Westside Family Healthcare Issues Public Comment on Health Resources & Services Administration Proposed Rule

WASHINGTON, July 27 -- Lolita A. Lopez, president and CEO of Westside Family Healthcare Inc., Wilmington, Delaware, has issued a public comment on the Health Resources and Services Administration proposed rule entitled "Proposed Rescission of Executive Order 13937; Access to Affordable Life-saving Medications". The comment was written and posted on July 16, 2021:

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Westside Family Healthcare, Inc. (Westside) is the largest Federally Qualified Health Center (FQHC) in Delaware, receiving federal grant funds under Section 330 of the Public Health Service Act. To give you an understanding of our role as an essential health care provider and the value of the 340B program savings to our patients and our operations, first let me provide some background on our organization and the communities we serve.

Established in 1988, Westside grew rapidly over the years from a two exam-room health center in a small Hispanic neighborhood on the west side of Wilmington to five health center delivery sites and a mobile health unit caring for more than 27,000 patients in underserved areas of Delaware. The health centers are located across the upper half of the state, in Wilmington, Northeast Wilmington, Newark, Bear, and Dover. We are a Joint Commission-accredited health center organization and are also certified as a Primary Care Medical Home. Westside is an essential health care safety net provider with a mission "to improve the health of our communities by providing equal access to quality health care, regardless of ability to pay." Westside provides primary medical, prenatal, dental, and behavioral health care services, as well as comprehensive support services that reach beyond conventional medicine to address the social, emotional, and economic factors that can adversely affect health outcomes. These services include disease management and prevention, social services, care management, low-cost medication programs, enrollment in sliding scale or insurance programs, on-site contracted laboratory services, 24-hour provider on-call service, interpretation for patients with limited English proficiency or hearing disabilities, an online patient portal, community educational outreach, and health education classes.

In 2019, Westside provided 93,328 patient visits for 27,754 patients. The overwhelming majority of Westside's patients face severe economic barriers to accessing healthcare services. In 2019, 48% of Westside's patients were at or below 100% of the federal poverty guideline (FPG), and the income of 86% of patients was at or below 200% of the FPG. Additionally, 29% of patients were uninsured, 48% were enrolled in Medicaid or Medicare, and only 23% were privately insured. While 23% of patients have private insurance, many remained underinsured with high deductibles forcing privately insured patients to enroll in Westside's sliding fee scale and self-pay. Its sliding fee scale makes Westside one of the few affordable, high-quality health care providers for uninsured patients in Delaware.

In addition to economic barriers, Westside's target population also faces racial and ethnic barriers to care. In 2019, 46% of patients were of Hispanic/Latino origin. During the same year, 33% of patients identified as African American, 51% identified as White, 3% of patients identified as Asian, 6% of patients identified as more than one race, and 7% refused to report their race. Furthermore, 41% of patients were best served in a language other than English, with most requiring Spanish interpretation services.

As you are aware, FQHCs have played a vital and indispensable role in support of the COVID-19 response across the nation over the past year and a half. Westside is no exception. Through close, ongoing collaboration and partnership with Delaware Division of Public Health (DE DPH), other local health care organizations, and numerous community organizations, Westside has been at the forefront of developing and implementing a range of pandemic response activities, most importantly the provision of timely and accessible COVID-19 testing and vaccination, for both our patients and non-patients, at our health centers and out in the community. Furthermore, when DE DPH recognized that typically underserved populations were being vaccinated at lower rates, perpetuating inequities, Westside stepped up even further with an intensive "MaxVax" initiative, providing rotating days for walk-in COVID-19 vaccination at each of our sites to provide greater access for these populations. We have also had to simultaneously adjust our own normal operations, with infection prevention and control measures and the addition of telehealth services, to provide a safe and effective environment for our staff and to provide continuity of care for our patients. These times have been challenging, but it has also been highly fulfilling and consistent with our mission for Westside to support the community during such an unprecedented time of crisis.

