Help Community Pharmacy Make its Best Case
to the Supreme Court
In the coming months, the Supreme Court will hear a case focused on state regulation of PBMs in the case of Rutledge v. PCMA. A date for oral arguments has not yet been set, but a decision in the case is expected before June 30. If it comes down in our favor, the decision could significantly empower states to regulate PBMs.
NCPA is seeking to build a coalition of partners to make the best legal arguments. If you have not done so, please consider an investment in NCPA's Legislative/Legal Defense Fund. The LDF can accept both corporate and individual funds, and it supports our entire advocacy operation. This includes attorneys and outside counsel. The better funded the LDF, the more resources we can dedicate to this landmark case and better prepare for the legislative battles in the states once a decision is rendered. It should be noted that PCMA is already staffing up in key states.
More Information on the case can be found on this summary page. NCPA has dedicated significant staffing and financial resources supporting related issues for over 15 years, with this current Supreme Court case representing the culmination of those efforts. Please help us ensure we have the necessary resources to prevail by investing in the LDF.
Sens. Grassley and Wyden Provide Update
on Insulin Price Spikes
This week, Senate Finance Committee Chairman Charles Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Ore.) provided an update on their efforts to investigate the role of prescription drug manufacturers and pharmacy benefit managers (PBMs) “in the rapid rise of insulin prices.”
The Senators also highlighted insulin-related provisions in the updated Prescription Drug Pricing Reduction Act, which passed the Finance Committee, and was updated in December 2019. The bill would: (1) create a Medicare Part D out-of-pocket cap; (2) create “an option for Part D beneficiaries to spread their drug costs over the entire year;” (3) lower cost-sharing in the initial phase of the Medicare Part D benefit; (4) eliminate the coverage gap, which “may reduce diabetics’ annual cost-sharing by hundreds of dollars;” (5) create an inflation rebate in Medicare Part D; and (6) expand a requirement that Medicare Part D plans “make the costs patients pay for a medication available in the prescribing physician’s electronic medical record.”
Additional information can be found in the Chairman and Ranking Member’s joint press release.
Kentucky Senate Committee Passes Bill
to Limit PBM Role in Medicaid
A bill to limit the role of PBMs in Kentucky’s Medicaid Managed Care program passed a Kentucky Senate committee on Wednesday. Sen. Max Wise, the sponsor of Senate Bill 50, said he is determined to push through the measure to rein in PBMs that are squeezing Kentucky pharmacies out of business. Kentucky is following in the footsteps of West Virginia, who recently carved-out the prescription drug benefit from their Medicaid Managed Care program, saving the state over $50 million in one year.
DOJ and FTC Propose New Guidelines
to Evaluate Mergers Like CVS/Caremark/Aetna
The DOJ and FTC recently proposed an overhaul of antitrust rules for vertical mergers. A vertical merger is the merger of two companies that operate in the same supply chain but don't directly compete with one another, such as CVS/Caremark/Aetna, Cigna/Express Scripts, and UnitedHealth/Optum Rx. If finalized, the guidelines would replace rules that haven't formally been updated since 1984 despite new thinking about how such deals affect competition. NCPA believes these guidelines need to be stricter and will be submitting comments to that effect. NCPA also has sample comments available for pharmacists who wish to comment prior to the Feb, 26 deadline. These can be submitted through NCPA’s Legislative Action Center.
Register Now for the 2020
NCPA Congressional Pharmacy Fly-in
Registration for NCPA’s 2020 Congressional Pharmacy Fly-in now open. The Fly-in, which will be held April 21-22, is an opportune time to meet with legislators or their key staff about community pharmacy’s legislative priorities. You'll fly in, spend a few hours with the NCPA Advocacy Center staff, and then have some face time with your members of Congress and/or their staff. It's your chance to tell them how their votes affect your business and the patients you serve. This year, there is also the added possibility that the Supreme Court may hear oral arguments in Rutledge v. PCMA during the fly-in week. Don’t miss out.
