The National Association of Specialty Pharmacy (NASP) has scored several advocacy victories in the past year, including regulatory action aimed at preventing the growth of payor “claw-back” fees that threaten the financial viability and survival of pharmacies across the country.
Although these successes are to be applauded, “we need all specialty pharmacists who care about the future of this profession to get involved to address the needs of specialty pharmacies and the patients they serve,” said Julie Allen, NASP government afffairs advisor and principal at Powers Pyles Sutter & Verville, in Washington, D.C. Ms. Allen led a session on NASP advocacy and grassroots lobbying at the group’s 2022 Annual Meeting & Expo.
Lest anyone feels their sole voice carries no weight, “don’t underestimate yourself,” Ms. Allen stressed. “The key is to communicate not just how an unfair market practice affects your own pharmacy, but also the health of your patients, because those patients are in that legislator’s district and legislators care about their voters’ concerns and well-being.”
It’s also wrong to assume legislators are uninterested if there is no specialty pharmacy directly in their congressional district, Thomas Cohn, MS, Asembia’s chief strategy officer, noted during the session. Despite that absence, “you can be sure they have constituents who are being served by specialty pharmacy,” whether the patient receives prescriptions at home, via telepharmacy or other outside effort, he said.
Cuts in pharmacy reimbursement are a prime example of an issue that requires patient-centric messaging for legislators to make it a priority, Mr. Cohn noted. Payment reductions can put considerable financial pressure on a specialty pharmacy itself, but this problem may not resonate with a legislator or staffer who often is juggling the business concerns of multiple constituents. “Instead, if you help share a compelling story about one of your patients’ out-of-pocket costs being higher as a direct result of some of the same financial adjustments and payor policies, a legislator is far more apt to listen,” he said.
Ms. Allen agreed. “It’s incredibly important to personalize payment and other issues and ensure they are relatable for policymakers.”
Explaining How Pharmacy DIR Fees Hurt
Even something as complex as pharmacy direct and indirect remuneration (DIR) fees administered by plans and pharmacy benefit managers (PBMs) can be explained in a meeting with legislators and ther staffers based on their ultimate effect on patients. Still, it’s important to start these discussions with a bit of background. Payors claim the claw-back DIR fees, which can be assessed up to six months after a pharmacy fills a Medicare Part D prescription, are largely based on a pharmacy’s performance on quality measures. However, specialty pharmacies know this has been an excuse for collecting fees because there is a lack of transparency on how payors apply these measures, Ms. Allen noted. What’s more, “they are nearly always measures that are outside of a specialty pharmacy’s control.”
What is clear is the damage these DIR fees can wreak, she stressed. IQVIA estimated that in one recent three-year period, almost 2,200 pharmacies—many with specialty arms—closed nationwide because DIR fees forced them to ultimately provide drugs significantly below their acquisition cost.
“So, how does this all translate to a legislator’s constituents?” Mr. Cohn asked. “These fees and the financial pressures they bring can cut the number of employees you have, shift the drugs you are able to dispense and impact all of the patient care services you provide.”
These types of discussions, he added, are also a good opportunity to emphasize that patients should be able to use their pharmacy of choice when filling prescriptions and seeking medication management support.
There is another consequence of the DIR fee dance, the speakers noted. NASP has seen, in practice, that plan sponsors continue to opt for a higher negotiated drug price in exchange for higher pharmacy DIRs. This is important because these extra dollars above the plans’ bid go to the plans’ profit—and not back to the patient.
This dynamic has been shifted to a certain extent by a Centers for Medicare & Medicaid Services (CMS) Part D rule, finalized in April 2022, that included several reforms such as eliminating a regulatory loophole that has long allowed for the growth of pharmacy DIR fees through pharmacy performance metrics assessed after the point of sale, according to the speakers.
The new rule, which goes into effect in 2024, will allow patients to benefit from reduced cost sharing as a result of all fees being assessed at—versus after—the point of sale. NASP, along with other pharmacy societies and stakeholders, played a key role in getting these reforms included in the Part D rule. The effort represents “the first significant step” toward achieving DIR reform, Ms. Allen noted.
Tips for Becoming a Better Grassroots Advocate
The speakers offered several additional tips for specialty pharmacists who want to become involved in grassroots advocacy:
Keep informed. A powerful first step is to become educated about the most pressing practice issues that specialty pharmacists face. A great way to do that is to join NASP, the speakers noted. Members receive NASP’s updates on everything that the organization is doing on behalf of the specialty pharmacy profession, with a focus on government relations. The speakers also suggested joining the government relations committee to keep abreast of key issues.
