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What happens next in health care depends largely on COVID-19, especially in light of the breaking news that the President has been diagnosed with COVID-19. And then, of course, on the 2020 presidential election itself.
Scope of practice and vaccination authority don’t usually grab much public attention. But when the US Department of Health & Human Services (HHS) preempted state practice acts to allow all pharmacists to order and provide coronavirus disease 2019 (COVID-19) tests and provide routine pediatric immunizations, the profession hit the headlines. What happens next in health care depends largely on COVID-19, especially in light of the breaking news at press time that the President has been diagnosed with COVID-19. And then, of course, on the 2020 presidential election itself.
Presidential candidates regularly trade barbs on access to care, drug pricing, health insurance, and similar issues. But exactly how the 2 candidates, President Donald Trump and Joe Biden, might address health care issues is murky.
As vice president during the Obama administration, Biden was a strong supporter of the Affordable Care Act (ACA). As a candidate in 2020, he has called for broader access to health care and a national, science-based approach to the COVID-19 pandemic. Biden routinely wears a face mask in public and has called for a national policy favoring masks to reduce COVID-19 transmission.
As president, Trump has repeatedly criticized the ACA. When legislative attempts to derail ACA failed, the administration tried legal challenges. The Supreme Court will hear arguments to block the ACA in November.
On the COVID-19 front, the administration has taken contradictory positions. Trump has largely left pandemic response up to the states and said at the debate between he and Biden at the end of September, held days before this positive COVID-19 diagnosis, that he thinks masks are "ok," and that he wore them when thought they were needed. However, he has rarely appeared in public wearing a mask. At the same time, HHS has overruled states to expand the scope of practice for pharmacy, medicine, and other health care professions nationwide under the Public Readiness and Emergency Preparedness (PREP) Act.
Trump also appointed a science-heavy COVID-19 task force headed by veteran clinicians and Washington insiders Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and Deborah Birx, MD, global AIDS coordinator for the US Department
of State. However, he has derided both Fauci and Birx while touting purported miracle cures including hydroxychloroquine and convalescent COVID-19 plasma.
Key Pharmacy Issues
The clear contradictions in administration responses to COVID-19 leave pharmacists, and everyone else, with more questions on health care policy in 2021 than answers.
“We are asking all the candidates about their positions on pharmacy issues, and we don’t have clear answers yet,” said Michael Jackson, RPh, executive vice president and chief executive officer of the Florida Pharmacists Association. "We do know that the status quo can't remain. We have got to change dramatically."
Change should start in the pharmacy supply chain and payment models, Jackson continued. Both presidential candidates, as well as other candidates up and down the ballot, have to recognize that pharmacy is not a cost center, but a cost container. Current payment models are driving pharmacies out of business.
Independent pharmacists have been complaining about direct and indirect remuneration (DIR) fees for years. More recently, chains and hospitals have added their objections.
“It’s pretty dire when you get the entire pharmacy industry to stand behind one issue,” said Brian Caswell, RPh, president of the National Community Pharmacists Association (NCPA) and owner of 4 pharmacies in Kansas and Missouri.
“DIR fees mean that on a quarterly basis, you have somebody reach into your bank account and pull a big chunk of money out, which totally disrupts your budget [and your] plans
to improve your business [and] make capital investments so you can step up and do a better job of taking care of your patients. Everyone is being hurt by DIR fees, including patients.”
Caswell noted that one of his stores lost $100,000 to DIR fees in 2019. That kind of unpredictable loss made him reconsider a $200,000 automated multidose strip-and-pouch packaging unit that could help meet strong patient demand for drug packaging to ease adherence. No one knows how the next president might approach DIR fees.
“We have a president [whom] we know a little bit about related to pharmacy issues, and we have a candidate who wasn’t big in the pharmacy space in his previous elected positions,” said Karry La Violette, advocacy center director and senior vice president of Government Affairs for NCPA. “We have a lot of unknowns with Biden, but he wouldn’t be a hard sell. We know what we are getting with the Trump administration, sometimes unpredictable, but we know where they’re coming from.”
By the end of both parties’ conventions, neither candidate had staked out positions on DIR fees, pharmacy benefit manager (PBM) regulation, drug pricing, scope of practice, the 340B drug pricing program, or other key pharmacy issues. Neither the Trump nor Biden campaigns responded to repeated information requests for this article. But the two have very different perspectives on how health care should be delivered.
