NCPA discusses DIR with GOP Doctors Caucus

This week, NCPA staff met with members of the House GOP Doctors Caucus on Capitol Hill. They were also joined by staff from NACDS. Topics of discussion included PBM transparency and the CMS’s proposed rule to fix pharmacy DIR. The GOP Doctors Caucus is composed of 16 medical providers, including physicians, dentists, podiatrists, and pharmacists, in Congress who utilize their medical expertise to develop patient-centered health care policy. Members in attendance included Reps. Phil Roe (R-Tenn.), Andy Harris (R-Md.), Buddy Carter (R-Ga.), Brad Wenstrup (R-Ohio), Larry Buschon (R-Ind.), Brian Babin (R-Texas), John Joyce (R-Pa.), and Roger Marshall (R-Kan.). NCPA looks forward to continuing working with the caucus on behalf of patients and community pharmacies.

Miss. and Va. delegations add their support
for HHS DIR proposal

Members of the Mississippi and Virginia 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 Miss. letter was led by Rep. Steven Palazzo (R-Miss.) and was co-signed by Reps. Trent Kelly (R-Miss.) and Michael Guest (R- Miss.). The Va. letter was led by Rep. Robert Wittman (R-Va.) and was signed by Reps. Morgan Griffith (R-Va.) and Ben Cline (R-Va.).

PhRMA executives testify
before Senate Finance Committee

This week, the Senate Finance Committee held a hearing entitled, “Drug Pricing in America: A Prescription for Change, Part II,” with testimony from seven pharmaceutical manufacturers. Chairman Charles Grassley (R-Iowa) emphasized the need for legislation to stop companies from engaging in practices that raise drug prices for patients. Witnesses from the pharmaceutical industry stressed their willingness to identify policy solutions to reduce costs for patients, such as eliminating rebates. Most of the witnesses called for the rebate rule to apply to commercial plans, and expressed support for removing barriers to value-based agreements. Ranking Member Ron Wyden (D-Ore.) and Democratic committee members emphasized repeatedly that drug manufacturers are responsible for setting high list prices that make drugs unaffordable for patients.

Register now to attend next month’s
Congressional Pharmacy Fly-in

NCPA’s Congressional Pharmacy Fly-in (April 10-11) is next month, and two pharmacy champions, Reps. Doug Collins (R-Ga.) and Peter Welch (D-Vt.) have confirmed their participation. 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. Registration is open, so don’t delay, register now online or by calling 1-800-544-7447. If you’ve already registered, don’t forget to schedule your hill visits. Visit 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.

Invite your legislator to work during
the upcoming in-district work period

Congress has an upcoming in-district work period from March 16-24. 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.

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 US. 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.

FY19 appropriations language for compounding in effect

Congress finalized appropriations report language for fiscal year 2019 regarding compounding pharmacy regulation under the Food, Drug, and Cosmetic Act (FDCA) and the Drug, Quality and Security Act (DQSA). The Committee states its expectations of FDA regarding the MOU, implementation framework and office use compounding, Pharmacy Compounding Advisory Committee (PCAC), and state-licensed compounding pharmacies. This does not change current law, but it does give congressional directives to FDA to clarify the regulatory guidance documents and processes that it has implemented. The Committee’s specific concerns and expectations include the following:

