Amended Complaint Filed in DIR Lawsuit

Earlier this week, NCPA filed an amended complaint and added plaintiffs to the pharmacy DIR fees lawsuit that was originally filed in January. The additional plaintiffs to the complaint include the American Pharmacists Association, the Coalition of State Rheumatology Organizations, Fruth Pharmacy, Hi-School Pharmacy Services, Kare Drug, and Tyson Drug Company. Their active support of this litigation helps bolster our case as it makes its way through the courts. The government response to the amended complaint is expected in mid-May.

NCPA, Pharmacy Groups File Federal Lawsuit Challenging
Washington State’s Flawed Medicaid Reimbursement Plan

NCPA joined NACDS and the Washington State Pharmacy Association (WSPA) in a federal lawsuit challenging CMS’s approval of a Washington State Medicaid reimbursement plan. The complaint asks the court to direct CMS to set aside their final approval of the reimbursement plan because it is not in compliance with federal regulations. The state provided no evidence to support the adopted reimbursement rate. The $4.00 Medicaid fee-for-service dispensing fee adopted by Washington is the lowest in the country, and less than half of its’ neighboring states. In March 2019, CMS disapproved the state’s Medicaid reimbursement, and Washington filed an appeal. In November of last year, an administrative law judge also ruled that Washington State’s Medicaid reimbursement plan violates Medicaid rules. In the waning moments of the former Administration, CMS reversed their original decision, and with little explanation, approved this flawed Medicaid reimbursement that could potentially reimburse pharmacies well below their costs. This lawsuit is not only important for Washington State, it is important for every state because of the dangerous precedent of CMS approving below costs dispensing fees. The recently filed complaint can be found here.

Congressional Democrats and Republicans
Release Competing Drug Pricing Plans

House Democrats and Republicans have reintroduced two competing bills to address rising drug prices. Highlights of the Democrat bill, H.R. 3, the Lower Drug Costs Now Act of 2021, include: a $2,000 per year cap on Medicare beneficiaries’ out-of-pocket spending on prescription drugs, authority for the HHS Secretary to negotiate a maximum price for up to 250 of the costliest drugs in the U.S. at no more than 120% of the volume-weighted average price in six other countries (i.e., international price indexing), drug pricing transparency provisions, and standardized pharmacy quality metrics in Part D. A detailed summary of H.R. 3 can be found here.

Highlights of the Republican bill, H.R. 19, the Lower Costs, More Cures Act of 2021, include: a $3,100 per year cap on Medicare beneficiaries’ out-of-pocket spending on prescription drugs, a $50 cap on spending for insulin and related supplies after seniors hit their deductible, preventing the use of spread pricing in Medicaid by requiring PBMs pass through payments in their entirety and requiring Medicaid managed care plans reimburse pharmacies based on state FFS reimbursement, changing Medicare Part B reimbursement, and drug price transparency provisions that include commissioning a report on PBM anticompetitive practices. A summary of H.R. 19 can be found on the House Republican Energy & Commerce Committee website here.

Help Your Patients Fight Back Against PBM Steering

A NCPA survey last fall indicated that a vast majority of community pharmacies have lost patients due to unfair steering by PBMs, and this problem persists. Now, you can help your patients fight back against these unfair practices. NCPA has developed materials that you can use in your pharmacy to alert your patients to the resources available on Fight4Rx such as sample letters and who they can contact to express their dismay at being steered away from your pharmacy by their PBM. Help raise awareness of these resources by promoting them to your patients. Contact Michael Rule (Mrule@ncpa.org) with any questions.

Pennsylvania Governor Visits NCPA Member Pharmacy

Pennsylvania Gov. Tom Wolf (D) recently visited See-Right Pharmacy in Harrisburg, praising its role in vaccinating community members, and saying community pharmacies are essential in the fight against COVID-19. This visit comes as more state legislators are speaking out to encourage the commonwealth to further include independent pharmacies in its vaccine rollout plans. See-Right is owned by NCPA member Darrin Silbaugh, RPh. The pharmacy has administered more than 2,000 doses of the Moderna vaccine since Jan. 27. “Local community vaccine providers are essential partners in an equitable vaccine distribution,” Wolf said in a briefing outside the pharmacy after his visit. Photos from the visit are available here.

Member of Congress Recognizes
Pennsylvania Pharmacy Owner

U.S. Rep Madeline Dean (D-Pa.) invited Dr. Mayank Amin of Skippack Pharmacy in Schwenksvile , Pa., to be her virtual guest to President Biden’s Joint Address to Congress last week. Amin and his staff have vaccinated more than 30,000 people in suburban Philadelphia. Their work has helped reduce the COVID-19 infection and death rate in the region and has helped move the district toward reopening. “Community leaders like Dr. Mak are the true heroes of this recovery, and I am proud to uplift him and his story as my virtual guest to the presidential address,” Dean said in a statement. 

CMS Releases Final Medicare Part D
DIR Reporting Guidance for 2020

On April 28, 2021, CMS released the final Medicare Part D DIR Reporting Guidance for contract year 2020. Under existing provisions of the original Part D program and later modified by the ACA, Part D sponsors are required to report DIR data at the plan benefit package (PBP) summary level and the more detailed National Drug Code (NDC) level. For the 2020 reports and previous years resubmissions (2016-2019), CMS made two minor technical changes for the summary reports – adding separating pound signs (#) to delineate data in the required #8C (Amounts Received from Pharmacies comments field) and #9C (Amounts Paid to Pharmacies comments field) section of the report. Part D sponsors are required to complete and submit the reports by July 31, 2021. NCPA will continue to fight through legal, legislative, and regulatory avenues to end post point of sale claw-backs and pursue opportunities to bring transparency to the pharmacy DIR reporting process in upcoming comments on pharmacy performance reporting.

