Congressional support
for HHS’ DIR proposal continues to grow

This week, Republicans on the House Energy & Commerce Committee and the Kansas House delegation sent letters to HHS Secretary Azar, in support for the provisions of CMS’s proposed rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, which would reform the use of pharmacy direct and indirect remuneration (DIR) fees, or pharmacy price concessions. The letter from Republicans on Energy & Commerce, which is the committee of jurisdiction for Medicare Part D was led by pharmacy champion Rep. Cathy McMorris Rodgers (R-Wash.), and she was joined by Reps. Brett Guthrie (R-Ky.), John Shimkus (R-Ill.), Greg Gianforte (R-Mont.), and Bob Latta (R-Ohio). The Kansas delegation letter was led by Rep. Roger Marshall, MD (R-Kan.) and was co-signed by new Ways & Means Committee member Rep. Ron Estes (R-Kan.) and freshman Rep. Steve Watkins (R-Kan.).

Ways and Means Committee holds drug pricing hearing

This week, the House Ways and Means Committee held a hearing focused on drug pricing issues in the Medicare program. Chairman Richard Neal (D-Mass.) noted that while healthcare innovation is “part of the economic fabric” of the nation, he believes the “high cost” of the innovation is being “excessively passed” to consumers. He repeatedly stated that drug pricing issues “cross the political spectrum” and that he intends to work across the aisle and with the Department of Health and Human Services (HHS) to find “realistic, sustainable outcomes.” Ranking Member Kevin Brady (R-Texas) echoed Chairman Neal’s call for bipartisan-backed policies, but asserted that Republicans “reject” approaches involving price controls or government negotiation. Members and witnesses discussed a wide range of policy options during the hearing, including reforms to Medicare Part B provider reimbursement, changing liability levels in Part D, and patent reforms, among others. Rep Jason Smith (R-Mo.) spoke at the hearing about the need to fix DIR fees and said, "Pharmacists continue to remind me they are being hammered by unpredictable fees months after filling prescriptions for their patients."

Register now to attend
2019 Congressional Pharmacy Fly-in

NCPA’s Congressional Pharmacy Fly-in is two months away, but there’s no reason not to register now. Rep. Peter Welch (D-Vt.), lead sponsor of H.R 803, the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, recently confirmed that he will speak at the PAC breakfast. This is also an opportunity to take to meet with your members of Congress, or their staff. With a bipartisan desire in Congress to tackle the high cost of prescription drugs and pro-pharmacy legislation addressing issues such as pharmacy DIR pending in Congress, your voice needs to be heard! Your voice carries additional weight and your attendance is even more critical if you are represented by a member of the Energy and Commerce or Ways and Means health subcommittees, which have jurisdiction over most pharmacy legislation. Plus, you can earn up to 3.5 hours of CE credit at briefings on a range of issues, including DIR fees and potential changes to Medicaid. Registration is open, so don’t delay, register now online or by calling 1-800-544-7447. If you’ve already registered, don’t forget to schedule your hill visits. Visit NCPA’s Legislative Action Center to look up the contact information for your legislators. Contact Michael Rule at michael.rule@ncpanet.org if you have any questions.

Have you completed the retail and specialty
Cost of Dispensing survey?

If you have not yet done so, please complete the cost of dispensing survey. Your responses will assist in estimating costs of dispensing nationally and in each state. These estimates will then be used to inform policy questions related to reimbursing costs of dispensing across the US. It’s your opportunity to provide information on costs of dispensing and underlying factors, for consideration by Medicaid agencies and other payers. Findings from prior surveys have been used by Medicaid agencies to determine their cost of dispensing rates. The survey is likely to take a few hours to complete and possibly more, depending on the information system and number of pharmacies. You may complete the survey by paper, online, or through a spreadsheet for multiple pharmacies at once. To complete the survey online, please access the survey here.

NCPA responds to misleading PBM whitepaper

This week, NCPA released a rebuttal document to several claims made in a pro-PBM state issues whitepaper by Visante. As PBM practices have been receiving increased scrutiny from legislators into the role they are playing in increasing the costs of prescription drugs, these PBM commissioned reports are not surprising. Nor is it surprising that the conclusions do not hold up.

FDA seeks nominations
for compounding advisory committee

The FDA has issued a call for nominations for nonvoting industry representatives to serve on 17 of the Center for Drug Evaluation and Research's public advisory committees, including the Pharmacy Compounding Advisory Committee. The agency is also calling for industry groups to participate in the selection process. FDA advisory committees include four types of members: scientific/medical experts, consumers, patients, and industry representatives. Nominations for the nonvoting industry representative positions must be submitted within 30 days. Selected members will serve a four-year term beginning Nov. 1.

