See you next week for the
NCPA Congressional Pharmacy Fly-in?
NCPA’s Congressional Pharmacy Fly-in is less than just days away (April 10-11). If you have not yet registered, you can still do so onsite at the registration table. Don’t miss out on the opportunity to hear HHS Secretary Alex Azar and two pharmacy champions, Reps. Doug Collins (R-Ga.) and Peter Welch (D-Vt.) who have both confirmed their participation at the Congressional Pharmacy Fly-in. This is also an opportunity to make your voice heard in meetings with your legislators or their key staff members. With a bipartisan desire in Congress to tackle the high cost of prescription drugs and pro-pharmacy legislation addressing issues such as DIR pending in Congress, your interests must be represented! 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. Due to the revised schedule, we suggest requesting house visits for after 1:00 on April 10 and Senate visits for April 11. Go to 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. If you are unable to join us at the Fly-in, there will be an opportunity to participate in virtual advocacy to support our priority bills through the Legislative Action Center.
Note: For those who will be arriving for the fly-in early, NCPA PAC will be hosting a breakfast fundraiser for Sen. Joni Ernst (R-Iowa) on Tuesday, April 9 at 7:15am at the Alexandria Hilton, and we cordially invite you to attend. Click here to see the invitation for more information.
Invite your legislator for a visit
during the upcoming Congressional recess
Congress has an upcoming two week in-district work period from April 13-28. This 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.
Sens. Capito and Tester introduce DIR legislation
This week, Sens. Shelley Moore Capito (R-W.Va.) and Jon Tester (D-Mont.) introduced S. 988, the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, a bill with wide bipartisan support in the 115th Congress. The legislation would ensure that community pharmacists receive reimbursement at the rate posted at the time prescriptions are filled by prohibiting Medicare Part D plan sponsors and PBMs from retroactively reducing payments on accurate reimbursement claims submitted by pharmacies. Doing so would help ensure community pharmacies are able to continue to serve Medicare beneficiaries and combat the growing financial uncertainties these small businesses are facing. The House companion, H.R. 803, was introduced by Reps. Peter Welch (D-Vt.) and Morgan Griffith (R-Va.) in February.
N.Y. and Texas House delegations
support CMS’ proposed pharmacy DIR rule
Members of the New York and Texas House delegations recently sent letters to HHS Secretary Azar supporting 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. The New York letter was led by Reps. Kathleen Rice (D) and Lee Zeldin (R) and was co-signed by Reps. Anthony Brindisi (D), Yvette Clarke (D), Chris Collins (R), Antonio Delgado (D), Brian Higgins (D), John Katko (R), Peter King (R), Sean Patrick Maloney (D), Joseph Morelle (D), Tom Reed (R), Elise Stefanik (R), Tom Suozzi (D), and Nydia Velazquez (D). The Texas letter was led by Reps. Mac Thornberry (R) and Eddie Bernice Johnson (D) and was co-signed by Reps. Brian Babin (R), John Carter (R), Michael Cloud (R), Henry Cuellar (D), Louie Gohmert (R), Vicente Gonzalez (D), Lance Gooden (R), Will Hurd (R), Filemon Vela (D), and Roger Williams (R).
NCPA urges Senate Finance Committee
to scrutinize PBM practices at next week’s hearing
Next week, representatives from five PBMs will testify before a Senate Finance Committee hearing, "Drug Pricing in America: A Prescription for Change." This is the third hearing in the committee's investigation into drug prices. In advance of the hearing, NCPA has submitted a statement for the record expressing the concerns of community pharmacy and our patients. Above all, the statement emphasizes that addressing the role of PBMs is a critical component of tackling drug prices. NCPA also urges Congress to pass H.R. 803/S. 988, the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, legislation (news on the new Senate bill below!) that would eliminate the retroactive nature of pharmacy price concessions and S. 476, the Creating Transparency to Have Drug Rebates Unlocked Act, legislation that would require negotiated prices for Part D drugs to include all price concessions and be provided at the point of sale. Additionally, NCPA urges Congress to limit and control the way PBMs and plan sponsors impose arbitrary and inconsistent performance-based standards and incentive payment schemes on community pharmacies.
