NCPA Advocacy Update

Week ending Sept. 27

Author: APCI Staff/Tuesday, October 1, 2019/Categories: Legislative Affairs

Senate Finance Committee releases legislative language
of drug pricing bill

Earlier this week Senate Finance Committee Chairman Charles Grassley (R-Iowa) released an updated version of the Prescription Drug Pricing Reduction Act of 2019, legislation that was passed by the Finance Committee, and a report on the legislation. Of note, the bill language requires HHS to create standardized quality metrics for payments made to and from a pharmacy (also known as quality based pharmacy DIR). Additionally, the language seeks to eliminate spread pricing practices in Medicaid managed care and provides that managed care payments made to pharmacies have to be paid in the same manner as Medicare fee-for-service payments in a state. The bill language also requires Part D insurers to report to pharmacies, at least annually, any post-point-of-sale adjustments for price concessions or incentive payments for covered Part D drugs, including those made by a PBM. NCPA will continue to work with industry allies and partners to advance changes to pharmacy DIR.

Contact your legislators and urge them to address pharmacy DIR fees by supporting S. 640/H.R. 1034, the Phair Pricing Act.


Energy and Commerce Health Subcommittee
considers drug pricing legislation

This week, the House Energy and Commerce Health Subcommittee held a hearing titled, “Making Prescription Drugs More Affordable: Legislation to Negotiate a Better Deal for Americans.” The subcommittee examined legislation to permit the Secretary of Health and Human Services (HHS) to negotiate prescription drug prices in Medicare and other plans, focusing primarily on H.R. 3, the Lower Drug Costs Now Act, released last week by House Speaker Nancy Pelosi (D-Calif.). Democratic and Republican members agreed that Congress must address high prescription drug costs, but strongly disagreed over the effectiveness of HHS negotiations and potential impact on patients and innovation. Democrats criticized manufacturer practices, stated high drug costs harm patients, and suggested innovation originates at the National Institutes of Health (NIH). Meanwhile, Republicans sharply criticized the majority for advancing partisan legislation to establish HHS negotiations and set U.S. prices using an international index. Subcommittee Chairwoman Anna Eshoo (D-Calif.) stated she believes a subcommittee markup will take place before full committee action. NCPA worked with community pharmacy champion, Rep. Peter Welch (D-Vt.) to submit a statement for the record on the necessity to include pharmacy DIR fee reform in any drug pricing package. Another community pharmacy champion, Rep. Morgan Griffith (R-Va.) highlighted the role that PBMs play in drug pricing and that the House bill also needs to tackle their anticompetitive practices.


Congress’ October recess starts today

Congress will be away from Washington until October 15. If you have not done so, it’s not too late to extend an invitation to your legislator to visit your pharmacy or schedule a group meeting with multiple community pharmacists with legislators to discuss priority issues. These carry extra value if your legislator is new to Congress so you can familiarize them with community pharmacy and our issues or if they are a member of the Energy and Commerce or Ways and Means health subcommittees, the starting points for much of community pharmacy’s legislation in the House.

Pharmacy visits and face-to-face meetings are tremendously effective ways to communicate with legislators and to establish yourself as a resource to them as issues arise. Visit NCPA’s pharmacy visits webpage or contact Michael Rule at michael.rule@ncpanet.org for tips on arranging a visit with your legislator.


NCPA President meets with Ways and Means Committee staff
to discuss LTC issues

NCPA was one of two LTC pharmacy organizations that recently received a request from the House of Representatives Ways and Means Committee to respond to an inquiry about the use of antipsychotics in nursing homes. NCPA has been working with NCPA LTC Division member on responses to questions in the inquiry and met this week with committee staff. NCPA President Bill Osborn was in attendance at the meeting and explained his experiences caring for LTC patients and working with prescribers on appropriate therapy. NCPA will continue the dialog with staff who are seeking more information on this important issue.


FDA grants enforcement discretion
in response to NCPA request

Last week NCPA sent a letter to the FDA requesting enforcement discretion for an upcoming requirement under the Drug Supply Chain Security Act that necessitates wholesale distributors verify a pharmaceutical product's serial number with a manufacturer before accepting a saleable return from a pharmacy. This requirement was slated to go into effect starting Nov. 27, 2019. In the letter, NCPA expressed concerns that the verification systems necessary to facilitate this requirement were not ready and could have a dire impact on community pharmacy’s ability to return product to wholesale distributors. On Monday, the FDA responded to NCPA’s request by granting enforcement discretion. NCPA hopes that this enforcement discretion will give the industry time to work out the kinks with verification systems to ensure a smooth process for the return of saleable product under the DSCSA.


