Throughout the coronavirus disease 2019 (COVID-19) global pandemic, we have—rightly &mdash;seen an outpouring of support for frontline workers risking their lives for the benefit of others. Companies, schools, and community organizations have offered support through donations and free services. In New York and cities around the world, residents regularly cheered their 

 from their homes to thank them for their work addressing this crisis on the frontlines.

Pharmacists have been central health care heroes in the frontline fight against the spread of COVID-19. Throughout the pandemic, pharmacists have played a critical role in the COVID-19 response in several ways. These efforts include standing up mobile testing facilities, working alongside their colleagues to draft protocols and response plans, reinforcing messages about how to control the spread in their communities, providing curbside delivery, conducting virtual consultations, and compounding hand sanitizers.

Because they are trusted by patients, readily accessible in most American communities, and are highly skilled, pharmacists are vital to our COVID-19 recovery. However, unlike their acute and physician office counterparts, pharmacists’ legal capacity to assess, prescribe, and administer biological products varies from state to state.

For example, although pharmacists in all 50 states, Washington, DC, and Puerto Rico are permitted to administer vaccines, 

 the types of vaccines they can administer and restrict the types of patients they can serve. Furthermore, without provider status under Medicare Part B, pharmacies often 

experience hurdles obtaining reimbursement

 for emergency services provided during public health emergencies.

To effectively respond to COVID-19, our country is being asked to use all available health care resources to the fullest, which is why there has never been a better, or more important time, to grant provider status to pharmacists.

Fully leveraging pharmacists in COVID-19 response efforts

The Department of Health and Human Services (HHS) has 

recognized the important role that pharmacists will play in COVID-19 relief

. On September 9, 2020, HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP) 

authorizing state-licensed pharmacists to order and administer COVID-19 vaccinations

 to patients 3 years of age and older, preempting any state and local laws that prohibit ordering or administering vaccines.

In addition to vaccine administration, pharmacists can also help to relieve the strain on resources COVID-19 has caused if they are leveraged more fully. To preserve scarce hospital and acute setting resources, 

pharmacists should also have broad access to test for COVID-19

, as well as flu, strep and minor ailments.

 by several major pharmacy organizations, including APhA, NCPA, ASHP, AACP and others goes even further, advising that pharmacists should also be allowed to order testing, conduct and interpret results, counsel patients and initiate treatment for infectious diseases where appropriate. During a time in which every provider is a vital resource, more patients receiving these services at the pharmacy frees up physician offices and hospitals for more urgent care. Additionally, integrating pharmacists into direct patient care has been shown to improve patient outcomes across health care settings and disease states.

Ensuring that patients can access testing, vaccines and necessary care will be critical to public health. Unfortunately, a physician shortage was already in place prior to the start of the pandemic, a situation that has only become exacerbated by providers becoming infected with COVID-19 and/or an increasing caseload.

According to the American Association of Medical Colleges 2019 report, there is currently a shortage of nearly 

. There is also a significant number of patients living in health care “deserts,” where access to care is limited.

The National Center for Biotechnology Information states approximately 20% of the US population, more than 50 million people, live in rural areas whereas only 9% of the nation’s primary care physicians practice in these communities. Pharmacists are uniquely positioned to help address this need. Ninety percent of Americans live within 5 miles of a pharmacy and, through the use of telepharmacy, pharmacists can deliver care remotely to medically underserved areas.

Although pharmacists are valued community health care providers and their ability to improve outcomes as part of a patient’s care team has been proven, as of October 2020, only 

 allowed pharmacists to qualify as medical providers under the rules of Medicare Part B. Because of this, pharmacists face administrative barriers when seeking reimbursement for clinical services provided.

As was the case in past public US health emergencies, such as the H1N1 outbreak and Hurricane Katrina, pharmacies often experience financial burdens resulting from their response operations. In its 2017 report on public health and community partnerships, the Johns Hopkins Center for Health Security 

 that some pharmacies historically have been unable to obtain reimbursement from payers for emergency services provided outside of their normal authorized scope of practice. If 

pharmacists are permitted to order and administer COVID-19 vaccinations

, per the recent HHS guidance, they must also be permitted to make claims.

Additionally, the ability for pharmacists to participate in COVID-19 relief efforts varies widely across the country, because legal scopes of practice (SOP) vary. Before a pharmacist can legally provide services, their state must first authorize these services under its legal SOP. If they are granted Medicare Part B provider status, more pharmacists would be authorized to provide patients with an expanded set of services, reducing the current burden on other sites of care.

