In this month’s 340Buzz: The administration looks to 340B to help tackle the HIV epidemic; Apexus releases updates to its FAQs; HRSA releases an update about ceiling prices; 340B legislation springs up at the state level; judge makes additional ruling on 340B reimbursement cuts.
Drug prices and HIV
During the State of the Union back in February, the President shared the administration’s goal to “eliminate the HIV epidemic in the United States within 10 years” and “defeat AIDS in America.” Shortly thereafter, the administration released a plan with more details and steps needed to achieve this goal. The plan states, “The new initiative seeks to reduce the number of new HIV infections in the United States by 75 percent within five years, and then by at least 90 percent within 10 years, for an estimated 250,000 total HIV infections averted.”
The FY2020 HHS budget included a $291 million proposal to help execute on this plan.
Brett Giroir, MD, HHS Assistant Secretary for Health, spoke about this goal during a Kaiser Family Foundation forum in late April. As 340BHealth reports, Giroir said that the initiative would focus on preventive care for people at high-risk for contracting HIV.
One form of preventive care that has been proven effective is a once daily pre-exposure prophylaxis (PrEP) oral medication. However, as NPR notes, the price of PrEP is about $1,600 per month, and the CDC says that only about 10 percent of the 1.2 million people who would benefit from PrEP are currently on the treatment. The high cost of the drug is presumably where the 340B program could come into play.
“HHS expects most new patients receiving care through the initiative will be uninsured. So Giroir says the administration wants to utilize 340B discounts so more patients can obtain HIV preventive care from Ryan White HIV/AIDS Clinics (RWCs) and federally qualified health centers (FQHCs),” reports 340BHealth. “We are very cognizant about the price of PrEP,” Giroir said. “We intend to use the 340B program, which allows PrEP to be obtained at a much lower cost to the government.”
“The administration’s recognition of the value of the 340B program in supporting access to care for at-risk populations is welcome news to 340B entities, who are key providers of HIV care … Moving together toward our shared goal of eliminating HIV in the U.S. depends on 340B remaining an available resource for all eligible safety-net providers who are leading the charge on HIV, including hospitals,” said 340BHealth.
Updates to Apexus FAQs and HRSA program update
In March, 340BHealth reported that Apexus, the prime vendor that works with HRSA to answer stakeholder questions and provide critical information about the 340B program, had made updates to some of the answers on its FAQ pages.
The updates included a modification to FAQ 1239, “If I notice an incorrect price loaded in OPAIS, how do I correct this?”
The answer reads, in part, “Covered entities with concerns over the accuracy of 340B prices should first exhaust all other avenues to resolve the matter before contacting OPA,” and then goes on to suggest several steps entities can take to verify prices.
340BHealth said of this change, “The Apexus FAQ has been modified due to HRSA’s launch of the ceiling price database on April 1. Hospitals with concerns about the accuracy of 340B ceiling prices should follow the above steps to resolve concerns before contacting OPA. Hospitals should note that the pricing database displays the 340B ceiling price at the unit level. Hospitals may wish to calculate the package price in order to validate the ceiling price and compare it to the purchase price.” (HRSA also provided additional information related to the recently published list prices, which offers further clarification on how the package price will now be included in addition to the unit price.)
Also included was the addition of a new question, FAQ 1564, “When can I expect to hear from HRSA about the status of a change request?”
The answer reads, in part, “HRSA makes every effort to process change requests as soon as possible. Changes take approximately 10 business days to appear in 340B OPAIS, but the actual time frame will depend on the volume of requests pending at HRSA. Also, the process may take longer if verification from a grant official, program officer, or other external authority is required.”
340BHealth commented on the change, noting, “This Apexus FAQ provides useful information regarding change requests. Hospitals should make their Authorizing Officials (AOs) aware when change requests are submitted. Those requests will be automatically cancelled if the AO does not accept the request within 15 calendar days of submission. Hospitals also should note that changes to contract pharmacy details (e.g., store name, address, etc.) should be made through the DEA registry and not through a change request.” (HRSA utilizes the DEA registry to confirm contract pharmacy details.)
Sentry urges covered entities to continue utilizing the Apexus FAQ page for important 340B program information, and to contact us directly for questions relating to your 340B management and compliance software. We have a variety of training programs, online learning tools, and 340B experts available to help you make the most of the program.
