Health Policy Weekly 04 08 22

April 22, 2022

Health Policy Weekly

Hospitals say IPPS not enough

Apr 22, 2022

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Hospitals say IPPS not enough

On Monday, the Centers for Medicare & Medicaid Services (CMS) released the proposed rule for updating the fiscal year (FY) 2023 Medicare Hospital Inpatient Prospective Payment System (IPPS) for acute care hospitals and long-term care hospitals’ prospective payment system.

The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users is approximately 3.2%. This reflects the projected hospital market basket update of 3.1% reduced by a 0.4% productivity adjustment and increased by a 0.5% adjustment required by legislation. Responding to the 3.2% payment increase, the American Hospital Association issued a statement calling it “simply unacceptable,” due to “the extraordinary inflationary environment and continued labor and supply cost pressures hospitals and health systems face.”

New technology add-on payments (NTAP)
CMS received 18 new applications for NTAP for FY 2023 under the traditional pathway; 5 applicants subsequently withdrew their applications. We have organized the 13 remaining applications by drug/device and therapeutic area. Discussions of the applications start on page 279 of the display copy.

FY 2023 NTAP applications under the traditional pathway

	Therapeutic area	Product name	Disease/condition
Drug	Oncology	CARVYKTI (ciltacabtagene autoleucel)	Multiple myeloma (chimeric-antigen receptor [CAR] T-cell therapy)
		lifileucel	Melanoma
		mosunetuzumab	Multiple myeloma
		treosulfan	Preparative regimen for allogenic hematopoietic stem cell transplantation in patients with acute myeloid leukemia or myelodysplastic syndrome
	Protein disorder	DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)	Light chain amyloidosis
	Anti-viral	LIVTENCIT (maribavir)	Post-transplant cytomegalovirus infection/disease
	Cardiovascular	narsoplimab	Hematopoietic stem cell transplantation-associated thrombotic microangiopathy
	Cardiovascular	TERLIVAZ (terlipressin)	Hepatorenal syndrome type 1
	Autoimmune	spesolimab	Generalized pustular psoriasis
	Central nervous system	UPLIZNA (inebilizumab-cdon)	Anti-cluster of differentiation 19 B-cell depleter for treatment of neuromyelitis optica spectrum disorder
Device	Respiratory	Hemolung Respiratory Assist System	Respiratory failure
Device	Respiratory	XENOVIEW (hyperpolarized Xenon-129 gas for inhalation)	High-resolution, 3-dimensional images of the lungs and assessment of their functional status when inhaled by a patient during a pulmonary MRI scan

CMS proposed to discontinue the NTAP for 11 technologies because they are no longer “new.” The technologies are listed in table II.F.-01 on page 268 of the display copy. CMS proposed to continue the NTAP for 15 technologies because they would still be considered new (page 303). The technologies are listed in table II.F.-02 on pages 273 and 274 of the display copy.

Last year, CMS proposed to extend the NTAP for 13 technologies that otherwise would be discontinued in FY 2022 because they would no longer be considered new. The agency justified this one-time exception due to the “utilization of inpatient services reflect[ing] generally markedly different utilization for certain types of services in FY 2020 than would have been expected in the absence of the PHE [public health emergency].” CMS proposed to discontinue the NTAP for those technologies in FY 2023; they are listed in table II.F.-03 on pages 277 and 278 of the display copy.

Beginning with applications for FY 2021, a medical device that is part of the Breakthrough Devices Program of the Food and Drug Administration (FDA) and has received marketing authorization for the indication covered by the Breakthrough Device designation may qualify for NTAP under an alternative pathway. CMS received 19 applications for NTAP for FY 2023 under the alternative pathways. Six applicants withdrew applications before CMS issued the proposed rule. Discussion of the remaining 13 applications begins on page 547 of the display copy.

