- COVID-19 Updates: CDC in Talks to Waive Costs of Coronavirus Testing While FDA Takes Steps to Increase Testing Capacity
- In Light of Coronavirus, Grassley Hopes Administration’s Push on Drug Pricing Will Bring His Bill to the Floor
- House Energy & Commerce Health Subcommittee Unanimously Passes Three Bills to Strengthen Patient Protections
- FDA Issues Final Guidance on Path for Authorized Biologics
COVID-19 Updates: CDC in Talks to Waive Costs of Coronavirus Testing While FDA Takes Steps to Increase Testing Capacity
Throughout a heated House Oversight & Reform Committee hearing last Thursday (Mar. 12), Centers for Disease Control and Prevention Director Robert Redfield was non-committal on covering costs for coronavirus testing. Currently, in the US almost all private health plans include hospital coverage only, with most patients being left to pay different amounts of the bill. Kristine Grow, a spokeswoman for America’s Health Insurance Plans, commented that the groups have not agreed to waive out-of-pocket fees for testing.
At one point in the hearing, Rep. Kelly Porter (D-Calif.) pointed out that tests could run more than $1,330 and commented that CDC has the authority to cover health care expenses under existing federal regulations. But despite initially coming to a common understanding, Redfield commented later in the hearing that the administration “is currently examining all avenues” for the uninsured to afford tests and treatment and that in the meantime, concerned citizens should visit community health centers.
Experts, including George Washington University health law and policy professor Sara Rosenbaum, have suggested that the CDC use its grant programs to allocate the funding. Rosenbaum said an example of public health agencies using CDC appropriations to offer free screenings include tuberculosis screenings and family planning. (InsideHealthPolicy)
Meanwhile, the FDA is letting the New York State Department of Health use a third-party reviewer to authorize diagnostic tests. Roche Molecular Systems is the FDA’s third Emergency Use Authorization for a laboratory-developed test and can provide results in three and a half hours, as well as generate more than 4,000 results a day. (InsideHealthPolicy)
Additionally, FDA device center chief Jeff Shuren said the agency has been notified by 30 other laboratories that they plan to test or are testing diagnostics under the agency’s new policy for LDTs during the coronavirus emergency. Shuren commented that the agency has been “encouraging test developers to come to the FDA and work with us,” and has set up a 24-hour hotline for laboratories that need authorized tests, or want to process or validate a diagnostic test for the virus. (InsideHealthPolicy)
In Light of Coronavirus, Grassley Hopes Administration’s Push on Drug Pricing Will Bring His Bill to the Floor
The White House is showing signs of renewed interest in lowering drug prices last week as the coronavirus pandemic brings to light questions on Americans’ access to affordable testing and medication. The administration sent principles for drug pricing reform to Capitol Hill that are aligned with many of the policies in Senate Finance Committee Chair Chuck Grassley’s (R-Iowa) proposed drug pricing bill. Last week, White House Domestic Policy Council Joe Grogan endorsed the main elements of Grassley’s bill in a Wall Street Journal op-ed and offered support for Sen. Martha McSally’s (R-AZ) bill, which includes a watered-down version of House Democrats’ drug price negotiation plan.
The Congressional Budget Office announced that Grassley’s drug pricing plan could save the government close to $95 billion in the next ten years. According to the projection, Medicare Part D enrollees would save about $72 billion in out-of-pocket spending on drugs. So far, changes to the bill have overall lowered consumers’ expected premium savings from $5 billion to $1 billion over a decade.
Grassley is hoping to recruit more supports of the bill from his own party, after Senate Majority Leader Mitch McConnell (R-Ky.) has made clear that he will not bring the bill to a vote until Grassley has done so. Republican Senate members have been reluctant to show support for the bill because of a provision that would fine drugmakers that raise prices over the rate of inflation. Consequently, that provision of the plan accounts for most of its savings, according to the CBO. (InsideHealthPolicy)
“I think what’s going to change on drug pricing is what I have to do to get Republican co-sponsorship, to make the leader’s job easier to bring it up, so that the Republican caucus is not split down the middle,” Grassley noted last Wednesday.
House Energy & Commerce Health Subcommittee Unanimously Passes Three Bills to Strengthen Patient Protections
Last week, the House Energy & Commerce health subcommittee approved three new bills aimed at strengthening patient protections for Medicare and Medicaid beneficiaries. Topics covered in the three new bills include Medicare enrollment, kidney transplant medication and non-emergency medical transportation.
The committee unanimously approved the Beneficiary Enrollment Notification and Eligibility Simplification Act (BENES), which was introduced by Rep. Raul Ruiz (D-Calif.) and aims to eliminate coverage gaps between a person’s initial enrollment period and the general enrollment period. The bill also pushes back the enactment date to 2022 to give agencies, including CMS, extra time to implement it. (InsideHealthPolicy).
The second bill to be unanimously approved is the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act, introduced by Rep. Ron Kind (D-Wis.), which would ensure transplant recipients have lifelong access to immunosuppressive medications beyond the 36-month supply Medicare currently covers. The amended bill includes steps for incorporating CMS’ feedback on how the agency would implement the provisions of the bill. (InsideHealthPolicy).
The third unanimously approved bill is the Protecting Patient Transportation to Care Act, which was introduced by Rep. Buddy Carter (R-GA) and aims to require CMS to keep non-emergency transportation benefits in Medicaid.
FDA Issues Final Guidance on Path for Authorized Biologics
Earlier this month, the FDA published a final guidance opening up a path for authorized biologics, one of several published by the FDA in recent weeks to facilitate the March 23 transition. At this time, certain products previously approved as drugs will be officially licensed as biologics.
The final guidance, named the ‘Deemed To Be a License’ provision of the Biologics Price Competition and Innovation Act, requires that a marketing application for a “biological product” must be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act). The guidance claims, “any person (including an application holder for a biological product that is the subject of a ‘deemed’ 351(a) BLA) may seek to establish the biosimilarity or interchangeability under section 351(k) of the PHS Act of a proposed biosimilar or interchangeable product to another biological product licensed or deemed licensed under section 351(a) of the PHS Act.”
Commenting on the final guidance, one biologic product expert explained that nothing about the wording change would prevent an authorized biologic from coming to market similar to how an authorized generic would; however, the authorized biologic still wouldn’t be able to be substituted at the pharmacy because interchangeability designation only applies to biosimilars. More information on interpreting the “Deemed to be a License” provision can be found here. (InsideHealthPolicy)