“You could have a President Biden focused on public options,” explained Tom Krause, JD, MHS, vice president of Government Relations for the American Society of Health-System Pharmacists (ASHP).“You could have a President Trump preserving some selected aspects of the ACA but overall oppos- ing it. Trump has a preference for a very state-based approach to managing response to the COVID-19 pandemic. Signals we’re seeing from Biden would be a more nationally focused response. Those are fundamental contrasting visions of health care.”
Learning From COVID-19
If current trends continue, more than 200,000 Americans will have died from COVID-19 by election day on November 3. There are endless, unsolvable arguments over how many deaths might have been avoided had the federal government taken a different approach to the pandemic. But from the health care perspective, the pandemic has brought a few positives changes.
When the federal government declared a public health emergency on January 31, HHS was able to make sweeping changes to the provision of and payment for health care services under the PREP Act.
HHS authorized physicians and other clinicians to practice in states in which they were not licensed under some circumstances and allowed pharmacists to order and administer COVID-19 tests. HHS later authorized pharmacists to provide point-of-care testing for influenza and COVID-19, expanded pharmacists’ authority to provide pediatric immunizations, and adapted reimbursement mechanisms to pay pharmacists directly for some COVID-19–related services.
“With the pandemic, pharmacists and pharmacies have been able to work as providers,” said Ilisa Bernstein, PharmD, JD, FAPhA, senior vice president of Pharmacy Practice and Government Affairs for the American Pharmacists Association (APhA). “There have been a lot of flexibilities and gains that have been achieved for pharmacists and for patients during [COVID-19]. In the next administration, whether it’s the same party or a different party, we’re going to watch and push for those flexibilities and gains to be maintained [and] move to further gains that can continue to make a difference in patient care.”
The problem is that COVID-19– related improvements in patient care all depend on the public health emergency. Once the emergency expires, state regulations take over. And not all states changed their regulatory approaches.
“There have been national mandates, but the actual changes to practice acts have not been uniform,” said Ken Thai, PharmD, president of the California Pharmacists Association and chief executive officer of 986 Pharmacy Corporation. “The next administration needs to get rid of the barriers, the handcuffs, to allow everyone to pitch in as part of the provider team—nurses, doctors, pharmacists— to give patients the best possible care and the best possible outcomes.”
Provider status has been on the pharmacy wish list for years. Bipartisan provider status legislation has been introduced in Washington but has never moved out of committee. California pharmacists gained provider status in 2014.
“Even 6 years later, recognizing that if we perform a service, we need to get paid for it, hasn’t happened to the extent that we have been able to unleash pharmacists’ true powers to help their patients,” Thai said. “With DIR fees, pharmacists are paying to provide services because there is negative reimbursement because of actions taken by the PBMs. I’m hoping this election highlights what we have been doing and the outcomes we have provided. For too many people, we haven’t just been the most available health care provider, we have been the only provider because so many physician practices were closed or limiting visits.”
None of these changes will happen on their own. Political candidates don’t respond to stakeholders they don’t hear from. Pharmacists have to make their own case, time and again, until change happens.
APhA, ASHP, NCPA, and other pharmacy groups are lobbying both candidates, Krause said. ASHP has pointed out that a public option for health coverage has the potential to increase covered populations. That could expand government negotiating power when it comes to issues such as patient access and drug pricing.
APhA is emphasizing the improved patient outcomes that pharmacists and pharmacy have produced from the expanded flexibility and practice that authorities put into place during the pandemic.
Caswell at NCPA is pushing the need for pharmacists to speak individually as well as through their organizations.
“We have a pandemic that has become political, and pharmacists have to get involved,” Caswell said. “A Republican mantra for a long time has been local control. And a Democratic mantra has always been patient choice. That’s a perfect combination of working with the patient-provider decision-making process and we pharmacists have to be part of that discussion. Pharmacists have to speak their mind, talk to every one of their candidates at the local, state, and federal levels, [and] utilize their contacts to get our message out there. If we can move our solutions, our personal relationships with patients, to be unencumbered by the payment system, we’re going to see better outcomes, happier patients, and happier pharmacists.”