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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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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Assisted Reproductive Technologies: A Bioethical Argument for Medicaid Coverage

By Sravya Chary

Assisted reproductive technologies (ARTs) such as artificial insemination, egg retrieval, and in-vitro fertilization (IVF) have revolutionized the landscape for people facing reproductive obstacles. Disappointingly, none of these technologies are covered under Medicaid — an insurance program for low-income adults and children, and people with qualifying disabilities.

Given the high prices of ARTs, those on Medicaid, which includes a disproportionate number of BIPOC individuals, are left behind in sharing the benefits of advancements in reproductive technologies. It is vital for ARTs to be covered under Medicaid to uphold reproductive justice and autonomy for this patient population.

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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.

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Ensuring 340B Discounts Trickle Down to Low-Income Patients

By Sravya Chary

The 340B prescription drug program was created with the original intent of providing discounted drugs to vulnerable patients. However, this program inadvertently created a revenue stream for for-profit retail pharmacies and intermediaries, which is cutting into the benefit received by low-income patients.

In a previous blog post, I discussed the pitfalls of a recent 340B advisory opinion released by the Department of Health and Human Services (HHS). The aim of this opinion was to provide more clarity regarding contract pharmacy use within the 340B program. However, the opinion ultimately did not alleviate the tension between pharmaceutical manufacturers and 340B representatives.

As one facet of a long-term solution to this ongoing issue, I proposed further investigation of 340B savings to analyze whether discounts are truly trickling down to vulnerable, low-income patients.

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Pill pack.

HHS’s 340B Advisory Opinion: Helpful or Harmful?

By Sravya Chary

A recent advisory opinion released by the Department of Health and Human Services (HHS) left many 340B advocates hungry for answers and pharmaceutical manufacturers frustrated.

The 340B program discounts the price of drugs paid by safety net hospitals to pharmaceutical manufacturers. The program is of critical importance to low-income and uninsured patients, especially during the COVID-19 pandemic.

HHS should take timely measures to resolve the concerns raised by the advisory opinion and resume the free flow of 340B discounted drugs to vulnerable patients.

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A calculator, a stethoscope, and a stack of money rest on a table.

In Defense of Medicare Coverage of Innovative Technologies

By Abe Sutton

On January 12th, the Centers for Medicare & Medicaid Services (CMS) finalized a prior proposal to establish Medicare coverage for breakthrough medical devices approved by the U.S. Food and Drug Administration (FDA).

While some have expressed concerns about the proposal, I believe it is a balanced attempt to encourage innovation and CMS was right to finalize it.

In this post, I give an overview of the general regulatory standards, walk through what the Medicare Coverage of Innovative Technologies (MCIT) proposal does, and lay out a case for why it deserved to be finalized.

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a pill in place of a model globe

Issuing the Most Favored Nation Interim Final Rule Was a Mistake

By Abe Sutton

While the Most Favored Nation (MFN) Interim Final Rule (IFR) advances a well-calibrated policy to standardize pharmaceutical prices across developed nations, procedurally, its issuance was a mistake.

The Trump administration would have been wiser to issue a Notice of Proposed Rulemaking (NPRM) for two reasons: first, an NPRM would have circumvented some of the procedural vulnerabilities of the IFR. And second, had the Trump administration issued an NPRM, President-Elect Biden’s team would have faced significant pressure to finalize the policy.

In this post, I touch on what MFN is, examine why the interim final rule is legally vulnerable, explore why the Biden team likely would have adopted the policy had an NPRM been issued, and explain how industry should think about this situation.

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pills

Cuts to 340B Drug Reimbursement May be Harmful During COVID-19

By Sravya Chary

On October 19, 2020, the U.S. Court of Appeals for the District of Columbia decided not to revisit two rulings that upheld Medicare reimbursement cuts for hospitals that participate in the 340B program.

The 340B program provides drugs at discounted prices to hospitals that primarily help under-served populations. Slashing Medicare reimbursement for safety-net hospitals that participate in the program may have devastating effects on the individuals who rely on these hospitals for discounted drugs and care, especially during the COVID-19 pandemic.

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