Finally, Westside Family Healthcare is a "covered entity" for purposes of the 340B Drug Pricing Program. Westside is qualified to participate in HRSA's 340B Drug Pricing Program as a covered entity because it is an FQHC. We have held covered entity status for two decades and are therefore fully familiar with the program. The value of this program in terms of providing substantial savings for our patients and our organization has been tremendous.

Support for Rescission of Executive Order 13937

Westside Family Healthcare strongly supports HHS' proposal to rescind the Final Rule entitled "Implementation of Executive Order on Access to Affordable Life-Saving Medications", and retract the related requirements for awarding new grants under section 330(e) of the Public Health Service Act. We appreciate the opportunity to comment on rescinding this regulation, and to highlight health centers' existing and continued commitment to provide affordable medications to underserved populations.

In brief, Westside Family Healthcare supports HHS's proposal to rescind the final rule for the following reasons:

1. The Final Rule would reduce access to care for underserved populations, which is contrary to the intentions of the health center program. Implementing the rule would lead to significant administrative burdens and costs for health centers, reducing available resources to support critical services for all their patients - including those who use insulin and injectable epinephrine.

2. The Final Rule's definition of "low income" as persons below 350% Federal Poverty Guidelines (FPG) is inconsistent with every known Federal program, and this new definition significantly increases the administrative burden on health center staff and reduces the resources health centers devote to general patient care.

3. If implemented, the Final Rule would require health centers to divert critical resources away from vital COVID-19 pandemic response efforts across the country.

4. If implemented, the Final Rule would only improve access for a small population of patients, and health center services would drastically be reduced given the increase in administrative costs and loss of 340B savings.

In addition, Westside Family Healthcare urges the Biden Administration to revoke the "Executive Order on Access to Affordable Lifesaving Medications", on which this Final Rule was based.

We now discuss each of these topics in detail.

The Final Rule would reduce access to care for underserved populations, which is contrary to the intentions of the health center program. Implementing the rule would lead to significant administrative burdens and costs for health centers, reducing available resources to support critical services for all their patients - including those who use insulin and injectable epinephrine.

Westside Family Healthcare commends the Biden Administration for recognizing the valuable role health centers play in ensuring access to affordable primary, preventive, dental, behavioral health, and pharmaceutical services for medically vulnerable populations. We support HHS's proposal to rescind the final rule because, as stated in the NPRM, health centers would need to "absorb significant additional cost, time, and ongoing support staff to create and maintain new reporting, monitoring, technical and administrative re-engineering, staff training, and workflow re-designs to assess eligibility for patients to receive insulin and injectable epinephrine consistent with the final rule". Examples of this added administrative burden include:

* Determining in real time whether a patient has a high remaining deductible - a process that is particularly complicated given delays in medical billing and claims processing

* Adjusting the charge for qualifying patients for every form of insulin and EpiPen every quarter, when the 340B price changes

* Keeping Third Party Administrators, contract pharmacies, and other pharmacy partners abreast of and compliant with new charges, eligibility rules, etc.

Based on HRSA's estimate, implementing the Final Rule would require each health center organization to hire one additional full-time equivalent (FTE) eligibility assistance worker at approximately $50,000 annually. Westside Family Healthcare strongly maintains that a full-time FTE would have a more meaningful positive impact on patient access by focusing on existing efforts, such as helping patients apply to pharmaceutical manufacturers' Patient Assistance Programs, and connecting them to enabling services in the community.

The Final Rule's definition of "low income" as persons below 350% FPG is inconsistent with every known Federal program, and this new definition significantly increases the administrative burden on health center staff and reduces the resources health centers devote to general patient care.

Westside Family Healthcare also supports rescinding the Final Rule because of multiple issues resulting from the definition of "low income" as individuals with incomes at or below 350% FPG:

This definition further exacerbates the administrative burdens that the Final Rule would create.

