2018 ASH Advocacy Efforts to Ensure Patient Access to Care
Drug Access
High drug prices are a major issue facing patients with hematologic conditions and ASH continues to identify and advocate for ways to ensure access to safe and effective hematologic drugs. Updates on the Society’s major advocacy efforts in these areas are included below.
- President Trump’s Drug Pricing Blueprint: In early May, the Trump Administration released American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. ASH submitted comments on the blueprint on July 16. The Society’s comments focused on the proposal to move some drugs from Medicare Part B to Medicare Part D. ASH strongly opposes this proposal as it has the potential to increase out-of-pocket costs for patients due to differing benefit designs between Part B and Part D. Additionally, moving drugs from Part B to Part D will likely increase practices that could lead to unintended consequences related to quality control, patient safety, waste, and increased costs.
- Step Therapy: In August, the Administration issued guidance to Medicare Advantage plans allowing the use of step therapy for Part B drugs beginning in January 2019. ASH signed onto a letter, led by the American Medical Association (AMA), expressing concern about this guidance. Step therapy protocols that require patients to try and fail certain treatments before allowing access to other, potentially more appropriate treatments can both harm patients and undercut the physician-patient decision-making process. ASH, the AMA, and the other signees urged CMS to reinstate its 2012 policy prohibiting Medicare Advantage plans from utilizing step therapy protocols for Part B physician administered medications.
- Prescription Drug Specialty Tiers: Many insurance companies have divided prescription medications and treatments into "tiers," generally based on cost. For drugs in Tiers 1, 2, and 3, most health plans charge fixed co-pays, such as $10, $25 and $50, respectively. But increasingly, insurers are moving certain drugs into a "specialty tier" (Tier 4 or Tier 5). Instead of a copay for specialty tier drugs, patients are responsible for coinsurance, meaning they pay a percentage of the actual cost of the drug – sometimes as much as 25 percent or even 50 percent.
As part of the Coalition for Accessible Treatments, ASH has advocated for legislation in the U.S. House of Representatives (H.R. 2999, the Patients' Access to Treatment Act) that would significantly limit how much consumers pay for Tier 4 drugs (including biologics and other drugs for diseases and conditions such as cancer and anemia) by requiring a fixed co-pay for specialty tier drugs that is in line with Tier 3 drugs. The legislation, reintroduced in the 115th Congress in June 2017 by Representatives David McKinley (R-WV) and G.K. Butterfield (D-NC), would end the practice of "discriminating between medications" by requiring a fixed co-pay for specialty tier drugs that is in line with Tier 3 drugs.
Representatives McKinley and Butterfield, along with ASH and other organizations in the Coalition for Accessible Treatments, remain committed to passing legislation addressing this issue and plan to reintroduce their bill in the 116th Congress, which begins in January 2019. Supporters of the bill are also working to find a champion to introduce companion legislation in the Senate.
- Oral Chemotherapy Parity: While oral and patient-administered forms of chemotherapy have become more prevalent and represent the standard of care for many types of cancers for their convenience, efficacy, and low rate of side effects, they are covered differently than IV drugs, leaving many patients responsible for unsustainable high monthly co-payments.
- Federal Legislation – As part of the Coalition to Improve Access to Cancer Care (CIACC) (formerly the Patients Equal Access Coalition (PEAC)), ASH has advocated for legislation to ensure that cancer patients have equality of access (and equality of insurance coverage) to all approved anticancer regimens including, but not limited to oral and intravenous drugs. In early March 2017, Representatives Leonard Lance (R-NJ) and Brian Higgins (D-NY) reintroduced the Cancer Drug Parity Act (H.R. 1409), which, as of October 2018, had 170 bipartisan cosponsors. It is unlikely the bill will be considered before the end of the year. Representative Lance lost his reelection bid and will not be returning for the 116th Congress, but Representative Higgins has indicated he remains committed to the issue and plans to reintroduce the bill in the 116th Congress with an as yet to be named Republican colleague. Representative Higgins, along with ASH and other CIACC member organizations, is continuing to work to find a champion to introduce companion legislation in the Senate. (Senators Mark Kirk (R-IL) and Al Franken (D-MN) were the bill’s sponsors in the past two Congresses; however, Senator Kirk lost his reelection bid and did not return to the Senate for the 115th Congress and Senator Franken resigned from Congress in January 2018.)
- State Legislation – Although only federal legislation will ensure coverage for all cancer patients, as of September 2018 43 states plus the District of Columbia have passed legislation to limit patient out-of-pocket costs for oral anti-cancer medications. ASH has supported legislative efforts at the state level and will continue to work with stakeholders and advocacy groups to support ongoing legislative efforts in a number of additional states. Specifically, ASH has been working to support oral parity legislation in Michigan, Tennessee, and North Carolina, and has also been supporting a larger effort to limit out-of-pocket costs for all prescription medications in New Jersey.
- Michigan: As with efforts in other states, ASH continues to work as part of a larger coalition of patient and provider organizations to seek passage of oral parity legislation in Michigan. Oral chemotherapy legislation was reintroduced in June 2017, marking the fourth attempt to pass oral parity in Michigan. In October 2017, the bill passed the Senate by a vote of 36-1. However, the legislation must still pass the House, where it faces substantial hurdles, including personal opposition by the Speaker of the House. A hearing for the bill in the House Health Policy Committee was recently scheduled for December 5, 2018 potentially allowing a chance for the bill to pass the House before the end of the legislative session.