Revisions to quality programs due to COVID-19 PHE
Due to how the COVID-19 PHE skewed measure data, CMS proposed to suppress several measures in the Hospital Value-Based Purchasing (VBP) and Hospital-Acquired Condition (HAC) Reduction Programs. CMS also proposed a special scoring methodology for FY 2023 that would result in each hospital receiving a value-based incentive payment amount that matches their 2% reduction to the base operating diagnosis-related group (DRG) payment amount. The agency also proposed to suppress all 6 measures in the HAC Reduction Program for FY 2023. As a result, hospitals participating in the HAC Reduction Program will not be given a measure score, a Total HAC Score, nor will hospitals receive a payment penalty in FY 2023.

The proposed rule will be published in the May 10 edition of the Federal Register and becomes effective October 1, 2022.

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Value Corner

UPI: ICER tells manufacturers don’t call us, we’ll call you

Yesterday, the Institute for Clinical and Economic Review (ICER) announced plans to assess the comparative clinical effectiveness and value of treatments for multiple sclerosis. Stakeholder comments are being accepted on the Draft Scoping Document through May 12, and the topic will be reviewed by the New England Comparative Effectiveness Public Advisory Council (CEPAC) in January 2023.

Last Thursday, ICER posted a protocol on how it will conduct its fourth analysis of “Unsupported Price Increases” (UPI) among prescription drugs in the US market. ICER will examine the most significant price increases that occurred in 2021. This year’s analysis will also evaluate whether new evidence was available to support the 3 highest list price increases in 2020 for drugs covered through Medicare Part B. ICER will notify manufacturers with products potentially under review between April 27 and May 18, and the final report is expected to be published on December 6.

Last Wednesday, ICER published its Draft Evidence Report on the comparative clinical effectiveness and value of betibeglogene autotemcel (beti-cel), a potentially curative gene therapy, for the treatment of beta thalassemia. ICER found beti-cel to be superior to standard of care (lifelong regular blood transfusions and iron chelation therapy), with an uncertain magnitude of net health benefit ranging from incremental to substantial. ICER’s preliminary cost-effectiveness analysis included co-base cases with a cost per quality-adjusted life-year (QALY) gained for beti-cel compared to standard treatment of $92,200 in the healthcare system perspective and $33,600 in the modified societal perspective, meeting ICER’s thresholds for cost-effectiveness. Of note, ICER’s analysis assumes payment is made through an outcomes-based contract in 5 equal yearly payments totaling $2.1 million, with payment only made for patients who achieve and maintain independence from transfusion through all 5 years. ICER is accepting stakeholder feedback on these preliminary findings through May 10.

Last Tuesday, the Midwest CEPAC held a public meeting on ICER’s “Special Assessment of Outpatient Treatments for COVID-19.” Relative to usual symptomatic care, the voting panel rated the long-term value for money of molnupiravir as low to intermediate, PAXLOVID (nirmatrelvir/ritonavir) as intermediate to high, and fluvoxamine as intermediate to high. Public comments during the meeting called for the use of a modified societal perspective as a co-base case and the need to re-engage with patients and their representatives regarding the impact of COVID-19. The Final Evidence Report will be published on May 10.

Earlier this month, the Partnership to Improve Care (PIPC) announced a new website to track state-specific policy proposals that reference ICER or the QALY.

If you need assistance with all things ICER or value-related, please contact Kimberly Westrich.

Digital interview: Addressing medication affordability amid evolving copay rules

AmerisourceBergen experts Colleen Cummins and Corey Ford outline copay considerations for biopharma companies amid an evolving regulatory landscape.

Watch interview

Regulatory Update

Supreme Court hits escape key on Medicaid work requirements

On Monday, the Supreme Court of the United States (SCOTUS) announced it will no longer review the legality of Medicaid work requirements. Instead, SCOTUS referred the matter to the Secretary of Health and Human Services (HHS) to determine the appropriate path forward for Medicaid work requirements.

