National Hemophilia Foundation Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule
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We appreciate the opportunity to submit these comments on the Notice of Benefit and Payment Parameters for 2023 (NBPP). Separately in this docket, HFA and NHF have joined with other national patient advocacy groups to commend many of the 2023 NBPP's proposed policies - as well as to suggest areas where the NBPP can and should go further to improve access to coverage and care. In this letter, we supplement those comments to highlight several issues especially important to the blood disorders community. First and foremost, we reiterate our longstanding request for consumer protections against copay accumulator adjustment policies. We also urge you to strengthen NBPP standards governing nondiscrimination in benefit design, inclusion of essential community providers (ECPs), formulary adequacy, and plan transparency for drugs covered under the medical benefit.
About blood disorders and current patient challenges in accessing care Hemophilia is a rare, genetic disorder that impairs the ability of the blood to clot properly for about 30,000 Americans. Without treatment, people with hemophilia can bleed internally, sometimes as a result of trauma, but sometimes simply from everyday activities. This bleeding can lead to severe joint damage and permanent disability, or can even - with respect to bleeds involving major organs and/or the brain -- lead to death. Another prevalent inherited blood disorder is von Willebrand disease (vWD), which is estimated to affect more than three million Americans.
Individuals living with blood disorders have complex, lifelong medical needs. They depend on the ongoing use of prescription biologic medications (clotting factor or other novel therapies) to avoid and/or treat painful bleeding episodes, that if left untreated, could lead to permanent joint damage and debilitating lifelong pain, and as mentioned above, even death. These biologic medications, derived from human blood plasma or created by recombinant technology, are highly effective, but extremely expensive. Since there are no cheaper generic or biosimilar equivalents, the annual cost can exceed several hundred thousand dollars annually. As a result, people living with blood disorders depend on access to quality health coverage, comprehensive pharmacy benefits, and meaningful affordability protections.
Strengthen discriminatory benefit design policies Our organizations strongly support your proposals to strengthen safeguards against discriminatory benefit designs. The needs of people with blood disorders are significantly challenged by current trends in health spending and insurance benefit design, including increasing out-of-pocket (OOP) costs./1
These burdens are exacerbated by payer strategies that target specialty and high-cost medications via tiering and coinsurance. Such benefit designs increasingly shift costs to the "sickest" enrollees - exposing them to onerous annual cost-sharing, impeding access to treatment, and undermining the protections against financial toxicity that insurance should confer./2
It's hard not to conclude that these plan designs are used to discourage enrollment by individuals needing high-cost care/3 -- subverting the Affordable Care Act's (ACA) promise of quality health insurance for all Americans, regardless of health status.
We agree with your statement that adverse tiering strategies - where all treatments for a chronic condition are placed on the highest tier - are presumptively discriminatory. We encourage you to prohibit such tiering strategies, outright, and to take action against additional related practices. For example, many plans implement discriminatory coverage policies of drugs covered under the medical benefit (a category that includes blood disorder treatments some 50% of the time). Similar to adverse tiering, plans often employ burdensome utilization management policies that impede timely access to care. And finally, as discussed below, plan use of copay accumulator adjuster programs has discriminatory effect.
Policy request: We ask that, in addition to refining nondiscrimination requirements as they apply to plan design, you explicitly prohibit any harmful and discriminatory practice that impedes access to care.
Protect patients who rely on copay assistance programs to meet cost-sharing requirements Because patients with blood disorders require medication therapy over the course of their lifetime, most face the prospect of hitting their OOP maximums year after year (in 2022, up to
Given this reality, copay assistance programs are a lifeline and are often the only way that many individuals with blood disorders can afford their OOP costs, access their medications, and adhere to their treatment regimens.
That lifeline is threatened by the application of insurer/PBM copay accumulator adjuster programs (CAAPs). Payers that use this strategy accept copay assistance, but then disregard the dollars received when calculating the member's deductible and/or OOP maximum. The copay assistance funds end up benefiting the payer's bottom line, and not the patient. When the copay assistance dollars run out, the member's accumulator (OOP) is reset to reflect what the patient paid out of their own pocket, leaving them to either pay the entire deductible and/or other OOP costs, (up to the full
In general, copay assistance is only available for specialty medications (i.e., biologics, infused or injectable drugs). These medications are typically used by people living with chronic or life-threatening conditions.
It is all too easy for health plans to implement CAAPs as a way of adversely selecting against such costly enrollees. In this manner, they undermine ACA protections for people with pre-existing conditions. These policies target the most financially and medically vulnerable patients, enabling insurance issuers to engage in what amounts to "backdoor" underwriting of insurance policies for those who use specialty medications.