Health center program rules require providing sliding fee discounts to all uninsured and underinsured patients with incomes below 200% FPG. By defining low income as below 350% FPG, significantly higher than any other Federal program, every health center in the country would have to implement new policies and procedures to establish "new, distinct, and higher 'low income' thresholds" applicable to only two types of drugs, and then create new billing procedures for these drugs. Due to this narrow focus, it would be extremely burdensome for health centers to determine eligibility before a visit without an in-depth medical assessment. Instead of health center staff screening every patient for income eligibility, staff would have to focus on if the patient will need insulin or injectable epinephrine before assessing income status. Traditionally, the health center staff that determine income eligibility have limited medical training and usually do not have access to patients' Personal Health Information. HHS should not require health centers to implement new policies and procedures that would require patients to share more personal information than necessary with non-clinicians.

This definition would reduce the amount of 340B savings that health centers could retain on insulin and EpiPens, which would impact critical services that all patients, including those who use insulin and EpiPens, receive at their local health center.

Altering the definition of "low income" would also jeopardize health centers' ability to retain 340B savings. This is because insurance contracts generally prohibit health centers from billing them any more than their "usual and customary" (U&C) rate for each specific drug. To date, several insurers have argued that the discounted rates that health center charge an uninsured or underinsured patient below 200% FPG should qualify as their U&C rate, and therefore should be the maximum they bill the private insurer. Fortunately, health centers have been largely successful in pushing back against these claims, by pointing out that long-standing program rules requires them to provide discounts off their regular rates to persons below 200% FPG. If HHS does not rescind this Final Rule, it would be very difficult for health centers to argue that the 340B price is not their U&C, as very few cash patients would not qualify for the 340B price. As a result, this would transfer the benefit of the 340B savings from the health center to the insurers. If health centers are forced to give up 340B savings on insulin, that would have a significant impact on their finances, and ultimately their ability to provide comprehensive primary and preventive care for all patients, regardless of a patient's ability to pay.

The Final Rule would require health centers to divert critical resources away from vital COVID-19 pandemic response efforts across the country.

Westside Family Healthcare appreciates HHS acknowledging the countless hours health centers have devoted to responding to the COVID-19 pandemic and the undue burden the final rule would place on health centers. Health centers have been on the ground in force for over a year, fighting the spread of the virus in hard-to-reach communities, including communities of color and among special populations. While mass COVID-19 vaccination sites continue and vaccinations are being incorporated into routine or other clinic visits, health centers are reaching deep and wide into their communities to ensure they are equitably distributing vaccines. In each of their communities, health centers are working to ensure medically underserved and uninsured populations have access to testing, and that COVID-19 patients receive follow-up services. To this date, health centers have delivered over 6.5 million COVID-19 vaccinations and over 11 million COVID-19 tests, responding to the needs of their underserved communities and patients.

As one of the many FQHCs combatting the pandemic, Westside Family Healthcare is proud to have provided 12,009 COVID-19 vaccines to date to underserved, uninsured, and vulnerable communities across Delaware, as shown in the table below. Out of those who reported, 57.6% of those vaccinated were Hispanic and 22.6% were Black or African American. Westside's efforts have notably supported DE Division of Public Health in addressing equity concerns.

Table omitted: https://downloads.regulations.gov/HRSA-2021-0003-0299/attachment_1.pdf

When COVID-19 hit, health centers across the country rapidly converted their in-house pharmacies to drive-through and home delivery structures, to serve their patients as safely and efficiently as possible. Health centers staff from the C-suite to the front desk are all doing their part to educate their patients, build confidence in the vaccine, and create innovative solutions to bring more patients in the door. Rescinding this Final Rule will enable health centers to continue to their vital work without having critical financial and administrative resources diverted to activities with significantly less positive impact.

The Final Rule would only improve access for a small population of patients, and health center services would drastically be reduced given the increase in administrative costs and loss of 340B savings.

Westside Family Healthcare continues to be concerned about the on-going confusion and misinformation around how the health center and 340B program operate, and what this final rule would do if implemented. Specifically:

* If implemented, this Final Rule would have no impact on the price of insulin or EpiPens. Some recent media reports have claimed the Final Rule, if allowed to go into effect, would lower the price of insulin. That is simply untrue. Drug prices are set by drug manufacturers, who roughly tripled the price of insulin during the last decade. The Mayo Clinic reported that one vial of Humalog, which cost $21 in 1999, cost $332 in 2019, reflecting a price increase of more than 1000%.

