New Federal Regulations and Proposals May Hurt High-Risk Cancer Community
October 31, 2018 - With midterm elections looming, the White House and federal agencies recently announced new regulations and proposals—ranging from drug pricing to state ACA waivers and insurance plans to health reimbursement accounts—that will impact health care in the U.S. Some may have negative consequences for our community but expansion of health reimbursement arrangements (HRAs) could provide a silver lining.
ACA and Health Plans
The Centers for Medicare and Medicaid Services (CMS) released new guidance that will significantly change the standards that states must meet to be granted a waiver from certain Affordable Care Act (ACA) requirements. In an effort to give states more power and flexibility, the Administration would permit them to revise their health insurance marketplace rules, allowing the addition of cheaper plans that offer fewer benefits and less coverage. These plans—likely to attract younger, healthier Americans—won't be required to cover pre-existing conditions, key cancer screenings or treatment.
While not slated to take effect until 2020, the departure of young, healthy people from the traditional ACA marketplace plans could lead to higher premiums for everyone else. The cancer community may be especially hard-hit.
Drug Pricing and Cost Transparency
In recent weeks, the Administration announced proposals aimed at lowering the cost of drugs in the U.S. as well as improving cost transparency. The International Pricing Index (IPI) model proposal would require medications paid for by Medicare (known as Part B drugs) to be reimbursed based on the drug prices in other "economically-similar countries." It was announced shortly after the release of a report comparing prices charged by drug companies in the U.S. with prices charged in other countries. The report states that "prices and reimbursement rates for Part B drugs are significantly higher for U.S. providers" but also notes a number of caveats and limitations of the analysis. We are hopeful that this proposal will not create a standoff between pharmaceutical companies and U.S. health insurers. FORCE wholeheartedly supports lower drug pricing as long as it does not impact accessibility for patients.
The Administration also issued a Drug Pricing Transparency proposal that would require pharmaceutical companies to include in television ads the list price of any drug paid for by Medicare or Medicaid that exceeds $35/month. Many drugs will not be subject to these drug pricing transparency requirements because they are not advertised on TV. As a result, this proposal will not provide a complete picture of available drugs and their costs. It has the potential to confuse patients and deter them from seeking medications because the list price often seems exorbitant and does not reflect what they will ultimately pay. Some people may forgo treatment if they think it will be too costly. This could be especially detrimental for cancer patients and those on medications to help lower cancer risk.
FORCE supports transparency in health care costs and making medications more affordable and accessible for patients. We will submit comments on behalf of our community and will continue to monitor these proposals as they progress.
Health Reimbursement Arrangements (HRAs)
A newly proposed rule would allow small- and medium-sized employers to fund tax-free accounts called health reimbursement arrangements (HRAs) that workers can use to buy their own coverage on the ACA marketplaces. Whether this is a positive thing for the cancer community remains to be seen.
One concern is that employers may try to entice less healthy employees to accept the HRA and move to the individual market. With an increased number of "high-risk" individuals in the marketplace, premiums will likely rise. We will be tracking the HRA proposal and its possible consequences in the coming months.
4/25/2022 - FORCE added its support to an effort spearheaded by SNMMI asking the House Energy and Commerce and Ways and Means Committee Leadership to schedule a hearing on the Facilitating Innovative Nuclear Diagnostics (FIND) Act.
5/2022 - Joined a coalition letter to the HHS Secretary emphasizing that regulatory reform of the framework for clinical laboratory diagnostics is essential to protect patients and ensure access to innovative, high-quality diagnostic tests.
3/29/2022 - Signed on in support of the Right Drug Dose Now (Right) Act, which will advance utilization of evidence-based pharmacogenomic (PGx) information in clinical practice, advance precision medicine, and improve quality of care.