NCPA analysis of CMS’ final drug pricing rule

Last week, CMS announced its final rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. Most notably, CMS declined to take the opportunity to reform pharmacy DIR. NCPA's Advocacy Center team has thoroughly examined the rule and has created a comprehensive summary of the rule and what it means to NCPA members. Here's NCPA's official statement on the 2019 rule.

Senate pharmacy champions express disappointment
over pharmacy DIR inaction

Senate pharmacy champions, Sens. Shelley Moore Capito (R-W.Va.) and Jon Tester (D-Mont.) are circulating a sign on letter among their Senate colleagues addressed to President Trump expressing disappointment that the administration failed to act on pharmacy DIR fees. Click here to email your Senators to encourage them to add their name to this letter to demonstrate broad bipartisan disappointment at the administration.

House Energy and Commerce Health Subcommittee
holds drug pricing hearing

This week, the House Energy and Commerce Health subcommittee held a hearing on bills addressing drug pricing transparency. Unsurprisingly, a PCMA representative testified that increased transparency would drive drug costs up and that they would only support releasing data on rebates and negotiations in “aggregate” which did not go over well with many members of the subcommittee. Included in the hearing were two bills that NCPA has endorsed.

• H.R. 2155, the Public Disclosure of Drug Discounts Act, introduced by Reps. Spanberger (D-Va.), Arrington (R-Texas), and Boyle (D-Pa.), that would require PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive.
• H.R. 2376, the "Prescription Pricing for the People Act, introduced by Reps. Nadler (D-N.Y.) and Collins (R-Ga.), would require the Federal Trade Commission (FTC) to conduct a study on the state of competition in the drug supply chain. This study would focus on whether PBMs have engaged in any anti-competitive practices, such as steering patients to pharmacies for anti-competitive purposes, giving such pharmacies more favorable rates than it offers to competing pharmacies, or using its market power to depress the use of lower-cost prescription drugs. The bill also requires that the FTC provide policy recommendations for how to improve transparency and competition in the pharmaceutical supply chain.

Committee leaders request comments on bipartisan
Medicare Part D drug pricing legislation

This week, Ways and Means Committee Chairman Richard E. Neal (D-Mass.) and Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-N.J.), along with Ranking Members Kevin Brady (R-Texas) (Ways and Means) and Greg Walden (R-Ore.) (E&C) announced the solicitation for comments on draft legislation to reform and improve the Medicare Part D program that would establish an out-of-pocket cap for Medicare beneficiaries based on the current catastrophic threshold.

Bipartisan Senate legislation takes aim at PBMs

This week, Senate HELP Committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) released a discussion draft of legislation to reduce health care costs, the Lower Health Care Costs Act of 2019 that includes over thirty provisions addressing surprise medical billing, prescription drug costs, transparency, health information technology, and public health priorities.

PBMs are addressed in the draft by prohibiting PBMs from utilizing spread pricing and requiring that PBMs pass on 100 percent of any rebates or discounts they negotiate with drug companies to insurers. The Chairman stated the committee will mark up the bill in June, and he hopes it will be considered by the full Senate in July.

Congress’ Memorial Day Recess starts today

The Memorial Day in-district work period starts today. Congress will be away from Washington until June 3. 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 and 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 Annual Convention registration
flash sale ends May 29

If you have not done so, make sure you register for the NCPA 2019 Annual Convention before May 29 to take advantage of the flash sale discount. Save $100 on Convention registration using code FLASH100. Fine print: This rate is for owner/managers and staff pharmacists ONLY. Here's a sneak peek at the preliminary Convention brochure. See you Oct. 26-29, in San Diego!

NCPA discusses Medical at Home with CMS

This week, NCPA staff and NCPA LTC Division members participated on a call with CMS’ Medicare Part D staff to discuss CMS’ recognition of medical at home services. NCPA asked CMS to recognize these services at a level comparative to skilled nursing facility services. NCPA explained the value LTC community pharmacists provide to patients at home with services such as specialized packaging, medication reconciliation, hand-delivery, and consulting services, as well as review of any unnecessary drugs, duplication of therapies, or adverse reactions. We also discussed recognition of patients in assisted living facilities (ALF) who LTC pharmacists service at a high level of care. Lastly, NCPA informed CMS of PBMs potentially restricting Medicare patient access to community pharmacy locations as well as charging a very significant fee for any new ownership status. NCPA will continue to engage with CMS in discussing medical at home, assisted living services, and inappropriate PBM credentialing practices.

