NCPA, NACDS discuss DIR fees with HHS officials

Representatives from NCPA and NACDS recently met with staff of the Secretary of Health and Human Services focused on drug pricing to discuss community pharmacy perspectives on elimination of post point of sale pharmacy DIR fees. NCPA will continue to fight for resolution to our members’ number one issue and is anxiously awaiting decisions by HHS on how to address drug prices, including the DIR issue.

NCPA board member Hugh Chancy
urges House subcommittee to ban “gag clauses”

In testimony before the U.S. House Energy and Commerce Subcommittee on Health this week, pharmacist-owner and NCPA board member Hugh Chancy told lawmakers how so-called "gag clauses" have impacted his patients and his business. This is the fourth time in the last 9 months that NCPA has been invited to testify before this influential committee. Chancy urged support for draft legislation to prohibit restrictive contractual language that may result in patients being charged inflated prices for their medications. Click here to view the Energy and Commerce Committee’s press release on the hearing which featured Chancy’s testimony and how PBMs threaten community pharmacies.

The Health Subcommittee marked up this draft legislation today, which is the first step towards passage of a bill to ban gag clauses in the House. Energy & Commerce Committee Chairman, Rep. Greg Walden (R-Ore.) issued a press release highlighting his support for the legislation and included this quote from his constituent and NCPA Board Member Michele Belcher : “Gag clauses are an unnecessary restriction on our ability as pharmacists to communicate with our patients," said Michele Belcher, owner and pharmacist at Grants Pass Pharmacy, and board member of the National Community Pharmacists Association. "I once received a cease and desist letter for trying to help a child with a terminal disease access his medication. That should never happen. I applaud Representative Walden for taking this issue on.”

Special hotel rate for NCPA Annual Convention
expires Wednesday

If you have not yet registered for the NCPA Annual Convention, or reserved your hotel room, there is still time to do so and take advantage of the special hotel rate. But, you better act fast – the special rate for NCPA members expires Wednesday, Sept. 12. Rooms are going fast and NCPA recently opened room blocks at two additional hotels – the Lenox and the Colonnade. Register today! Here's the complete convention schedule.

Senate acts to eliminate “gag clauses”

This week, the U.S. Senate unanimously passed S. 2553, the Know the Lowest Price Act, which was endorsed by NCPA. The legislation allows pharmacists to tell Medicare Part D beneficiaries if the cash price for a prescription drug is lower than the price through their insurance coverage. The legislationwas introduced by Sens. Debbie Stabenow (D-Mich.), Susan Collins (R-Maine), Claire McCaskill (D-Mo.), John Barrasso (R-Wyo.), Ron Wyden (D-Ore.) and Bill Cassidy (R-La.).

North Dakota court rules against PBMs

In a significant win for community pharmacy, the U.S. District Court of North Dakota on Wednesday issued a thorough decision denying PCMA's challenge to two of North Dakota's laws regulating PBMs and their relationship with pharmacies. Defendants in the suit, the North Dakota Board of Pharmacy, the state attorney general and the state health officer, won on nearly every claim. Indeed, the court held that neither ERISA nor Medicare preempts the challenged State laws – except for an isolated provision that mandated certain disclosures to plan sponsors, which the Court held was preempted by Medicare (but not ERISA). Read the court's decision here. As a result, North Dakota may enforce the laws in their entirety – except for the plan-disclosure provision, which is preempted as to Medicare Part D plans but not preempted as to non-Part D plans, including ERISA plans. PCMA filed an appeal Wednesday.

Energy and Commerce Committee leaders question
PBM role in pharmaceutical supply chain

On August 30, House Energy and Commerce Committee leaders sent letters to various pharmacy benefit managers asking questions as they seek to better understand the role of PBMs in the drug supply chain. The letters were signed by Energy and Commerce Committee Chairman Greg Walden (R-Ore.), Health Subcommittee Chairman Michael C. Burgess, M.D. (R-Texas), and Oversight and Investigations Subcommittee Chairman Gregg Harper (R-Miss.). The letter questioned studies conducted by PBMs claiming that they save a total of $654 billion across plan sponsors and members, Medicare Part D and its beneficiaries, and managed Medicaid plans. NCPA applauds these efforts and has continued to educate the committee on the role PBMs play in the drug supply chain.

NCPA announces Advocacy Center realignment; Cassity named VP, Federal and State Government Affairs

Anne Cassity has rejoined NCPA as vice president, federal and state government affairs, as we continue to grow our advocacy influence and effectiveness. Cassity formerly managed NCPA's federal advocacy program, leaving in 2011 to become health care policy advisor to then-governor Bobby Jindal of Louisiana. Most recently, she served as government relations director for Centene, a managed care organization, in Louisiana.