NCPA Advocates for Pharmacist Participation
in Diabetes Prevention
This week, NCPA submitted comments to the National Clinical Care Commission (the Commission) on its request for feedback concerning limitations and gaps related to prevention and treatment of diabetes. The Commission is responsible for providing recommendations to HHS on diabetes prevention and treatment. NCPA brought the Commission’s attention to burdensome requirements that limit pharmacists from providing enhanced diabetes services to patients in need. We urged the Commission to explore the pharmacists’ role in the National Diabetes Prevention Program (National DPP) and to work with CMS to clarify the ability of pharmacists to provide Diabetes Self-Management Treatment Services (DSMT).
Administration Releases Medicaid Block Grant Initiative
On January 20, 2020, the Trump Administration announced the Healthy Adult Opportunity (HAO) initiative which they say will offer states more flexibility in designing the Medicaid benefit while allowing for budget predictability. Regardless of the name, this initiative would turn Medicaid into a “block grant” to the states, but only can apply to the expansion population. The HAO initiative applies to all Medicaid services, medical and the prescription drug benefit. The flexibility touted by the Administration could have a negative impact on patient access, patient choice and pharmacy reimbursement for the Medicaid expansion population in both the Medicaid Fee-for-Service and Medicaid Managed Care drug benefit programs. The ultimate approval by CMS would be on a state by state basis. It is important to remember that states do not have to participate.
NCPA wants to work with our state partners to ensure pharmacies and patients are not adversely impacted by the HAO. Please find NCPA’s overview and outline of the Healthy Adult Opportunity initiative and recommended actions to take here.
NCPA Travels to Wisconsin to Support AB 114
NCPA’s Director of State Government Affairs, Matt Magner traveled to Madison, Wisconsin to testify in support of AB 114 in front of the Assembly Committee on Health. The bill would require PBMs to become licensed in the state, limit retroactive claim reductions, prohibit gag clauses/copay clawbacks, and establish pharmacy audit protections. The committee also heard from dozens of independent pharmacists and patients in support of the PBM regulations. NCPA thanks PSW and all pharmacy advocates for their work on this important bill.
NCPA submits letter in support of Maine LD 1928
NCPA submitted a letter to the Maine Committee on Health Coverage, Insurance and Financial Services in support of LD 1928. The bill would bring clarity to pharmacy reimbursements by prohibiting retroactive claim reductions and adjudication fees.
ACA Proposed Rule Expands Medical Loss Ratio
Reporting to Include DIR
HHS recently proposed ACA marketplace rules for 2021, amending medical loss ratio (MLR) reporting requirements for health insurers. The rule proposes to require plans to deduct DIR received by not only the issuer, but PBMs as well, for purposes of MLR calculation. The current MLR reporting requirement does not include all of the prescription drug rebates or other price concessions that the issuer allows the PBM to retain. The proposed rule asserts that enrollees fail to receive the benefit of prescription drug rebates and price concessions and that current regulations enable PBMs these to inflate the incurred claims and MLRs.
Accordingly, HHS sets forth the following two proposals:
- Require issuers to deduct, from incurred claims, prescription drug rebates and other price concessions not only when received by the issuer, but also when received and retained by a PBM. The phrase “price concession,” is intended to capture any time a plan or PBM receives something of value related to the provision of a covered prescription drug (i.e., manufacturer rebate, incentive payment, direct or indirect remuneration, etc.) regardless from whom the item of value is received.
- Require issuers to report the prescription drug rebates and price concessions described above as non-claims (administrative) costs. These proposed revisions would align more closely with the MLR provisions that apply to Medicare Advantage, Part D, and Medicaid Managed Care, which require that the full amount of prescription drug rebates and price concessions be deducted from incurred claims.
HHS proposes that these amendments would become applicable for the 2021 MLR reporting year. NCPA will be submitting comments, which are due on March 2nd.
