Economic Protectionism Prevents Health Care Delivery Evolution

Pharmacists are ready to provide care and get paid for their services.

The COVID-19 pandemic has shown an ability, at scale, and willingness by pharmacists in community settings to schedule patients for services, such as infusions, testing, and vaccinations, and deliver them effectively, professionally, and safely. Many COVID-19 vaccinations have been performed at pharmacies. When given a choice, patients largely prefer going to a pharmacy to receive basic health services. Pharmacists are trained to respond to public health measures, such as prescribing treatment under standardized protocols and screenings. They are undisputedly the drug therapy experts, and pharmacies are an ideal setting of care for frontline health care service delivery and referral to behavioral health, primary care, and other care team members.

However, pharmaceutical manufacturer and provider policy and politics have long suppressed the pharmacist’s ability to use their 4 years of postgraduate training, often with an additional year or 2 of residency. “Provider status” is a long-sought after umbrella phrase for a host of door-opening service and professional sustainability provisions. Lack of said “status” is less about scope of practice and more about accessing insurance coverage. No honest physician or physician advocate believes that basic health care service assessment and delivery cannot be done effectively and safely by a pharmacist practicing in a community pharmacy. If so, they would be clamoring to put a host of OTC medications back on “legend” status, requiring a prescription from a qualified health care professional before one could purchase them. Athlete’s foot, dry eyes, heartburn, and of course, seasonal allergies all necessitate a diagnosis or self-diagnosis when accessing those products over the counter. Every day, pharmacists screen hundreds of thousands of patients for a brief intervention, and either refer them to a care team member or suggest treatment. Once upon a time, these treatments, now available over the counter, were inaccessible without seeing a prescriber at a physician’s office.

Uncurious Case Example

Loratadine was approved by the FDA in 1993. Hailed as the first truly nonsedating antihistamine with a nearly flawless adverse effect (AE) profile, it was destined to be a blockbuster drug. Because it did not cross the blood-brain barrier, it did not have many of the well-documented anticholinergic and sedation effects of diphenhydramine. Antihistamines remain a very widely used class of drugs, with estimates of 50 million Americans using them for allergies alone.¹

Upon loratadine’s initial FDA approval, patients were faced with a choice to continue to using their existing OTC antihistamine, with all its known AEs and dangers, or use a clearly superior, safer medication. But they would need to have an office visit, tell the prescriber they had been using antihistamines for years, get a prescription, go to the pharmacy, and wait to have it filled to finally achieve wakefulness. Then in 2002, the same year that loratadine came off patent, it miraculously became available over the counter. A regulatory requirement was no longer needed to get a prescription from a list of qualified prescribers, which did not and still largely does not include the experts trained for years in drug therapy. So the drug went from a highly restricted prescription-only medication to a product widely available with no restrictions at all and no requirement for health care provider input or monitoring in a single day. One day at patient needed a prescription, and the next day the patient could pick it up at a truck stop while asking the cashier for medication advice, thanks solely to the loss of patent protection.

Manufacturer and Provider Economics Drive Policy

More effective and safer diagnostic testing and medications continue to be brought to the market. And that benefits all of us if we can access them. Billions of dollars in upfront investments by manufacturers and taxpayers require a “what-the-market-will-bear” pricing strategy, segmented by ability to pay. A combination of perceived out-of-pocket costs, price sensitivity, and product value largely determines how and when devices and drugs are paid for when health insurance is in play. If an antihistamine costs $100 but a patient only pays $30 because of insurance coverage, the patient is more likely to purchase the medication, at about the same cost if it were available over the counter. Filing for an OTC approval and taking it to market while a drug is on patent would be an outlier from a regulator’s perspective and shows negligence of the highest order to the profit and loss statement of a manufacturer. Early OTC entry is also frowned upon by medical visit billers, who cherish those easy and quick patient visits that result in prescribing medications that should be available without prescriptions.

One of the nation’s major insurers, Anthem, made an unprecedented petition in 1998 to the FDA to move loratadine, along with 2 other nonsedating antihistamines, to OTC status. The insurer ultimately achieved its goal, only to have the manufacturers demur on producing the OTC-labeled product until patents ran out in 2002. Certainly, any health care professional of any type would look back at the period from 1993 to 2002 and question the requirement of a physician visit to get a refill authorization on loratadine, especially when the individual asking for that refill authorization is trained specifically in drug therapy and drug therapy maintenance after initial diagnosis.

PREP Act Benefits Pharmacists and Supervised Staff

We have learned lately that pandemics bring gaps in health care system infrastructure and policy into acute focus. Need billions of annual prescription fills to be made while an infectious disease is spreading in the community? No worries; pharmacies can do that effectively and safely. Need hundreds of millions of vaccinations administered over a few months? Pharmacies are up to the task. Need access points for widespread testing for COVID-19, influenza, and other ailments as the pandemic abates? Pharmacies are here. More infusion sites for monoclonal antibodies because of slow uptake from the conventional sites of care? On it. All these functions, whether conventional or unconventional, were supported or made possible by the Public Readiness and Emergency Preparedness (PREP) Act, countrywide and not through a mishmash of incremental state policy wins.

COVID-19 Testing Available At Home

Despite all the above, we found the economics of special interests rearing their ugly heads again during the pandemic’s early days. Initially, many states resisted the federal government’s use of the PREP Act and neglected to follow its authorizations for pharmacists to order testing and vaccinations, while testing manufacturers were in the process of applying to the FDA for home test and OTC use for their products. Curiously, none of the laboratories, medical providers, or states were against that.

Galling Case of Remote Therapeutic Monitoring

This brings to mind what is perhaps the most vexing coverage and qualifying provider policy about to ever take root. Remote Therapeutic Monitoring is a new service that covers “musculoskeletal system status, respiratory system status, therapy [medication] adherence, and therapy [medication] response” with billing codes (989X[1-5]) is be covered under Medicare as of 2022.² Clinical psychologists, nurses, occupational and physical therapists, speech language pathologists, and other practitioners will likely be able to bill for the service but not pharmacists.

Time to Engage Professional Associations

There is no more critical time to engage local, national, and state professional associations. All the gains made during the pandemic so that pharmacists could serve patients in their communities, providers on the care team, and public health may be lost when the PREP Act amendments are allowed to expire. Worse, the underlying trend provides a through line that ignores the pandemic and seeks to give everyone on the care team a role in optimizing medication use, except the pharmacist. Get out there and get active.

Troy Trygstad, PharmD, PhD, MBA, is vice president of pharmacy provider partnerships for Community Care of North Carolina, which works collaboratively with more than 2000 medical practices to serve more than 1.6 million Medicaid, Medicare, commercially insured, and uninsured patients. He received his PharmD and MBA degrees from Drake University and a PhD in pharmaceutical outcomes and policy from the University of North Carolina. He also serves on the board of directors of the American Pharmacists Association Foundation and the Pharmacy Quality Alliance.

References

1. Allergy facts and figures. Asthma and Allergy Foundation of America. Updated April 2021. Accessed November 16, 2021. https://www.aafa.org/allergy-facts/

2. Lacktman NM, Ferrante TB.CMS proposes new remote therapeutic monitoring codes: what you need to know. Foley & Lardner LLP. July 15, 2021. Accessed November 16, 2021. https://www.foley.com/en/insights/publications/2021/07/cms-new-remote-therapeutic-monitoring-codes