Currently, there are more than 40 pending pieces of legislation pertaining to provider status and the level of integration pharmacists should experience in the field. These range from bills about the prescription of hormonal contraceptives to the administering of COVID-19 injectable medications. Nonetheless, pharmacists were ostracized from the HEALS Act, the Senate’s $1 trillion coronavirus stimulus legislative package, excluding them from the expansion of testing and immunization.

 was issued by Scott J. Knoer, executive vice president and chief executive officer of the American Pharmacists Association proclaiming that, “Now is the time for an all-in push for the inclusion of temporary pharmacist provider status in Medicare Part B.” And he is 

At present, the National Association of Chain Drug Stores, the American Public Health Association, the National Community Pharmacists Association, and numerous other organizations are all working toward this common goal: to encourage realization of the viability of pharmacists as qualified providers.

The success of the eventual distribution and uptake of the COVID-19 vaccine with depend on the seamless coordination of manufacturing, delivery, and administration across all states and territories. Ensuring pharmacists are equipped and able to be adequately reimbursed for their services prior

to the release of the vaccine will be vital to this process, especially to ensuring that rural and vulnerable populations have access to the vaccine.

Pharmacists are already an integral part of the US health care system, providing invaluable guidance to their patients and advocating on their behalf, improving patient outcomes, improving efficiency, and reducing the cost of care. During this public health care crisis, pharmacists’ position as accessible and trusted community health providers will be vital to the success of our COVID-19 response and immunization effort.

In order to fully realize the potential of pharmacists to fill in gaps in care, address underserved populations, and relieve a health care system straining for resources, the time to grant pharmacists provider status is now.

Articles

The American Journal of Pharmacy Benefits

Throughout the pandemic, pharmacists have played a critical role in the COVID-19 response in several ways

The Importance of Provider Status for Pharmacists

We are all familiar with the patient assistance programs (PAPs) primarily sponsored by drug manufacturers or a partner organization and generally consider them a good thing for assisting patients with high out-of-pocket costs for expensive specialty drugs, especially in this era of high-deductible insurance plans.

Many health care systems have gone so far as to develop organized programs to connect patients with PAPs as a means of enhancing access to medications and reducing their financial burden. This is also potentially beneficial for the institution because it reduces bad debt. At my organization, we have a new job category called medication access specialists, who, among other things, are responsible for connecting patients to PAPs and helping families and patients navigate the sometimes confusing process. Therefore, at the micro level, this is a good thing.

Access to high-cost medications is increased, health care providers are insulated to some extent from unpaid bills, and patients reduce their out-of-pocket costs. In fact, to not participate in a PAP can be interpreted as overpaying for a drug, somewhat like paying the list price for a new car. Of course, the exclusion of governmental insurance plans is unfortunate because these patients are often the ones in greatest need of financial assistance.

So, what could be bad about PAPs? First, it is important to recognize that the funding of PAPs is a business strategy, a budgeted operating cost, and is essentially “baked in” to the overall pricing of pharmaceuticals. For many years, employers, payers, and pharmacy benefit managers (PBMs) have been developing benefit designs to incentivize patients and providers to make cost-effective treatment decisions. Through tiered co-pay and deductible structures, they are attempting to ensure that patients have inancifal skin in the game. Although the true success of these benefit design strategies is controversial, with some evidence that they may have detrimental effects on patient care and outcomes, they are intended to attempt to bend the curve on escalating costs of care. PAPs were primarily introduced to nullify the impact of benefit design on patient financial risk and assure providers that high-cost treatments will not be financially harmful to patients.

The intent is to promote newer, higher-cost treatment options. Given that the cost of PAPs is baked in, it is also a cost-shifting or subsidy strategy, where the expense of high-cost drugs is shared across all commercially insured beneficiaries. On a macro level, the use of PAP programs has the effect of increasing the cost of care for all. That is the bad part of PAPs, but the reality is, you need to participate or you are subsidizing someone else’s drug costs.

Things started getting ugly when “accumulators” and now “maximizers” entered the fray. Understandably, employers and payers do not appreciate that PAP dollars are being used by patients to pay down their deductible and maximum out-of-pocket expense while the plan experiences escalating pharmacy benefit costs because of these expensive agents. High-deductible plans often offer beneficiaries a lower contribution option by taking on some financial risk. If patients on high-cost drug therapy know they are not assuming that financial risk because of being able to use PAP money to eliminate their deductible, one could argue that the system is being gamed to some extent. In response, accumulator programs entered the arena. The accumulator programs offered by payers and PBMs essentially capture the dollars being contributed by PAPs and exclude them from being applied to patients’ deductibles and out-of-pocket maximums.

