As discussed in this prior blog post, beginning in 2018 the U.S. Department of Health and Human Services (HHS) reduced reimbursement rates for Medicare prescription drugs to 340B hospitals by nearly thirty percent. The American Hospital Association (AHA) filed suit, and on June 15, 2022 the U.S. Supreme Court ruled that the cuts imposed by HHS, without conducting a survey of the hospitals’ acquisition costs, exceeded the agency’s authority and remanded the matter to the U.S. District Court for further proceedings.

Upon remand, District Court Judge Rudolph Contreras ruled that HHS must reimburse 340B hospitals at the default rate of average sale price plus six percent for the remainder of 2022.  And, when CMS published its Calendar Year 2023 OPPS Final Rule it provided reimbursement to 340B hospitals at a rate of average sale price plus six percent. However, what has remained a question is how the 340B hospitals would be made whole for the past underpayments beginning in 2018. This question has yet to be decided.

This issue was recently before the District Court, where the AHA argued that the only rational result would be for the Court to award the hospitals the difference between what they were paid and the average sale price plus six percent they were entitled to. Unfortunately for providers, Judge Contreras rejected the AHA’s position, finding that the proper course of action was to remand the matter to the agency to determine in the first instance what it believes to be the appropriate remedy. While Judge Contreras noted that the AHA could seek additional judicial review if it was dissatisfied with the agency’s selection of a remedy, this decision means additional delay should the agency fail to propose a reasonable approach to return the money owed to providers in a timely manner.

It is anticipated that HHS will propose a remedy in April 2023. While it is difficult to predict what remedy the agency will propose, the AHA is hoping the proposed remedy does not take budget neutrality into account. If the agency were to take such an approach, non-340B hospitals would almost certainly be negatively impacted by the decision resulting in a classic “rob Peter to pay Paul” scenario and almost guaranteeing to trigger more litigation.

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Paul L. Croce Paul L. Croce

Counsel, Healthcare Department

Mr. Croce focuses his practice in the field of healthcare. His work includes representing clients in hospital reimbursement matters before the Department of Health and the Division of Medical Assistance and Health Services. He provides counsel on issues related to…

Counsel, Healthcare Department

Mr. Croce focuses his practice in the field of healthcare. His work includes representing clients in hospital reimbursement matters before the Department of Health and the Division of Medical Assistance and Health Services. He provides counsel on issues related to contracting, civil litigation and professional licensing matters, and represents a variety of healthcare industry clients including physicians, dentists, hospitals and for-profit and non-profit healthcare systems.

Mr. Croce also has substantial experience defending attorneys and other licensed professionals against claims of malpractice and ethics grievances.

Contact information:

pcroce@greenbaumlaw.com | 973.577.1806 | vCard | LinkedIn

For more information visit the Greenbaum, Rowe, Smith & Davis LLP website.

Photo of John W. Kaveney John W. Kaveney

Partner, Healthcare and Litigation Departments

Mr. Kaveney focuses his practice in the area of healthcare law, representing a range of clients that includes for-profit and non-profit hospitals and health systems, academic medical centers, individual physicians and physician groups, ambulatory surgery centers, ancillary service…

Partner, Healthcare and Litigation Departments

Mr. Kaveney focuses his practice in the area of healthcare law, representing a range of clients that includes for-profit and non-profit hospitals and health systems, academic medical centers, individual physicians and physician groups, ambulatory surgery centers, ancillary service providers, medical billing companies, skilled nursing and rehabilitation facilities, behavioral health centers and pharmacies.

His practice in the healthcare field encompasses advising healthcare clients on corporate compliance matters, including the implementation of new, and the assessment of existing, corporate compliance programs. He also assists healthcare clients with compliance audits and investigations, as well as guiding clients through the self-disclosure and repayment processes. Finally, he provides general legal advice concerning compliance and regulatory matters under state and federal healthcare laws.

In the area of information privacy and data security, Mr. Kaveney advises healthcare clients on issues arising under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH). This includes the implementation and assessment of privacy and security policies and procedures to ensure the proper protection and utilization of protected health information both by healthcare providers and the business associates with which they contract. In addition, he represents healthcare clients in investigating, reporting, and remediating information breaches and the liability such breaches create under various information privacy and security laws.

