Fitting the bill: Pharmacy legislation tackles important issues
President Roosevelt’s signing of the 1938 Federal Food, Drug, and Cosmetic Act let the Food and Drug Administration establish category standards for the first time, protecting citizens from harmful ingredients.
Subsequent pharmacy legislation has also emphasized consumer safety, including potential drug risks. While these issues remain paramount, recent years have seen a greater focus on the need of the retail pharmacy itself, particularly when it comes to legislation impacting scope of practice and profitability.
At the state and federal levels, new and proposed legislation addresses issues like pharmacy
benefits management reform and pharmacists’ authority to prescribe and/or dispense certain medications, monitor health conditions and address other patient areas. The goal is to reach more patients, particularly the elderly and underserved, and increase profitability through expanded services, insurance reimbursement and elimination of PBM price gouging.
“I’m tracking about 200 bills,” said Neal Watson, member relations/government affairs director at the National Association Boards of Pharmacy. “Out of all those, the top five revolve around PBM reform, pharmacy practice acts, scope of practice, prescription drugs and hormonal contraceptives.”
[Read more: The Future of Pharmacy Care Coalition applauds intro of Senate legislation]
Emphasis on PBM reform has never been as intent as it is now. Legislation, in short, aims to regulate PBMs’ irregular pricing policies. Policies make reimbursements to pharmacies unpredictable, resulting in lower profits and, in the case of some independent pharmacies, business closures.
PBM Reform:
The PBM Transparency Act (S. 127): Introduced in January, it would prohibit PBMs from engaging in certain practices when managing prescription drug benefits under a health insurance plan. It would also prohibit PBMs from arbitrarily, unfairly, or deceptively “clawing back” reimbursement payments, increasing fees or lowering reimbursements to pharmacies.
Drug Price Transparency in Medicaid Act (S. 1038 & H.R. 1613): Proposed in April, this would improve transparency and protect taxpayers by preventing pharmacy benefit managers from using spread pricing in Medicaid managed care programs.
Prescription Pricing for the People Act (S. 113): Proposed in January, 113 keeps the pressure on the Federal Trade Commission to complete its probe into the role and recent merger activity of PBMs, including possible anticompetitive behavior.
Protect Patient Access to Pharmacies Act (S. 2052): Announced in June, S. 2052 provides reform of abusive business practices that have permitted the monstrous growth of pharmacy direct and indirect remuneration fees resulting in neighborhood pharmacy closures. The bill helps to secure Medicare patients’ freedom to receive medications and care from the pharmacy of their choice by improving enforcement of the “any willing pharmacy” law intended to prevent the exclusion of pharmacies from Part D plan networks.
“We’ve never seen so much congressional interest in PBM reform,” said Anne Cassity, SVP of government affairs, National Community Pharmacy Association. “Both patients and pharmacies are energized. Much comes down to contracts and leveraging PBMs, which represent 80% of covered patients. PBMs dominate all insurance markets, whether it’s Medicare, Medicaid or other insurance. Right now, these are take it or leave it contracts, with no negotiation room. If you don’t sign, you could potentially lose 30% to 40% of patients.”
The COVID-19 pandemic brought scope of practice to the forefront. Under the COVID-19 Public Health Emergency Act (which expired in May), pharmacists were authorized to provide immunizations and other services. This opened the eyes of legislators and the pulic to their value and capabilities. Today, key focuses in many states include allowing pharmacists to prescribe hormonal contraceptives, HIV Pre-Exposure Prophylaxis and Post-Exposure Prophylaxis and diagnosing and treating influenza and other common ailments.
Vaccinations and letting pharmacists monitor conditions like diabetes and high blood pressure are also priorities. Other legislation focuses on reimbursing pharmacies for corresponding consultative services.
“A big lesson learned during the pandemic is that pharmacy teams can do much to improve health care access,” said Chris Krese, SVP of congressional relations and communications, NACDS. “Americans look at the situation and say, `We benefited from pharmacy access and we don’t want to roll that back.’”
The list of recently passed and proposed legislation is long. In addition to laws affecting pharmacies, several states are supporting legislation that provides insurance reimbursement for OTC health care products. There is also hope that two federal bills legalizing CBD as an ingredient in food, beverages and dietary supplements will pass. But the prognosis looks grim, with the FDA accused of delaying the process.
[Read more: Pharmacy orgs laud DIR fee and pharmacy access bill as vital for PBM reform]
New York and other states are supporting bills that would ban sales of sports nutrition and weight management products to consumers under 18. Supporters contend products augment eating disorders; opponents disagree. Restrictions, they believe, would hurt sales and dissuade some retailers from offering products.
