Speaker Pelosi releases drug pricing legislation
This week, House Speaker Nancy Pelosi (D-Calif.) released long-awaited drug pricing legislation. H.R. 3, the Lower Drug Costs Now Act, that would require the Secretary of Health and Human Services (HHS) to negotiate at least 25 drugs annually among the “250 brand-name drugs that lack price competition with the greatest cost to Medicare and the whole U.S. health system.” Prices negotiated by HHS would be available in the commercial market. The legislation "establishes an upper limit for the price reached in any negotiation as no more than 1.2 times (or 120 percent) of the volume-weighted average of the price of six countries (Australia, Canada, France, Germany, Japan, and the United Kingdom), known as the Average International Market (AIM) price." Other provisions of the bill would: (1) Create a $2000 out-of-pocket limit on Medicare Part D beneficiary prescription drug costs; (2) establish a "new inflation rebate" for all of the over 8000 drugs in Medicare Parts B and D; and (3) reinvest in the National Institutes of Health. The House Energy and Commerce Committee’s Subcommittee on Health will hold a hearing on the legislation next week, and the bill is expected to see a vote on the House floor in October.
Morning Consult publishes NCPA op-ed
This week, Morning Consult published an op-ed titled “Upside-down — and Unsustainable” by Karry LaViolette, NCPA’s Senior Vice President for Government Affairs and Director of the Advocacy Center. The piece presses the need for policymakers to address pharmacy DIR fees and notes that these retroactive fees often result in pharmacies being reimbursed below their cost for the medication. Moreover, because seniors are charged the higher price at the pharmacy counter rather than the net price after pharmacy DIR is assessed, they are pushed into the “donut hole” more quickly.
Ombudsman for the Small Business Administration
pushes CMS on DIR Fees
Following testimony by NCPA member and pharmacy owner Brian Hose, the Small Business Administration’s National Ombudsman sent an inquiry to CMS regarding CMS' engagement on pharmacy DIR fees and requesting a high-level review of the concerns raised during Hose's remarks. The SBA is specifically looking at the effect DIR fees have on small business community pharmacies. Hose testified at the SBA's Regulatory Fairness Hearing on how pharmacy DIR fees affect his small business. CMS is required to respond within 30 days.
NCPA joins stakeholders requesting
USP to revisit <795> and <797>
NCPA, along with the International Academy of Compounding Pharmacists (IACP), National Alliance of State Pharmacy Associations (NASPA), and multiple state pharmacists associations, submitted a formal letter to the United States Pharmacopeia Convention (USP) expressing concern with USP’s recent denial of industry requests to revise the beyond-use date (BUD) restrictions in Chapters <795> and <797>. In the letter, the organizations further requested USP to instruct the Expert Committee to engage compounding pharmacists to develop alternative BUDs that will ensure continued patient access to compounded medications. NCPA will continue to work with stakeholders to address these concerns with USP.
NCPA urges CMS to implement safeguards
if extending antipsychotic PRN refills
This week, NCPA submitted comments to CMS on the “Medicare and Medicaid Programs: Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Efficiency, and Transparency” proposed rule where CMS proposes to remove the in-person requirement for extending PRN orders for anti-psychotics beyond 14 days. NCPA supported the proposal but stressed the need for safeguards to protect residents from inappropriate prescribing practices that place the convenience of caregivers above the residents’ medical interests. NCPA also asked CMS to work with industry stakeholders to educate prescribers and LTC facility staff about the increased risk of mortality when using antipsychotics based on evidence-based medicine. Lastly, NCPA supported CMS’ goals in delaying certain Phase 3 requirements, but because the original November 2019 deadline is quickly approaching, we urged CMS to update LTC facilities as swiftly as possible. NCPA’s LTC Division will continue to monitor any changes to anti-psychotic fill requirements and advocate for LTC community pharmacies.