Senate Finance Committee leaders
demand answers from PBMs in insulin price spikes
On Tuesday, Senate Finance Committee Chairman Chuck Grassley (R-Iowa) announced that he and Ranking Member Ron Wyden (D-Ore.) sent letters to the three “leading pharmacy benefit managers (PBMs),” seeking information on their role “in the skyrocketing cost of insulin in the United States.” Chairman Grassley and Ranking Member Wyden question if the PBMs “are appropriately leveraging their power for the benefit of taxpayers and patients, especially patients who take multiple or high-cost medications.” The Senators wrote to Cigna Corporation, CVS Health Corporation and Optum, seeking information and documents on issues including: (1) PBM business relationships with insulin manufacturers, public insurance programs, private insurance plans, and pharmacies; (2) PBM practice to determine rebates and formulary placement; and (3) patient health information collected by PBMs, including how the information is used and protected. The Senators requested responses by April 16, 2019. The Finance Committee has announced a hearing scheduled for April 9, 2019 on prescription drug prices, including testimony from the three PBMs, as well as Humana, Inc. and Prime Therapeutics LLC. NCPA has been working with Senate offices on questions that the PBMs need to answer and has encourage members to share their stories with their respective Senators on how PBMs harm community pharmacies and patients.
E&C Health Subcommittee holds first hearing
on insulin price spikes
On Tuesday, the House Energy and Commerce Oversight Subcommittee held the first in a series of hearings to examine the patient impact of rising insulin prices, explore factors responsible for high costs, and identify potential legislative solutions. Subcommittee Chair Diana DeGette (D-Colo.) emphasized a strong, bipartisan commitment to fix the problem of high insulin prices. Chairwoman DeGette, Subcommittee Ranking Member Brett Guthrie (R-Ky.), and Members of both parties discussed risks faced by constituents with diabetes who cannot afford insulin, and agreed that Congress must act to help patients. Chairwoman DeGette suggested addressing list prices, but stopped short of offering specific policies. She announced the Subcommittee will hold a hearing next week on Wednesday, April 10th with 3 insulin manufacturers and the 3 largest pharmacy benefit managers (PBMs), and projected that it would not take a full year to legislate on the issue.
Final CMS rule that could address
pharmacy DIR fees expected soon
Community pharmacists are eagerly awaiting release of a drug pricing rule that, if finalized as proposed, would move pharmacy price concessions to point-of-sale, eliminating the retroactive nature of pharmacy direct and indirect remuneration (DIR) fees. The final rule could be issued any day now.
NCPA has developed a timeline of activity of our, and our members’ efforts, in fighting to fix the pharmacy DIR issue, which will be among the high-priority at next week’s 2019 Congressional Pharmacy Fly-In in Washington, D.C. next week.
Minimum requirements necessary
to support HHS’ proposed rebate rule
NCPA has talked to stakeholders and analyzed the implications of a proposed HHS rule for community pharmacies, including but not limited to potential legal, commercial, financial, and regulatory impacts. NCPA has also been working closely with industry veterans and consultants to prepare NCPA's comments, which will serve as an important voice for community pharmacies' role in a world without rebates, and has created a document listing what we believe are the minimum requirements for NCPA to support the proposed rule. NCPA also has sample comments available which can be submitted through NCPA’s grassroots portal outlining the seven minimum requirements. The comment deadline is Monday, April 8.
Make sure your data is included
in the retail/specialty cost of dispense survey
If you have not yet done so, please complete the retail/specialty 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 U.S.. 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. While, the survey is likely to take a few hours to complete and possibly more, depending on the information system and number of pharmacies, the data you provide is immensely important. 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. The extended deadline to complete is Tuesday, April 9.