- Tennessee: Oral parity legislation was reintroduced in the Tennessee General Assembly in early February of 2017. The bill successfully passed the House Insurance Subcommittee last March and was scheduled to be considered by the full House Insurance & Banking Committee last April. However, facing opposition in the Senate, the bill’s sponsor pulled the bill from further consideration which means that the bill will not be able to pass in this legislative session. ASH’s coalition partners have decided to spend the remaining time this session educating lawmakers about the need for oral parity and dispelling myths. The bill’s longtime sponsor, Senator Ketron, will be retiring from the General Assembly to run for County Executive and so the coalition will begin searching for a new champion to introduce legislation in 2019.
- North Carolina: Oral parity legislation showed early promise in the previous legislative session by passing the House in April 2017 by a vote of 90-22, however after moving to the Senate, the bill stalled and not considered before the end of the 2018 legislative session. The bill faced considerable challenges for advancement due to the President of the Senate’s personal opposition. ASH and coalition partners will continue to work to educate lawmakers and reintroduce the bill when the new legislative session begins in 2019.
- New Jersey: ASH is part of a coalition that is advancing legislation to limit the out-of-pocket costs for all prescription medications, not just anti-cancer regimens. During the 2017 legislative session, the bill passed the Senate by a vote of 35-0 and companion legislation showed initial promise in the House by moving through committee without a single “no” vote; however, the bill was never considered by the full House. Both sponsors have reintroduced legislation for the 2018 legislative session. However, leadership in the State Assembly has shown opposition to the bill by deploying delaying tactics such as re-referring the legislation to different committees for additional consideration and votes. The New Jersey legislative session last through the end of the calendar year, so coalition partners remain hopeful that the bill may yet be considered. Should the bill not pass prior to the end of the calendar year, supporters plan to reintroduce the legislation in early 2019.
- Michigan: As with efforts in other states, ASH continues to work as part of a larger coalition of patient and provider organizations to seek passage of oral parity legislation in Michigan. Oral chemotherapy legislation was reintroduced in June 2017, marking the fourth attempt to pass oral parity in Michigan. In October 2017, the bill passed the Senate by a vote of 36-1. However, the legislation must still pass the House, where it faces substantial hurdles, including personal opposition by the Speaker of the House. A hearing for the bill in the House Health Policy Committee was recently scheduled for December 5, 2018 potentially allowing a chance for the bill to pass the House before the end of the legislative session.
ASH Action to Address Pain Management-Related Issues
ASH Released Statement on Opioid Use in Patients with Hematologic Diseases and Disorders
To address ASH members’ concern about potential adverse effects that policy changes could have on the administration of necessary and appropriate pain medicine for patients with hematologic conditions such as sickle cell disease, blood cancers, and bleeding disorder, the Society released the ASH Statement on Opioid Use in Patients with Hematologic Diseases and Disorders on March 13, 2018.
- In 2018, ASH’s nominee Dr. Amanda M. Brandow, from the Medical College of Wisconsin, was selected to serve on the United States Department of Health and Human Services (HHS) Pain Management Best Practices Inter-Agency Task Force, which was established to propose updates to best practices and issue recommendations that address gaps or inconsistencies for managing chronic and acute pain. Additionally in June, ASH submitted comments to the Taskforce, encouraged the consideration of the implications of pain in special populations including patients with hematologic conditions such as sickle cell disease, blood cancers, and bleeding disorders, as the group develops the recommendations.
Work with the Food and Drug Administration (FDA)
In 2018, ASH continued to partner with the U.S. Food and Drug Administration (FDA) to offer the following educational programs:
- On October 17-18, ASH and the FDA co-hosted the Sickle Cell Disease (SCD) Clinical Endpoints Workshop to identify opportunities to bring uniformity and standards to existing SCD endpoints, identify gaps, and propose development of new endpoints as a focus for future research.
- The ASH-FDA Speaker Series, a program where ASH brings experts to the FDA to educate their staff on important topics in hematology, continued to be well received. During the first half of the year, Dr. Wilson Wyndham, from the National Cancer Institute, presented on clinical trial design for precision medicine. The most recent program, presented by Dr. Scott Armstrong from the Dana-Farber Cancer Institute, focused on targeting epigenetic mechanisms in leukemia and solid tumors.
- ASH and FDA are co-sponsoring two programs at the ASH Annual Meeting that will feature drugs recently approved to treat hematologic disorders. FDA product-reviewers will discuss the safety and efficacy issues from the products' clinical trials and toxicity studies. The programs will also include clinicians who will discuss their perspectives on the use of the products in the real-world setting.
ASH also submitted the following comment letters to FDA to advise the Agency on the following issues with hematologic implications.
Affordable Care Act
While there have not been major legislative attempts to repeal and replace the Affordable Care Act (ACA) in 2018, significant changes have been made to the law through both regulation and legislation. The Tax Cuts and Jobs Act, which was signed into law December 2017, included language to repeal the individual mandate penalty beginning January 1, 2019. Additionally, in June, the Department of Labor released a final rule that significantly alters the way that association health plans are regulated. Essentially the rule makes it much easier for an association to be considered a single multi-employer plan under ERISA, and as such, association health plans do not have to comply with many of the ACA’s most significant consumer protections, such as the law’s rating rules and the essential health benefits. Furthermore, on August 1, the Departments of Health and Human Services, Labor, and Treasury issued a final rule to dramatically expand access to short-term, limited-duration insurance coverage. The final rule allows insurers to renew or extend short-term coverage for up to 36 months. The Obama-era rule on short-term plans limited the maximum duration to three months. Again, short-term plans do not have to comply with the ACA’s market reforms, meaning insurers can charge higher premiums based on health status, exclude coverage for preexisting conditions, impose annual or lifetime limits, opt not to cover entire categories of benefits, rescind coverage, and require higher out-of-pocket cost-sharing than under the ACA. ASH will continue to monitor changes made to the law and the potential impact on patient access to care.
