After a nearly 24-year hiatus from the mandatory provider-based attestation requirement, the Consolidated Appropriations Act of 2026 (Act, signed into law on Feb. 3, 2026), mandates (again) that hospitals file attestations of...more
2/5/2026
/ Attestation Requirements ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
False Claims Act (FCA) ,
Filing Deadlines ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Medicare ,
New Legislation ,
New Regulations ,
Outpatient Prospective Payment System (OPPS) ,
Regulatory Oversight ,
Regulatory Requirements ,
Section 340B
2026 is shaping up to be a pivotal year for health care reimbursement.
From major CMS payment rules to evolving disclosure requirements, AI scrutiny, and mounting pressure on providers across the care continuum, the 2026...more
1/22/2026
/ Centers for Medicare & Medicaid Services (CMS) ,
Disclosure Requirements ,
Enforcement Actions ,
Enrollment ,
Guidance Update ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Home Health Care ,
Hospice ,
Hospitals ,
Medical Devices ,
Medical Equipment ,
Medical Reimbursement ,
Medicare ,
PECOS ,
Physician Fee Schedule ,
Physicians ,
Price Transparency ,
Regulatory Oversight ,
Regulatory Requirements ,
Reimbursements ,
Revocation ,
Rural Health Care Providers
Key Takeaways -
CMS launches Drug Acquisition Cost Survey beginning Jan. 1, 2026. OPPS hospitals must submit NDC-level pricing data for both 340B and non-340B drugs, which CMS will use to inform CY 2027 reimbursement...more
Summary:
On October 30, 2025 despite HRSA being impacted by the government shutdown, the agency approved 8 drug manufacturers / 9 drugs for participation in HRSA’s 340B Rebate Model Pilot Program (340B Rebate Pilot)....more
Key Takeaways -
HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more
On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment...more
On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers....more
4/22/2024
/ Claim Procedures ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Healthcare ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
340B Covered Entities (CEs) are getting a glimpse into what they can expect to be repaid due the fallout from CMS’ unlawful 340B payment reduction that was struck down by the U.S. Supreme Court in June 2022. CMS discussed a...more
It has certainly been a year of ups and downs for 340B hospitals. While litigation continues in the manufacturer 340B price restriction space, and 340B hospitals continue to experience financial, legal and operational...more
On Friday, July 15th, CMS published its CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule) and gave 340B covered entities a glimpse into how the agency intends to react to...more
7/19/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Authority ,
Remedies ,
Section 340B
Wednesday, the United States Supreme Court handed down a highly anticipated, unanimous opinion, AHA v. Becerra, confirming that CMS exceeded its statutory authority when it implemented a discriminatory reimbursement structure...more
6/17/2022
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Lack of Authority ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
SCOTUS ,
Section 340B ,
Statutory Authority
The end of 2021 brings positive indications of the continued acceptance of telehealth as an important clinical care approach post public health emergency (“PHE”). The Centers for Medicare and Medicaid Services (“CMS”), like...more
2/22/2022
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inpatient Prospective Payment System (IPPS) ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
Medicare Advantage ,
Outpatient Prospective Payment System (OPPS) ,
Payor Contracts ,
Physician Fee Schedule ,
Section 340B ,
Surprise Medical Bills ,
Telehealth
Recently, HRSA verbally confirmed that it has assigned Administrative Dispute Resolution (ADR) panelists, a key development to move a handful of pending ADR complaints forward. Those complaints contain allegations that drug...more
On Monday, July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule). While the Proposed Rule...more
7/22/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Reform ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drug Coverage ,
Prescription Drugs ,
Reimbursements ,
Section 340B
The Centers For Medicare & Medicaid Services Issues New Inpatient Prospective Payment System Final Rule -
On September 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare...more
12/31/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Cramdown ,
Drug Pricing ,
Health Care Providers ,
Healthcare Reform ,
Inpatient Prospective Payment System (IPPS) ,
Medicaid ,
Medicare ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Section 340B ,
Telehealth ,
Value-Based Care
On November 27, 2020, CMS published its Most Favored Nation (MFN) Model Interim Final Rule (IFR) that seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive...more
12/10/2020
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Cross-Border Transactions ,
Drug Pricing ,
Interim Final Rules (IFR) ,
Medicare Part B ,
Most-Favored Nations ,
Prescription Drugs ,
Section 340B ,
Trump Administration
There are initial indications that the Health Resources and Services Administration (HRSA), which administers the federal 340B drug pricing program, may allow hospitals to begin using 340B drugs at offsite locations (“Child...more
Late last week, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment System (“OPPS”) final rule [CMS-1717-FC]. While many hospitals had hoped for relief from recent...more
11/6/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Coding ,
Drug Pricing ,
Final Rules ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicaid Reform ,
Medicare ,
Medicare Payment Reform ,
Off-Campus Departments ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Services ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Recovery Audit Contractors (RACs) ,
Rulemaking Process ,
Section 340B
Polsinelli is pleased to share the Health Care Reimbursement and Payor Dispute Update. This newsletter is a designated source of news, information and guidance on the constantly evolving reimbursement industry.
...more
11/1/2019
/ Administrative Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Contract Disputes ,
Enrollment ,
Health Care Providers ,
Injunctive Relief ,
Managed Care Contracts ,
Medical Reimbursement ,
Medicare ,
Payor Contracts ,
Revocation ,
Site-Neutral Exception ,
Universal Health Services Inc v United States ex rel Escobar
On July 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment Systems (“OPPS”) proposed rule [CMS-1717-P]. ...more
8/6/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
General Authorization ,
Health Care Providers ,
Outpatient Prospective Payment System (OPPS) ,
Price Transparency ,
Proposed Rules ,
Rulemaking Process ,
Section 340B ,
Two-Midnight Rule
This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more
8/6/2019
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare Reform ,
MACs ,
Medicare Payment Reform ,
Payment Rates ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Remedies ,
Rulemaking Process ,
Section 340B ,
Underpayment
In this issue, Polsinelli’s 340B and Reimbursement teams provide an update on the most recent developments in the ongoing 340B /Part B Payment litigation and also highlight recent Government Accountability Office (“GAO”)...more
5/16/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
GAO ,
Health Care Providers ,
HRSA ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Provider Payments ,
Section 340B
A federal district court granted a permanent injunction against the Medicare Part B 2018 Outpatient Prospective Payment System (“OPPS”) payment cuts for separately payable, non-pass through drugs purchased through the 340B...more
1/7/2019
/ Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Low-Income Issues ,
Medical Reimbursement ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Permanent Injunctions ,
Prescription Drugs ,
Section 340B
On Wednesday July 25, 2018, the Centers for Medicare and Medicaid Services (CMS) released an advance copy of the CY 2019 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule. ...more
Hospitals with off-campus provider-based departments (“PBDs”) under construction (or “mid-build”) at the time of the Bipartisan Budget Act of 2015 – which limited Medicare payment to off-campus provider-based departments that...more