PBMs are a formidable force. Total revenue stands at $400 billion and is expected to reach $900 billion by the end of the decade, said Krese. Three PBMs (CVS/Caremark, OptumRx and Express Scripts) control 85% of the market. This near-monopoly allows these “middlemen” to secure large discounts from drug manufacturers.
The FDA has been reviewing PBM practices, but PBMs are crafty. For reform to work, it must be comprehensive and hard hitting. “PBM practices are taking a toll on patients and communities,” said Krese. “There’s tremendous momentum behind reform at the state and federal levels. Reform is needed across all payer segments, Medicaid, Medicare and private insurance. Our message to congress is that we need real reform and it needs to happen immediately. This can’t result in reform in name only.”
PBM practices seem shrouded in mystery, a mystery that must be deciphered. “The PBM Transparency act is a way to move a bit of the cloak of secrecy about how PBMs make money,” said Ed McGinley, partner, Pharmacy Management Consultants.
Another problem with PBMs are DIR fees or “clawbacks.” Often, more than 18 months after a pharmacy fills a Medicare prescription, payers retract money paid to pharmacies due to a pharmacy’s performance on unknown “quality” issues.
Clawbacks make profits unpredictable and erode the bottom line. “Your numbers aren’t what you think,” said Carmen A. Catizone, founding partner, CLM Pharmacy Advisors. “You think you’re making 20% gross profit and later you’re whacked with a clawback. Those watching the bottom line are seeing a slow profit drain. Down the road, how does this impact patient care?”
“PBMs do things that deprive patients of pharmacy freedom, making it possible for pharmacies to not be part of networks,” said Krese. “This means seniors may not have access to a pharmacy nearby or one they have a relationship with.”
[Read more: NACDS applauds Biden administration for extending “PREP Act” pharmacy access]
Mike McBride, VP partner relations at drug supplier Upsher-Smit Laboratories, believes this issue is crucial. “It’s no exaggeration that the future of retail pharmacy will be based on what happens with PBMs. Everyone needs to make a profit to remain in business. But these ‘middlemen’ have exceeded what’s fair.”
Reimbursement for Pharmacy Services:
Pharmacy and Medically Underserved Areas Enhancement Act of 2023 (S. 1491): Introduced in May, this bill would authorize Medicare payments for pharmacists who offer services like health and wellness screenings, immunizations and diabetes management in underserved communities.
Equitable Community Access to Pharmacist Services Act” (H.R. 1770): Introduced in March, 1770 would ensure access to essential pharmacist services for seniors and rural and other underserved populations, including testing and treatment for COVID-19, flu, RSV and strep throat and vaccinations for flu and COVID-19. Payment would be made under Medicare Part B.
If PBMs are blocked from overcharging one way, experts fear they will find another. “If you reform [payments] one way, they’ll need to come up with another way to replace that revenue,” he added. “When we think of priorities, it’s about sustaining patients’ access to pharmacy services so they have freedom of choice.”
Non-dispensing healthcare services allow pharmacies to create a revenue stream that could somewhat offset PBM costs—if they are reimbursed for consultations. Services can be vital for patients who cannot wait for a doctor’s appointment, have transportation limitations or live in rural or inner city areas with few doctors.
“Pharmacists aren’t always considered providers,” said Cassity. “We’re very interested in expanding the scope of practice so pharmacists are paid for non-dispensing services. Bills would provide greater access for patients.”
E. Michael Murphy, PharmD, MBA, Advisor for State Government Affairs at the American Pharmacists Association, said almost 90% of the population lives within 5 miles of a pharmacy. “Pharmacists are often the most accessible health professionals, particularly for vulnerable communities,” he added. “Services may help patients avoid more complicated, expensive care down the line, with patients ending up in hospitals.”
[Read more: Pharmacy orgs commend Senate intro of ‘Drug Pricing Transparency in Medicaid Act’]
In Iowa, for example, there are 223.6 physicians per 100,000 residents, indicated Becker’s Hospital Review. Massachusetts, in contrast, has 466 per 100,000. According to Seth Brown, director of public affairs for the Iowa Board of Pharmacy, 24% of Iowa is rural, making the bill particularly important. “There’s areas with shortages of medical professionals,” he added. “Pharmacists being reimbursed is critical. Much of this is about keeping rural pharmacies open and making sure they’re paid.”
