One Health Issues Public Comment on Health Resources & Services Administration Proposed Rule

WASHINGTON, March 13 -- David Mark, CEO of the Bighorn Valley Health Center Inc. dba One Health, Hardin, Montana, has issued a public comment on the Health Resources and Services Administration proposed rule entitled "Implementation of Executive Order on Access to Affordable Life-Saving Medications". The comment was written and posted on March 11, 2021:

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On behalf of One Health, and the 10,000 medically-underserved patients we serve in rural Montana, I am writing to express my strong support for delaying the effective date of the regulation entitled "Implementation of Executive Order on Access to Affordable Life-saving Medications" (hereafter, "the regulation") until at least July 20, 2021, as proposed at www.federalregister.gov/d/2021-05165.

We strongly support the proposed delay as it:

1. Is consistent with the "Regulatory Freeze Pending Review" issued by the White House Chief of Staff on January 20, 2021.

2. Will allow for consideration of new policy questions that have arisen since the regulation was initially delayed.

Each of these points is discussed below.

1. Extending the delay is consistent with the "Regulatory Freeze Pending Review" issued by the White House Chief of Staff on January 20, 2021.

On January 20, White House Chief of Staff established a Regulatory Freeze Pending Review, addressing regulations that had been finalized by the previous Administration but not yet finalized. Pursuant to that Regulatory Freeze policy, on January 21, HHS delayed the effective date of this regulation for 60 days, until March 22, 2021, stating that the delay was "necessary to give Department officials the opportunity for further review and consideration... consistent with" the Regulatory Freeze memo. A further extension of the effective date, until July 20, is also consistent with Regulatory Freeze memo for the following reasons:

* As indicated by the volume and range of comments submitted last fall in response to the proposed rule,/1 this regulation raises significant questions of "fact, law, and policy." (For example, the rule has no basis in law, and diverges significantly from the plain language meaning of the Executive Order on which it is based.) Given the critical role that HRSA's Bureau of Primary Health Care (BPHC) is playing in national efforts to provide COVID vaccinations to medically underserved populations, it is understandable that BPHC was unable to address all these questions during the initial 60-day delay. The Regulatory Freeze memo states that "where necessary to continue to review these questions of fact, law, and policy" agencies should "consider further delaying, or publishing for notice and comment proposed rules further delaying, such rules beyond the 60-day period." Thus, given the number of questions raised about the regulation, and the effort required to address them, the Regulatory Freeze indicates that a further delay is in order.

* The Regulatory Freeze memo states that pending rules should be reviewed and approved by "a department or agency head appointed or designated by the President after noon on January 20, 2021." As neither an HHS Secretary nor a HRSA Administrator have yet to be appointed under the current Administration, there has not yet been an opportunity for an individual in either of these positions to review this regulation, or to delegate their authority to another individual. As a result, the regulation's effective date must be delayed at least until a HHS Secretary or HRSA Administrator has been appointed and is able to review it.

2. A new issue of "fact, law, and policy" must be considered: the impact of implementing this regulation on Community Health Centers' efforts to vaccinate hard-to-reach populations against COVID-19.

In addition to the questions of fact, law, and policy raised during the NPRM comment period, there is a new - and time-sensitive - issue that HRSA must consider when determining whether and when to make this regulation effective. It involves how the administrative and operational burdens involved in implementing the regulation will impact Community Health Centers' (CHCs') role as national leaders in the effort to vaccinate hard-to-reach populations against COVID-19.

As discussed in the NPRM comments, implementing this regulation as written would be highly burdensome and disruptive for CHCs' registration staff, I.T. departments, in-house pharmacy staff, and contract pharmacy arrangements; it will also lead to reduced financial resources for the CHC (See Attachment A for details). Under the best of circumstances, it would take many months and substantial expense for a CHC to come into compliance with the regulation - and the middle of a pandemic is far from the best of circumstances.

As HRSA and Congress are aware, CHCs have been on the front lines of fighting COVID since last winter. Since the rule was initially delayed in January, CHCs have been assigned the critical role of leading national efforts to vaccinate hard-to-reach populations. While CHCs readily accept this responsibility, their staff and resources are currently stretched to unprecedented levels. Staff from practically every department are being called on to support vaccination efforts. (See Attachment B for one CEO's discussion of their CHC's "all hands-on deck" vaccination efforts this week.) At the same time, many CHC staff continue to be out on leave, either due to COVID exposure or to family responsibilities related to the pandemic. This raises a new policy question that must be considered before a final decision can be made about the regulation - how the significant administrative and operational burdens created by this regulation should be reconciled with the critical demands placed on CHCs to vaccinate hard-to-reach populations against COVID-19.

For these reasons, I strongly urge HRSA to delay this rule through at least July 20, 2021, and to give serious consideration to extending the delay for the duration of the Public Health Emergency.

In closing, I would like to highlight the significant concerns that the CHC community raised about this regulation during the initial comment period:

* The regulation, and the underlying Executive Order, are based on fundamental misunderstandings of how both CHCs and 340B operate.

* CHCs are non-profit providers whose mission is to make insulin, other medications, and a wide range of other health services affordable for low-income patients.

* This regulation would do nothing to change the price that drug companies charge for insulin.

* For the roughly 90% of diabetic patients who aren't CHC patients, this regulation would have zero impact on the price they pay for insulin.

* The roughly 10% of diabetic patients who get their care from CHCs are already assured access to affordable insulin and other drugs.

