Originally written by Joyce Frieden and published on MedPageToday on 08/15/2022.
WASHINGTON — What has 308 pages and discusses everything from pregnancy to Medicare Part B? It’s the proposed rule from the Department of Health and Human Services (HHS) implementing the non-discrimination parts of the Affordable Care Act (ACA).
The proposed rule, which was published August 4 in the Federal Register, implements Section 1557 of the ACA, which addresses non-discrimination in healthcare. The Biden administration has interpreted that section of the act very expansively, which means that the rule would cover a wider range of healthcare providers than it did under previous administrations, said Katie Keith, JD, MPH, director of the Health Policy and the Law Initiative at the Georgetown University Law Center in Washington. For example, it will “apply to Medicare Part B providers for the first time, and will require physicians to not be discriminatory in all these ways,” she said.
Maryanne Tomazic, JD, MPH, clinical instructor at the Harvard Law School Center for Health Law and Policy Innovation in Cambridge, Massachusetts, agreed. “This proposed rule is a lot stronger, and a welcome change for many,” she said, adding that it expands protections for several groups, including “people who are LGBTQIA. Discrimination manifests itself in the healthcare system in many ways; patients can face physical or linguistic barriers when they try to access care. Some patients have health insurance that will categorically exclude care related to gender dysphoria or other diagnoses.”
“We’ve also seen patients have insurance plans that will take groups of drugs used to treat a certain chronic condition like HIV, and put those drugs on the most expensive formulary tiers, leaving the patient and the provider with no affordable options for treatment,” Tomazic said. “The proposed rule will result in a very strong final rule that prevents these situations from happening, and where it doesn’t, it explains how people can seek redress.”
The administration is also requiring the non-discrimination provisions to apply across an entire organization even when a particular provision applies only to part of the entity, which is different from the Trump administration’s interpretation. Under the Trump administration, the idea was “if you sell [an ACA] marketplace plan, this just means you can’t discriminate there, but under Biden it applies to all of these bigger and broader products,” Keith said. “They’re saying, ‘We want this to apply in a very comprehensive way.'”
As far as applying the provisions to physicians who take Medicare Part B, “I don’t know how many more physicians and Part B providers this brings in,” since many physicians may already have been included under other provisions, Keith added. “But they just wanted to button it up and say that Part B was included.”
Tomazic said that HHS had taken a “different stance” in the past regarding including Part B in the non-discrimination rule. “To determine whether someone had to comply with a non-discrimination protection, the agency looks in part to whether they receive federal financial assistance,” she explained. “In the past, they excluded those receiving Medicare Part B payments because Part B was seen as a payment to the beneficiary, who paid out-of-pocket first for the services. This rule recognizes that nowadays the program is structured differently, in that providers, if they participate in Part B, directly bill [Medicare] and receive payment” or indirectly participate in the program because their patients receive Part B funding.
The proposed rule also seeks to address discrimination related to pregnancy, including pregnancy termination, said Nicole Huberfeld, JD, professor of health law, ethics, and human rights at the Boston University School of Public Health. By seeking comments on this portion of the proposed rule, “it seems to me that they were trying to figure out how the Dobbs decision of the Supreme Court impacts an interpretation of discrimination on the basis of sex that includes every facet of pregnancy.” Huberfeld was referring to the recent Supreme Court decision that overturned Roe v. Wade.
The proposed rule also requires some healthcare entities to appoint a “1557 coordinator, so there’s a compliance aspect to this,” Huberfeld said. “And policies are supposed to be clearly stated, including for people with limited English proficiency, and training is supposed to occur. Big entities, I imagine, will incorporate Section 1557 into their compliance programs.”
Huberfeld also noted that the rule will likely interact with state laws that put limitations on treatment of transgender children. “I see potential for conflict there,” she said.
The rule also addresses discrimination that occurs in clinical algorithms used in healthcare decision-making, Tomazic pointed out. “While these algorithms can be helpful in forming these healthcare decisions, we need to take a critical eye on what these tools are based on. If the underlying theory is flawed or biased itself, using the algorithm to dictate care can be discriminatory and even exacerbate existing disparities.”
One example, which is cited in the proposed rule, is the kidney function measurement known as estimate of glomerular filtration rate (eGFR); providers sometimes use an algorithm that “has incorporated an adjustment for race and ethnicity, and because of that adjustment … it could inappropriately keep people who are Black from certain treatment options, like being on the transplant list,” she said.
She encouraged providers to send in their comments about the rule; comments are due by October 3. “A rule that is informed by discrimination people face has the potential to be more effective. And healthcare professionals are at a position of knowing what their patients face when navigating the healthcare system. They know what it’s like to get the denial from insurance … This is an opportunity for them to kind of raise up the economic barriers that their patients are experiencing — or that they themselves experience — in the healthcare system.”