• MOU: The Committee states concerns with FDA’s Draft MOU due to FDA’s intention to place requirements on states that will result in many states refusing to sign the MOU. The Committee also expects the FDA to clarify the distinction between dispense and distribute.
• Drug Compounding Implementation Framework and Office Use Compounding: The Committee expresses concerns that many provisions of the DQSA and the re-enactment of Section 50BA have been implemented through agency guidance documents instead of the formal notice and comment rulemaking process as required by federal law. The Committee directs FDA to explain how the agency will implement its use of guidances. The Committee expresses disapproval of the GFI “Prescription Requirement Under Section 503A of the FDCA” due to FDA’s involvement with legitimate state licensed pharmacy practice. The Committee also encourages FDA to either prescribe a pathway for office-use, or hold a public meeting to explain the legal rationale for disallowing office-use.
• Drug Compounding Pharmacist on PCAC: The Committee reiterates the importance of FDA appointing voting members of the PCAC who have sufficient experience in preparing, prescribing, and using compounds to adequately represent the interests of providers and patients who use compounds.
• Drug Compounding Under State-Licensed Pharmacies: The Committee reminds the FDA that state-licensed compounding pharmacies are not drug manufacturers, but rather, are inspected by state boards of pharmacy pursuant to state laws and regulations. The Committee is also concerned that FDA is publishing inspection records of pharmacies on its website, but not publishing the same information for other manufacturing concerns. Therefore, the Committee directs FDA to use the same level of transparency for the findings of all inspection activities.

Gottlieb announces 2019 opioid agenda

This week, FDA Commissioner Scott Gottlieb issued a statement reviewing FDA’s actions in 2018 to combat the opioid crisis and laid out the FDA’s 2019 policy and regulatory agenda to further this effort. Gottlieb expressed that addressing the opioid crisis is a top priority of the entire Administration with FDA playing a key role in curtailing the epidemic. The FDA aims to reduce the misuse and abuse of opioids by ensuring that these drugs are appropriately prescribed and disposed of when not used. The FDA is also considering formally evaluating each candidate opioid to determine how a novel opioid might fit into the therapeutic armamentarium that’s available to patients and providers. Further, the agency plans to continue evaluating the effectiveness of REMS programs for opioid products. In addition, Gottlieb stated the importance of supporting addiction recovery and reducing overdose deaths by prioritizing the use of MAT. Other FDA priorities for 2019 include research and innovation in non-addictive pain treatments, as well as strengthening enforcement against illicit opioids.

Pa. report finds manufacturer rebates
to PBMs inflate drug costs

This week, Pa. Auditor General Eugene DePasquale released a new report on how manufacturers’ rebates artificially inflate the prices people pay for prescription drugs. According to DePasquale, rebates can drive up the cost for prescription drugs by as much as 30%. Moreover, PBMs may be favor higher list price drugs with higher rebates on their formularies over lower priced alternatives. DePasquale made several policy recommendations to address this, including:

• The Pennsylvania General Assembly should mandate that pharmacy benefit managers receive a flat fee for service for providing administration of each prescription drug claim
• Congress should mandate that 100 percent of all rebates should go back to the third-party payer and mandate that health insurers pass along the savings to patients.
• Congress should consider revising the Social Security Act after determining whether the rebate percentages required for all medications should be altered or increased because the last mandated increase went into effect 10 years ago, in 2009.

This is the second report from the PA auditor in the last few months. In December, his office released a report which found PBMs were driving up costs in the state’s Medicaid program.

Ky. State Sen. clamors against the black box

Last week, NCPA shared this report out of Kentucky on PBM profits. As a follow up, this report was also highlighted by State Sen. Max Wise, who made an impassioned speech to his Senate colleagues, pointing out that PBMs took a minimum profit of $123 million last year, while seven pharmacies closed due to "pitiful reimbursements." He said Kentucky "was taken advantage of" by PBMs and warned that "this topic is not going away." NCPA appreciates the senator’s efforts in speaking out for taxpayers and against PBM abuse.

NCPA to attend NCOIL spring meeting

NCPA will be attending the National Council of Insurance Legislators (NCOIL) spring meeting in Nashville from March 14-17. One of the health committee agenda items is consideration of a resolution in support of amending ERISA to allow state policymakers to enact more meaningful healthcare reform. For those interested in attending the link to registration is http://ncoil.org/register-now/.

NCPA state legislative activity update

NCPA tracks state legislation related to our top three state priorities: Medicaid reform, scope of practice and compensation for services, and PBM reform and regulation. Click here for a report of bills that have been introduced so far this session specifically dealing with these three issue areas. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the attached report. Bills that have moved this week are listed at the top in the “Recently Updated” section.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.