Additionally, Mr. Kaveney provides counsel on Medicaid and Medicare reimbursement matters before the Division of Medical Assistance and Health Services and the Provider Reimbursement Review Board, as well as assisting clients in civil litigation and with professional licensing and medical staffing concerns.

Contact information:

jkaveney@greenbaumlaw.com | 973.577.1796 | vCard | LinkedIn

For more information visit the Greenbaum, Rowe, Smith & Davis LLP website.

Photo of James A. Robertson James A. Robertson

Partner and Chair, Healthcare Department

Mr. Robertson’s healthcare practice is reflective of his significant expertise across a wide range of legal disciplines, enabling him to effectively counsel clients on a myriad of healthcare regulatory, corporate and litigation matters. He represents a diverse array…

Partner and Chair, Healthcare Department

Mr. Robertson’s healthcare practice is reflective of his significant expertise across a wide range of legal disciplines, enabling him to effectively counsel clients on a myriad of healthcare regulatory, corporate and litigation matters. He represents a diverse array of healthcare industry clients including for-profit and not-for-profit healthcare and hospital systems, academic medical centers, nursing homes, home health agencies, medical device manufacturers, pharmaceutical companies, integrated delivery networks, physicians and physician practice groups, and healthcare private equity funds.

Mr. Robertson provides comprehensive representation in connection with all types of healthcare transactions, including corporate mergers and acquisitions, joint ventures, and divestitures. He assists clients with the structuring and creation of clinically integrated networks (CINs), organized delivery systems (ODSs), accountable care organizations (ACOs), multiple employer welfare arrangements (MEWAs), and health insurance companies. He oversees the establishment and purchase/sale of individual physician and group practices, ambulatory surgery centers, nursing homes, and assisted living facilities. He structures and negotiates compensation arrangements with physicians in connection with employment and exclusive contracting arrangements, medical directorships, physician recruitment initiatives, hospital department management, office and equipment leases, and management services arrangements. He also negotiates managed care agreements and risk-sharing arrangements with payors and represents healthcare clients in payor litigation.

On the regulatory and compliance fronts, Mr. Robertson regularly provides guidance on issues related to fraud and abuse laws, including the federal Anti-Kickback Statute and Stark Law, the New Jersey Codey Law, the certificate of need statute and Community Healthcare Asset Protection Act (CHAPA), as well as other regulatory compliance issues associated with healthcare transactions and physician-integration arrangements. He develops, implements, and maintains corporate compliance programs for hospitals and other providers in the healthcare industry and is well-versed in the compliance issues associated with, and the implementation of requirements under, the Health Insurance Portability and Accountability Act (HIPAA), the Emergency Medical Treatment and Labor Act (EMTALA), and the Affordable Care Act (ACA).

In the area of information privacy and data security, Mr. Robertson advises healthcare clients on issues arising under HIPAA and the Health Information Technology for Economic and Clinical Health Act (HITECH). This includes the drafting and negotiation of HIPAA compliant business associate agreements with third party vendors, drafting and assisting in the enforcement of privacy and security policies within client organizations, and providing guidance on record retention requirements and the physical or electronic storage of medical records. In addition, he represents healthcare clients in investigating, reporting, and remediating information breaches and the liability such breaches create under various information privacy and security laws.

Mr. Robertson assists clients in seeking advisory opinions from federal and state regulatory agencies, and regularly represents healthcare entities in Medicare, Medicaid, charity care, graduate medical education (GME) and disproportionate share hospital (DSH) reimbursement matters before state administrative agencies and the federal Provider Reimbursement Review Board. His work also encompasses internal audits and investigations, responding to government inquiries, investigations, subpoenas and search warrants, and providing advice in connection with voluntary self-disclosures and corporate integrity agreements (CIAs).

Mr. Robertson is a resource for addressing medical staff matters, providing counsel on fair hearing requirements and designing state-of-the-art medical staff bylaws. He also provides guidance in connection with strategic initiatives on system affiliations including the establishment of outpatient health care offices, diagnostic imaging facilities and ambulatory surgery centers.

Contact information:

jrobertson@greenbaumlaw.com | 973.577.1784 | vCard | LinkedIn

For more information visit the Greenbaum, Rowe, Smith & Davis LLP website.