illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Expanded Reimbursement Codes for Remote Therapeutic Monitoring: What This Means for Digital Health

By Adriana Krasniansky

New reimbursement codes for virtual patient monitoring may soon be incorporated into Medicare’s fee schedule, signaling the continued expansion and reach of digital health technologies catalyzed by the COVID-19 pandemic.

In July 2021, the Centers for Medicare & Medicaid Services (CMS) proposed adding a new class of current procedural terminology (CPT) codes under the category of “remote therapeutic monitoring” in its Medicare Physician Fee Schedule for 2022 — with a window for public comments until September 13, 2021. While this announcement may seem like a niche piece of health care news, it signals a next-phase evolution for virtual care in the U.S. health system, increasing access possibilities for patients nationwide.

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Reforming How Medicare Pays for Digital Health

By Robert Horne and Lucia Savage

The Fourth Industrial Revolution, also known as the digital revolution, leverages technology to blur the lines between products and services. In the health insurance sector, this revolution offers policymakers unique opportunities to improve coverage and payment efficiencies while providing meaningful benefits to beneficiaries.

Medicare could lead this charge. Congress has an opportunity to reform Medicare in 2024, when the Trust Fund will become insolvent. Policymakers expect Congress to address this problem legislatively to prevent interruptions in coverage for seniors.

If past behavior is any indication, the legislation will also include reforms to improve how the program operates and spends money. Reforms to Medicare’s traditional coverage and reimbursement approaches that harness the digital revolution can help the program secure additional value. We know this because other sectors of the U.S. economy that have fully embraced this revolution have realized additional value.

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Doctor working with modern computer interface.

To Set the Price Tag for Telehealth, First Understand Its Value

By Mary Witkowski, Susanna Gallani, and David N. Bernstein

As the economy reopens, a debate has emerged about whether to continue supporting telehealth and digital practices, or whether to return to pre-pandemic practices, practically relegating telehealth solutions and digital interactions to lower-value exceptions to traditional medical care.

The next set of regulatory and payment policies will likely set the trajectory for how digital health is integrated into the overall care model. We suggest that rather than making these policy decisions based on incremental thinking relative to historical pricing of in-person care, they ought to be based on an assessment of how they generate value for patients.

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Burgess Hill, West Sussex – 12 January, 2021 Covid-19 home PCR self-test kit.

Pandemic Diagnostics: Present and Future Implications of Self-Testing Reimbursement

By David A. Simon

The process of diagnosing a disease or condition, including detection of SARS-CoV-2 infection, is changing.

Consumers now can not only collect their specimen from their living room couch, but they can test it while watching Netflix. Sampling, testing, and obtaining results all can be done in a patient’s home.

For communicable diseases like COVID-19, the disease caused by SARS-CoV-2 infection, at-home testing has considerable public health benefits. In addition to being more convenient than traditional diagnostics, self-testing can substantially reduce or eliminate the risk that infected individuals will spread the virus en route to a testing site.

This innovation has been spurred, in part, by a powerful incentive: the federal government has all-but guaranteed reimbursement for these tests.

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A male pharmacist is examining a drug from a pharmacy inventory.

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

By Ameet SarpatwariBeatrice Brown, Alexander Egilman, 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 June. The selections feature topics ranging from an analysis of the characteristics of clinical studies supporting supplemental indications approved between 2017 and 2019, to an evaluation of the effect of California’s prescription drug coupon ban on generic drug use, to a comparison of how various international regulatory bodies approach postmarket safety communication. A full posting of abstracts/summaries of these articles may be found on our website.

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Close-up Of Stethoscope On Us Currency And American Flag.

America’s Underinsurance Crisis in the Age of COVID-19

By Dessie Otachliska

The COVID-19 pandemic has shone a light on the underinsurance crisis that has long kept millions of Americans on the precipice of financial disaster — just one unexpected illness or injury away from bankruptcy.

A 2019 Gallup poll showed that 25% of Americans reported delaying treatment for serious medical conditions due to cost concerns — the highest proportion since Gallup first began asking the question in 1991. Even during the pandemic, when medical treatment could mean the difference between life and death, studies show that nearly 1 in 7 Americans would avoid seeking medical care if they experienced key COVID-19 symptoms because of fears associated with the cost of treatment.

These statistics are unsurprising, and the concerns they underscore well-founded: the average treatment costs for COVID patients with symptoms serious enough to require inpatient hospital stays range from $42,486 for relatively mild cases to $74,310 for patients with major complications or comorbidities.

In the pandemic context, hesitance to seek medical treatment due to fear of the associated cost has proved tragically fatal. Darius Settles died after being dissuaded from seeking further COVID-19 treatment due to his uninsured status. The Nashville, TN hospital where Settles originally received care had failed to disclose the possibility that his medical costs would be covered by the federal government. And, despite the availability of reimbursement funds, the hospital nonetheless sent his widow a bill for a portion of his treatment costs.

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Baby feet in hands

Colorado Passes Landmark Birth Equity Bill Package

By Alexa Richardson

This month, activists in Colorado succeeded in passing a sweeping package of bills designed to address lack of access, inequities, and mistreatment throughout the obstetric system.

The ambitious provisions offer a new model for legislative approaches to transforming maternity care.

The bills, SB21-193, SB21-194, and SB21-101, were crafted in large part through the efforts of Elephant Circle, an organization that advocates birth justice by promoting self-determination and support for pregnant people, and tackling power and oppression. In an interview, Elephant Circle Founder and Director, Indra Lusero, described the Birth Equity Bill Package as “an opportunity to change the conversation by pulling together the broad range of issues facing pregnant people and presenting them as one coherent policy platform.”

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?

By Beatrice Brown

On June 7, 2021, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of aducanumab (Aduhelm), a biologic manufactured by Biogen for the treatment of Alzheimer’s disease.

The FDA’s decision, which went against the near-unanimous opinion of its own advisory committee following its meeting in November 2020, has been embroiled in controversy over whether the available evidence demonstrated benefits that outweigh the risks of the drug. Namely, questions remain whether: 1) the conflicting evidence from the two pivotal trials is sufficient to suggest clinical benefit worthy of approval; and 2) the surrogate measure used to justify its accelerated approval is actually correlated with clinical benefit.

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a pill in place of a model globe

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

By Ameet Sarpatwari, Beatrice Brown, 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 May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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Hundred dollar bills rolled up in a pill bottle

Aducanumab: A Bitter Pill to Swallow

By Emily Largent

On June 7, the U.S. Food and Drug Administration (FDA) used the Accelerated Approval pathway to approve aducanumab, which will go by the brand name Aduhelm, to treat patients with Alzheimer’s disease (AD). Aducanumab, developed by Biogen, is the first novel therapy approved for AD since 2003. This news has left many experts stunned.

I have at least one colleague, Dr. Jason Karlawish, who has publicly stated that he will not prescribe aducanumab. Other clinicians have said they will only prescribe it reluctantly. These are individuals who have dedicated decades of their lives to treating patients with AD, to conducting path-breaking research and serving as investigators in clinical trials, and to advocating for public policies that will better serve AD patients and their families. Many have also seen their own families affected by AD. My colleagues are hardly indifferent to the suffering wrought by AD and would like to have a meaningful treatment to offer to patients and their families. But, they have concluded, aducanumab is not it.

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