Wisconsin Primary Health Care Association Issues Public Comment on Health Resources & Services Administration Proposed Rule

WASHINGTON, Oct. 28 -- Stephanie Harrison, CEO of the Wisconsin Primary Health Care Association, Madison, has issued a public comment on the Health Resources and Services Administration proposed rule entitled "Executive Order on Access to Affordable Life-saving Medications". The comment was written on Oct. 26, 2020, and posted on Oct. 27, 2020:

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The Wisconsin Primary Health Care Association (WPHCA), the member association for the 17 Federally Qualified Health Centers ("Health Centers") in Wisconsin, appreciates the opportunity to submit a comment on Executive Order 13937, "Executive Order on Access to Affordable Life-Saving Medications."

WPHCA supports the critical goals of the Notice of Proposed Rule-Making (NPRM) to improve access to life-saving medications for low-income individuals, along with the vision to maximize administrative efficiency and improve care. Especially during the pandemic, WPHCA agrees that ensuring access to medications such as insulin and epinephrine is vital to the health of all patients, including those that are uninsured and underinsured.

The core mission shared by every Health Center is ensuring that all people can access high-quality, affordable health care, regardless of their ability to pay. This includes access to primary care, preventive care, dental care, mental health services, substance use disorder services - and pharmaceuticals. Health Centers in Wisconsin serve over 300,000 individuals, the majority (80%) have incomes below 200% of the Federal Poverty Level (FPL), and approximately 56,000 patients served by Wisconsin Health Centers are uninsured. Ensuring that low-income uninsured and underinsured patients can afford their prescribed medications is one of the central aspects to the Health Center model of care.

Health Centers devote significant staff time applying to drug manufacturers' Patient Assistance Programs on behalf of their patients, providing co-pay supports, implementing affordable insulin initiatives, and managing chronic conditions for medically vulnerable patients. To ensure drugs are affordable and accessible to patients, many Health Centers discount drugs even below the 340B price. By both law and regulation, Health Centers reinvest every penny of savings from the 340B program back into patient services and expanding access to care. Health Centers are part of the solution for affordable and accessible drugs, and are responsible, accountable partners in the 340B program.

This NPRM, while well-intentioned, would add administrative burdens to Health Centers, reducing efficiency and ultimately causing disruption to current operations and patient care. We strongly urge the Administration not to issue a final version of this regulation, as it is based on a fundamental misunderstanding regarding how Health Centers operate the 340B program.

If implemented, many diabetic patients would end up paying more for their insulin. Depending on the type of insulin a patient needs, the 340B price could be far above what Health Centers currently charge low-income patients. For example, the 340B price for inhaled insulin is hundreds of dollars. Health Centers currently discount this price for their low-income patients, but would be prohibited from doing so under the NPRM. Additionally, many diabetic patients would face dramatic fluctuations in how much they pay for insulin from one calendar quarter to the next. It is not unusual for the 340B price for a one-month supply of a particular brand of insulin to be one penny during one quarter, and over $100 in another quarter. Therefore, under the NPRM, a low-income patient's cost for insulin could switch from three cents to over $300 in just a few months. To keep drugs affordable for low-income patients, Health Centers would seek to put them on the type of insulin with the lowest 340B price. As 340B prices change quarterly, this could require changing patients' insulin prescriptions quarterly, creating potential clinical complications for patients.

If HHS does finalize the regulation, we strongly urge several important adjustments to the regulatory text, which are enumerated below.

1. The NPRM defines a "low-income" patient, for the purposes of this proposed regulation, as an individual with an income less than 350% of the federal poverty level (FPL). However in the 330 program, which authorizes Health Centers, "low-income" is defined as 200% of FPL. If enacted as written, the consequences of this provision would entail requiring a new, narrow benefit category of patient eligibility for discounted services, including systems to identify such patients, reprogramming of practice management systems, and transfer of such details into pharmacy operations. To remedy this provision of the NRPM, we request that HHS establish eligibility at 200% FPL to ensure alignment with other Health Center services and avoid establishing new eligibility categories. This would also avoid setting a new "usual and customary" charge which would lower reimbursement from private insurers.

2. The NPRM diverges from the original Executive Order, which required charging patients the exact 340B price, whereas the NPRM allows charging that price or less. This inconsistency causes significant confusion and we request clarification.

3. A growing number of private insurance contracts require that Health Centers bill them no more than their "usual and customary" cost for a specific drug. By requiring the 340B price for all patients below 350% FPL, this would eliminate the possibility of retaining any 340B savings on such drugs due to the reduced "usual and customary" cost. If the NPRM is finalized as written, Health Centers may be forced to operate in violation of the terms of their contracts with such insurers. To remedy this issue, ensure consistency with insurance contracts, as many private insurers prohibit providers from charging a patient less for a drug or other service than the amount due under their deductible or cost-sharing agreements.

4. Regulatory language in the NPRM does not consistently clarify that only "Health Center patients" are eligible for the 340B price.

5. Define "high cost-sharing requirement" to indicate that a qualifying low-income patient should be charged the lesser of their cost-sharing amount or the total amount that they would be charged under this regulation if they were uninsured.

6. Define "minimal administration fee" to cover costs associated with dispensing, 340B compliance and oversight, and the additional administrative work required to identify patients, if the eligibility level is not aligned with other Health Center services. Further, clarify that this fee is unique to insulin and epinephrine.

WPHCA affirms the NPRM's intentions to ensure that patients have access to affordable medications and appreciates the administration's ongoing dedication to protecting patients. On behalf of Wisconsin's Health Centers, thank you for consideration of our concerns and comments.

Sincerely,

Stephanie Harrison

CEO

Wisconsin Primary Health Care Association

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=HRSA-2020-0004-0001

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