WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

Now Is the Time for a Sex-Based Civil Rights Movement in Health Care

By Valarie K. Blake

The Biden administration and all three branches of government are poised to finally deliver a sex-based civil rights movement in health care that generations have waited for.

Sex discrimination is prevalent in health care, but especially so for LGBTQ people. Combine this with other forms of discrimination that LGBTQ people experience, and the result is a population that suffers from serious health disparities, including heightened risks of mental health conditions, substance use disorders, and suicide.

A much needed ban on sex discrimination in health care finally passed in 2010, as part of the Affordable Care Act (ACA). Section 1557 of the ACA prohibits health care entities that receive federal money from discriminating on the basis of sex, along with race, age, and disability. Specifically, Section 1557 bans sex discrimination in health care by way of extending Title IX, which previously applied to educational entities only. Section 1557 reaches most hospitals, providers, and insurers. Sex equality in health was a long time coming. Similar bans on discrimination by recipients of federal money had passed decades earlier: race discrimination in 1964, disability discrimination in 1973, and age discrimination in 1975.

Despite its historic nature, Section 1557 has yet to deliver on its promise, owing to delays and volatility in rulemaking and near-constant litigation. The statute was barebones, requiring interpretation, but the Obama administration only promulgated a rule and began full enforcement six years after the passage of the ACA. The Obama rule broadly banned gender identity and sexual orientation discrimination, but the part of the rule banning gender identity discrimination was judicially stayed only months later in Franciscan Alliance v. Burwell.

Read More

stethoscope, pills, ampules, and notepad with "claim denied" written on it.

Preserving Meaningful External Review Despite Insurers’ Rulification of Medical Necessity

By Daniel Schwarcz and Amy B. Monahan

Increasingly, health insurers are crafting their coverage terms in ways that undermine a vital consumer protection created by the Affordable Care Act (ACA): the right to appeal health plan claim denials that are based on medical judgments to an independent, external reviewer. The ACA extended this right to all health plans to protect consumers against the risk of unreasonable coverage determinations — a risk that is all too familiar given insurers’ financial incentives to deny claims.

Yet, as revealed by our new article, Rules of Medical Necessity, this essential consumer protection is becoming increasingly illusory as health insurers shift from broad standards to concrete rules for defining when care is medically necessary. For that reason, this post proposes that the Biden/Harris administration should promulgate rules allowing external reviewers to set aside insurers’ rules of medical necessity even when they are contained in insurance policies or formal health plan documents. Instead, federal regulations should make clear that the ACA requires external reviewers to apply traditional, standard-based, definitions of medical necessity when reviewing denials of coverage that are premised on medical judgments.

Read More

Symposium Introduction: Recommendations for a Biden/Harris Health Policy Agenda

By Erin C. Fuse Brown

This digital symposium explores recommendations for the Biden/Harris administration’s health policy agenda. We asked leading health law scholars to describe one health policy action the administration should pursue, beyond the pandemic response. Their recommendations make up this symposium. The responses range from concrete policy changes to broad reform ideas and can be grouped into three categories, those that (1) Reverse and Restore; (2) Reinforce; (3) Reform.

Read More

Steps 1, 2, 3, 4 signpost.

The Ongoing Step Therapy Debate

By Laura Karas

Senator Lisa Murkowski’s (R-AK) reintroduction this February of a federal bill, the Safe Step Act, has revived the debate over the prudence of step therapy protocols.

Step therapy is an insurer utilization-management tool imposed in response to high drug prices. As its name implies, step therapy requires “steps” before a patient can receive his preferred medication (i.e., the one his provider has prescribed). Typically, a patient must “try and fail” a less costly medication or series of medications before becoming eligible for insurance coverage of the medication in question. In effect, step therapy allows an insurer’s “preferred therapy” to supersede patient and provider preference.

The need for step therapy is closely bound to the problem of high drug prices. But the crux of the step therapy debate boils down to the following: Who should decide which pharmaceutical drugs your health plan covers? You and your doctor, or your insurer?

Read More

gavel on top of a pile of bills and pills

Federal Court Halts Implementation of 340B Dispute Resolution Rule

By Sravya Chary

The U.S. District Court for the Southern District of Indiana’s recent decision to grant Eli Lilly’s motion for a preliminary injunction rightfully halted the implementation of a dispute resolution rule for the 340B Drug Pricing Program.

The Alternate Dispute Resolution Final Rule (“ADR Final Rule”), issued on December 10, 2020, attempted to settle oft-occurring battles between pharmaceutical manufacturers and 340B covered entities. A few weeks later, the Department of Health and Human Services (HHS) released a 340B advisory opinion defining the department’s understanding of the statute.

The 340B Drug Pricing Program was established by Congress in 1992 with the intent to stretch federal resources to serve the nation’s most vulnerable patients. In practice, however, the program has deviated from its original intent.

Read More

Senior citizen woman in wheelchair in a nursing home.

Telehealth and the Future of Long-Term Care

Join us on Wednesday, April 7 for further discussion of these issues during our virtual event, “Triumphs & Tensions of the Telehealth Boom.

By Tara Sklar

The COVID-19 pandemic accelerated the trend away from providing health care and long-term care in institutional settings in ways not previously imagined; the result of a reckoning with the massacre that disproportionately killed hundreds of thousands of older adults living in nursing homes or similar congregate facilities, along with the staff who cared for them.

Beyond the immediate staffing and infection control issues at hand, this juncture leads to a larger question, in the U.S. and abroad: how can we best care for an older population in the decades — and not just years — ahead?

The major advances and shortfalls that have surfaced during the pandemic around telehealth and its related technologies in digital home health care are essential to this discussion.

Read More

Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Viewing Telehealth Policymaking Through the Lens of Disability

Join us on Wednesday, April 7 for further discussion of these issues during our virtual event, “Triumphs & Tensions of the Telehealth Boom.

By Laura C. Hoffman

As a means for delivering health care, telehealth will only be as successful as it is accessible to our most vulnerable populations.

Although the utilization of telehealth has the great potential to increase access to health care while simultaneously reducing barriers to access for individuals, people with disabilities face multiple barriers to telehealth. The COVID-19 pandemic has further highlighted these challenges.

Read More

Hundred dollar bills rolled up in a pill bottle

New Rule Might Increase Out-of-Pocket Drug Costs for Patients

This blog post is adapted from a commentary published in the American Journal of Managed Care.

By Bryan Walsh andAaron S. Kesselheim

Patients may face increased out-of-pocket drug costs as a result of a new rule finalized by the Centers for Medicare & Medicaid Services (CMS) in July 2020 that would permit wide use of co-pay accumulator adjustment programs (CAAPs).

These increased costs may have effects on medication adherence, and in turn may affect health outcomes. In a recent commentary published in the American Journal of Managed Care, we explain the background to this rule and suggest ways CMS could narrow it to avoid these potential negative effects.

Read More

Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

Doctor, DNA, microscope concept illustration.

Legislative Success in FL Suggests Time is Ripe for Further Genetic Nondiscrimination Protections

By Anna C F Lewis and Anya E R Prince

On July 1, a law banning the use of genetic information by life, long-term care, and disability income insurers took effect in Florida.

Florida’s success marks a potential turning point of bipartisan appeal for this issue.

The passage of this law, which we explore in a recent article published in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), was propelled by a campaign that argued that an individual’s DNA should not be weaponized against them, that affordable insurance shouldn’t just be for the genetic elite, and that an individual should be able to keep their genetic data private.

Read More