ASTCT’s Outreach on CAR-T
The Centers for Medicare and Medicaid Services (CMS) requested comments on their Proposed Decision Memo for Chimeric Antigen Receptor (CAR-T) T-cell therapy. ASTCT submitted comments to the agency prior to the March 17 deadline. The public comment period is closed and we expect the final coverage determination to be released no later than May 17. ASTCT’s comments can be viewed here.
The proposed National Coverage Analysis would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment. ASTCT emphasized that patient access could be limited with the proposed coverage policy and recommended that the agency leverage existing registry reporting rather than coverage with evidence development (CED). Our comments suggested ways to revise the policy and to protect access to approved CAR-T therapies and those therapies likely to be approved within the next five years. Additionally, ASTCT raised a series of questions that the agency must address prior to the policy’s implementation such as requesting clarification on the data collection and analysis requirement if the CED is implemented in the final rule.
ASTCT worked in collaboration with various other stakeholders in order to submit cohesive comments to the agency. CMS received 93 comments from different stakeholders such as hospitals, healthcare systems, professional associations and societies, patient advocacy organizations, payers, and researchers. Approximately 32% of commenters agreed with ASTCT’s position that the NCD should be finalized without the CED. Others requested that CMS remove the patient reported outcomes (PROs) as a requirement or asked that it be made optional.
ASTCT will continue to work with CMS on coverage and reimbursement issues to protect appropriate patient access to CAR-T therapy.
CMS HOPPS Transmittal
CMS released a transmittal with updates on CAR-T coding and billing in the Hospital Outpatient Prospective Payment System (HOPPS) for April 1. The transmittal states, effective April 1, 2019 hospitals may report the new CAR-T revenue codes 087X (Cell/Gene Therapy) and 089X (Pharmacy) and value code 086X (Invoice Cost) established by the National Uniform Billing Committee.
ASTCT is digesting the language and clinical scenarios included in the transmittal and will continue to have conversations with CMS. ASTCT will provide an update to membership on these changes during a webinar on Tuesday, April 23 at 2:00 p.m. CST. Click here to register.
ASTCT’s online coding resources have been updated on the website and can be found here.Please reach out to firstname.lastname@example.org with any questions.
The President’s Budget was released on May 11, 2019. The FY 2020 Budget requests $87.1 billion for the Department of Health and Human Services (HHS), a 12-percent decrease from the 2019 estimated levels. The Budget proposes over $1 trillion in cuts to mandatory health spending. On March 12, 13, and 14 (respectively), the Secretary of HHS, Alex Azar, testified before the House Energy and Commerce Subcommittee on Health, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (Labor HHS) and the Senate Committee on Finance. Secretary Azar noted that the budget invests in the highest priority of public health needs such as combatting the opioid epidemic, supporting services for serious mental illness, and preparing for public health threats. The budget proposes to reduce funding for the National Institutes of Health (NIH) by $4.5 billion. Since 2016, the NIH has received more than $108 billion in total funding, including approximately $2 billion in increases in each year for the past three years.
Additionally, the Budget proposes strategies to address high drug prices and increase access to lifesaving medicines by restructuring the current payment incentive structures in Part D and Part B and fostering greater competition. In Medicare Part B, the budget intends to provide true catastrophic coverage for all beneficiaries through a newly established out-of-pocket maximum. It would also require plans to cover more of the costs of catastrophic coverage, to encourage efficient management of the Part D benefit. In addition, the Budget would eliminate cost sharing for generic drugs for low-income seniors to encourage the use of higher value products and reforms the coverage gap discount program to equalize the treatment of brand and generic drugs for the purposes of calculating out-of-pocket spending. The Budget would also permanently authorize a Medicare Part D demonstration that provides retroactive and point-of-sale coverage to certain low-income beneficiaries through a single plan.
For Medicare Part B drugs, the budget proposes a limit on increases in Medicare's ASP-based payment for a drug based on inflation as measured by the consumer price index. The Budget would require all Part B drug manufacturers to report ASP data and provide the Secretary of HHS with the authority to apply civil monetary penalties to manufacturers who do not report required data. The Budget would reduce average sales price-based payments when the primary patent expires until a competitor to the innovator product is commercially available.
Medicare Part B spending is growing faster for hospital outpatient departments than for physicians according to MedPAC. MedPAC also found that Part B drug spending grew faster among hospitals that participated in the 340B Program than among hospitals that did not participate in the 340B Program. The Budget proposes to modify hospitals' payment for drugs acquired through the 340B drug discount program to reward them based on the charity care they provide and to reduce payment if they provide little to no charity care. The Budget would also eliminate pass-through payment for new drugs, biologicals, and biosimilars to ensure beneficiaries who need these drugs benefit from the discounts hospitals receive when they acquire these drugs through the 340B drug discount program, and so they are treated the same as all other drugs purchased through the 340B program.
Finally, the Budget would provide the Secretary of Health and Human Services with authority to consolidate certain drugs currently covered under Part B into Part D where there are savings to be gained for beneficiaries and the Federal Government through increased price competition.
The FY2020 appropriations submissions cycle is underway. ASTCT submitted requests for programmatic funding and report language to the Senate and House Labor, Health and Human Services, Education, and Related Agencies (Labor HHS) subcommittees. We focused on gene and cellular therapies and the potential policy barriers that could prevent patients from receiving innovative treatments. We requested report language that urged the relevant agencies to develop policies that support the innovation of these new gene and cell therapies. We also requested an additional $2.5 billion increase in research funding to NIH. This request is being carried by the entire biomedical research community.
Energy and Commerce Committee Activity
The House Energy and Commerce Subcommittee on Health held a markup on March 27 on drug pricing bills introduce in the House. The bills in markup address how to lower health care and prescription drug costs. ASTCT is closely following the drug pricing conversation on Capitol Hill and will monitor the legislation as it moves to the House floor.
“What the Health” Podcast – Kaiser Health News hosts a health policy podcast that discusses the latest in policy from Congress, The White House, and related federal agencies. This episode discusses the Presidential Budget, cuts to Medicare, insurance plans in the ACA marketplace, and federal requirements for coverage in Medicaid.
What’s Next for the FDA – On March 5, FDA Commissioner, Scott Gottlieb, announced that he will be stepping down from his position next month. His efforts as Commissioner included speeding up the drug review process to encourage more generics and biosimilars getting to market faster. Dr. Ned Sharpless, director of the National Cancer Institute, will serve as the Acting Commissioner at the FDA. Secretary Azar said that this is a temporary position and a replacement for Commissioner Gottlieb has not yet been announced.
Paying Patients to Use Lower-Price Health Providers Can Result in Savings, Health Affairs says—A new study in Health Affairs found that paying people to use lower cost providers could result in lower overall health care costs. The study found that a program that pays patients $25 to $500 for using a lower-price medical provider for each of the 135 elective procedures, researchers found the effort led to a 2.1 percent reduction in the average price paid of all eligible services. Employers and health insurers are embracing strategies that encourage patients to switch to lower-price providers in order to trim health costs.
The Lasting Impacts Surprise Billing is having on Americans—An article published by NBC News on March 19, emphasizes the financial concerns Americans face when they receive unexpected medical bills in the mail. Additionally, Kaiser Health News weighed in on the issue on their “What the Health” podcast on March 21. Lawmakers on Capitol Hill are closely monitoring the surprise billing issue and are looking for potential legislative solutions. The House Education and Labor Subcommittee on Health, Education, Labor and Pensions is slated to hold a hearing on surprise billing on April 2.