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The Patient Protection and Affordable Care Act (PPACA) gave the Department of Health and Human Services (DHHS) the power to update minimum healthcare coverage nationwide to bring it up to date with current best medical practices by directing the Secretary of DHHS to define the “essential health benefits,” (EHB) which would be the minimum coverage provided by the PPACA and would help to alleviate the gaps in medical coverage and treatment seen from state to state. The Secretary of DHHS has ignored the mandate by deciding not to provide a uniform definition of EHB.

Instead, after a year of meetings, an extensive report by the Institute of Medicine, and nationwide “listening sessions,” the DHHS announced in an Essential Health Benefits Bulletin dated December 16, 2011 (December 16 Bulletin) that it intended to allow the States the “flexibility” to choose one of the following four benchmark approaches:

1. The largest plan by enrollment in any of the three largest small group insurance products in the State’s small group market;

2. Any of the largest three State employee health benefit plans by enrollment;

3. Any of the largest three national FEHBP plan options by enrollment; or

4. The largest insured commercial non-Medicaid Health Maintenance Organization (HMO) operating in the State.

In other words, the states are allowed to choose one of four status quo approaches as the definition of EHB. Instead of aiming for a nationwide standard of care based on evidence-based and population-based medicine, the DHHS has fallen back to relying on the standards built up over years of political wrangling and insurer lobbying. The science has fallen out of the discussion.

Not only is this approach inconsistent with Section 1302(b) of the PPACA, which directs that the Secretary of Health and Human Services define essential health benefits, it is also merely reflective in that it allows a state to choose a benchmark consistent with what the state already provides. It adds no new mandate to what is covered by any state, despite the letter and spirit mandate of the PPACA.

Second, the proposed approach also seemingly ignores the findings of the October 6, 2011 IOM report, “Essential Health Benefits—Balancing Coverage and Cost” (EHB Report). The EHB Report proposes that HHS embrace a framework for establishing EHB that considers “the population’s health needs as a whole,” “encourage[s] better care by ensuring good science is used to inform coverage decisions,” “emphasize[s] the judicious use of resources,” and “carefully use[s] economic tools to improve value and performance.” The EHB Report also encourages public involvement in defining the EHB and, although it suggests “some flexibility” at the state level, does not suggest that merely looking to current coverage by large state healthcare plans is the best approach.

This is a distinction that makes a difference in the lives of many Americans. The science of medicine is evolving at a rapid rate and state-mandated insurance coverage has not kept up with the advances in medical treatment. For instance, individuals born with Phenylketonuria (PKU) and similar inborn errors of metabolism must maintain strict low protein diets and consume medical formula in order to thrive. Untreated PKU and similar disorders leads to severe mental retardation, neurological problems and other physical and mental complications. Current medical practice dictates that individuals with PKU remain “on diet” and on formula for their entire lives. Prior medical practice was to take individuals off diet and formula when they had reached a certain level of development.  Under this approach, many PKU patients suffered severe intellectual, emotional, and medical setbacks. Many state laws are outdated and do not require coverage of medical foods or formula for life. Thus, the insurance plans in those states do not provide this coverage.  Under the “intended approach” outlined in the December 16 Bulletin, those with PKU and related disorders may not receive coverage of their medical formula and low protein foods.

The approach to defining EHB as set out in the EHB Report supports defining EHB to include coverage for formulas and low protein foods to treat inborn errors of metabolism:

  • It is good science to provide coverage for medical foods and formulas to treat inborn errors of metabolism.  The science shows that medical formulas and a low protein diet work to allow children and adults born with inborn errors of metabolism to lead productive lives. Decades of evidence support treating individuals with PKU and other inborn errors of metabolism with medical foods.  Failing to ensure coverage for PKU and other inborn errors of metabolism will lead to severely damaged infants and children. Further, public policy already supports the need to identify these disorders (as reflected in mandatory newborn screening for PKU and related inborn errors of metabolism). This same policy supports mandating coverage for treatment of these disorders.

 

  • It is consistent with a “population-based” healthcare approach to provide coverage for medical foods and formulas for the entire population of individuals who suffer from inborn errors of metabolism.  All of those who suffer from inborn errors of metabolism should have the same access to the state of the art treatment for the condition, i.e. diet and treatment for life. For those who suffer from inborn errors of metabolism, medical foods and formulas are akin to insulin for individuals who suffer from diabetes.

 

  • It is consistent with ethics to provide coverage for medical foods and formulas for individuals who suffer from inborn errors of metabolism.  We know that inborn errors of metabolism can lead to catastrophic outcomes if they are not treated. We also, thankfully, know how to treat them. We know that the use of medical foods works to allow people with inborn errors of metabolism to lead normal, productive lives. It would be unethical not to provide coverage for these foods.

 

  • Finally, basic economics also supports coverage of medical foods for inborn errors of metabolism. Yes, the foods are expensive (and more expensive for those without insurance), but the burden to society at large is even greater if these individuals do not receive treatment (a treatment that we know works). They may require more care, including more frequent trips to the emergency room. And many will eventually need to be institutionalized if they are unable to afford the medical foods they need to develop properly.

It is incorrect to suggest that that the EHB Report by the IOM supports the DHHS’s intended approach as set out in the December 16 Bulletin.  As explained above, the intended approach ignores the framework suggested by the EHB Report and substitutes the current lowest common denominator approach.  Because current coverage for medical foods and formulas for those with inborn errors of metabolism is a patchwork among the states, if the DHHS implements its intended approach, many individuals with PKU and related disorders will be left without coverage for their necessary formula and medical foods. This is an unacceptable result when we know that the medical foods and formulas work to improve outcomes and cost less than the outcomes that result if we do not provide treatment.

PKU and related inborn errors of metabolism is just one example of medical problems that may not be properly addressed if the DHHS moves forward with its proposed approach of allowing the States to define EHB by what is currently covered under their large health plans.  The DHHS will have squandered an opportunity to ensure that all Americans have access to healthcare that is consistent with accepted medical practices and, in fact, will cause many Americans to be treated in accordance with what we now know to be bad medicine (such as those Americans who have PKU who are forced to go off-diet without coverage for formula and medical foods).

Disclosure: This issue is a personal one for my family. My 20-month old daughter, Juliana, was born with PKU.