For nearly 40 years, federal courts have routinely upheld agency action under the principle of judicial deference established in the seminal case of Chevron U.S.A. v. Natural Resources Defense Council, Inc., which requires courts to uphold an agency’s interpretation of the statute it administers if the statutory language is ambiguous, and the agency’s interpretation is reasonable. Critics have argued that federal judges have been too quick to find an ambiguity in the face of complex and often dense statutory language and rush to defer to an agency’s interpretation, secure in the knowledge that Chevron deference will provide cover for their rulings.

However, this past June the U.S. Supreme Court issued two decisions addressing the outer limits of agency power in American Hospital Association v. Becerra and West Virginia v. Environmental Protection Agency, signaling renewed judicial oversight over agency action.

In AHA v. Becerra, the Court admonished the Department of Health and Human Services (HHS) for improperly lowering drug reimbursement payments to hospitals that serve low-income communities under a program called “340B,” finding that the Medicare statute explicitly and solely permits HHS to set the reimbursement rate for hospitals for certain outpatient prescription drugs that the hospitals provide to Medicare patients using only one of two methods:

  • If HHS conducted a survey of hospitals’ acquisition costs for prescription drugs, then HHS may set the reimbursement at the average of the hospitals’ acquisition costs.
  • If HHS did not conduct a survey, then HHS is required to set reimbursement rates at the average sales price charged by manufacturers for the drugs, i.e., 106% of the drug’s average sales price, and is prohibited from varying reimbursement rates for different groups of hospitals.

Without conducting a survey, in 2018 and 2019, HHS established two separate reimbursement rates, substantially reducing the reimbursement rates for 340B hospitals to 77.5 % of the average sales price for each drug while at the same time maintaining the historical rate of 106% of the average sales price for non-340B hospitals. This resulted in a reduction in the reimbursement rates for 340B hospitals of about $1.6 billion annually. However, the Court held in AHA v. Becerra that because HHS did not conduct a survey of hospitals’ acquisition costs (as required by the express language of the Medicare statute), it acted unlawfully by reducing the reimbursement rates for 340B hospitals.

Further, in West Virginia v. EPA, the Court determined that a Congressional statute, authorizing the EPA to establish emissions caps at a level reflecting “the application of the best system of emission reduction . . . adequately demonstrated,” did not empower EPA to devise carbon emissions caps based on a generation-shifting approach, i.e., by restructuring the nation’s overall mix of electricity generation, to transition from 38% to 27% coal by 2030. By taking this generation-shifting approach, EPA broke from its 50-year history of setting performance standards under the Clean Air Act based on measures that would reduce pollution by causing plants to operate more cleanly.

Applying what is known as the “major questions doctrine,” the Court held that EPA did not have the authority under the language of the Clean Air Act to promulgate regulations that would essentially reconfigure electric energy production nationwide from coal-generated power plants to solar, wind and gas powered plants. Rather, the Court noted, such a dramatic shift in policy is a matter for Congress.

Both decisions are notable particularly because they ignore Chevron and find instead that agency authority is limited by the language and scope of the agency enabling statutes. In AHA v. Becerra, the agency’s power was clearly defined in the Medicare statute and in West Virginia v. EPA, the scope of the extraordinary power claimed by EPA for itself was not granted by Congress in any textual provision of the Clean Air Act. The upshot of these decisions is that federal agencies must be circumspect about relying on innocuous statutory language or general “catch all” provisions to justify their actions where such language or provisions do not (and were never intended to) authorize agency action.

Hospitals should vigilantly monitor HHS’s regulatory actions which adversely affect Medicare reimbursement to ensure that such actions are supported by clear Congressional authority rather than simply by an exploitive interpretation which aggrandizes HHS’s own power.

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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: | 973.577.1784 | vCard | LinkedIn

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