Hundred dollar bills rolled up in a pill bottle

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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U.S. Capitol Building at Night

How a Public Option Would Lead to Single Payer

By Abe Sutton

This past Democratic Party presidential primary season highlighted the differences between the health policy approaches championed by Senator Sanders and President Biden.

But, despite short-term distinctions and differences in services covered between Medicare For All’s single payer and a public option built on the Affordable Care Act, I believe that in the long run, these approaches are indistinguishable. This is because a public option would lead to single payer over time.

In this post, I walk through three ways that many public option proposals would pave the way for single payer.

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Image of a gavel and stethoscope on top of each other

Reflections on Recent Medicaid Reform Efforts

By Abe Sutton

In the context of limited regulatory resources, Trump’s Centers for Medicare & Medicaid Services (CMS) prioritized allowing states to impose work requirements over Medicaid fiscal reform.

Now that the Trump Administration’s term in office has ended, it is worth exploring, with the benefit of hindsight, the value of this decision. Setting aside moral arguments used to criticize Medicaid work requirements, administering the requirements proved to be challenging, as did justifying them in court. Additionally, amid indications Medicaid work requirements will not be politically sustainable, it is worth considering whether Medicaid fiscal reform would have led to more significant taxpayer savings.

In this post, I provide an overview of Medicaid work requirements and explore some of the reforms included in the Medicaid fiscal reform proposal CMS ultimately chose not to implement.

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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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NHS building

COVID-19 and the State of Health and Social Care in England

By John Tingle

The COVID-19 pandemic has exacerbated challenges facing the provision of health and social care in England, a recent report from the Care Quality Commission (CQC) finds.

The CQC is the independent regulator of health and social care in England. Every year they produce an assessment of the state of the country’s health and social care. The yearly lookbacks include information on trends, challenges, successes, failures and opportunities.

The most recent report analyzes service provision both pre- and post COVID-19, and draws key conclusions from this information. From a patient safety perspective, the report contains important lessons about issues the COVID-19 pandemic has brought into sharp focus. The report also highlights trailing patient safety problems that existed before the pandemic, and are still present as England grapples with the pandemic’s second wave.

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

Short-Term, Limited-Duration Insurance May Be Here to Stay

By Abe Sutton

Short-term, limited-duration insurance (STLDI) may be here to stay despite legal attacks, poor branding, and a potential Democratic victory in the upcoming Presidential election.

Though the Obama administration curtailed STLDI, it is now likely to endure due to black letter administrative law and changes in circumstance since 2016.

In light of this, a potential Biden administration should package legislation codifying the current regulations with legislation increasing individual market subsidies. A package along these lines could appeal to both sides of the aisle.

In this post, I provide an overview of what STLDI is, explain why administrative law precedents complicate the reversal of current regulations, and propose a path forward for a potential Biden administration. Read More

Pile of colorful pills in blister packs

Duplicate Discounts Threaten the 340B Program During COVID-19

By Sravya Chary

The 340B program, which provides discount drugs to safety-net hospitals, faces an uncertain future due to revenue leakage faced by pharmaceutical manufacturers and increased demand spurred by the COVID-19 pandemic.

Over the last few months, growing demand for 340B drugs and hard-to-monitor billing issues have placed an immense and unforeseen financial burden on pharmaceutical manufacturers. In response, some pharmaceutical manufacturers have threatened to withhold 340B drugs from contract pharmacies, thus limiting access to steeply discounted drugs for eligible patients.

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