The employers and plans derive savings, because patients are still responsible for meeting their out-of-pocket deductibles. These changes have understandably been very unpopular with patients and patient advocacy groups, who perceive this as their insurer “stealing” the PAP dollars that are intended to reduce the patient’s financial burden, not the payer’s financial burden. This argument (logical or not) has gained traction, leading to legislation banning the practice in at least 4 states, and similar bills are being considered in many others.

In response to patient dissatisfaction and legal challenges to accumulator programs, the maximizer companies have emerged. And now things get murky. These appear to be commercial companies aligned with but not directly owned by PBMs. There are 2 important nuances relative to the operations of at least some of the programs. First, the patient using highcost specialty drugs is required to sign up separately for the maximizer benefit or face significant financial penalties (see explanation below). Second, the highcost specialty drugs included are defined by the payer as “nonessential health services” and can therefore be removed from the Affordable Care Act—required maximum out-of-pocket costs but are still covered by the plan. Essentially, a maximizer program sets the patient’s out-of-pocket contribution or co-pay for that drug at the maximum amount allowed by the PAP, divided across the year.

For example, if the maximum allowable on the PAP is $15,000 per year, the patient’s out-of-pocket cost will be $1250 per month. That is, the co-pay becomes very flexible, based on the dollars available from the PAP, and the company takes every dollar available. Thus, if the patient does not sign up to participate in the maximizer program, their outof- pocket cost would be $15,000 per year under this example, because it is their “co-pay” for a nonessential health service. Under the maximizer arrangement, the patient’s out-of-pocket cost for treatment is $0, so there is no contribution to the deductible or maximum outof- pocket cost from their drug therapy.

The ugly part of this is that the maximizer companies take a fee that can be as high as 25% of the maximum PAP amount. In the example above, that would be a fee of $3750 on the $15,000 PAP contribution. Therefore, 25% of the pharmaceutical company dollars intended to relieve the patient’s financial burden is now going to a for-profit company that frankly adds no value to the health care system. It is just another drain on the cost of health care. However, until all this nonsense goes away, employers and payers probably have no alternative but to play the game, or they will just be overpaying and subsidizing somebody else’s savings.

This punching and counterpunching between manufacturers, payers, PBMs, and other intermediaries is likely to continue in one form or another. Maximizer programs may lead to the dwindling or death of PAPs as we know them, but rest assured other strategies to nullify the management of expensive drug benefits will emerge from the industry...and then the other parties will identify countermeasures. It should be fun to watch, at least for those who enjoy bloody heavyweight slugfests.

Curtis E. Haas, PharmD, FCCP, is the chief pharmacy officer for the University of Rochester health care system in New York.

For many years, employers, payers, and pharmacy benefit managers have been developing benefit designs to incentivize patients and providers to make cost-effective treatment decisions.

Patient Assistance Programs: The Good, the Bad, and the Ugly

 the federal anti-kickback statute (AKS). For example, a kickback arises if a pharmacy pays commissions to a 1099 independent contractor marketing representative (individual or marketing company) that generates patients for the pharmacy who are covered by a federal health care program (FHCP).

In the durable medical equipment (DME) arena, kickbacks were alleged in Operation Brace Yourself. In this example, the DME supplier pays a lead generation company, which in turn pays a telehealth company, which in turn pays a telehealth physician, who in turn writes an order for a back brace, and the order subsequently goes back to the DME supplier that started the process.

Many lead generation and telehealth companies have left the orthotics space and have entered the genetic testing space. In this example, a genetic testing lab pays a lead generation company, which in turn pays a telehealth company, which in turn pays a telehealth physician, who in turn writes an order for a lab test, and that order goes back to the genetic testing lab that started the process.

Recent Department of Justice (DOJ) press releases address kickbacks in the pharmacy space. Here are some excerpts:

Three Charged in $180 Million Health Care Fraud and Money Laundering Scheme — 

“To…facilitate their scheme to defraud health care benefit programs, the defendants [owners of pharmacies] allegedly conspired to and engaged in a scheme to solicit and pay kickbacks and bribes to marketers, physicians, other medical providers, and beneficiaries to refer, prescribe, and receive prescriptions for medically unnecessary compound medications. The defendants also allegedly conspired to and engaged in a scheme to launder the proceeds of their fraudulent activity by concealing the proceeds they obtained and conducting monetary transactions of a value greater than $10,000, including the purchase of numerous assets, such as real estate, luxury automobiles, a three-carat diamond, and other high-priced goods. The charges announced…alleged schemes billing Medicare, TRICARE…and private insurance companies for medically unnecessary compounded medications.”

