by Ellen Riker, Artemis Policy Group, Hemophilia Alliance Advocacy Consultant

In a Medicare Learning Network newsletter released on Oct 19, CMS notified providers that Medicare’s policy for allowing separate payment (outside the bundled hospital DRG payment) for blood clotting factors and other treatments provided to inpatients with Hemophilia would also apply to patients with any of the new VWD Diagnoses Codes. As a reminder, new diagnoses codes for VWD were approved by CMS and CDC and became effective October 1, 2022. The update states that the Medicare Administrative Contractors (MACs) must adjust claims already processed for treatments provided as of 10/1/22 for any of the clotting factor J-codes for patients with any of the new VWD diagnoses codes. The update can be found at: MM13381 – Update for Blood Clotting Factor Add-on Payments (cms.gov) and the CMS Manual update can be found at: r12290cp.pdf (cms.gov).

by Artemis Policy Group, Hemophilia Alliance Advocacy Consultants

The 118th Congress continues to bring unprecedented events – the first ousting of a Speaker of the House of Representatives in history has been followed by an inability to elect a new Speaker. Unlike at the beginning of the Congress, the House can proceed with business (as Members already have agreed upon the rules under which they will operate). However, congressional business has slowed significantly and the timing could not be worse.

The House turmoil comes just after the government narrowly averted a shutdown by passing legislation, known as a continuing resolution, which extends fiscal year 2023 funding levels for federal agencies and programs until November 17, 2023. To complete the appropriations process for fiscal year 2024, Congress must pass twelve bills before the November deadline. If Congress fails to act by November 17, we once again face the threat of another shutdown or Congress must pass another short-term continuing resolution to buy more time.

Energy and Commerce Request for Information on Drug Shortages: The Alliance submitted a letter in response to the draft legislation on drug shortages under consideration by the Committee. We supported the bill’s provision to facilitate the use of 503B compounding facilities to meet patient needs during drug shortages. We also encouraged the Committee to consider enacting a policy to waive annual fees for manufacturers creating products to address drug shortages. Giving DDAVP as an example, we explained that the costs are prohibitively high, which results in high prices for patients.

Comment Letter to FDA on Draft Guidance for Industry: Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act: The Alliance, along with NBDF and HFA submitted a comment letter to FDA in support of its guidance regarding the regulation of 503B facilities. We shared our recent experience with the recall of the Ferring Pharmaceuticals product, Stimate and the work with STAQ Pharma to fill in the gap. The letter states,

“This experience underscores the importance of products produced by 503B facilities. Often, the 503B is the only source for needed medications in proven shortages or total non-availability in the US. Since 503B facilities are required to follow Current Good Manufacturing Practice regulations (cGMP), and they are inspected to that standard by the FDA, quality assurance is ensured, where it may not be in compounded products. There is also a proven expiration date available to licensed dispensing agents who are regulated in each state. In the case of the DDAVP nasal spray, there are also additional specific quality control measures and dating, including the cGMP requirements regarding droplet size and droplet distribution insuring proper dosing for the patient.”

On September 29, the United States District Court for the District of Columbia ruled that insurers can no longer implement copay accumulator adjustor programs (CAAPs) for drugs that lack generic equivalents. CAAPs essentially disallow copay assistance from counting towards a person’s out-of-pocket maximum or deductible, increasing patients’ costs. While the court ruling is a significant positive step forward, additional guidance from the Biden Administration is needed for implementation and enforcement of the policy.

The Alliance advocates against the practice of CAAPs and supports the Help Ensure Lower Patient (HELP) Copays Act (H.R. 830/S. 1375). In addition to banning the practice of CAAPs, this legislation would address copay maximizers (or the “EHB Loophole”), another practice by insurers that results in patients paying more for their vital treatments by carving them out of the essential health benefits (EHB).

Because the court ruling does not address everything in the bill, the legislation likely is still necessary. The Advocacy team will continue to monitor implementation of the court ruling and update the community accordingly.

The Office of Management and Budget (OMB) recently released proposed revisions to the Uniform Grants Guidance (UGG) with which HTCs must comply. In the press release describing the Proposed Rule, the White house described the changes as a “fundamental rewrite” of the UGG. However, the preamble to the proposed rule states that, except in cases where OMB proposes edits for consistency with statutory requirements, they generally sought to maintain the existing content of the UGG. Additionally, OMB seeks to reduce agency and recipient burden, clarify sections that recipients or agencies have interpreted in different ways; and rewrite applicable sections in plain language, improving flow, and addressing inconsistent use of terms. Comments are due by December 4, 2023. Additional information on the Guidance was presented by Mike Glomb at the Fall meeting. His slides can be found on the Alliance website.