Ms. Allen emphasized the value of the material sent in these alerts. “While we want you to stay informed, we don’t expect you to master all of the intricacies of the policy initiatives NASP is working on, and we certainly don’t expect everyone to memorize all of the facts. So we do our best to break down the key issues to help you make an informed, strong connection with whomever you are calling on.”
Can’t visit in person? Use form letters or emails. The speakers acknowledged that not everyone can find the time to visit their local congressperson, let alone make the trek to Washington. That’s why NASP’s government relations team developed several “plug-and-play” grassroots emails that specialty pharmacists can use to contact federal legislators and regulators about issues of concern.
“We try to make this extremely simple and user-friendly,” Ms. Allen said. “The email form allows you to self-populate a message, plug in where you’re from and personalize it a little bit, so that it’s very clear it’s coming from you. But the format ensures you’re still hitting all of the key advocacy issues NASP has identified. Then you hit send and it goes directly to the member of Congress or federal regulator it needs to get to.”
For some advocacy issues, the letters are targeted to legislators, the speakers noted. In other cases, they are drafted for regulatory agencies such as the Federal Trade Commission (FTC), given its oversight of anti-competitive business practices, or CMS, based on its actions on coverage determinations and other key reimbursement issues.
During a Q&A session, an attendee questioned whether form letters really carry any weight, since much of the content is repeated across multiple letters. “There definitely is power in numbers, even if some of the content overlaps,” Ms. Allen said. Agencies such as CMS and the FTC, for example, “more than appreciate how trade groups operate.” In the case of the Medicare Part D rule affecting DIR fees, “for something as complex, and with as much bearing, as this rule had on pharmacy, CMS looked for—and responded to—the incredible volume of advocacy that NASP and our other pharmacy partners generated.”
Meet with regulatory agencies. As noted, sending a form letter to these agencies certainly can help amplify NASP’s lobbying efforts. But in-person meetings are also key, with the FTC being a prime example, the speakers noted. They first reiterated the FTC’s mission: to protect the public from unfair, anti-competitive business practices. In the case of specialty pharmacy, vertical integration among the largest PBMs and specialty pharmacy providers has eroded the ability of specialty pharmacies to compete for contracts that are the life-blood of their business, the speakers noted. So the message that NASP has been relaying to the FTC—and one that can be amplified during grassroots meetings—is that without those contracts—without being in a preferred network—independent operators have to cancel prescriptions, they said. Those anti-competitive restrictions erode patient choice of where to get their prescriptions filled, they erode the patient-pharmacist clinical connection, and nobody wins except the big players.
Meet with legislative offices. Work to get to know your member of Congress and senators, whether that means coming to D.C. or meeting back home in state/district offices. It also can be helpful to have them visit your specialty pharmacy business.
Don’t understimate the value of meeting with congressional staffers. Can a junior staff person really influence the policy decisions of their bosses? That was another question posed during the Q&A segment, to which Ms. Allen responded, “Don’t discount the young ’uns!” These staffers often understand far more policy nuances than the elected officials for whom they work, she noted. Plus, “they have to report every meeting they have with constituents every week. They are also the ones heavily involved in finalizing legislative proposals and advancing their boss’s efforts. So your voice will be heard.”
Getting Heard on the Hill
It’s critically important to ensure that NASP’s voice is heard—an effort that works hand-in-hand with grassroots lobbying, stressed Sheila Arquette, RPh, NASP president & CEO. In a separate session at the NASP meeting, Ms. Arquette praised Ms. Allen and NASP member advocacy for getting the organization “recognized as a specialty pharmacy thought leader on Capitol Hill, with CMS and other federal agencies and the administration.”
Ms. Arquette cited the team’s success in getting the aforementioned DIR fee reforms included in the Medicare Part D final rule as a singular accomplishment. “This part of the rule, which as noted goes into effect in 2024, came at the urging of NASP after a decade of our calling for reforms and bringing an immense amount of pressure on Congress and CMS,” she said.
As this advocacy process unfolded, “we worked hard to remove the regulatory loophole that has long permitted the excessive growth of retroactive DIR fees.” But this wasn’t just a victory for specialty pharmacy’s bottom lines, Ms. Arquette stressed. These fees “force patients to pay more for their specialty medications under Part D, and our successfully lobbying for reform has resulted in reduced out-of-pocket cost for prescription drugs for Medicare Part D beneficiaries. So it all comes back to the patient.”
Author: David Bronstein