Washington, DC’s HOT July
by Artemis Policy Group, Hemophilia Alliance Advocacy Consultants

Congress has returned from its July 4th Recess with a full plate for the remainder of the month. In healthcare, bills on PBMs and pandemic-related issues seem to have the greatest chance of moving forward but the House and Senate Committees of jurisdiction are far apart on many policies. The future of 340B continues to play out mostly in press releases of new organizations forming, several related to a split among Community Health Centers. There is the potential for the introduction and movement of bills impacting 340B related to contract pharmacy and hospital reporting. Below is a recap of what we have seen in the last month.

ASAP 340B – As reported in our May and June newsletters, PhRMA and NACHC (the National Association of Community Health Centers) have formed a new organization, the Alliance to Save America’s 340B Program—ASAP 340B. The new group released a set of principles about how they intend to save the program, many of which could negatively impact HTCs (not allowing subgrantees to participate in 340B and limiting mail-order pharmacy and telehealth). The Alliance team have met with most of the manufacturers in our space to share these concerns. This has resulted in an FAQ on ASAP 340B’s website stating that the coalition has no intent on harming HTCs or their participation in 340B. The group plans to draft a bill incorporating the principals. We will share the details once this is made public.

ACH and 340C – In July of 2022 a group of Community Health Centers formed a new organization – Advocates for Community Health (ACH). According to its website, the organization is focused on innovative policy and advocacy initiatives and recently contact the Alliance about a proposal to create a new subset within the 340B program called 340C. ACH defines 340C as follows:
340C is completely voluntary – anyone who participates in 340B may choose to participate in 340C. The proposal maintains key provisions of the original 340B program, including the prime vendor, certification processes, and a prohibition on resale of drugs.

If entities opt to participate in 340C, they are subject to detailed accountability and transparency standards, including the following:

• Any funds generated shall be reinvested into program operations, patient care, and other community benefits, as determined by the covered entity leadership and governing board, to the populations served.
• Entities shall submit annual reports attesting to these requirements.
• Participants are subject to audits of records that establish their compliance.

In return for agreeing to these standards, entities will have access to:

• Reimbursement at wholesale acquisition cost (WAC) for all Medicaid drugs,
• Protection against discriminatory network and reimbursement actions by health insurers and PBMs, and
• Unlimited use of contract pharmacies as necessary.

340B Health – After years of not wanting to engage Congress in a legislative solution to the reporting and restraints that drug manufacturers have instituted related to contract pharmacy use in 340B, 340B Health is working on legislation with Representative Matsui on a bill to put contract pharmacy policy back to where it was before restrictions were first instituted by Eli Lilly in 2020. A draft of the bill is not available yet, but 340B Health is considering provisions to limit the ability of manufacturers to impose conditions on obtaining the 340B discount and create a separate civil monetary penalty for conditions that impede access to 340B, but do not directly result in an overcharge.

It is unclear if the bills being considered by these groups will move forward. If nothing else, it shows Congress the divisions among participants in the 340B program and the controversial nature of any attempts to make changes.

Senate RFI on 340B – A bipartisan group of Senators, including Senators Tammy Baldwin (D-WI), Shelley Moore Capito (R-WV), Ben Cardin (D-MD), Jerry Moran (R-Ks), Debbie Stabenow (D-MI), and John Thune (R-SD), issued a Request for Information(RFI) seeking ideas for how Congress can “further the original intent of the program, strengthening the program’s ability to support entities serving eligible patients.” More specifically, the RFI asks:

1. What specific policies should be considered to ensure HRSA can oversee the 340B program with adequate resources? What policies should be considered to ensure HRSA has the appropriate authority to enforce the statutory requirements and regulations of the 340B program?
2. What specific policies should be considered to establish consistency and certainty in contract pharmacy arrangements for covered entities?
3. What specific policies should be considered to ensure that the benefits of the 340B program accrue to covered entities for the benefit of patients they serve, not other parties?
4. What specific policies should be considered to ensure that accurate and appropriate claims information is available to ensure duplicate discounts do not occur?
5. What specific policies should be considered to implement common sense, targeted program integrity measures that will improve the accountability of the 340B program and give health care stakeholders greater confidence in its oversight?
6. What specific policies should be considered to ensure transparency to show how 340B health care providers’ savings are used to support services that benefit patients’ health?

Responses will not be made public and are due July 28. The Hemophilia Alliance is evaluating this opportunity and a potential response.