Efforts to support key provisions of the CMS’ proposed Part D rule kicked into high gear with several developments, including:
- 120-stakeholder letter to CMS supporting the agency’s announced consideration to require application of retroactive pharmacy DIR fees instead into the “negotiated price” at point-of-sale. The letter includes a wide variety of community pharmacy allies as well as major health systems, grocers and others.
- Bipartisan congressional sign-on letters to CMS backing the pharmacy DIR fee provisions. Nearly 80 U.S. Representatives joined a House letter led by Reps. Morgan Griffith, Peter Welch, Austin Scott, Dave Loebsack, and Buddy Carter that closed this week and will be available soon. A parallel Senate letter led by Senators Capito and Tester is open until Jan. 18th and continues to garner support. Click here to ask your Senator to sign on. Both letters encountered fierce opposition from PBM industry advocates to which NCPA responded with rebuttal points to back our Hill supporters. In addition, Reps. Doug Collins and Dave Loebsack circulated a separate sign-on letter focused on additional key provisions in the proposed rule. Please urge your Representatives to sign before the Jan. 16th deadline.
- Dozens of patient advocates and other stakeholders were engaged by NCPA staff and encouraged to support key provisions of the proposed rule. Many indicated they would express support in their own comments to CMS, and others joined a positive sign-on letter to CMS.
- NCPA prepares official comments to CMS. Among the arguments is a new survey of community pharmacists describing the challenges DIR fees increasingly present to pharmacists and their patients.
This has been an all-hands-on-deck effort by NCPA staff and particularly those copied on this email. Thanks everyone for your hard work and support.
CMS advises states on Medicaid work requirements: In response to the demands of several states, CMS released guidance to state Medicaid directors intended to help those who wish to adopt work or “community involvement” requirements on Medicaid recipients for continued eligibility. The guidance exempts several classes of recipients, such as caregivers, pregnant women and others. The next day CMS approved the first such 1115 demonstration project, for Kentucky. CMS indicated it received similar requests from nine other states: Arizona, Arkansas, Indiana, Kansas, Maine, New Hampshire, North Carolina, Utah and Wisconsin. Many patient advocacy organizations decried the policy change, with some examining filing legal challenges, and the Ranking Members of the Senate Finance Committee and House Energy & Commerce Committee requested a GAO review of CMS procedures leading up to the new policy.
Opioid epidemic roundup: The Senate HELP Committee heard testimony from Sam Quinones, journalist and author of the influential book Dreamland. He discussed prescribing practices, insurance coverage affecting access to non-opioid pain management and the importance of funding research and local programs. Senators discussed these and additional issues including opioid prescription limits and re-setting any patient expectations to be completely pain-free following treatment. In addition, an announced Jan. 17 hearing of the House Ways and Means Oversight Subcommittee will examine CMS efforts to utilize data to identify individuals in the Medicare Part D program who are at risk to abuse opioids, as well as the tools that CMS has available to prevent individuals from receiving unnecessary opioids.
AMA asks NCPA to raise awareness about clarification of CDC opioid prescribing guidelines: The Centers for Disease Control and Prevention has addressed concern that buprenorphine, when used for the treatment of substance use disorder, is being erroneously used in the calculation of Morphine Milligram Equivalents (MME) to assess risk of opioid use disorder and overdose. The CDC guideline, in fact, made clear that dosage thresholds in the Guideline were not meant to and should not apply to dosing of opioid agonists/partial agonists used for the treatment of opioid use disorder. The CDC has further clarified this in a letter to the American Society of Addiction Medicine. The AMA and ASAM are working together to share this information to ensure that all health care professions and other relevant stakeholders are aware of this.
New report keeps 340B program in GOP crosshairs: The Republican majority on the House Energy & Commerce Committee released a report calling for changes to the 340B drug discount program, following the panel’s extensive investigative work in the area. Specifically, the report raises concerns about oversight and transparency in the program. It lists 12 recommendations, such as greater enforcement by and more authority for the HHS agency that regulates 340B.
