The ACA’s Nondiscrimination Rule: Puzzling Misreading of the Statute

By Elizabeth Sepper

Like other healthcare civil rights statutes, the Affordable Care Act’s Section 1557 links nondiscrimination requirements to federal funding. Programs that receive “federal financial assistance” can’t discriminate against individuals based on their race, sex, age or disability. HHS has proposed to exclude Medicare Part B payments from “federal financial assistance.” As a result, physicians’ offices would be outside Section 1557’s reach. The statute, however, bars this puzzling and contradictory interpretation.

For almost fifty years, HHS has taken the position that Medicare Part B payments to physicians are “contracts of insurance.” Because previous civil rights statutes—like Title VI of the Civil Rights Act and the Rehabilitation Act—explicitly excluded “contracts of insurance” from the definition of “federal financial assistance,” physicians were exempted from compliance. Payments under Medicare Part B and other insurance contracts did not suffice to create nondiscrimination obligations.

HHS’s interpretation of Section 1557 would again exclude Medicare Part B payments from the ambit of “federal financial assistance.” But, this time, the statute doesn’t allow it. Section 1557 specifically states that federal financial assistance includes “contracts of insurance.” HHS can’t have it both ways, defining Part B as “contracts of insurance” when the statute excludes them and defining Part B as something else (it’s not clear what) when the statute includes contracts of insurance. The only permissible interpretation of Section 1557 means providers who participate in Medicare can’t discriminate.

In a series of posts this week, we’re blogging on the proposed HHS Nondiscrimination Rule. You’ll find our first post here. Look for our next posts on religious exemptions and remedies under Section 1557 later this week.

The Common Rule NPRM: Biospecimens

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

As we previously announced, sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”).  The Common Rule NPRM is the latest development since the Advanced Notice of Proposed Rulemaking (“ANPRM”) was published on July 26, 2011.  The Academic and Clinical Research Group (“ACRG”) will be publishing a series of topic-specific blogs in the coming weeks to assist institutions in digesting various aspects of the proposed regulations, preparing to submit any comments by the December 7, 2015 deadline, and grappling with implementation changes once the final rule issues.  We have also prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed revisions.

In this installment, we discuss the NPRM’s proposed changes to biospecimens research.  The NPRM did not back down from one of the more controversial aspects of the ANPRM, proposing a fundamental shift in the applicability of the human subjects protection framework to non-identified biospecimens research.  However, once the shock of the new definition of “human subject” wears off, the reality is that most of the changes codify how the research community has tried to apply the existing Common Rule to the challenging arena of biobanking, secondary research, and genomic and other “omics” research.  That said, many of the carve-outs (i.e., exclusions and exemptions) intended to balance this shift are more restrictive than at first they seem.

ACRG Rapid Rundown:  Six Things You Need to Know Continue reading