Pharmacy Practice Without the Affordable Care Act – Guest Writer Olivia C. Welter

The Patient Protection and Affordable Care Act (ACA) provided millions of Americans with access to health insurance. However, in today’s political climate with the recent confirmation of Amy Coney Barrett, there is a possibility that the ACA will get overturned in the near future. We know that this means tens of millions of Americans will lose access to their health insurance and hundreds more will lose access to basic consumer protections, but what does it mean for the profession of pharmacy? Our profession must begin to grapple with the implications if the ACA is overturned: the reduction in coverage for Medicare beneficiaries, increased threats to Medicaid funding and 340B, and significant impacts to the pharmaceutical industry.

Impact to immunizations

As a result of the provisions laid out in the ACA, preventive healthcare has become standard practice in healthcare. Repealing the ACA means that insurers would no longer be required to cover certain services with no cost sharing responsibility for the patient. This includes vaccines. One vaccine in particular that has had a heavy influence on community pharmacy is the influenza vaccine. If influenza vaccinations no longer have a zero-dollar copay at the pharmacy, many patients would likely opt out of getting the annual vaccine. For some independent practices, this loss could prove to be devastating. Flu vaccines bring in significant profits for pharmacies each year, and often this profit makes up for losses related to direct and indirect remuneration (DIR) fees and reduced reimbursement for prescriptions, both of which already contribute to why community pharmacies are struggling.

The numbers signify that the influenza vaccination rate in pharmacies has significantly increased in the years after this provision of the ACA was implemented; the 2012-2013 flu season saw 18.4% of adult patients receiving their vaccine at a pharmacy, and in the 2018-2019 early season pharmacies provided 32.2% of flu vaccines. Overall, the estimate for total number of adults receiving a flu vaccination in the early part of flu season was almost 10% greater in 2018-2019 than it was in 2012-2013. While there is not definitive evidence that the ACA is the only cause of increasing flu vaccine rates, it still demonstrates that 10% of adults in the United States, or nearly 21 million people, put themselves and those around them at lower risk of severe flu disease in the years after the ACA went into effect.

Note from the TGP: Given the nature of the global health pandemic, we wanted to remind all readers how it is especially important that you receive the flu vaccine this year. With many public health experts warning that the coming months will be dangerous, please take the necessary steps that you can take to protect not only your health, but that of the people around you as well.

It would be in insurers’ best interest to continue covering vaccines as they have been, but if the ACA is overturned, they will have the ability to decide whether or not their covered patients will receive necessary vaccines at no cost. If we do end up seeing this shift, community pharmacies may face yet another barrier as a result of patients choosing to forgo the vaccine because of the copay.

Impact to MTM

In addition to immunization programs, community pharmacies provide Medication Therapy Management (MTM) services as a way to ensure proper medication outcomes and improve revenue. In general, MTM is known to contribute to cost savings as well as improved patient outcomes. One study showed that pharmacist-provided MTM services resulted in 12% fewer hospital admissions per 1,000 patients. There are many different aspects of MTM, but Comprehensive Medication Reviews (CMRs) often generate the highest payment for pharmacies relative to other MTM services offered.

As part of the ACA, Part D plans are required to cover an annual CMR for targeted beneficiaries. These CMRs are responsible for a significant amount of interventions among a high-risk patient population and help bring additional revenue to the pharmacy. In 2019, 73% of plans targeted only the patients that met minimum requirements, while only about 27% of plans offered expanded eligibility to include more beneficiaries in MTM efforts. This shows that nearly three-quarters of Part D plans are only willing to cover what is absolutely necessary when it comes to MTM. If requirements put in place by the ACA no longer remain, these plans may revert back to covering only the requirements established in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Unfortunately, this would leave out the annual CMR requirement among other fundamental MTM standardizations.

