NCPA, pharmacy stakeholders and pharmacists
weigh in on drug pricing RFI
This week, NCPA submitted comments regarding the Trump Administration’s blue print and request for information (RFI) on reducing prescription drug prices and patient out of pocket costs. NCPA's letter asked that CMS consider eliminating pharmacy price concessions – known as DIR fees – altogether. At a minimum, NCPA requests CMS, in its upcoming 2020 Part D Rule, require all pharmacy price concessions be included at point of sale. "A rule of this stature would demonstrate this administration's dedication to meaningfully address rising prescription drug costs for beneficiaries," the letter states. In addition, NCPA urged CMS to develop a pharmacy-specific incentive-based performance program that recognizes the work of the pharmacy profession in service to the patient to reduce costs and improve medication adherence and health.
NCPA’s comments on DIR echo those expressed by pharmacy stakeholders in a multi-signatory letter in which 153 organizations expressed support for this approach. Additionally, nearly 2,000 comments were submitted on the RFI by community pharmacists urging the administration to address pharmacy DIR.
Separately, NCPA submitted a joint comment letter with NACDS urging CMS to finalize a rule requiring all pharmacy price concessions and a portion of manufacturer rebates be included in the negotiated price at point of sale. Moreover, twenty-one members of the United States Senate sent a bipartisan letter to HHS Secretary Azar supporting addressing retroactive DIR fees. This effort was led by Sens. Shelley Moore Capito (R-W.Va.) and Jon Tester (D-Mont.). A similar letter led by Reps. Morgan Griffith (R-Va.) and Peter Welch (D-Vt.) is circulating in the House and will close on July 27. NCPA has a grassroots message that can be sent to legislators urging them to sign on to the House letter prior to the deadline. Please share the grassroots link with your stakeholders and encourage them to voice support.
Will the Administration limit rebates?
The Trump administration appears poised to ban or limit rebates that are calculated as a percentage of list prices.
This week, the HHS Inspector General sent a proposed rule to the Office of Management and Budget, “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection.” Typically, proposed rules from agencies are sent to the OMB for an economic impact score before being released to the public for comment. While the actual text of the proposed rule has not been disclosed, it appears it would both remove old “safe harbor” protections and create new ones for rebates between PBMs and manufacturers.
This proposal follows the administration’s Drug Blueprint request for proposal, which sought input on how to lower drug prices. Banning or limiting rebates that are calculated as a percentage of list prices has been mentioned by Secretary Alex Azar as a possible way to bring down costs.
In comments submitted to HHS on the Blueprint, NCPA argues that any discussion of changing the rebate system is incomplete without also discussing eliminating pharmacy DIR fees. NCPA will be monitoring this proposed rule in the days ahead.
Congressional panel examines
health care transparency initiatives
This week, the House Energy and Commerce Subcommittee on Oversight and Investigations, chaired by Rep. Gregg Harper (R-Miss.), held a hearing entitled “Examining State Efforts to Improve Transparency of Health Care Costs for Consumers.” The hearing looked at recently adopted state laws and policies that improve transparency by making information more readily available on health costs for patients, including state laws to ban so called pharmacy gag clauses. The witnesses were Dr. Michael Chernew, Professor at the Department of Health Care Policy, Harvard Medical School, and Dr. Jaime King, Professor at the UC Hastings College of Law. Rep. Morgan Griffith (R-Va.) asked the witnesses about gag clauses and the need for more PBM transparency, citing a report from the Virginia Bureau of Insurance that was requested by Delegate Keith Hodges, RPh on how PBMs charge for their services and explored whether they save money or increase health care costs through spread pricing. Rep. Buddy Carter (R-Ga.) echoed Rep. Griffith’s concerns with gag clauses and advocated for passage of his legislation, H.R. 5343, the Prescription Transparency Act of 2018. Rep. Carter also discussed potential concerns with more vertical integration in healthcare citing the pending CVS-Aetna merger and raised efforts by states to take a look at Medicaid Managed Care contracts with PBMs and how they were actually costing, instead of saving, the taxpayers money.
Rep. Martha Roby, a supporter of community pharmacy,
prevails in primary runoff
This week, Representative Martha Roby (R-Ala.) won the Congressional primary runoff in Alabama’s second congressional district. Roby defeated former Democratic Representative Bobby Bright, who switched parties and ran as a pro-Trump candidate. NCPA supported Roby’s campaign and urged its members to do the same. President Trump carried the district overwhelmingly in 2016 and Roby is favored to win the general election in November.
NCPA accompanies APCI
on key advocacy visits
This week, representatives from APCI were on Capitol Hill meeting with policymakers about PBM spread pricing in light of what has been uncovered in Ohio’s Medicaid Managed Care program. Representing APCI were Bill Eley, NCPA National Legislation Committee member Cole Sandlin, and Eric Pachman. The group met with the offices of Rep. Doug Collins (R-Ga.), Rep. Buddy Carter (R-Ga.), Sen. Doug Jones (D-Ala.), as well as staff from the House Energy and Commerce and House Judiciary Committees. The group also met with senior staff from the Medicaid team at CMS. NCPA government affairs staff member Adam Harbison joined the group and assisted in scheduling these meetings to discuss the need for more oversight of PBMs and their Managed Care contracts.
Upcoming August Congressional recess
presents in-district meeting opportunities
The House of Representatives is scheduled to begin its August recess on Friday, July 27 and is not scheduled to return until Tuesday September 4. This extended in-district work period, is an excellent opportunity to invite legislators to visit your pharmacy or to schedule a group meeting with multiple community pharmacists with legislators and discuss priority issues.
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.
FDA Releases Biosimilars Action Plan
On Wednesday, the FDA released the Biosimilars Action Plan (BAP), including key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars. The BAP is focused on four key areas:
- improving the efficiency of the biosimilar and interchangeable product development and approval process;
- maximizing scientific and regulatory clarity for the biosimilar product development community;
- developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors; and
- supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.
FDA Commissioner Scott Gottlieb discussed the BAP at the Brookings Institution; his remarks can be found here: Dynamic Regulation: Key to Maintaining Balance Between Biosimilars Innovation and Competition. He stated that, “enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation.” NCPA will continue to advocate for community pharmacy and encourage increased access to biosimilars.
NCPA provides advocacy update
to Tennessee Pharmacists Association
Last Friday, NCPA staff member Allie Jo Shipman presented at the Tennessee Pharmacists Association summer meeting in Hilton Head, SC. She provided an update on NCPA efforts and advocacy on the federal and state legislative and regulatory fronts.
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.