Circuit should reexamine other questions of law in the case, like Medicare Part D preemption.

Public Health Emergency Extended into April

The current COVID-19 Public Health Emergency is extended for a fourth time, effective Jan. 21, for an additional 90 days until April 21. HHS Secretary Alex Azar announced the extension on Jan. 7. This applies to pharmacists’ ability to provide COVID-19 testing, immunity from liability claims under the Public Readiness and Emergency Preparedness (PREP) Act, the ability to administer childhood vaccines, and other flexibilities that have been implemented by HHS since the start of the PHE on Jan. 31, 2020. Be sure to visit NCPA’s Coronavirus Advocacy page for more information on federal, state, and local developments related to the PHE that affect pharmacists.

HHS Releases Final Rule to Review and Sunset Regulations

On January 8, 2021, HHS finalized a rule requiring the agency to review existing regulations, with some exceptions, every ten years. If regulations are not reviewed and assessed within the timeframe, they will be deemed expired. Rules older than ten years will have to be reviewed within five years after the effective date. Since NCPA submitted comments on the original draft, HHS has made some changes to the final rule to extend the time for existing regulations. Eventually, over time, almost every regulation affecting pharmacy will be reviewed, but HHS will control the timeline for reviewing regulations older than ten years. This final rule will take effect on March 20, 2021.

NCPA Provides Pharmacy Perspective
on Vaccine Injury Table Change

This week, NCPA submitted comments in response to proposed revisions by HRSA and HHS to the National Vaccine Injury Table. The agency is seeking to remove Shoulder Injury Related to Vaccine Administration (SIRVA) and vasovagal syncope from the Table as HRSA believes those injuries are the result of breaches of standard of care by the administrator rather than the actual vaccine. However, NCPA believes HRSA is mistaken in making these changes. Additionally, these changes would potentially increase liability for administrators, such as pharmacists, and hinder vaccine development by drug manufacturers during a pandemic when public policy should be encouraging widespread vaccine administration.

Pharmaceutical Manufacturers File 340B Lawsuit

This week, Eli Lilly, AstraZeneca, and Sanofi filed a lawsuit against HHS over the Office of General Counsel (OGC) advisory opinion which expresses the view of the agency that contract pharmacies should be treated as agents of covered entities and should be supplied 340B discounted drugs. The suits, filed in Delaware, Indiana, and New Jersey, allege HHS did not follow the Administrative Procedures Act (APA) when drafting the opinion and would open the manufacturers to liability for any limitations on contract pharmacies – which could expose them to fines or revocation of their ability to participate in other federal programs like Medicare and Medicaid – although the advisory opinion does not have the force of law. This is just the latest salvo in the ongoing battle between drug manufacturers and covered entities over the 340B program. NCPA will continue to convene the 340B Task Force to discuss the impacts on pharmacy and policy solutions to ensure community pharmacy participation in 340B.

NCPA Encouraging Members to Participate in cBHT Efforts

In response to negative conclusions within the FDA commissioned NASEM report on cBHT, NCPA is encouraging members who compound hormone therapies as part of their business to participate in the following opportunities to ensure the FDA does not interrupt their business. The Partnership for Personalized Prescriptions has established a cBHT Testimonial Portal to collect stories about the benefits of cBHT to share with Members of Congress. Additionally, a prescriber survey has been created. NCPA encourages interested pharmacies to share the effort with the prescribers you work with and to urge them to complete the survey.

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.

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. The weekly update is intended exclusively for the recipient and is not for external distribution.