CMS proposes $9B repayment to 340B hospital participants

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Earlier this week, the Centers for Medicare and Medicaid Services (CMS) issued a proposal to remedy its four years of payment cuts to the more than 1,600 hospitals participating in the 340B Drug Pricing Program through one-time, lump-sum payments that will total roughly $9B. 

In 2018, CMS reduced drug reimbursement to 340B covered-entity hospitals by nearly 30 percent, in an attempt to align reimbursement with hospitals’ actual drug acquisition costs. The Supreme Court overturned those cuts in 2022, ruling that the Department of Health and Human Services (HHS) had violated rulemaking procedure. As CMS rulemaking on Medicare payment must be budget-neutral, the agency will offset the remedy payments with a 0.5 percent cut to all hospitals for non-drug items and services covered under the Hospital Outpatient Prospective Payment System (OPPS) over the next 16 years. Stakeholders have until September 5th to comment on the proposed rule. Once the final rule is published later this year, CMS plans to repay 340B participant hospitals within 60 days of their application for remedy.

The Gist: After worries about how last year’s Supreme Court ruling would be implemented, 340B participant hospitals will be relieved to receive their payment corrections up front instead of over time, especially given current margin challenges.

But while this issue is now set to be resolved, other critical decisions about the 340B program’s fate are pending before courts. Earlier this year, Bayer and EMD Serono became the 20th and 21st drugmakers to restrict discounts to contract pharmacies, following an appellate court decision in January that sided with the pharmaceutical manufacturers.

Meanwhile, appellate courts in other jurisdictions are set to hear at least two more cases on the issue, amid conflicting rulings about whether HHS can enforce contract pharmacy discounts.

Health Groups Turn Up Heat on 2021 Medicare Fee Schedule

The CMS logo over an illustration of a male and female physician having opposite reactions to a fever chart

Physician groups and other healthcare providers continued expressing their dissatisfaction with the 2021 Medicare physician fee schedule proposed rule from the Centers for Medicare & Medicaid Services (CMS).

“While we support the CPT coding revisions and revaluations of office and outpatient evaluation and management (E/M) services recommended by the AMA/Specialty Society RVS Update Committee [RUC], we strongly oppose the proposed budget neutrality reduction proffered by CMS for these and other physician fee schedule changes proposed for 2021,” said a letter sent Monday to CMS Administrator Seema Verma from 47 medical and health specialty groups including the American College of Surgeons, the American College of Radiology, and the American Academy of Ophthalmology. The groups represent 1.4 million providers, including physicians, social workers, and speech-language pathologists.

If adopted as proposed, the fee schedule would “reduce Medicare payment for services provided in patients’ homes, physician offices, non-physician practices, therapy clinics, skilled nursing facilities, hospitals and rehabilitation agencies — at a time when the spread of COVID‐19 remains unchecked,” the letter said.

The proposed fee schedule, which was announced in early August, includes “simplified coding and billing requirements for E/M visits [that] will go into effect January 1, 2021, saving clinicians 2.3 million hours per year in burden reduction,” CMS said. “As a result of this change, clinicians will be able to make better use of their time and restore the doctor-patient relationship by spending less time on documenting visits and more time on treating their patients.”

However, the proposed rule also lists (on p. 50375) the estimated impacts of the rule’s payment changes for each specialty, which includes losers as well as winners.

Three specialties fare the best: endocrinology, with a 17% increase; rheumatology, with a 16% increase; and hematology/oncology, with a 14% increase. At the bottom are nurse anesthetists and radiologists, both with an 11% decrease; chiropractors, with a 10% decrease; and interventional radiology, pathology, physical and occupational therapy, and cardiac surgery, all with a 9% decrease. Surgical specialties in general took some of the biggest hits, with cuts in every category ranging from 5% to 9%.

The proposed rule also lists the fee schedule’s final conversion factor — the amount that Medicare’s relative value units (RVUs) are multiplied by to arrive at a reimbursement for a particular service or procedure under Medicare’s fee-for-service system. Due to budget neutrality changes required by law, the proposed 2021 conversion factor is $32.26, a decrease of $3.83 from the 2020 conversion factor of $36.09, CMS said. Comments on the proposed rule were due by 5 p.m. on Monday.

American Medical Group Association (AMGA), which represents group practices, also weighed in on the proposed rule. “AMGA is concerned that the CMS proposed 2021 Physician Fee Schedule rule would inadvertently exacerbate the financial situation facing our membership that is a result of the ongoing novel coronavirus 2019 (COVID-19) pandemic,” the association said in a statement. “While appreciative of the effort to increase support for primary care services, the Physician Fee Schedule’s budget neutrality requirements effectively shift funds from one specialty to another, potentially undermining the team-based approach to care that is the hallmark of the group practice model.https://tpc.googlesyndication.com/safeframe/1-0-37/html/container.html

In its comments on the rule, the American Association of Neurological Surgeons (AANS) took particular issue with the fact that the changes to the E/M codes were not included in global payments for some surgical procedures that include an E/M visit. “The AANS … strongly urges CMS to apply the RUC-recommended changes to the E/M component of the 10- and 90-day global surgery codes to maintain the relativity of the fee schedule and to comply with the Medicare law’s prohibition on specialty payment differentials,” the AANS wrote in its comments.

The AANS also wasn’t happy with a proposed add-on code known as GPC1X, which CMS said could be used for “visit complexity inherent to E/M associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient’s single, serious, or complex condition.”

The code is nothing more than a “holdover” from an earlier bundled payment scheme that has since been replaced, the AANS said. “Instead of correcting a system that would have resulted in unfair payment reductions, the agency is creating a new coding scheme that inappropriately discriminates among physician specialties — over-inflating payments to individual specialties and causing steep cuts to others.” The association urged CMS to get rid of the add-on code, noting that “more than $3.3 billion will be redistributed between specialties if this code is implemented, and it is a significant contributor to the steep reduction in the conversion factor.”

The American Association of Orthopaedic Surgeons objected to a decrease in the work RVUs for knee and hip arthroplasties. “The overall physician work for these procedures has not changed since they were last evaluated in 2013,” the group said in a statement. “If anything, orthopaedic surgeons and their staff are spending more time on the preoperative work that is essential to the clinical success and cost savings of Medicare alternative payment models.”https://tpc.googlesyndication.com/safeframe/1-0-37/html/container.html

If these Medicare cuts are finalized, it sends a strong signal: when providers in the vanguard of value-based care begin to achieve some efficiencies in the delivery of care, CMS will use those positive developments as a justification to cut Medicare fee-for-service reimbursement regardless of the extra work that goes into achieving these outcomes,” C. Lowry Barnes, MD, president of the American Association of Hip and Knee Surgeons, said in a statement.

Congress has also gotten involved in the proposed rule. Last Friday, representatives Michael Burgess, MD (R-Texas) and Bobby Rush (D-Ill.) introduced H.R. 8505, which would temporarily waive the legislation’s budget neutrality provision and avoid the payment cuts.