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Product recall announced; patient organizations are in ongoing communications with manufacturer

Bayer announced the recall of two lots of Kogenate^®Â FS antihemophilic factor (recombinant) 2000 I.U. vials on July 19, 2019. Bayer announced that 3000 I.U. of one product (Jivi), past its expiration date, had been mislabeled as another product (2000 I.U. of Kogenate FS) and distributed to the public for six months. This is a deeply troubling event that gives rise to questions, concern, and outrage within the community.
On July 26th, HFA and NHF submitted a letter to Bayer focusing on the company’s plans for accomplishing the recall. You can read the HFA-NHF letter here and Bayer’s response, received late yesterday, here. You can also read a separate letter about the recall that Bayer sent out to health care providers (HCPs) here. Bayer sent the HCP letter on July 19^th but shared it with HFA and NHF yesterday.
The patient organizations’ July 26^th letter is only the first step in continuing communications among HFA, NHF, Bayer, and the U.S. Food and Drug Administration. The July 26^th letter focused specifically on the recall process because HFA and NHF wanted timely information about Bayer’s plan to execute the recall and assurance that mislabeled product is not still in use. We continue to press for information about how this serious event happened, what the implications might be for patient health and care, and how Bayer will ensure similar errors do not happen again. HFA and NHF are also following up on these questions with the FDA and with our respective teams of medical advisors.
This is an ongoing discussion and HFA and NHF will keep the bleeding disorders community informed as information is gathered.
Please note that NHF and HFA do not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, treatments, or opinions. If you have any questions or concerns about your medical treatment, including your possible exposure to recalled product, please consult your physician.

Lawmakers continue to grapple with drug pricing policy

On July 25^th, the Senate Finance Committee narrowly approved a bipartisan drug pricing bill sponsored by Sens. Grassley and Wyden. Some key features of the bill include:

• Penalizing manufacturers who increase the price of their drugs beyond the inflation rate;
• Capping yearly patient out-of-pocket spending under Medicare Part D (remember that Part D covers most prescription drugs for seniors, but not products such as clotting factor); and
• Providing a pathway for state Medicaid programs to adopt new financing mechanisms to pay for high-cost novel treatments like gene therapies.

There are other, much-discussed drug pricing reforms that don’t appear in the Grassley-Wyden bill. The bill does not address high “launch prices” for new drugs. It focuses on drug purchases under Medicare and Medicaid, and so would not directly affect Americans with private or job-based insurance. And the bill does not give Medicare authority to negotiate with manufacturers over drug prices. Even though it avoids these hot topic issues, the bill remains controversial and its prospects for passage uncertain.
The Grassley-Wyden bill is only one of many drug pricing developments in the news right now. Others include:

• The President stated (July 5) that he would issue an Executive Order ensuring the U.S. pays no more than other countries for prescription drugs (“most favored nation status”), but he offered no details on how this would work.
• A federal court overturned a new rule that would have required manufacturers to disclose drug list prices in TV advertisements, one day before the rule was to go into effect (July 8).
• The Administration withdrew its proposed reforms to the rebate system for drugs covered under Medicare Part D (July 10).
• The Administration’s October 2018 proposal to link Medicare payments for Part B drugs (including clotting factor) to international drug prices has not been finalized and remains pending.
• Democrats in the House of Representatives are working on a drug pricing package and expect to introduce it in September. The House bill is expected to include some form of Medicare negotiating authority.
• Other Senate committees are also working on drug pricing bills, at least one of which may be bundled together with surprise billing

Quick Hits:

• The U.S. Centers for Medicare and Medicaid Services rejected Utah’s application to receive enhanced federal funding for a partial expansion of the state’s Medicaid program. Under the Affordable Care Act, states that expand their Medicaid programs to cover adults earning up to 138% of the Federal Poverty Level are entitled to enhanced federal funding to support their expansion of coverage. Utah voters, by ballot initiative in November 2018, had called on their state to make Medicaid coverage available to people earning up to the ACA’s 138% threshold, but Utah lawmakers opted instead to offer coverage only up to 100% of the FPL. In a July 29^th statement, CMS reiterated its opposition to the ACA in general – but noted that CMS for now will continue to allow enhanced federal funding only for full Medicaid expansions.
• On July 29^th, a federal court overturned CMS’s approval of Medicaid work and reporting requirements adopted by the state of New Hampshire. The same court had previously invalidated similar programs in Arkansas and Kentucky. HFA in coalition with other patient advocacy groups has opposed state applications to impose work and reporting obligations on Medicaid enrollees.
• On July 29^th, CMS proposed rules that would require hospitals to publicly disclose the prices they negotiate with insurance companies. CMS’s stated goal is to increase competition among hospitals so patients can comparison-shop. The proposed rule will remain open for comment for 60 days.
• On July 18^th, HFA along with 26 other patient groups wrote to CMS expressing strong opposition to Medicaid block grants (a system of capped federal funding for state Medicaid programs). Block grants undercut Medicaid’s guarantee of comprehensive coverage for people with serious and chronic health conditions, because states that run up against their funding caps would have to deny care, roll back eligibility, or incur new costs that the federal government would otherwise help pay.
• On July 19^th, a federal court upheld the Administration’s rule expanding the availability of short-term health plans. HFA had joined with 10 other patient groups in an amicus curiae brief to the court, explaining the devastating impact that patients could face if short term plans were made more widely available. The patient groups released a statement expressing disappointment in the court’s decision.
• A federal appeals court heard oral argument on July 9^th in Texas v. United States, the lawsuit challenging the constitutionality of the ACA. HFA had joined with other patient groups in urging the appeals court to uphold the ACA; the patient groups also issued a statement on the case, ahead of oral argument, urging the court to prioritize patient protections. It is too early to predict when or how the court will rule, but HFA will continue to monitor the litigation and keep the community informed.