As part of the staff realignment, Scott Brunner, CAE, will oversee communications, grassroots, and external affairs as senior vice president, communications & external affairs. Ronna Hauser, PharmD, will continue to oversee NCPA’s federal policy and regulatory affairs as vice president, pharmacy policy & regulatory affairs. Brunner, Cassity and Hauser will all report to Karry La Violette, senior vice president, government affairs, and director of the NCPA Advocacy Center. For reference, the up-to-date NCPA Advocacy Center staff directory is attached.

Senate reaches deal on opioid legislation

Senators have reached a deal on a bipartisan package to address the opioid crisis, paving the way for a potential vote next week. The agreement comes after weeks of slowed negotiations between lawmakers over hot-button provisions like requiring Medicaid to cover treatment at more inpatient facilities and loosening privacy restrictions for substance abuse patients' medical records. Neither provision made it into the final deal, but they are part of an opioid response package passed by the House earlier this year. The Senate package largely matches what the House passed in H.R. 6 earlier this summer. Once the Senate passes its package, the two chambers will move to go to conference to iron out their differences although a final deal isn’t expected until the lame duck session after Election Day.

August recess proves fruitful
for Congressional pharmacy visits

Nearly 20 legislators took advantage of the opportunity to either visit a community pharmacy or meet with pharmacists during the August congressional recess, including members of key committees. Ways and Means Committee chairman Rep. Kevin Brady (R-Texas) visited Magnolia Pharmacy and discussed several important issues. Additionally, Rep. Frank Pallone (D-N.J.), the ranking member on the Energy and Commerce Committee met with a group of constituent pharmacists, which included representatives from NCPA, the New Jersey Pharmacists Association and Garden State Pharmacy Owners (GSPO) to discuss issues such as DIR and MAC. Similarly, Rep. Brett Guthrie (R-Ky.), a member of the Energy and Commerce Committee and the lead sponsor of H.R. 592 to recognize pharmacists as health care providers under Medicare met with several of his constituent pharmacists. Finally, Rep. Diane DeGette (D-Colo.) held a press conference at a local pharmacy regarding opioids.

NCPA appreciates all legislators who took the time to meet with constituent pharmacists during the August break and all the pharmacists who welcomed legislators into their pharmacies or otherwise took time to attend a meeting.

For information on hosting a pharmacy visit, click here or contact Michael Rule at michael.rule@ncpanet.org for more information.

FDA releases revised compounding MOU

Today the FDA released a revised memorandum of understanding between the agency and the states in regards to compounding. The stated goal is to collaborate with the states to maximize resources to impact public health. The FDA states the revised draft MOU addresses patient access concerns previously raised by stakeholders, while retaining critical safety provisions. NCPA will thoroughly review the revised MOU and provide further guidance upon completion of the review process.

Ohio and Pennsylvania taking action to address
PBM abusive practices in Medicaid managed care

The State Auditor of Ohio released a report showing that PBMs pocket over $224 million annually off spread pricing alone in the state’s Medicaid managed care program. Based on the Auditor’s findings, the Ohio Department of Medicaid directed the state’s five managed care plans to terminate all contracts with all PBMs. The state will switch to a pass-through pricing model on Jan. 1, 2019.

Pennsylvania’s Auditor General has also decided to look into PBM practices in the Medicaid managed care program, and has scheduled four regional hearings throughout September to hear from pharmacists and other stakeholders about PBM issues. NCPA’s Matt Magner will be offering comments giving a national perspective at one of the regional hearings.

Alaska legislation addresses abusive PBM practices

States continue to lead the way in addressing abusive PBM practices as this week, Governor Bill Walker (R-Alaska) signed legislation that goes a long way in combating the unfair PBM business practices in Alaska. The legislation, H.B. 240 contained four main provisions that:

• requires PBMs to register with the state as third party administrators which is giant a step towards more oversight for a predominately unregulated industry;
• prohibits the use of “gag clauses” by PBMs so pharmacists can disclose to their patient the cheapest payment option without fear of being penalized;
• reforms abusive and arbitrary PBM practices to ensure that pharmacies are subject to fair audit requirements and procedures; and
• provides transparency for the price of drugs included on the MAC drug list. Alaska’s small business owners and healthcare providers will have access to pricing lists that accurately reflect the current pharmaceutical marketplace prices.

NCPA previously submitted a letter endorsing this important legislation.

NCPA, NACDS provide pharmacy recommendations to TRICARE

NCPA, along with NACDS, sent a follow up letter to Stephanie A. Barna, Acting Assistant Secretary of Defense for Manpower and Reserve Affairs, United States Department of Defense, thanking her for hosting the June meeting of stakeholders to discuss potential policies and pilot program features on the topic of the TRICARE pharmacy benefit. Specifically, ways to restore access to retail pharmacies for TRICARE beneficiaries who rely on brand name, maintenance medications. The recommendations in our letter focus on anticipating the needs of the program and explains how a pilot bringing acquisition cost parity to TRICARE is consistent with broader goals.