CMS Releases Part D Proposed Rule
and Part C and D Payment Policies Advance Notice
On February 5th, the Centers for Medicare & Medicaid Services (CMS) released the Part D Proposed Rule for contract year 2021 and 2022, as well as Part II of the Calendar Year (CY) 2021 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will not be publishing a Call Letter for 2021, and instead proposes to codify much of the guidance typically included in the annual Call Letter through the Part D Proposed Rule.
The Part D Proposed Rule contemplates requiring Part D sponsors to disclose to CMS the pharmacy performance measures they use to evaluate pharmacy performance; proposes to allow Part D plans to have up to two specialty tiers by proposing a new preferred specialty tier with lower cost sharing; proposes plans to implement a new beneficiary real time benefit tool (RTBT); and implements several SUPPORT Act provisions. NCPA is carefully analyzing the proposal and will be seeking member input prior to commenting by the April 6th deadline.
The Advance Notice adds certain opioids and antipsychotic use measures to the display page for 2021. Further, CMS considers implementing PQA medication adherence measures in future Star Ratings measures. CMS also states it plans to develop measures to assess generic and biosimilar utilization in the Part D program. Lastly, CMS states it will begin reporting an initial opioid prescribing measure in the Patient Safety reports for 2020. NCPA is carefully analyzing the advance notice and will be seeking member input prior to commenting by the March 6th deadline. A summary of the Part D Rule is available here and a summary of the Part C and D Payment Policies Advance Notice is available here.
NCPA Asks FDA for Extension
on Animal Compounding Comments
NCPA joined the Alliance for Pharmacy Compounding (APC) and the American Pharmacists Association (APhA) in asking the FDA to extend the comment period by 90 additional days for Draft Guidance for Industry (#256) “Compounding Animal Drugs from Bulk Substances.” Our groups asserted that our members and other stakeholders have grave concerns about the potential negative impact this draft guidance will have on access to and the quality of compounded medications in the treatment of animals. NCPA will be submitting comments to FDA on this draft guidance. Additionally, Reps. Kurt Schrader (D-Ore.) and Ted Yoho (R-Fla.) sent their own letter to FDA expressing concerns with the proposal and requesting a 90 day extension to the comment period. NCPA was notified that an extension will be granted but the new comment deadline has not yet been announced.
ONDCP Releases 2020 National Drug Control Strategy
This week, the White House Office of National Drug Control Policy (ONDCP) released its 2020 National Drug Control Strategy, setting the Administration’s priorities to address drug trafficking and use, aiming to increase access to medication-assisted treatment (MAT) and mandatory prescriber education. Last year, NCPA’s Advocacy Center and Innovation Center met with Mr. Kemp Chester, ONDCP’s Associate Director, commending the office for releasing the 2019 National Drug Control Strategy, which established a comprehensive approach to drug abuse prevention, treatment, and reducing the availability of illicit drugs. NCPA will continue to engage with ONDCP to advocate for the pharmacist’s role in helping stem the tide of the opioid crisis.
Virginia Senate Passes PBM Licensure and Patient Choice Bill
The Virginia Senate passed SB 251, which would require PBMs to register with the commonwealth, limit PBM adjudication fees, and protect patient choice of pharmacy. NCPA sent a letter to the Virginia Senate Commerce and Labor Committee supporting of the bill which was originally filed as SB 862. The bill has now moved to the Virginia House
Indiana House Passes PBM Licensure Bill
The Indiana House passed HB 1042, which would require PBM to become licensed by the state and give the Insurance Commissioner regulatory authority over PBMs. The bill has now moved to the Senate.
Idaho House Passes PBM Licensure Bill
The Idaho House passed HB 386, a PBM licensure and MAC transparency bill. The bill has now moved to the Senate.
Texas Board of Pharmacy to Create Compounding Taskforce
This week, the Texas State Board of Pharmacy announced that it will create a task force to look at how compounding pharmacies operate. The task force will come up with specific regulations for compounding pharmacies, training for inspectors and be a resource for the board. The idea for the taskforce came from NCPA board member Jeff Carson and NCPA provided feedback on the proposal.
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