Flex Spending for Supplements and Oral Care:
Dietary Supplements Access Act (H.R. 5214): If signed into law, consumers could use their pre-tax health savings accounts and flex spending accounts to purchase dietary supplements and oral care products. The bill builds off a 2020 bipartisan victory that expanded HAS and FSA eligibility to include OTC medicines and feminine hygiene.
Some services were rendered by pharmacists under the COVID-19 Public Health Emergency Act. Industry experts want to ensure access is ongoing. “Think of all the services they provided during the pandemic,” said Brown. “At the end of the day, we want to keep the focus on the patient and make sure access continues and expands.”
The Consumer Healthcare Products Association supports the bill. David Spangler, SVP of legal, government affairs and policy, said most people have flexible spending accounts as part of their insurance plans. He added that products would not have to be prescribed by a doctor to be covered. It is estimated that around 60 million people already use FSAs and HASs to save money on eligible healthcare.
To date, products containing CBD have not been legalized at the federal level. While they are legal in some states, a lack of federal guidelines governing ingredients and other product aspects has prevented large retailers and CPG suppliers from entering the category. Consequently, most suppliers are small, offering merchandise that is inconsistent in quality and performance.
CBD in Food and Supplements:
CBD Product Safety and Standardization Act of 2023 (H.R. 1628): Introduced in March, this bill would authorize regulation of interstate commerce with respect to food containing cannabidiol derived from hemp and for other purposes.
Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023 (H.R. 1629): Also proposed in March, 1629 would make hemp, cannabidiol derived from hemp and any other ingredients derived from hemp, lawful for use under the Federal Food, Drug, and Cosmetic Act as an ingredient in a dietary supplements and for other purposes.
“CBD is out of the barn,” said Steve Mister, president and CEO of the Council for Responsible Nutrition Foundation. “Millions of consumers use it. But they’re not sure how well-made products are. Consumers are fending for themselves. Large retailers won’t touch CBD because of the cloud of uncertainty. You also have big brands that want to get in the space but are staying on the sidelines. And hemp farmers can’t get rid of it because the market never took off.”
Many experts believe legislation will not pass any time soon because the FDA is stalling it. They pointed to a January announcement in which the FDA said that “existing regulatory frameworks for human and animal food and dietary supplements are not currently appropriate for the use of cannabidiol in those products.”
The agency determined that these uses of CBD raise safety concerns, especially with long-term use and for certain sub-populations, and that a new regulatory pathway is needed to provide safeguards and oversight to minimize potential safety risks that cannot be adequately managed under current food and dietary supplement regimes. The agency intends to work with congress to develop a cross-agency strategy for regulating such CBD products.
[Read more: Legislative Reform: Opportunities for action at both state, federal levels on issues important to retail pharmacy]
Eric Steenstra, president of Vote Hemp, called the situation “extremely frustrating.” He added, “since passage of the Farm Bill, the FDA has spent four years gathering information and studying this. I think the bills have little chance of passing. The FDA will try to stop them; they don’t support it. They’ll say there’s claims about liver toxicity. But Valid Care tested 1,000 people and found no toxicity.”
State Bills:
Pseudoephedrine Log Exchange: The National Precursor Log Exchange is a near real-time electronic logging and compliance system that tracks sales of OTC cold and allergy medications containing pseudoephedrine, which can be used to manufacture
methamphetamine.
NPLEx was developed to comply with the federal Combat Methamphetamine Epidemic Act enacted in 2006. Since then, NPLEx has been utilized by 38 states to comply with methamphetamine precursor legislation, as well as New York and California, voluntarily. NPLEx is available free to pharmacies in states that pass legislation mandating use.
Massachusetts S.1106: The bill would make the Commonwealth the 39th state in the country to adopt NPLEx as a means of governing all pseudoephedrine sales. CHPA supports this bill, which was introduced in February.
Mississippi S. 2282 was signed into law by Governor Reeves in March. This bill removed the “repealer” language within the existing NPLEx statute, allowing for NPLEx to remain in place into perpetuity.
West Virginia H.B. 3077 was signed into law by Governor Justice. The CHPA-supported bill removes sunset language from the state’s existing National Precursor Log Exchange law. Regulations will remain in place long term.
Passage of the two bills could revolutionize the CPG industry with big players getting behind major launches. “Major companies are salivating at the idea of adding CPG,” said Jonathan
Miller, general counsel, U.S. Hemp Roundtable and office partner-in-charge, Frost Brown Todd. “Colas, candy, chips and bottled waters would be prime targets. If legalized, the effect would be immediate. I hope congress develops a pathway to regulate CBD for dietary supplements, food and beverages.”