Pharmacist Provider Status Legislation Introduced in Senate

This week, Sens. Charles Grassley (R-Iowa), Robert Casey (D-Pa.), and Sherrod Brown (D-Ohio) reintroduced S. 1362, the Pharmacy and Medically Underserved Areas Enhancement Act. This companion legislation to H.R. 2759 would allow Medicare to reimburse pharmacists who provide care to Medicare patients in underserved communities. Specifically, the Act would allow Medicare beneficiaries to receive basic care such as immunizations, diabetes management, blood pressure screenings and routine checks from pharmacists, since there is currently no avenue for Medicare to directly reimburse pharmacists for providing this care.

NCPA, Other Pharmacy Groups Request COVID-19
Regulatory Flexibilities be Made Permanent

NCPA joined 11 other pharmacy stakeholder groups in a sign on letter to ask the Department of Health and Human Services to extend certain regulatory flexibilities that were authorized during the COVID-19 pandemic to allow pharmacists to more fully support the public response effort. These regulatory flexibilities include: pharmacists’ ability to order, authorize, test, treat, and administer immunizations and antivirals against infectious diseases; removal of operational barriers that address workforce and workflow issues which previously prevented pharmacists from engaging in patient care; compounding flexibilities to address current and future drug shortages; and reimbursement for specific pharmacist-provided patient care services.

Senate Legislation Would Require FTC to Examine PBMs

This week, Sens. Charles Grassley (R-Iowa) and Maria Cantwell (D-Wash.) reintroduced S. 1388, the Prescription Pricing for the People Act of 2021. The legislation requires the FTC to examine the effects of PBM consolidation and vertical integration on drug pricing, as well as anticompetitive PBM practices, and provide policy recommendations to Congress to improve competition and protect consumers. S. 1388 is cosponsored by Sens. Marsha Blackburn (R-Tenn.), Richard Blumenthal (D-Conn.), Thom Tills (R-N.C.) and Joni Ernst (R-Iowa). NCPA worked closely with the sponsors, as well as former Rep. Doug Collins, on this legislation last Congress and has endorsed it once again.

Oklahoma Governor Vetoes Pro-Patient,
Pro-Pharmacy PBM Bill

This week, Oklahoma Governor Stitt (R) vetoed SB 821 a pro-patient, pro-pharmacy bill which would address PBM conflicts of interests by prohibiting steering using copay differentials. Unfortunately, Governor Stitt put big business interests over patients and local small businesses. SB 821 is a commonsense approach to ensuring patient access to their community pharmacies. This bill would protect both patients AND employers from PBMs’ conflicts of interest because PBMs are steering patients to their OWN pharmacies. A recent Florida study found PBMs to reimburse their own pharmacies at a higher rate than other pharmacies which is bad for patients and businesses. The Oklahoma Pharmacists Association and NCPA have sent a call of action alert urging pharmacists in Oklahoma to contact their state senators to demand a veto override vote.

NCPA Requests State Boards of Pharmacy
Take Action on Compounding MOU

NCPA, along with American Pharmacists Association (APhA), Alliance for Pharmacy Compounding (APC), and PCCA, sent a letter to the individual state boards of pharmacies encouraging them to take action on the FDA Memorandum of Understanding (MOU) on interstate shipments of compounded drugs. The letter seeks to inform those state boards on the implications of signing or not signing the MOU and the impacts the decision would have on compounding pharmacies within their state. The organizations are advocating for the signing of the MOU because of the detrimental impacts it would have on patients who use compounded drugs. Additionally, the letter encourages states to review the MOU and make the determination whether or not the MOU would conflict with existing state law and take immediate action to modify statutes, if necessary, in order to sign. If further state legislative action is required, the groups encourage the state boards to contact the FDA and request a delay of enforcement for two years to ensure for adequate time to enact those changes.

Berkeley Research Group Releases Analysis on NASEM Report
on Compounded Bio-identical Hormone Therapy

Berkeley Research Group (BRG), commissioned by the Alliance for Pharmacy Compounding (APC), has released an analysis on the procedures and the conclusions drawn by the National Academies of Science, Engineering, and Medicine (NASEM) in their report on compounded bio-identical hormone therapy. BRG concludes:

• Bias may have influenced the conclusions and recommendations of the Committee;
• The conclusions drawn by the Committee regarding the safety and efficacy of cBHT are flawed;
• If implemented, the recommendations would harm patients.

BRG highlights the connections between the FDA and the members of the Committee responsible for drafting the report, as well as the preclusion of pharmacists with active experience in the cBHT patient population. The analysis also reveals the exclusion of studies with positive outcomes for cBHT patients by the Committee, which paints an incomplete picture of the safety and effectiveness of cBHT treatments.

NCPA will continue to work with other stakeholders to continue to put pressure on the FDA not to adopt the conclusions of the report on cBHT.

NCPA Submits Testimony in Support
of California Anti-steering Bill

NCPA submitted written testimony and provided virtual support for California SB 524. The bill would prohibit a PBM from distributing patient communications that can mislead patients to believe they must utilize a particular pharmacy, particularly a PBM-owned pharmacy. NCPA pointed out in its comments that such communications can thwart a patient’s ability to make healthcare decisions for themselves.

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.