NCPA’s Ronna Hauser Testifies
at Senate Judiciary Committee
Hearing on Opioids

This week, the Senate Judiciary Committee held a hearing titled, “Tackling the Opioid Crisis: A Whole-of-Government Approach” to review the implementation of CARA and the SUPPORT Act. Senators criticized the Drug Enforcement Administration (DEA) for not lowering the annual production limits for opioids and that 8 billion pills was far too many. NCPA’s Ronna Hauser, PharmD, Vice President, Policy and Government Affairs Operations was a witness on the hearing’s second panel and discussed the numerous initiatives that independent community pharmacies undertake to appropriately dispense and dispose of controlled substances and to identify possible overutilization. Hauser urged the Committee to consider expanding and utilizing the pharmacist’s role to help combat the opioid crisis and recommended that the DEA update its Pharmacists Handbook, which details the DEA’s position on how pharmacists should handle, dispense, and dispose of controlled substances and has not been updated since 2010. You can read Hauser’s full written statement here.

NCPA Meets With HHS Official About Drug Pricing

This Friday, NCPA staff met with John Brooks, HHS Senior Advisor for Drug Pricing Reform and CMS Principal Deputy Director of the Center for Medicare, to discuss pharmacy DIR fees, spread pricing in Medicaid managed care, importation, and the role of pharmacists as service providers. NCPA continues to have frequent contact with HHS and CMS officials in an effort to advance NCPA’s top advocacy priorities.

Arkansas PBM Case Timeline

The United States Solicitor General filed an amicus curiae brief on behalf of the federal government arguing that the Supreme Court should review the Eighth Circuit’s holding that ERISA preempts State laws that regulate PBM-pharmacy reimbursements. The Supreme Court will likely meet January 10, 2020, to decide which cases they will hear in their Spring 2020 term. Should they decide to hear the case, a rough timeline of activities is as follows:

• Week of January 13th-The Court will make public the cases they will hear in the spring term
• April 2020-Oral arguments before Supreme Court
• June/July 2020-Decision by the Supreme Court

New “Pill Mill” Legislation Introduced in Senate

This week, Senator Dianne Feinstein (D-Calif.), along with Senators Charles Grassley (R-Iowa), Shelley Moore Capito (R-W.Va.) and Richard Durbin (D-Ill.), introduced S. 3070, the Preventing Pill Mills Through Data Sharing Act. This bill would give the Drug Enforcement Administration (DEA) additional tools to hold drug distributors, manufacturers and pharmacies accountable for identifying, reporting and stopping suspicious orders of controlled substances. Among other requirements, the bill requires drug DEA-registrants (which includes pharmacies) to report the sale, delivery, or other disposal of all controlled substances monthly, rather than quarterly basis as current law requires. NCPA secured an important exemption on the reporting requirements for all pharmacy transfers for specific patient need. This means a pharmacy is only required to report to ARCOS if the pharmacy is distributing/selling controlled substances to another DEA-registrant and that distribution/sale is not for a specific patient need.

2020 Congressional Pharmacy Fly-in: April 21-22

Mark your calendars for NCPA’s Congressional Pharmacy Fly-in which will be held April 21-22. This is an opportune time to meet with legislators or their key staff about community pharmacy’s legislative priorities. Registration opens January 15, 2020. Stay tuned for more details.

NCPA Hosts Annual Pharmacy Checklist Webinar

This week NCPA's policy and regulatory team presented its annual Pharmacy Checklist via webinar to NCPA members. The webinar focused on recent changes to Part D plans and reviewed the most important regulatory and legislative actions that impact community pharmacies. A recording of the webinar will be made available in the near future to NCPA members through NCPA’s Education Opportunities webpage.

Trump Administration Seeks to Facilitate
Importation of Pharmaceuticals

This week the Trump Administration released two policy documents that seek to facilitate the importation of pharmaceutical products. The first document is a proposed rule, which would let states, drug wholesalers, or pharmacies apply to import certain drugs from Canada via plans submitted to HHS for review. The second document is guidance, which provides recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries. The guidance indicates that manufacturers can use a new National Drug Code (NDC) for foreign products and introduce such products into the U.S. supply chain. NCPA is evaluating these two documents on potential impacts any form of importation could have on community pharmacies and will respond to HHS via regulatory comments in the New Year.

New Jersey Enacts Legislation Addressing
Retroactive PBM Fees

For the second time, the New Jersey Legislature has passed A3717, which addresses retroactive PBM fees and claim adjustments. The legislature originally passed the legislation over the summer, but Gov. Phil Murphy (D) conditionally vetoed the measure. After tweaking the bill following the veto, the legislature has once again passed the legislation, which will now become law. The bill does the following:

• Prohibits a PBM from retroactively reducing a claim after it has been adjudicated;
• Applies MAC transparency laws to all reimbursement methodologies, including generic effective rate;
• Prohibits a PBM from requiring arbitrary accreditation/certification requirements as a condition of network participation;
• Protects a pharmacy’s authority to offer delivery services;
• Permits the Insurance Commissioner to review PBM compensation programs to ensure they are fair and reasonable.

New York PBM Licensure Bill Delivered to Gov. Cuomo

A PBM licensure bill (S6531) has been delivered to New York Gov. Cuomo (D) for his signature. NCPA submitted a letter of support urging the governor to sign the legislation into law. The governor has 30 days to take action, otherwise the legislation will be pocket vetoed.

Florida Introduces Comprehensive PBM Bill

Florida State Rep. Jackie Toledo (R-Tampa) has introduced HB 961, a comprehensive PBM regulation bill. The bill’s introduction is the result of the efforts of Small-business Pharmacies Aligned for Reform (SPAR), the Florida Pharmacy Association, and other community pharmacy advocates across the state. The legislation has already garnered significant attention from the media. The bill would:

• Prohibit the practice of spread pricing;
• Apply “maximum allowable cost” protections to all reimbursement methodologies;
• Prohibit PBMs from charging certain adjudication fees;
• Prohibit PBMs from reimbursing pharmacies at a rate that is less that the actual cost of the drug, including a dispensing fee;
• Prohibit PBMs from retroactively denying or reducing a claim amount;
• Establish several network requirements protecting patient access to pharmacy services;
• Prohibit PBMs from making referrals;
• Establish that a PBM has a fiduciary duty to covered individuals and payers;
• Require PBMs to file quarterly drug pricing reports with the state.

Tricare Copay Changes

Tricare copays will change on January 1, 2020, as established by the National Defense Authorization Act (NDAA). For fiscal year 2018, the NDAA established changes to prescription copays every two years for the calendar years of 2018 through 2027. Copay tiers will still incentivize mail order, however, the difference in copays between mail order and retail will be $3 instead of $4 for generics and will remain $4 for formulary brands.

GAO Recommends ONDCP Develop
Key Planning Elements

The US Government Accountability Office’s (GAO) recently released report titled DRUG CONTROL: The Office of National Drug Control Policy Should Develop a Plan to Meet Statutory Requirements assesses whether the Office of National Drug Control Policy (ONDCP) (1) met statutory requirements related to the National Drug Control Strategy in 2017, 2018, and 2019, and (2) has planned or implemented actions to meet new SUPPORT Act requirements. The report found that the ONDCP’s 2019 Strategy addressed some statutory requirements but not all, such as the required 5-year projection for budget priorities. GAO makes four recommendations to ONDCP to develop, document, and implement key planning elements to meet SUPPORT Act requirements, two of which ONDCP agreed to implement.

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 holidays, the Advocacy Center Weekly Update will not be sent on Dec. 27 or Jan. 3 and will resume on Jan. 10.

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