In related Apexus news, the vendor’s five-year contract with HRSA is up for renewal in September of this year. It is expected that HRSA will announce a solicitation for proposals in the coming weeks, with the intent of signing an agreement with an organization that has the capability to develop, maintain, and coordinate a Prime Vendor Program in accordance with Section 340B of the Public Health Service Act.
State lawmakers wade into the 340B fray
In addition to the many new proposed bills relating to 340B that have come and gone in the House and the Senate in the past year, the activity at the state level is at an all-time high.
Examples of state activity focused on 340B includes:
- California: Governor Gavin Newsom of California in January “issued an executive order requiring all state agencies to consolidate into a single drug purchasing entity that will negotiate with pharmaceutical companies together.” Such an order, as we previously reported, could have unintended negative consequences for the 340B program.
- Wisconsin: The recently proposed 2019 Senate Bill 59 from Wisconsin “is the executive budget bill under section 16.47 (1) of the statutes. It contains the governor’s recommendations for appropriations for the 2019-21 fiscal biennium.” An excerpt from this bill reads, “The bill requires pharmacy benefit managers to report to OCI [Office of the Commissioner of Insurance] the amount received from manufacturers as drug rebates and the value of price concessions provided by manufacturers for each drug. The bill also requires each hospital participating in the federal drug-pricing program, known as the 340B program, to report to OCI the per unit margin for each drug covered under the 340B program dispensed in the previous year, the total margin, and how the margin revenue was used. OCI is required under the bill to publicly post information submitted, analyze data collected, publish a report on emerging trends in prescription prices and price increases, and annually conduct a public hearing based on that analysis.”
- West Virginia: Jim Justice on March 1 approved legislation prohibiting pharmacy benefit managers (PBMs) from paying less to 340B covered entities or their pharmacies, including covered entity contract pharmacies, than is paid to non-340B entities. The new law applies to Medicaid managed care organizations but does not apply to drugs paid by Medicaid on a fee-for-service basis, which are governed by federal rules.
- Montana: Montana State Sen. Steve Fitzpatrick on March 15 introduced Senate Bill 335, which would apply to health insurers, pharmacy benefit managers, and plan sponsors. It would prohibit them from establishing contracts with 340B covered entities or their pharmacies that set prescription drug payment rates at levels below the national average drug acquisition cost – or the wholesale acquisition cost if a national figure has not been calculated. The bill would also ban additional fees or charges that are only imposed on 340B covered entities.
- South Dakota: House Bill 1137 was introduced in South Dakota on Jan 25. It would prohibit PBMs from discriminating “against a pharmacy participating in a health plan as an entity authorized to participate under section 340B of the Public Health Service Act … or any pharmacy under contract with such an entity to provide prescriptions.”
Judge calls for HHS to determine next steps
On May 6, U.S. District Judge Rudolph Contreras of the U.S. District Court for the District of Columbia ruled again that HHS’ 340B reimbursement cuts – which where the subject of much debate throughout 2018 and took effect in January 2019 – were unlawful.
However, as FierceHealthcare reports, “he did not grant the relief requested by the hospital groups, which included the difference between the amount they received under the 2018 and 2019 OPPS rules and the amount they are entitled.”
The judge opted not to require HHS to retroactively pay hospitals back for the amount they’ve lost during the time since the cuts have been implemented “given the havoc [it] may wreak on Medicare’s administration,” as Healthcare Dive notes.
As far as how to move forward, the judge called for HHS to come up with a plan to resolve the issue, setting an August 5 deadline for HHS to provide a progress report on that front.
“America’s 340B hospitals are pleased with the District Court’s decision and urge HHS to follow the judge’s directive to promptly resolve the harm caused by its unlawful cuts to Medicare reimbursement for certain 340B hospitals,” AHA and the other plaintiffs said in a joint statement after the ruling.
Expectations for summer and beyond
It’s too early to tell which state and federal bills may be passed into law and which will fall by the wayside, whether the administration’s plans to overcome the HIV epidemic will come to fruition, or what else awaits the 340B program and covered entities as we move into the summer months. We do know that there are key items on the radar that will impact covered entities, as indicated by the first five bills introduced this year.
This time last year, stakeholders were being asked to provide comments on the White House’s budget blueprint; this year, we anticipate the results from the feedback provided. Rest assured that Sentry will continue to keep an ear to the ground and offer a hand to its 340B customers.