* If implemented, this Final Rule would have no impact on 90% of American diabetic patients. The Final Rule would apply only to those patients who receive their primary care from a health center, and whose income is below 350% FPG. As 90% of diabetic patients in the US are not health center patients, this Final Rule would have zero impact on how majority of diabetic patients pay for insulin. For the 10% of diabetic patients who get their care from a health center, the impact would be minimal, as health centers are already committed to ensuring that their low-income patients can afford insulin and EpiPens (along with all other pharmaceuticals plus the full range of primary, dental, and behavioral health care services.) Westside Family Healthcare shares the Administration's goal to increase access to affordable medications around the country, and health centers will living through our mission to ensure access to affordable care for underserved patients. However, the Final Rule fails to address rising drug prices for diabetic Americans.

The Biden Administration should revoke the Executive Order on Access to Affordable Life-Saving Medications because it was founded on a misunderstanding of the 340B program and the health center program.

Westside Family Healthcare has multiple concerns with the previous Administration's Executive Order that led to this Final Rule. First, The Executive Order implies that health centers were benefitting inappropriately from the 340B program by not following federal regulations and the health center mission that require them to reinvest all 340B savings in activities that expand care for low-income populations. Depending on the drug, health centers will discount drugs for patients beyond the minimum requirements. For many drugs, including insulin and injectable epinephrine, the 340B price is still too expensive for many low-income patients. Health centers utilize the existing health center program's regulatory flexibility to provide additional discounts to ensure medication is affordable. In fact, discounting drugs below the 340B price is generally the first purpose for which health centers use their 340B savings.

Second, The Executive Order states that health centers pay only one penny for a month's supply of insulin or injectable epinephrine. This statement represents a very limited understanding of the 340B program because multiple pricing variables impact the 340B price. For example, the form of the drug, the manufacturer's past pricing decisions, and the calendar quarter can be a factor. Depending on the form of insulin, the 340B price can range from $100 to $450 for health centers. Additionally, 340B prices lack consistency, as the 340B price for a one-month supply of a particular brand of insulin could be one penny during a quarter and over $100 in the next quarter. Thus, to imply that FQHCs consistently pay only a penny for insulin and injectable epinephrine reflects a very narrow understanding of 340B pricing,/1 and drug pricing more generally. These basic misunderstandings of 340B, drug pricing, and the health center mission led to this Final Rule, which creates more harm than benefits for medically underserved patients.

Westside Family Healthcare strongly urges the Biden Administration to revoke the Executive Order on Access to Lifesaving Medications to end the looming threat targeting health centers in the 340B program. Over the last year, health centers have experienced, and continue to daily, attacks on their 340B savings and ability to participate in the 340B program. If the Biden Administration revokes the underlining Executive Order, health centers can shift their focus from regulatory 340B program threats to defending the external attacks on the 340B program and covered entities, like contract pharmacies.

Thank you for your consideration of these comments and we strongly urge you to rescind the Final Rule. If you have any questions, please contact:

Lolita A. Lopez, FACHE

President and CEO

300 Water St., Suite 200

Wilmington, DE 19801

lolita.lopez@westsidehealth.org

(302) 656-8292

Sincerely,

Lolita A. Lopez, FACHE

President and CEO

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Footnotes:

1/ A drug's 340B price is based on two factors, both of which are determined by its manufacturers' pricing decisions. The basic 340B price is either 87% or 77% (for generic and brand, respectively) of the drug's "sticker price." However, if the manufacturer increases the drug's sticker price faster than inflation, the statute requires additional discounts, called an "inflation penalty." If the sticker price is raised particularly fast, the inflation penalty may be large enough that the 340B price drops to one-penny. Thus, when a drug is penny-priced under 340B, it indicates that the manufacturer has increased the sticker price much faster than inflation.

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The proposed rule can be viewed at: https://www.regulations.gov/document/HRSA-2021-0003-0002

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