OTC medications containing pseudoephedrine are kept behind the pharmacy counter. Consumers must show identification to a pharmacist when purchasing them. When the 2006 law was passed mandating this, pharmacists complained that actions would take time away from other responsibilities since purchaser information must be logged and recorded.
In addition to feeding purchasing information into a national database, technology makes these OTC transactions “faster and more efficient,” said Carlos Gutierrez, VP, state and local government affairs at the Consumer Healthcare Products Association. “You just scan the ID, have the customer sign and they go.” Technology can be incorporated into POS systems.
Pharmacists’ ability to prescribe HIV PrEP and PEP should have a major impact on patients’ health. PrEP, which comes in pill and injectable forms, is meant to be taken before potential exposure. Since the first PrEP drug received approval from the Food and Drug Administration in 2012, it has made a major difference in HIV rates.
Chris Federico, PharmD, BCACP, president of the Rhode Island Pharmacists Association, said PrEP, if taken daily (oral form), reduces transmission by 90%. But time is of the essence. The post-exposure drug must be administered within 72 hours of contact to be most effective in preventing HIV. But it can be difficult to get a doctor’s appointment within this time frame.
“What if you don’t have a regular health care provider or can’t get an appointment?” added Federico. “What if it’s a Friday night or weekend? The other option is the ER, which increases overall health system costs. Pharmacists are much more accessible.”
HIV pre-/post-exposure prophylaxis:
Connecticut S.1102 expands pharmacists’ authority to administer vaccinations and codifies pharmacy technicians’ authority to administer vaccinations under the supervision of a pharmacist.
Signed into law in June, the bill also expands pharmacists’ authority to administer point of care tests and prescribe and dispense HIV pre-/post-exposure prophylaxis.
Rhode Island S. 563A guarantees no out-of-pocket costs to patients covered by health insurance plans for HIV PrEP and PEP. It also allows pharmacists to prescribe the drugs to eligible patients.
Arkansas H.B. 1007 will allow pharmacists to prescribe PrEP and PEP under a statewide protocol. Signed into law in March, it should help the Arkansas Department of Health achieve its goal of decreasing new HIV cases by 75% by 2025. The law also lets pharmacists initiate therapy and administer or dispense Naloxone, nicotine replacement therapy products and oral contraceptives.
A dozen other states allow pharmacists to prescribe HIV PrEP and PEP, sometimes under collaborative practice agreements. They include Illinois, Michigan, Minnesota, Montana, Nebraska, New Mexico, North Dakota, South Dakota, Tennessee, Vermont, Washington and Wisconsin.
Murphy believes the HIV PrEP and PEP bills are important steps in expanding scope of practice. “They’re being leaned on more to provide these preventative health care services, particularly in rural and underserved areas. Patients visit pharmacies more than any other health care setting.”
Today, 28 states let pharmacists prescribe hormonal contraceptives. About a half dozen joined the roster this year. The goal is to prevent unintended pregnancies by making birth control more accessible to women who do not want to wait for a doctor’s appointment, cannot afford to visit one or live in remote or inner city areas with few doctors. Pharmacists, on the other hand, are more plentiful and accessible.
According to the Centers for Disease Control, 49% of pregnancies are unintended. “This surprises many, but it points to the need to increase access to medications and reduce unintended pregnancies and associated health costs,” said Elise Barry, CEO of the New Jersey Pharmacists Association. A California study cited by the Center for American Progress found that 74% of respondents visited a pharmacist for contraception because it was faster than getting a doctor’s appointment.
Typically, pharmacists counsel patients before dispensing contraceptives by asking them a list of questions about health and lifestyle. Patients with compromising health conditions may be referred to physicians.
New laws expand scope of practice, but they also free up physicians. “This allows pharmacies to expand opportunities,” said McGinley. “When pharmacists started administering vaccines, it took a big load off physicians, along with the paperwork.”
[Read more: Invest in pharmacists to improve patient outcomes]
In 2016, Oregon was the first state that allowed pharmacists to independently prescribe hormonal contraceptives, said Catizone. Other states followed suit. It was this type of scenario that prompted Wisconsin to begin “pushing a bill” about five years ago, said Danielle M. Womack, MPH, VP of public affairs at the Pharmacy Society of Wisconsin. “It was brought to us by a legislator who’d heard about it in another state and thought it would increase contraceptive access.”
