2022 OPPS Final Rule Overview: CMS Finalizes Policies on 340B, Hospital Price Transparency, and Inpatient-Only List

On 2 November 2021, the Facilities for Medicare & Medicaid Providers (CMS) launched the 2022 Outpatient Potential Fee System (OPPS)/Ambulatory Surgical procedure Heart (ASC) Fee System closing rule (OPPS Final Rule),1 wherein the company finalized a number of of the insurance policies it proposed within the 2022 OPPS/ASC Fee System proposed rule (OPPS Proposed Rule).2 In abstract, within the OPPS Final Rule, CMS finalized its proposals to:

  • Considerably improve monetary penalties for noncompliance below the hospital value transparency guidelines;

  • Proceed the fee price of Common Sale Price (ASP) minus 22.5% for individually payable medicine or biologicals acquired via the Part 340B of the Public Well being Service Act (340B Program); and

  • Halt the elimination of the Inpatient Solely (IPO) checklist, and take away the regulatory references to the elimination of the checklist.

These insurance policies will take impact 1 January 2022.

HOSPITAL PRICE TRANSPARENCY

As we had mentioned in a previous client alert addressing the value transparency provisions within the OPPS Proposed Rule, CMS had proposed to considerably improve monetary penalties on hospitals for noncompliance with CMS’s value transparency guidelines (collectively, the Hospital Price Transparency Rule or the Rule). At present, penalties for noncompliance might not exceed US$300 per day. In finalizing its value transparency insurance policies as proposed, CMS will increase the greenback quantity of a Civil Financial Penalty (CMP) it could impose on a hospital for noncompliance. Starting 1 January 2022, the brand new penalties are as follows (all quantities are per hospital):

  • Most penalty for full yr of noncompliance: US$2,007,500

  • Minimal penalty for full yr of noncompliance: US$109,500

  • Day by day penalty – hospitals with mattress counts better than 30: US$10 per mattress

  • Most each day penalty – hospitals with mattress counts better than 30: US$5,500

  • Most each day penalty – hospitals with mattress counts lower than 30: US$3003

Along with growing the CMP for noncompliance, CMS additionally finalized its proposal to replace the Rule’s prohibition of sure actions that the company views as boundaries to accessing the machine-readable file. As such, CMS will now particularly require that the machine-readable file be accessible to automated searches and direct downloads.4

340B PROGRAM INFUSED DRUGS REIMBURSEMENT CUT

340B Program permits taking part hospitals and different suppliers to buy sure coated outpatient medicine from producers at discounted costs. Within the Calendar Yr (CY) 2018 OPPS closing rule, CMS diminished funds to hospitals for individually payable medicine or biologicals acquired via the 340B Program from ASP plus 6% to ASP minus 22.5%.

Within the OPPS Final Rule, CMS finalized its proposal with out modification to proceed the fee price of ASP minus 22.5% for individually payable medicine or biologicals acquired via the 340B Program.5 Rural sole neighborhood hospitals, kids’s hospitals, and PPS-exempt most cancers hospitals will proceed to be excepted from this fee coverage.6

Relatedly, and as mentioned in a previous client alert, the Supreme Courtroom introduced in July 2021 that it accepted the American Hospital Affiliation’s petition for certiorari in American Hospital Affiliation v. Becerra. At situation is CMS’s almost 30% lower to funds for specified coated outpatient medicine below the OPPS for sure hospitals taking part within the 340B Program, which supplier teams have been difficult in court docket since 2017. Supplier teams have been urging CMS to reverse the fee reductions as a part of the CY 2022 OPPS rulemaking course of. CMS’s determination to proceed the 340B fee cuts leaves open the likelihood that the important thing situation—whether or not CMS exceeded its authority to regulate the fee charges below the present statutory framework—will finally be determined by the Supreme Courtroom.

INPATIENT-ONLY LIST

The IPO checklist was established in rulemaking as a part of the preliminary implementation of the OPPS; the checklist identifies companies for which Medicare will make fee solely when such companies are furnished within the inpatient hospital setting.7 In CY 2021 OPPS closing rule,8 CMS finalized its proposal to eradicate the IPO checklist over a three-year interval.9 As a part of the primary section of the elimination of the IPO checklist, CMS eliminated 298 codes from the checklist starting in CY 2021.10

Following its determination to eradicate the IPO checklist, CMS indicated it obtained a big variety of stakeholder feedback strongly opposing that call.11 Within the OPPS Final Rule, CMS has finalized its proposal with some minor modifications (a) to halt the elimination of the IPO checklist; (b) to codify in regulation the company’s 5 longstanding subregulatory standards for figuring out whether or not a service or process ought to be faraway from the IPO checklist; and (c) so as to add again to the IPO checklist 293 of the 298 companies that have been eliminated in CY 2021.12 Because of this modification, CMS has amended the implementing laws to take away the reference to the elimination, via a three-year transition, of the checklist of companies and procedures designated as requiring inpatient care.13

1 Medicare Program: Hospital Outpatient Potential Fee and Ambulatory Surgical Heart Fee Programs and High quality Reporting Packages; Price Transparency of Hospital Customary Expenses; Radiation Oncology Mannequin, (show copy) [hereinafter OPPS Final Rule].

2 Medicare Program: Hospital Outpatient Potential Fee and Ambulatory Surgical Heart Fee Programs and High quality Reporting Packages; Price Transparency of Hospital Customary Expenses; Radiation Oncology Mannequin; Request for Data on Rural Emergency Hospitals, 86 Fed. Reg. 42018 (4 Aug., 2021) [hereinafter OPPS Proposed Rule].

3 OPPS Final Rule (show copy), at 1240–41.

4 Id. at 1232.

5 Id. at 520.

6 Id. at 513–14.

7 OPPS Proposed Rule, 86 Fed. Reg. 42018, 42115 (4 Aug., 2021).

8 Medicare Program: Hospital Outpatient Potential Fee and Ambulatory Surgical Heart Fee Programs and High quality Reporting Packages; New Classes for Hospital Outpatient Division Prior Authorization Course of; Medical Laboratory Charge Schedule: Laboratory Date of Service Coverage; Total Hospital High quality Star Score Methodology; Doctor-Owned Hospitals; Discover of Closure of Two Educating Hospitals and Alternative To Apply for Accessible Slots, Radiation Oncology Mannequin; and Reporting Necessities for Hospitals and Vital Entry Hospitals (CAHs) To Report COVID-19 Therapeutic Stock and Utilization and To Report Acute Respiratory Sickness Through the Public Well being Emergency (PHE) for Coronavirus Illness 2019 (COVID-19), 85 Fed. Reg. 85866 (29 Dec., 2020).

9 Id.at 86093.

10 Id.at 86094.

11 OPPS Proposed Rule, 86 Fed. Reg. at 42156.

12 OPPS Final Rule (show copy), at 636–37.

13 Id. at 666.

 

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