USP <800> implementation date approaching
For states that are implementing USP <800> without delay, the effective date is Dec. 1, 2019. Be sure to check with your state’s board of pharmacy for implementation details. NCPA has developed a blank USP <800> risk assessment template, and a sample template for testosterone, to help you create your own risk assessments for each hazardous drug as required by USP <800>. Access the USP 800 Risk Assessment Templates here.
NCPA responds to TRICARE RFI
This week NCPA submitted comments in response to a TRICARE RFI. TRICARE is collecting information on preferred networks and NCPA highlighted the problems with preferred networks for both patients and pharmacies, particularly those in underserved communities. The comments also emphatically stated that while we were responding to the RFI we do not support a preferred retail pharmacy network in TRICARE. NCPA also reiterated our continued support for a pilot program authorized by Congress that would allow community pharmacies to purchase brand name drugs at the same rate that mail order does.
NCPA requests enforcement discretion
for upcoming verification requirements
under the DSCSA
This week NCPA sent a letter to the FDA requesting that the FDA swiftly exercise enforcement discretion for an upcoming requirement under the Drug Supply Chain Security Act. The DSCSA requires wholesale distributors to verify with the manufacturer the accuracy of the serial number of all pharmaceutical product that is returned to the wholesale distributor and intended for resale. Under the provisions of the law, this verification requirement is slated to go into effect on November 27, 2019. It is NCPA’s understanding, however, that these systems are not ready to be in place by the November 27, 2019 deadline. Thus, NCPA is concerned that this inability to facilitate verification of saleable returns will cause community pharmacies to encounter a number of obstacles with inventory, including the ability to smoothly and effectively receive credit for saleable returns from wholesale distributors. NCPA is closely monitoring the developments of this compliance date and will continue to advocate for enforcement discretion from the FDA in the coming months.
NCPA joins pharmacy stakeholders
in requesting clarification
of DSCSA exclusion for states
This week, NCPA joined the American Pharmacists Association (APhA), American Society of Health-System Pharmacists (ASHP), MatchRx, and the National Alliance of State Pharmacy Associations (NASPA), in sending a letter to the FDA requesting clarification on the “specific patient need” exclusion under the Drug Supply Chain Security Act. The letter requested that the FDA provide reinforcement and dialogue between the FDA and states regarding the intent of the DSCSA that specific patient need transfers not be subjected to wholesale distribution licensure requirements under federal or state law.
NCPA and pharmacy stakeholders request
an updated DEA Pharmacist’s Manual
Earlier this week, NCPA sent a letter to the DEA along with APhA, the Academy of Managed Care Pharmacy (AMCP) American Society of Consultant Pharmacists (ASCP), ASHP, NASPA, and the National Association of Chain Drug Stores (NACDS). The letter requests that the DEA issue a revised Pharmacist’s Manual and routinely update the manual in the future. The DEA Pharmacist’s Manual has not been updated since 2010. In the letter, pharmacy stakeholders expressed concern that the DEA is not prioritizing the importance of answering pharmacists’ questions and providing information to help guide compliance with the Controlled Substances Act. The issuance of a revised manual would be a step in the right direction to help the pharmacy industry work in collaboration with the DEA to combat the opioid crisis and other issues under the DEA’s purview.
NCPA joins drug pricing transparency panel for CSRO
Last week, NCPA Director of State Affairs Matt Magner participated on a drug pricing transparency panel in Chicago for the Coalition of State Rheumatology Organizations. Magner was joined on the panel by Arkansas State Sen. Jason Rapert (R) and Dr. Bob Levin of the Alliance for Transparent & Affordable Prescriptions. Topics included efforts to pass PBM regulations in the states and the PBM industry’s opposition to those efforts.
North Carolina Insurance Commissioner’s
pharmacy advisory council
The North Carolina Department of Insurance recently created a new advisory committee to advise the Commissioner on any pharmacy issues that may come before the Commissioner, including the drafting of rules and regulations that address PBM licensing and practices. The overwhelming majority of members on the council are independent pharmacists.
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. Attached is 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.