FDA sends warning letter to trading partner
for violations of the track and trace law, first of its kind

This week, the FDA sent a warning letter to a large drug distributor for violations under the Drug Supply Chain and Security Act (aka the DSCSA or the track and trace law), acting on agency authority under this law for the first time since its passage in 2013. The letter alleges that the distributor sent missing and wrong pills to multiple pharmacies. The shipments were originally supposed to be for opioids. This warning letter is an important milestone for the supply chain because it serves as a warning to the industry that all U.S. trading partners, including pharmacies, should ensure they are adhering to their responsibilities under the DSCSA. Today, pharmacies should have processes in place to identify suspect or illegitimate product at their pharmacy. NCPA has created this checklist to help community pharmacies understand pharmacy-specific DSCSA requirements.

FDA Finalizes Additions to 503A Bulks List

Today, the U.S. Food and Drug Administration (“FDA”) issued a final rule under section 503A of the Federal Food Drug and Cosmetic Act, placing, for the first time, six bulk drug substances on the 503A bulks list, which is a list of substances that compounders can use to compound drugs. These substances include: Brilliant Blue G-250, cantharidin (for topical use only), diphenylcyclopropenone (for topical use only), N-acetyl-D-glucosamine (for topical use only), squaric acid dibutyl ester (for topical use only), and thymol iodide (for topical use only). This rule also identifies four bulk drug substances that are not included on the 503A bulks list, and therefore cannot be used by compounders who are not registered as outsourcing facilities under 503B. These substances include: oxitriptan, piracetam, silver protein mild, and tranilast. As the FDA works to develop the 503A bulks list, compounding pharmacists can review the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A for bulk drug substances nominated for the list that may be used in compounding. The final rule goes into effect on March 21, 2019.

NCPA Advocates for HIPAA Reform

This week, NCPA submitted comments to HHS Office of Civil Rights (OCR) on its Request for Information on Modifying HIPAA Rules to Improve Coordinated Care in which OCR asked for input on ways to reduce administrative burdens that may be impeding coordination of care. Specifically, NCPA commented on maintaining the current timeframe of thirty days in which covered entities must respond to patient Protected Health Information (PHI) access requests. NCPA also recommended that the signature and recordkeeping requirements be eliminated to free up time and resources for community pharmacists to spend on treatment and care coordination. NCPA will continue to work with OCR and other stakeholders to simplify disclosure requirements and/or provide education on these HIPAA standards to better assist health care professionals and support staff in identifying situations in which they are permitted to release PHI to other covered entities.

NCPA Applauds ONDCP on Opioid Strategy

This week, NCPA submitted a letter to James W. Carroll, Jr., recently confirmed Director of the White House Office of National Drug Control Policy (ONDCP), commending him and the ONDCP for releasing the National Drug Control Strategy, which establishes a comprehensive approach to drug abuse prevention, treatment, and reducing the availability of illicit drugs. NCPA expressed an interest in collaborating with ONDCP in combating the opioid crisis by advancing the pharmacist’s role in treatment and prevention of opioid use. For example, NCPA advocated for the pharmacist’s role in Medication Assisted Treatment (MAT) and participation in wider distribution of naloxone by allowing pharmacists to directly prescribe naloxone. Further, NCPA pointed to an increased opportunity for collaboration between the Drug Enforcement Agency (DEA) and community pharmacists with any expansion of DEA Take-Back Days. NCPA will continue to engage with the ONDCP to help stem the tide of the opioid crisis.

Allied Against Opioid Abuse
releases first “year in review” report

This week, Allied Against Opioid Abuse, which NCPA is a member, released its first “year in review” report. AAOA launched in February 2018 to help prevent the abuse and misuse of prescription opioids through education and awareness. The “year in review” report highlights several accomplishments of the coalition in its first year, including the development of the AAOA pharmacy toolkit to better engage pharmacists in the fight against opioid abuse.

CVS Caremark changes course on 340B cuts

Over the past several months, NCPA has received information that CVS Caremark was planning to institute substantial pay cuts to certain 340B pharmacies this spring. In response, NCPA has been exploring avenues to address the reimbursement cuts to the extent the cuts impact independent community pharmacists participating as contract pharmacies in the 340B program. Earlier this week, however, in a confidential notice sent to 340B providers and obtained by Modern Healthcare, CVS Caremark said that they would not move forward with the planned cuts. NCPA welcomes this announcement and continues to monitor changes important to community pharmacies participating in the 340B program

NCPA state legislative activity update

NPCA 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 the links 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 reports.

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.