At issue was Medicaid work-related requirements in Arkansas and New Hampshire. SCOTUS agreed with the Biden Administration that the issue is moot, as Medicaid work-related requirements have been paused since the beginning of the COVID-19 pandemic in 2020. Implementation of the programs has been halted as a condition of states accepting federal money. The Families First Coronavirus Response Act passed into law in March 2020 conditions a state’s receipt of an increase in federal Medicaid funding during the pandemic on its maintaining certain Medicaid parameters. Every state accepted money, including Arkansas and New Hampshire; therefore, no state may currently implement a work-related requirement.

A dozen or so Medicaid work-related requirements have either been approved or are pending before HHS. Without a legal resolution, we may continue to see legal challenges while the HHS Secretary determines next steps. Most recently, Georgia sued CMS after the Biden Administration rescinded Georgia’s work requirement.

Information buffet (AKA, other stuff that caught our attention)

The FDA released draft guidance on diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials.
CMS announced a series of cross-cutting initiatives (CCIs) to support its 6 strategic pillars—advance equity, expand access, engage partners, drive innovation, protect programs, and foster excellence—released last year.
CMS sent the proposed rule, CY 2023 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B, to the Office of Management and Budget for review.
Amneal Pharmaceuticals announced the FDA has approved its Biologics License Application for ALYMSYS (bevacizumab-maly), a biosimilar referencing AVASTIN (bevacizumab) that was developed by mAbxience. The product represents the third bevacizumab biosimilar approved in the US and the 36th biosimilar approved in total.
The Commonwealth Fund posted a blog on the ramifications of winding down Medicaid’s continuous enrollment protection for beneficiaries instituted during the PHE.
A JAMA Internal Medicine study found many National Cancer Institute-designated cancer centers mark up the price of infused cancer therapies for patients with private insurance “substantially,” ranging from 120% to 630% of estimated hospital acquisition costs.
Louisiana’s attorney general sued UnitedHealth Group’s OptumRx and UnitedHealthcare businesses, alleging the pharmacy benefit manager and insurer overcharged the state’s Medicaid department by billions of dollars through inflated prescription drug prices.

Heard on the street

“Although ADUHELM was barely mentioned during the hearing on AMX0035—which was convened by the FDA’s Division of Neurology, which also reviewed ADUHELM—its shadow was apparent as reviewers emphasized shortcomings in the Amylyx study instead of its strengths.”

– A person with amyotrophic lateral sclerosis commenting about how the criticism the FDA received over its approval of ADUHELM (aducanumab) appeared to color how the same advisory panel weighed the clinical evidence of Amylyx’s drug to treat ALS

Source: “Will the shadow of ADUHELM cloud FDA’s decision-making on an ALS therapy?,” STAT, April 21

Policy by numbers

$4,152

The Affordable Care Act caps an employee’s costs based on their income—but only for their own coverage, as that limit has not yet been extended to family coverage. The Biden Administration is considering a regulatory fix to this problem, known as the “family glitch.” Fixing the family glitch would reduce healthcare costs by $4,152 for a family of 4 with an income of $53,000.

Source: “Capping families’ health care costs: savings by state,” Third Way, April 13

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Featured contributors

Editor-in-chief

Jennifer Snow

Vice President, Reimbursement and Policy Insights, Xcenda

Managing editor

Scott Shields

Associate Director, Health Policy,
Xcenda

Contributing editor

Daniel Fellenbaum

Assistant Director, Reimbursement and Policy Insights,
Xcenda

Advisory board:

Willis Chandler
SVP and President | Biopharma Services and Commercial Solutions | AmerisourceBergen

Tommy Bramley, PhD, RPh
SVP, Global Consulting | AmerisourceBergen

Rita Norton
SVP, Government Affairs and Public Policy | AmerisourceBergen

Ana Stojanovska
Vice President | Commercial Consulting | AmerisourceBergen

Contributing authors:

James Amamoo | Leigh Gallo | Scott Shields | Kimberly Westrich

Production:

Laurie Kozbelt | Frank Jorfi