Final Call Letter for plan year 2020 released
This week CMS released its final call letter, an annual letter that outlines the way in which plans must operate in the Part D program. NCPA submitted comments to the draft call letter last month urging, among other things, that CMS work with PQA in establishing pharmacy specific quality metrics to measure pharmacy performance. NCPA also highlighted the ways in which community pharmacies can help combat the opioid crisis. NCPA is currently reviewing the letter for any impact to community pharmacies, including the final call letter’s language on maximizing competition among Medicare Advantage and Part D plans, as well as include important actions to address the nation’s opioid crisis. Over the past year, NPCA has provided feedback to CMS’ policies on “improving drug utilization review controls” to combat the opioid crisis, including Part D drug management programs for high risk opioid users, and improved safety alerts, such as the 7-day supply limit for opioid naïve patients. As many of these policies have recently gone into place for the current contract year, please reach out to NCPA should you have any input or concerns that CMS should know.
NCPA submits comments to HHS
regarding the Quantity Prescribed field
This week, NCPA submitted comments to HHS on its proposed rule that modifies the use of the NCPDP D.0 Standard Quantity Prescribed (460-ET) field. This proposal comes after the HHS Office of Inspector General (OIG) found that some LTC facility pharmacies may have incorrectly billed partial fills of Schedule II drugs as refills due to not being able to appropriately use the Quantity Prescribed field. HHS proposes to require all covered entities, including LTC facilities and pharmacies, to use the Quantity Prescribed field for Schedule II drugs for the following three transactions: (1) health care claims or equivalent encounter information; (2) referral certification and authorization; and (3) coordination of benefits. This change would enable covered entities to clearly distinguish whether a prescription is a “partial fill,” where less than the full amount prescribed is dispensed, or a “refill,” in HIPAA retail pharmacy transactions. NCPA mirrored NCPDP’s thoughts in its comments stating that HHS should adopt the November 2012 published version of the NCPDP Telecommunication Standard D.0 since that is the version voted on by industry.
FDA finalizes REMS guidance
This week, the FDA issued a final guidance titled, REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary. This guidance clarifies how the FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks.
State roundup:
Arkansas SB 472, which requires a health insurer to contract with a licensed healthcare provider (including pharmacists) if the healthcare provider is permitted to participate in Medicare, Medicaid, or any other federal health benefit plan, was signed by the governor this week.
Maryland had three bills pass the General Assembly that establish PBM regulations. HB 589 would increase transparency in the state’s Medicaid managed care program by requiring the Maryland Medical Assistance Program to audit the state’s PBMs; HB 754 would expand MAC appeal protections to all forms of reimbursement methods; and HB 759 would limit PBM conflicts of interest by prohibiting a PBM from requiring a beneficiary to use a pharmacy in which the PBM has an ownership interest.
Minnesota SF 278, which would require PBM licensure, give the insurance commissioner oversight of PBMs, ensure network adequacy without the inclusion of mail order, prohibit pharmacy accreditation or recertification requirements inconsistent with state and federal requirements, and provide for additional PBM transparency through added reporting requirements, has passed the Senate and is now in the House.
Montana SB 83, which prevents PBMs and health insurers from imposing fees on pharmacies if they are not apparent at the point of sale or at the time the claim is processed and prohibits PBMs and health insurers from charging a patient a copayment that exceeds the total cost of the medication, was signed by the governor.
New Mexico Last week, NCPA provided a letter of support to New Mexico’s Office of the Governor this week for SB 394, relating to pharmacy audits, and SB 415, related to reimbursement transparency. NCPA provided clarification and additional information regarding concerns from the governor’s office related to certain provisions in the two bills. SB 394 and SB 415, were both signed by the governor this week.
New York passed provisions this week in budget bill S 1507/A 2007 related to prohibitions on PBM spread in Medicaid and increased transparency through additional PBM and MCO reporting requirements.
Tennessee SB 650, which addresses pharmacy audits, PBM transparency, and contracting protections, passed out of the Senate Commerce and Labor Committee this week after excellent testimony by pharmacist legislator and bill sponsor, Senator Shane Reeves.
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 attached reports. 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.