As noted above, we support your proposals to address discriminatory benefit designs and ensure that insurance plans do not discriminate against people living with chronic illness through adverse tiering.
While we support CMS' intent to ensure that benefit design reflects clinical evidence rather than discriminate against people with higher health care needs, we strongly urge CMS to include language in this section prohibiting use of CAAPs, which discriminate against people living with chronic illness. The other benefit designs identified by CMS are obviously discriminatory, but so too are CAAPs.
Policy request: We urgently request HHS and CMS to require issuers and pharmacy benefit managers to count patient copay assistance dollars received by or on behalf of an enrollee, toward a beneficiary's out-of-pocket costs, putting patients' health first. In so doing, the Departments would uphold and build on the ACA's promise of meaningful health insurance for all Americans, regardless of health status.
Strengthen standards requiring plans to provide access to hemophilia treatment centers (HTCs) The NBPP proposes to strengthen network adequacy requirements and to increase the required participation of essential community providers (ECPs) in federally-facilitated marketplace plans. HFA and NHF support these changes and ask the agencies to take additional steps to safeguard access to HTCs.
Federally recognized HTCs provide integrated, multi-disciplinary, patient-centered care for people living with blood disorders and associated long-term complications, including inhibitors, liver disease and HIV/AIDS. The HTC network includes approximately 140 centers of excellence across the US that receive federal grants from the Health and
The ACA designates hemophilia treatment centers (HTCs) as ECPs - but patients still often face obstacles in gaining access to these providers due to HHS policies. Under current HHS policy, HTCs may be excluded from qualified health plans' (QHPs) networks despite their designation as ECPs, because HHS has categorized HTCs in the "Other ECP Providers" category along with STD clinics, TB clinics, Black Lung clinics and other entities. These providers serve very distinct patient populations, and yet plans could satisfy ECP policies by contracting with a TB clinic, rather than an HTC. In this case, individuals with bleeding disorders would not have access to providers with the needed expertise in their condition.
Currently, plans may exclude HTCs from their networks because it is an easy and apparently-compliant way to structure a network that adversely selects against high-cost enrollees with blood disorders. To guarantee QHP network adequacy, we respectfully request that HHS and CMS make accommodations to categorize HTCs separately, similar to
Policy Request: We ask that HHS and CMS remove HTCs from the "other ECP" category and categorize them separately.
Elucidate drug coverage standards and enhance transparency for drugs covered under the medical benefit
Current Essential Health Benefit (EHB) policies set standards for drug coverage based on US Pharmacopeia (USP) categories and classes. For years, however, USP categories focused on drugs covered under Medicare Part D - whereas treatments (injectables) available to treat hemophilia and related blood disorders fall within the scope of Medicare Part
Likewise, we strongly support requirements concerning formulary transparency, but current requirements only apply to plans' pharmacy benefit and do not extend to therapies covered under the medical benefit. It is particularly important for the blood disorders community that they understand whether their products are covered, what tier the products are placed on, and what the co-payments and/or co-insurance are for their needed medications. Please revise current transparency requirements to include drugs covered under medical benefit as well as those covered under the pharmacy benefit.
Policy Request: We ask that HHS and CMS clarify EHB standards for Part B covered drugs that will ensure inclusion of these essential medications in benchmark plan formularies. We also ask that you require transparency for drugs covered under the plan's medical benefit as well as for those products that appear in the formulary under its pharmacy benefit.
Conclusion
HFA and NHF appreciate the opportunity to provide these comments on the 2023 NBPP. We are deeply invested in ensuring that all people with blood disorders have access to affordable, quality health insurance, and appreciate your agencies' attention to the needs of the patient community. Please contact
Sincerely,
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Footnotes:
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4/ Recall that bleeding disorders are genetic and therefore often affect multiple individuals within a family - increasing the financial exposure for such families. See, e.g,
5/
6/ Six in 10 respondents to a recent national survey reported that they would have extreme difficulty affording their medication if copay assistance is not counted toward their out-of-pocket costs. NHF Press Release: National Patient & Caregiver Survey Shows that COVID-19 Has Exacerbated Treatment Affordability Challenges & Health Inequities for Vulnerable Americans (
7/
8/ Meanwhile, patients who manage somehow to scrape together the funds to continue on their treatment regimens will suffer a significant hit to their financial security -- while their health plan collects twice (or more) on the patients' deductibles. Limits on Copay Assistance Can Threaten Families' Financial Security. HFA Dateline (Spring 2021). https://www.hemophiliafed.org/dateline/HFA_Dateline_2021_Q1_Spring/
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The proposed rule can be viewed at: https://www.regulations.gov/document/CMS-2021-0196-0001
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