Hormonal Contraceptives:
Massachusetts H.B. 2133: Introduced in February, 2133 would require pharmacists to complete training approved by the State Board of Pharmacy related to prescribing hormonal contraceptive patches and self-administered oral hormonal contraceptives.
Rhode Island S. 103: This bill became law in June. It authorizes pharmacists to prescribe and dispense hormonal contraceptives, provided they complete a training program approved by the state board of pharmacy.
Wisconsin A.B. 176: Proposed in June, the bill would allow pharmacists to prescribe certain contraceptives.
Connecticut H.B. 6768: Signed into law in June, legislation lets pharmacists prescribe medications, medical devices, emergency contraception medication and FDA-approved hormonal contraception.
Indiana H.B. 1568: Legislation will allow pharmacists to prescribe and dispense hormonal contraceptives under a standing order and provides coverage for services by the state Medicaid program. The bill became law in June.
Maine S. 158 became law in June. It lets pharmacists prescribe and dispense hormonal contraceptives to patients who previously have been issued a prescription.
Nevada S.B. 161: Approved by the governor in June, SB 161 includes expansion of coverage by health plans of pharmacist-prescribed hormonal contraceptives.
New Jersey S. 275: Passed in January, legislation authorizes pharmacists to prescribe self-administered hormonal contraception pursuant to a standing order in accordance with protocols established by the New Jersey Board of Pharmacy and the State Board of Medical Examiners.
Vermont S. 37: Signed into law in May, S. 37 will allow pharmacists to prescribe emergency contraceptives pursuant to a state protocol.
Access is particularly important in Wisconsin’s many rural communities where “patients can
drive an hour to reach a clinic,” she added. It will also help people who cannot take time off to visit a doctor during working hours.
Access is also a big issue in New Jersey. That bill was sponsored by Sen. Shirley K.Turner, “who was concerned about access to women’s healthcare,” said Barry. Efforts coincided with those of other states, with the bill generating “quite a number of co-sponsors.”
In states where pharmacists have been prescribing contraceptives for some time, success has been mixed. Among Oregon Medicaid enrollees during its program’s first two years, 10% of all new oral and transdermal contraceptive prescriptions were written by pharmacists, indicated a study cited by Oregon Health & Science University. Most claims originated from retail chain pharmacies in urban areas. Almost 74% of patients receiving contraceptives had not used any form of prescribed birth control during the previous month.
But sans insurance reimbursement, pharmacy participation rates are low. “Expanding scope of practice can help create new or enhanced revenue streams and alleviate some third party [revenue] pressures,” said McBride. “Pharmacists can’t replace physicians, but there’s more they can do that patients can benefit from. Reimbursement is going to be the key piece. You cannot keep ratcheting down payment so it’s not worth it to pharmacists to provide patient services.”
Reimbursement was a key part of Rhode Island legislation, but “is not common in other states,” said Federico. Contraceptives, he added, will be part of enhanced curriculums at pharmacy schools and continuing education.
Removal of sales tax on OTC healthcare items makes these often necessary products “more affordable and increases consumer accessibility,” said Gutierrez. Despite benefits, however, most states have not removed taxes. “They get used to a revenue stream,” he added. “When times are good in state legislatures in terms of budgets, they’re more willing to consider at least a test pilot sales exemption for a few years.” Exempt products are FDA-regulated.
Not all new and proposed laws carry potential benefits to retailers and pharmacies. Several states have proposed bills that would age-restrict sales of OTC drugs and dietary supplements used for weight loss and muscle building. The contention is that products contribute to eating disorders. The bills have not made it very far in most places. In New York, however, the bill passed the state legislature.
Mister said there is no concrete evidence to back this accusation. “They’re pushing legislation saying products contribute to eating disorders and body dysmorphia. We recognize these are serious concerns. But they result from complex mental health issues, not these products.”
Findings published by The Strategic Training Initiative for the Prevention of Eating Disorders, based at the Harvard T.H. Chan School of Public Health and Boston Children’s Hospital, have given bills legs. But Mister said his group published its own study that found “nothing that would support the eating disorder hypothesis.”
If passed in New York, Mister said products would be placed behind counters, impeding sales. Some retailers might even exit categories. “It’s a big issue for us. We’re still hopeful we can persuade the governor to veto the bill. It’s been introduced in eight states. But New York is the only one where it’s gotten this far. To date, the sponsor has been unwilling to listen to us or have a meeting.”