Four Florida Men Charged for Their Roles in a $54 Million Compound Pharmacy Kickback Scheme — 

“Four Florida men were charged in an indictment…for their alleged participation in a compound pharmacy kickback scheme…The allegations stem from the defendants’ participation in a multi-million dollar conspiracy to defraud TRICARE…The indictment alleges that [the defendants] owned and operated [a pharmacy] for the purpose of targeting TRICARE beneficiaries and causing the submission to TRICARE of claims for expensive prescription compounded drugs that were not legitimately prescribed because they were induced and procured by the payment of illegal kickbacks and bribes.”

Six Texas Pharmacy Owners and Marketers Charged in $14 Million Kickback Scheme — 

“Six Dallas, Texas-area pharmacy owners and marketers were charged in a superseding indictment…for their roles in a scheme involving compound drug claims to TRICARE and the US Department of Labor, the vast majority of which were the product of over $14 million in illegal kickbacks and bribes….The superseding indictment alleges that [pharmacies affiliated with the defendants] utilized the same marketers but paid them differently depending on whether they were receiving a commission on a federal or private prescription, in order to disguise the illegal kickback payments to marketers…for the referral of federal prescriptions. These marketers were allegedly set up as sham W-2 employees to appear as though they were bona fide employees.”

Pharmacies can derive 6 important lessons from these pharmacy takedowns:

1. Every Employee is a Potential Whistleblower 

If a pharmacy is doing something it should not be doing, then someone knows about it. That someone is usually an employee. Virtually all employees are aware of whistleblower lawsuits. If an employee witnesses fraudulent actions by their employer, then the employee may be motivated to gather information and then hire an attorney who specializes in filing whistleblower lawsuits.

The lawsuit will be in the name of the employee and also in the name of the United States. The lawsuit will be filed in federal court and it will “go under seal.” This means that no one knows about the lawsuit except for the government.

A civil Assistant US Attorney (AUSA) will review the lawsuit and will likely appoint agents to investigate the allegations set out in the lawsuit. This investigation may take 6 to 12 months. After the investigation is completed—or even if it is still ongoing&mdash;if the AUSA concludes that the whistleblower lawsuit has merit, then the DOJ will intervene.

This means that the DOJ will take over prosecuting the lawsuit and the employee (and his/her attorney) can pretty much “sit on the sidelines.” It is at this time that the lawsuit is unsealed and is served on the employer.

The lawsuit is based on violation of the federal False Claims Act. Normally, whistleblower lawsuits are settled, with the relator receiving 15% to 20% of the settlement proceeds.

If the civil AUSA concludes that the facts indicate that a crime was committed, then the civil AUSA will hand the file over to a criminal AUSA to determine if, in addition to the civil allegations set out in the whistleblower lawsuit, the DOJ wants to bring criminal charges against the employer. 

Most pharmacies understand that if they bill for a product not delivered—or deliver one type of product and deliver another type of product&mdash;then a false claim arises. Equally as important, however, is that if a pharmacy is engaged in a kickback arrangement, then claims that ultimately arise out of that arrangement are also false claims.

3. Products and Services That Are Not Medically Necessary

By analogy, let’s discuss the example of back braces in the DME space. For decades, Medicare beneficiaries got along just fine without back braces. And then beginning about 5 years ago, a huge number of beneficiaries received back braces.

Was this spike in demand driven by the medical needs of the beneficiaries—or was this spike driven by lead generation companies (LGCs), the DME suppliers that paid the LGCs, sham telehealth companies, and telehealth physicians? The answer is obvious.

The lesson for pharmacies is that if they aggressively enter a particular market, it is important that their business model be legally compliant. The bottom line is that if a pharmacy finds itself submitting a large number of claims for products and/or services that were not used very much in the past, the pharmacy will likely be subjected to scrutiny. 

4. Large Claims Submissions Invite Scrutiny

have edits in place that spot claims submissions that are “out of the ordinary.” Examples of out of the ordinary claim submissions are:

A pharmacy has a history of submitting claims at a historically established dollar level and for particular products. But then the TPP notices a spike in the dollar amount of claims submissions for a particular product.

A pharmacy submits a noticeably greater number of claims for a particular product category than other pharmacies. 

As the old Charles Schwab commercial used to say: “You can put lipstick on a pig, but it is still a pig.” This phrase applies to fraudulent arrangements. At the end of the day, a pharmacy cannot hide fraud.