FDA postpones effective dates
in response to stakeholder concerns

After NCPA, IACP, and APhA expressed concerns with United States Pharmacopeia Chapters <795> and <797>, the organization has announced it is postponing until further notice the official dates of the new chapters, as well as <825>. Specifically, NCPA asked that USP reconsider beyond-use dating language in Chapter <797> because it would impede patient access to medically necessary compounded medications since pharmacists would not be permitted to extend BUDs even when direct scientific testing supports an extension. USP is a private organization that develops health and safety standards often adopted by state and federal regulators. However, USP <800> will still go into effect Dec. 1, 2019. NCPA has developed a risk assessment template to help you create your own risk assessments for each hazardous drug as required by USP <800>. If you have questions about how this may affect you, contact your local board of pharmacy.


Input from compounders needed by September 30
for FDA funded NASEM compounding study

Input from pharmacy compounders is needed to inform the work of the National Academies of Science, Engineering, and Medicine, which is conducting an FDA-funded study on the Clinical Utility of Treating Patients with Compounded "Bioidentical" Hormone Therapy (BHRT). The goal is to examine the clinical utility of treating patients with compounded BHRT products. NASEM will produce a report evaluating the available scientific evidence relating to the safety and effectiveness of these products and discussing whether the available evidence supports use of compounded BHRT products to treat patients. Industry leaders and associations are concerned that the information presented to NASEM may be one-sided, favoring commercially available BHRT, possibly with predetermined outcomes in mind. It is important that NASEM hears from practitioners about the "clinical need" and "effectiveness" of compounded BHRT. Comments should be sent before Monday, Sept 30. NCPA will submit comments as well.


FDA needs to address pharmacy concerns
before finalizing compounding MOU

The FDA has indicated it will finalize a memorandum of understanding (MOU), with states before the end of this year to address interstate distribution of compounded drugs. NCPA, IACP, and APhA have offered a "middle way" proposal that we believe accommodates FDA's need for data on the interstate shipment of compounded medications while preserving state board of pharmacy oversight of patient-specific dispensing and assuring patient access to essential compounded medications. Please contact your members of Congress to urge them to reach out to the FDA to assure that the final MOU addresses our concerns, as well as those raised by the National Association of Boards of Pharmacy, if the FDA wants states to sign the final MOU.


NCPA advocates for pharmacist recognition in Medicare
in comments on the physician fee schedule

NCPA submitted comments to CMS 2020 physician fee schedule proposed rule, and supported provisions that could provide an avenue for pharmacist to provide care in Medicare Part B. Of note, NCPA supported the expansion of MAT services and emphasized that pharmacists have expertise in medication management and have frequent interaction with their patients, pharmacists are best positioned to provide these services. NCPA also discussed discrepancies in the Part B program regarding care coordination and asked CMS to provide clarity on provisions of the proposed rule that appeared to exclude pharmacists from providing needed care to Medicare patients.


Department of Labor issues final rule
on employee overtime regulations

This week, the Department of Labor (“DOL”) released a final rule on overtime pay eligibility. The final rule increases the minimum salary for employees that fall under the overtime exception from $23,660 to $35,568 annually. In short, that means any employees making under $35,568 are now eligible for overtime pay. This rule, however, provides for a much lower threshold than that proposed by the Obama administration, which would have required the overtime threshold to be set at $47,476. NCPA submitted comments on both proposals advocating for small business community pharmacies. The rule goes into effect on January 1, 2020.


All practitioners may participate in discharge planning

The Centers for Medicare & Medicaid Services (CMS) issued a final rule that empowers patients preparing to move from acute care into post-acute care (PAC), a process called “discharge planning.” In the rule, CMS clarified that the discharge planning team may consist of all types of “practitioners,” including non-physician practitioners. CMS defers to providers in utilizing the appropriate practitioners they believe will effectively conduct a patient’s discharge planning process. CMS further stated that the discharge planning conditions of participation do not include requirements specific to individual practitioner categories. Therefore, community and long-term care pharmacists should work with their providers and practitioners to participate in the discharge planning process.


NCPA attends stakeholder meeting at CMS
on opioids action plan

Last week, John Beckner, NCPA Senior Director for Strategic Initiatives, attended a stakeholder meeting at CMS regarding it Opioids Action Plan. The meeting presented innovative options for addressing opioid use and highlighted the need for appropriate pain management. Key takeaways for CMS are the need to destigmatize chronic pain and to treat with both lifestyle modification and appropriate medication, like diabetes. NCPA will continue to remain engaged and identify opportunities for community pharmacists to be part of the solution to the opioid crisis.


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.

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