* Instead of helping more people afford insulin, this regulation would harm CHCs by imposing burdensome new requirements and reducing their ability to support discounts on medications and other services.

For these reasons, I urge the Administration to undertake a fresh review of the previously submitted comments and ultimately rescind this regulation.

I appreciate your consideration of these comments and look forward to continuing to work with you to expand access to affordable, high-quality care for medically underserved patients.

Sincerely,

David Mark, MD, CEO

Bighorn Valley Health Center, Inc. DBA One Health

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Attachment A:

Administrative and Operational Burdens on CHCs to Implement the Regulation Registration & IT:

* CHC case managers will need to start asking every patient - regardless of insurance status -- if they are an insulin-using diabetic or have intense allergic reactions. (Note: these are invasive questions for non-medical personnel to ask and raise potential HIPAA concerns.)

* Patients who are identified as insulin-using diabetics or having intense allergic reactions will have to be screened for incomes up to 350% FPL - when all other patients are screened only for incomes up to 200% FPL.

* CHC practice management software will need to be updated to indicate qualifying patients, creating further burden on front office workflows.

* CHC registration staff will likely be inundated by non-patients seeking discounted insulin. Staff will need to explain that the patient must become CHC patients to qualify.

All Pharmacies

* 340B Pricing is subject to quarterly changes, potentially causing the following burdens for pharmacists and pharmacy support staff:

- Out of pocket costs for insulin and could significantly vary quarter to quarter, causing patient and provider frustrations.

- CHC pharmacy dispensing systems will need to routinely update pricing data to reflect the latest insulin prices. These prices will come as a surprise to pharmacists, pharmacy staff, and patients alike.

- Patients seeking to move to lower-costs forms of insulin will reach out to their primary care providers (PCPs) for new prescriptions; this will create increased workflows for both PCPs and pharmacy staff.

In-House Pharmacy

* Every time a pharmacist fills a prescription for insulin or injectable epinephrine, they will need to look up in the CHC's practice management software to determine if the patient qualifies for the special (sliding fee) discount, and the exact cost for that drug this quarter. This is very time consuming and labor intensive, as this is a manual process.

* Setting up pharmacy billing software to allow discounted co-pays will be very burdensome and problematic. Again, this will only be for 2 classes of medications. The rest of the meds will be at full co-pay or cost.

Contract Pharmacy

* Most contract pharmacies - particularly the large chains -- will be unable or unwilling to accommodate the complicated eligibility and pricing determinations required under this rule. Their priority is to care for the patients from a clinical aspect, any further administrative burden from covered entities like CHCs could further damage our relationships with these partners. This will further destabilize the contract pharmacy model, which is already under attack from drug makers who are refusing to ship 340B-priced drugs to contract pharmacies, and from PBMs and payers who impose discriminatory contracting terms that discourage participation in 340B.

* For those contract pharmacies that are willing and able to accommodate these new requirements, the CHC's Third Party Administrator (which determines 340B eligibility for prescription claims dispensed by contract pharmacies) may be unable to provide the information needed to determine eligibility and pricing in a timely fashion.

* For those remaining contract pharmacy arrangements where both the pharmacy and the TPA are willing and able to accommodate the new requirements, the contract pharmacy will need substantial time and funding to develop new workflows, train staff, and reprogram point of sale systems.

Attachment B:

A CEO's account of her CHC's "all hands on deck" approach to COVID vaccination - and how this implementing regulation would impact those efforts

"I sincerely hope the Administration will recognize the critical role health centers are playing in the pandemic response, and the demand that is putting on our already-stressed thin human resources. That is even more so now that we have rolled out and are expected to be ramping up our vaccine efforts. For example, this week my mid-sized health center is conducting a total of 4 public vaccination clinics. One of those is at our practice in a small rural community where we expect to vaccinate about 100 people. Two others are being held at a church gymnasium in the center of our service area; one is a second shot clinic and the other is a first shot clinic. We expect at least 400 people at each. Finally, Saturday we will be traveling to one of the farms in the lower part of our service area to vaccinate on-site at least 1,000 migrant farm workers and their families.

"These events require that we mobilize a significant number of our staff for set up, traffic control, patient assistance, registration into the computer system, assessment and administration of the vaccine, and surveillance by clinical personnel after the shot. One core responsibility is management of the vaccine supply on site and drawing up the doses for administration being sensitive to the storage and timing requirements. That duty at our clinics has been assumed by clinical pharmacists as well as our nursing leadership. We also have to make sure our people are taken care of with water, food, and periodic breaks.

"The time and effort demand reaches to all corners of our organization -- from the facilities management team who help with the set up and traffic control, to IT who must ensure we have remote computer access, to me (the CEO) who will be one of several people on patient assistance duty at the migrant farmworker clinic this Saturday. Oh, and this Saturday we will have to be translating for the majority of those 1,000 people!

This is the demand now, and we have not even fully opened the floodgates in terms of receiving vaccines directly from the Federal government or expanding the list of those eligible to get a vaccine. Imagine if in the midst of this being an every-week schedule, my team having to stop and draft policies, determine new workflows at the pharmacy, develop patient education material, and train new staff on the new procedures ... all to address affordability of drugs that we already make affordable to our patients!"

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Footnote:

1/ As one example, see the comments submitted by the National Association of Community Health Centers, available at https://www.regulations.gov/comment/HRSA-2020-0004-0119.

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The proposed rule can be viewed at: https://www.regulations.gov/document/HRSA-2021-0002-0001

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