Furthermore, some pharmacists are employed exclusively to provide MTM services. These changes could potentially lead to fewer jobs for pharmacists. We all know how concerning the existing job market is for the profession, and a loss of positions in MTM practice only exacerbates the issue. While it is possible that insurers recognize the value of MTM services and may continue to provide MTM coverage as usual, there are no guarantees. Therefore, pharmacies and patients must be prepared for these hypotheticals to become reality. 

Impact to 340B

Medicaid expansion was a controversial yet key component of the ACA. A larger Medicaid coverage population meant that more public hospitals were able to meet requirements to enroll as 340B covered entities, specifically as disproportionate share hospitals (DSHs). Patients receiving Medicaid are a crucial factor in the calculation for DSHs to be eligible for 340B drug discounts. These savings are vital in order to maintain financial stability of safety net hospitals providing care to a disproportionately low-income population. DSHs are just one of many covered entities eligible to enroll in 340B, alongside children’s hospitals, community health centers, critical access hospitals, and more; the list of covered entities was expanded as part of the ACA, allowing for even broader access to 340B pricing and subsequent savings.

Thanks to the Medicaid expansion provision implemented by the ACA, the number of DSHs enrolled in 340B nearly doubled between 2005 and 2014. This increase allowed  lower-income patients to better access health care services. Recently, we’ve seen attacks on the 340B program by drug manufacturers, specifically through their refusal to provide the 340B discounted prices to 340B covered entities partnered with contract pharmacies. While financially vulnerable patients are caught in the middle of these 340B attacks, they are also the ones who will be affected should Medicaid funding be cut.

With the repeal of the ACA, federal funding for Medicaid programs would almost certainly be reduced; states may be limited to receiving block grants or per capita caps as their only form of funding from the federal government. Less funding leads to less patients covered under state insurance. Reversing Medicaid expansion foreshadows the reversal of 340B enrollment, and as a result fewer pharmacies will be entered into contracts to provide outpatient medications for patients treated within a 340B facility. The cumulative effects of slashed Medicaid funding and gatekeeping of 340B savings alludes to worsened outcomes for both patients and pharmacy practice.

Impact to the pharmaceutical industry

While direct patient care settings have seen the most positive change in response to the ACA, the pharmaceutical industry experienced a key success as well. With the passage of the ACA came the Biosimilars Price Competition and Innovation Act (BPCIA). Biologics are incredibly complex drugs, and thus, incredibly expensive. Though their pivotal role in the treatment of diseases, including cancer, has proven lifesaving for patients, their use can take a significant financial toll on patients and payers. BPCIA offered an incentive for the development of biosimilars – an abbreviated application process. Because of this process, manufacturers are able to develop biosimilar drugs at reduced costs compared to their respective reference biologic products.

BPCIA will no longer exist if the ACA is overturned, which would unravel an intricate framework that guides the biosimilars industry. Industry leaders expressed concerns after each time Congress tried to invalidate the ACA. If BPCIA is rescinded as part of the ACA decision, biosimilar approval would be halted, and entirely new legislation would have to be enacted in order for it to resume as usual. One industry executive even noted that this decision would ensure patients losing critical access to both biosimilar medications and prescription drug benefits.

Conclusion

The bottom line is that the ACA brought many positive changes to the pharmacy world, and its impact will perpetuate regardless of how the Supreme Court rules. Accountable Care Organizations and Patient-Centered Medical Homes are likely to remain even if the ACA is overturned, and these provisions are hugely beneficial to patient care. As a profession, we must remain active advocates in order to ensure pharmacists continue to provide quality patient care. Contact your legislators and remind them how the integration of pharmacists into care teams has led to health successes for patients over the lifespan of the ACA. Keep up with advocacy efforts stemming from professional organizations so that in the event the ACA does get overturned, we have an opportunity to push for new language in the next healthcare reform package. Though the future of preventive services, MTM, 340B, and biosimilars remain in limbo, we’ve learned important information about the impact that the ACA has had on patients and the profession of pharmacy, and we can carry that knowledge into impending discussions surrounding healthcare reform.