CMS provides additional guidance
on Part D plan bids for 2020

This week, HHS released a Q&A (click here) for Part D plan bids on their April 5 guidance, including information on the “voluntary two-year demonstration that would test an efficient transition for beneficiaries and plans to such a change in the Part D program,” “Specifically, if a final rule eliminating safe harbor protection for drug manufacturer rebates were to be finalized and in effect in 2020, CMS would test and evaluate the use of narrowed risk corridors to provide for an efficient transition for beneficiaries and plans to significant changes in the Part D program.” HHS issued this guidance as the final “rebate” rule is not expected to be issued until after June 3 and plan bids are due on June 3.

Oklahoma governor signs PBM regulation law

Gov. Kevin Stitt on Tuesday signed HB 2632, which is similar to a bill he vetoed a few weeks ago. The bill protects patient access to pharmacy services by establishing network adequacy and "any willing pharmacy" requirements, minimizes PBM conflicts of interest by prohibiting higher reimbursement rates for PBM-owned pharmacies, and limits PBM abuses by prohibiting retroactive claim adjustments and denials. NCPA CEO Douglas Hoey, an Oklahoma native, wrote a letter to the governor last week urging him to sign the bill. Read NCPA's statement on the new Oklahoma law.

Minnesota governor signs PBM licensure bill

Minnesota Gov. Tim Walz (D) has signed SF 278, the Minnesota Pharmacy Benefit Manager Licensure and Regulation Act which will require licensure of PBMs in Minnesota. The bill passed unanimously in the Senate and with only two dissenting votes in the House. The legislation is Minnesota's first step to license and regulate PBMs.

Tennessee passes comprehensive PBM reform bill

Tennessee HB 786 and SB 650 have passed both chambers and are headed to the governor for signature. The bill strengthens fair pharmacy audit laws, prohibits claims adjudication fees unless reported on the remittance advice, and provides additional patient and pharmacy protections.

20 states enact laws related to NCPA state priority issues

So far in the 2019 legislative session, 36 bills in 20 states have been signed into law that relate to NCPA’s top three state priorities – Medicaid managed care reform, PBM regulation and reform, and scope of practice/compensation for services. A brief summary of each bill in available in this report. Full text of the bill language is available by clicking on the individual bill numbers in the report.

PBM licensure bill headed to Alabama House Floor

The Alabama House of Representatives will consider a PBM licensure bill (SB 73) on Tuesday, May 28. The bill has already passed the Senate unanimously.

NCPA submits comments on proposed overtime regulations

This week, NCPA submitted comments to the Department of Labor on proposed overtime regulations. In its comments, NCPA supported the Proposed Rule to the extent the Proposed Rule seeks to minimize the impact of the salary-level test that the DOL uses to implement the executive, administrative, professional (“EAP”) exemption of the overtime requirements in the Fair Labor Standards Act (“FLSA”).

FDA clarifies section 503A bulks list final rule

Today, FDA issued a guidance to answer questions on the recent final rule that establishes the agency’s criteria for evaluating bulk drug substances that may be used to compound drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA). This final rule places six substances on the 503A bulks list and went into effect on March 21, 2019.

NCPA participates in NASEM’s
Compounded Pain Creams Workshop

This week, NCPA attended the National Academies of Sciences, Engineering, and Medicine’s (NASEM) workshop regarding the safety and effectiveness of ingredients used in compounded topical pain creams to help inform NASEM’s study that is sponsored by the Food and Drug Administration (FDA). The study will evaluate the available scientific data relating to the ingredients used in compounded topical pain creams to determine their safety and efficacy after which the NASEM committee will develop a report with its recommendations. Among the participants at the workshop were the FDA, the National Association of Boards of Pharmacy, pharmacists, providers, and patients who shared their perspectives on compounded topical pain creams. In particular, the pharmacist panel discussed the choice, safety, and effectiveness of all ingredients, formulation methods, and manufacturing methods used in compounded topical pain creams. NCPA will continue to engage with NASEM as their study on compounded topical pain creams progresses.

NCPA state legislative activity update

Click the links to view a report of bills that have been introduced so far this session specifically dealing with NCPA’s top three state priorities: Medicaid managed care payment reform, scope of practice and compensation for services, and PBM reform and regulation. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the 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.