CMS issues memo allowing MA Plans to utilize
step therapy for Part B drugs

On August 7th, the CMS issued a memo outlining that Medicare Advantage plans and their PBMs may apply a "step therapy" approach to Part B drugs provided under their plans for contract year 2019. CMS stated that the intent of this move is to help contain pharmaceutical costs by giving plans/PBMs the ability to negotiate better deals by leveraging step therapy as a means to achieve those deals. Step therapy is a form of prior authorization where an insurance company has to give prior approval before more costly medications are administered. While these memo only applies to MA Plans, NCPA will continue to monitor the impact of step therapy in these plans and its potential for a downstream impact on Part D plans.

House Energy and Commerce Committee send letters
to 340B contract pharmacies

Earlier this month, House Energy and Commerce Committee leaders sent letters to nine contract pharmacies participating in the 340B Program requesting a variety of information. Specifically, information regarding the process to become a contract pharmacy for a covered entity, mechanisms to prevent diversion in the Program, and any methods to prevent duplicate discounts at each pharmacy. In recent months, Congress has largely scrutinized hospitals participating in the 340B Program, these letters could signal Congress’ renewed interest in how other actors, including contract pharmacies, in the supply chain have contributed to the concerns surrounding the Program. The letters can be found here.

NCPA and NACDS send a follow up letter to CMS
on opioid edits for 2019 Part D plans

Last week NCPA and NACDS sent a joint letter to CMS requesting clarification on the care coordination edit outlined in CMS’ 2019 Call Letter. Specifically, the letter requested clarification on Call Letter language which may or may not instruct pharmacists to consult with a prescriber each time a prescription for an opioid exceeds the threshold, or in the alternative allow a pharmacist to initiate an override on their own based on knowledge of patient history and files. The letter follows a CMS meeting on the care coordination edit in which NCPA and NACDS both attended. In addition to this letter, both associations continue to have a formal dialogue with CMS regarding the implementation of this edit has the 2019 plan year nears.

NCPA submits comments to the FTC regarding PBM practices

The Federal Trade Commission (FTC) invited comment from stakeholders prior to its series of public hearings on whether broad-based changes in the economy, evolving business practices, new technologies, or international developments might require adjustments to competition and consumer protection enforcement law, enforcement priorities, and policy. On August 20th, NCPA submitted comments reiterating PBMs’ anticompetitive business practices and market dominance, stressing that they have contributed to increasing health care costs and negatively impacted consumer choice. In order to address PBM market dominance, NCPA argued for increased transparency in PBMs’ business practices, additional scrutiny of inherent PBM conflicts of interest, and fair contract negotiation between PBMs and independent pharmacies. The FTC hearings are expected to occur this September, and NCPA will be monitoring them to ensure community pharmacists’ voices are heard.

Medicare Part D Coverage of Multi-Ingredient Compounds

On August 10th, CMS issued a memorandum to clarify current CMS policies regarding Medicare Part D coverage of multi-ingredient compounds, which are products extemporaneously prepared by pharmacies to provide drug therapies that are not commercially available as FDA-approved products. Multi-ingredient compounds are only covered under Part D if they contain at least one ingredient that independently meets the definition of a Part D drug and do not contain any ingredients covered under Part B. On August 7th, the HHS Office of the Inspector General (OIG) released a report (OEI-02-16-00440) indicating that Part D spending on topical compounds was 24 times higher in 2016 than in 2010. These results alerted CMS to suspect possible fraud, waste and abuse. Therefore, CMS will be incorporating fraud training into current training programs and is encouraging plan sponsors to ensure medical necessity of these compounds through utilization management tools.

CMS updates Medicare diabetes prevention website

CMS has added new resources to the Medicare Diabetes Prevention Program website, including a beneficiary eligibility fact sheet, coach eligibility fact sheet, and a link to the MDPP supplier list. The beneficiary eligibility fact sheet provides details on beneficiary eligibility requirements and tips for MDPP suppliers to verify eligibility. The coach eligibility fact sheet lists the eligibility requirements for coaches and tips to help individuals become lifestyle coaches, and the MDPP supplier list is a downloadable list, including contact information of suppliers, and will be updated biweekly.

NAIC summer meeting

NCPA’s Matt Magner attended the National Association of Insurance Commissioners’ summer meeting in Boston, MA. The agenda included a discussion of PBM regulation, which has recently become of increasing interest to NAIC. Magner met with insurance commissioners and other state government officials to discuss the need for PBM transparency.

Medicare Diabetes Prevention Program: New Service Call

The 2019 Medicare and You Handbook includes information on the Medicare Diabetes Prevention Program, a new Medicare-covered service. CMS will be hosting a call to inform Medicare fee-for-service providers of the new service, eligibility requirements, and how to enroll patients; and will offer a question and answer portion. The call will be held on September 26th at 2:00pm. Click here to register.

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.