The pharmacy may attempt to disguise the fraud, but eventually the existence of fraud will come out. This is true with sham clinical trials.

clinical trial can be one that is connected to a hospital, connected to a medical school, and/or overseen by an Institutional Review Board. A sham

clinical trial is one that is merely a subterfuge designed to funnel money to referring physicians. 

6. 1099 Independent Contractor Marketing Reps

The AKS prohibits a pharmacy from giving anything of value (eg, commissions) to persons/entities in exchange for referring patients covered by an FHCP, arranging for the referral of FHCP patients, or recommending the purchase of a product or service covered by an FHCP.

If a pharmacy pays commissions to 1099 independent contractor marketing representatives for generating FHCP patients, then the AKS is likely violated. The safest course of action is for marketing representatives to be bona fide employees of the pharmacy. A pharmacy can pay to a W2 employee marketing representative a base salary plus discretionary bonuses based on a number of factors.

Jeffrey S. Baird, JD, is Chairman of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers and other health care providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization, and can be reached at (806) 345-6320 or 

A kickback can arise if a pharmacy pays commissions to a 1099 independent contractor marketing representative who generates patients for the pharmacy who are covered by a federal health care program.

Lessons Learned From Kickbacks in the Pharmacy Arena

A national pay-for-performance program offered enhanced reimbursements to oncology practices for prescribing high-quality, evidence-based cancer drugs, and successfully increased prescriptions without significantly changing the total spending on care, according to a study published in the 

. This is the first study to demonstrate how a national insurer’s voluntary pay-for-performance program could successfully change prescribing patterns among oncologists, the study authors noted.

Investigators analyzed insurance claims data for patients with cancer between 2014 and 2017, which showed that a payment of $350 per month per patient to oncology practices when oncologists prescribed evidence-based cancer drugs increased prescriptions of those drugs by 5.1 percentage points. Nearly 1900 oncologists were included in the study as were more than 25,000 patients with breast, lung, or colorectal cancers across 14 states. Specifically, 62.2% of patients under the program received evidence-based drugs compared with 57.1% of patients not in the program.

“We know that prescribing evidence-based cancer drugs is high-quality care and increases both the length and quality of life for patients with cancer,” said co-lead author Justin E. Bekelman, MD, in a press release. “And yet, changing prescribing patterns has been and remains a big challenge. Based on what we found here, paying oncology practices to prescribe evidence-based drugs can serve as a valuable tactic to improve the quality of cancer care.”

Evidence-based cancer regimens have been shown to result in better outcomes, including longer survival and less toxicity, but not all patients receive these drugs. The study authors noted that pay-for-performance programs in health care have historically shown mixed results, but insurers have implemented these programs as a way to improve the quality of care and decrease cost growth.

In oncology specifically, spending is largely driven by the high costs of cancer drugs and is expected to reach more than $170 billion in 2020. There are currently very few programs to improve care or reduce spending in this sector, according to the study.

A 3-year evaluation of Medicare’s Oncology Care Model program, for example, showed no significant impact on spending or utilization or emergency departments, hospitalizations, or cancer drugs. The Anthem Inc voluntary pay-for-performance program, called the Cancer Care Quality Program, is the first and largest to show a significant increase in evidence-based prescriptions in cancer care, according to the study authors.

In addition to the increase in prescriptions, the authors found that overall spending did not significantly change, although the amount spent on oncologic drugs over a 6-month period increased from $48,030 to $51,369, and patient out-of-pocket expenses increased from $2217 to $2470. The investigators also found significant variability in cancer drug prescribing among oncology practices, in which physicians prescribed 402 unique drug regimens, although just 60 of those were evidence-based regimens in the program.

According to the authors, both of these findings highlight the need for more interventions.

“The cost of cancer care is too high, just like other areas in health care,” said senior author Amol S. Navathe, MD, PhD, in a statement. “This program is a much-needed example of an effective program—one that improved quality of care for patients. As we look forward, we need to build on the success of this program to design programs that also decrease costs.”

Enhanced reimbursement to oncology clinics increases prescriptions of evidence-based drugs [news release]. EurekAlert!; October 7, 2020. https://www.eurekalert.org/pub_releases/2020-10/uops-ert100720.php. Accessed October 13, 2020.

Financial distress and disruptions to work and social activities were significantly associated with depression and anxiety, as well as generally diminished psychological wellbeing.

AJPB November 2020

The Importance of Provider Status for Pharmacists

Patient Assistance Programs: The Good, the Bad, and the Ugly

Lessons Learned From Kickbacks in the Pharmacy Arena

Enhanced Reimbursement Increases Prescriptions of Evidence-Based Oncology Drugs