MedPAC conducts winter meeting; expresses concern on CMS proposed Part D rule: The congressional advisory panel MedPAC unanimously advanced recommendations that would (1) require manufacturers of biosimilar products to pay discounts for drugs in the Part D coverage gap; and (2) exclude biosimilar manufacturers’ discounts in the coverage gap from enrollees’ true out of pocket spending. In their update on the Part D program, MedPAC staffers noted that catastrophic spending is projected to increase due to the emergence of new specialty drugs and biologics and also mentioned rising pharmacy DIR fees. During the ensuing discussion, Commissioners also discussed quality measures for Part D plans, including measures assessing drug appropriateness and adherence, following which the Chairman expressed intent to continue to focus on drug pricing issues and take a broader look at pricing factors. Separately, MedPAC sent a letter to CMS commenting on the proposed Part D rule. In the area of manufacturer rebates and pharmacy DIR fees, the Commission “shares CMS’s concerns and strongly agrees that a change is needed” to properly align incentives of plan sponsors/PBMs and the government. In comments addressed specifically at CMS’ interest accounting for some portion of manufacturer rebates in point-of-sale prices, MedPAC expressed agreement “with the principle behind the requirement”, while recommending alternative approaches.
HHS Secretary-designate Azar closer to confirmation: The Senate Finance Committee reportedly may vote as soon as next week on the nomination of Alex Azar to be HHS Secretary. The committee held a nomination hearing Jan. 9, at which Azar pledged to combat the opioid epidemic, renewed concerns that prescription drug costs are “too high” and discussed various proposed solutions, including government price negotiation and subjecting Medicare Part B drugs to Part D-style reform. While several Democrats criticized his role in pricing decisions while leading a major pharmaceutical manufacturer, the emergence of support from moderate Democrats for the nomination along with widespread GOP support makes his confirmation a virtual certainty.
NCPA staff joined forces with members of the National Grocers Association who flew-in to conduct meetings on Capitol Hill Jan. 10. Representatives from Brookshire Grocery Company, Harp’s Food Stores, and Associated Wholesale Grocers met with 10 House and Senate offices to discuss how DIR fees make it hard to run a business and advocate for Congress to support the 2019 Part D Rule proposal to ban retroactive pharmacy DIR fees. NCPA continues to broaden its advocacy and outreach efforts on the DIR front and join with other impacted stakeholders who are being adversely impacted by DIR fees.
By invitation from the HHS Assistant Secretary for Preparedness and Response (ASPR), NCPA participated in the Stakeholder Listening Session: Priorities for Pandemic and All-Hazards Preparedness. The Jan. 10 session was designed to solicit information and viewpoints on pandemic and all-hazards preparedness issues and concerns that are priorities for ASPR stakeholders. There was no attempt to garner consensus advice or recommendations. Breakout sessions focused on 4 areas: leadership, national disaster healthcare system, public health security capacity, and medical countermeasures enterprise. There were about 60 attendees ranging from health care organizations to fire chiefs to environmental groups. Interestingly, NCPA was the only pharmacy group represented. The meeting concluded with remarks by the current ASPR, Dr. Bob Kadlec.
In the States:
- CMS should reject Washington’s Medicaid pharmacy reimbursement state plan amendment: NACDS, NCPA and WSPA sent a letter to CMS urging the agency not to approve Washington’s state plan amendment, which is subject to pending litigation filed by the three pharmacy associations. The letter notes that the amendment “fails to satisfy the requirements of federal rules and laws” and that after “more than a year of working with the state, it is now time for CMS to disapprove the SPA.”
- Oral arguments held at the 8th Circuit Court of Appeals in PCMA v. Rutledge: The lawsuit brought by PCMA challenges Arkansas’ most recent PBM transparency bill under ERISA and Medicare Part D preemption grounds. Representatives from NCPA and the Arkansas Pharmacists Association (APA) attended the Jan. 9 hearing in support of the state. NCPA will continue to work closely with APA to monitor and provide additional support for the state in defending this important law.