340B Mega Guidance Withdrawn

On January 31, 2017, the Health Resources and Services Administration (“HRSA”) withdrew the 340B Program Omnibus Guidance (often referred to as the Mega Guidance).   The guidance addressed a number of significant issues under the 340B Program, including the definition of eligible patient and contract pharmacy arrangements.   The Mega Guidance was issued by HRSA in August 2015 after a HRSA “Mega Rule” was withdrawn in response to concerns that the issuance of the issuance of the “Mega Rule” exceeded HRSA’s regulatory authority.

Joy Hord

Joy Hord

Joy Hord focuses her practice on regulatory and compliance matters specifically related to the health care industry. Her clients include hospitals, physicians, pharmacies and other health care providers. Ms. Hord also has significant experience representing health care professionals and organizations with business law and transactional issues, such as mergers, acquisitions and joint ventures. Ms. Hord leads Parker Poe’s Health Care Practice, which includes attorneys from the firm’s North Carolina and South Carolina offices.

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OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released its 2017 Work Plan.  Published annually and updated throughout the year, the Work Plan identifies the OIG’s key areas of focus as it carries out its mission of protecting the integrity of programs within DHHS.  The OIG is charged with ensuring the integrity of more than 100 programs administered by DHHS, including those within the Centers for Medicare and Medicaid Services, Center for Disease Control and Prevention, the Food and Drug Administration, and the National Institute of Health. The OIG Work Plan summarizes the OIG’s current activities – comprised of both new and revised activities — along with information regarding previously identified activities that have been completed, postponed, or cancelled.

The Work Plan highlights new and continuing priorities applicable to various provider types, including hospitals, nursing homes, hospices, home health, clinical laboratories, physicians and other health professionals, medical equipment suppliers and manufacturers, pharmaceutical manufacturers and other providers and suppliers.

The 2017 Work Plan is available here.

The following is a sampling of some of the new and ongoing efforts highlighted in the Work Plan:

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Amanda Hayes

Amanda Hayes

Amanda Hayes counsels clients in connection with mergers and acquisitions, divestitures and other business matters, with a particular focus on the health care industry. She regularly serves as lead counsel on acquisitions and divestitures, guiding the client through deal structuring, due diligence, drafting, negotiation and closing. In addition to health care, Ms. Hayes’ mergers and acquisition experience includes a variety of industries, such as manufacturing, retail, automotive, contract research, environmental remediation, engineering and construction supply.

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OCR Issues Guidance on Ransomware Attacks and Determining Whether a Reportable HIPAA Breach Exists

The Office of Civil Rights (“OCR”) has issued new guidance in connection with an increase of malicious cyberattacks, namely ransomware attacks on healthcare organization’s computer systems. Ransomware is a defined by HHS as a type of malicious software whose defining characteristic is that it attempts to deny access to a user’s data, usually by encrypting the data with a key known only to the hacker until the requested ransom is paid.Read More

Chara O'Neale

Chara O'Neale

Chara O’Neale focuses her practice primarily on the representation of hospitals, physician groups and other health care providers in the resolution of legal, regulatory and business issues for entities involved in the health care industry.

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Parker Poe Hosts Health Care Symposium on Supreme Court Decisions


Raleigh, NC –  On July 16, 2015, Parker Poe hosted a Health Care Symposium co-sponsored by the North Carolina Society of Health Care Attorneys, the Federal Bar Association’s Health Law Section, and the Federal Bar Association’s Eastern North Carolina Chapter.

The Symposium was a review of the United States Supreme Court’s decisions impacting health care in the 2015 term. Panelists reviewed the Court’s opinions and their legal and practical implications. The Symposium was designed for health care providers, lawyers, policy makers, and others interested in health law and policy.

Matt Wolfe, an attorney  in Parker Poe’s Raleigh office, moderated the Symposium’s panels.  Matt was joined by Kimberly Cogdell Boies of NCCU Law; Catherine Dunham, Elon Law; Mark Hall, Wake Forest Law; Joan Krause, UNC Law; Jane Perkins, National Health Law Project; Barak Richman, Duke Law; Richard Saver, UNC Law; and Don Taylor, Duke Public Policy. Click here for a link to the video of the session.

If you would like further information about topics discussed, please contact Matt Wolfe at 919-835-4647 or mattwolfe@parkerpoe.com.

Matt Wolfe

Matt Wolfe

Matt Wolfe concentrates his practice in the areas of administrative litigation, government relations, and other regulatory matters. Matt formulates comprehensive political and public relations strategies on a broad range of federal and state policies. He drafts and monitors legislation, intervenes directly with legislative, executive, and local officials, and appears before state and federal executive agencies. Within his administrative litigation practice, Matt advises and counsels health care providers subject to federal and state regulatory actions.

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OIG Releases Joint Guidance for Health Care Boards

Yesterday, the Office of Inspector General (“OIG”) published “Practical Guidance for Health Care Governing Boards on Compliance Oversight.”  The guide is intended as an educational resource for the boards of healthcare entities of all sizes and is the result of a unique collaboration between the OIG and a number of private health care trade organizations.   Topics covered by the guide include:

  • expectation of the board with respect to compliance functions;
  • appropriate relationships between audit, compliance, and legal departments within the organization;
  • establishing expectations regarding reporting to the board;
  • identifying and auditing potential risk areas; and
  • encouraging a culture of compliance.

The guide can be found here.

Joy Hord

Joy Hord

Joy Hord focuses her practice on regulatory and compliance matters specifically related to the health care industry. Her clients include hospitals, physicians, pharmacies and other health care providers. Ms. Hord also has significant experience representing health care professionals and organizations with business law and transactional issues, such as mergers, acquisitions and joint ventures. Ms. Hord leads Parker Poe’s Health Care Practice, which includes attorneys from the firm’s North Carolina and South Carolina offices.

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Proposed Mega Rule Abandoned Under the 340B program

In very broad terms, the 340B program allows some safety-net health care providers to provide qualifying patients with affordable prescription drugs. In January, the Office of Pharmacy Affairs (OPA) of the Health Resources and Services Administration (HRSA) announced its intent to issue a proposed regulation for notice and comment by June. OPA stated that the proposed regulation would cover (i) the definition of an eligible patient under the 340B program, (ii) hospital and off-site facilities eligibility criteria, and (iii) compliance requirements for contract pharmacy arrangements.   Because of the proposed breathe of the rule, it was nicknamed the “Mega Rule”.

2014 has already been a big year for the 340B program. Developments this year have included ongoing developments in a lawsuit brought by members of the drug industry regarding 340B pricing on orphan drugs, ongoing audits of 340B covered entities and an Office of Inspector General report/OPA letter placing 340B providers on notice to monitor closely for potential diversion and duplicate discounts of drugs purchased under the program.  The 340B program has also been the target for criticism by the drug industry and lawmakers.

Last week, HRSA announced that the proposed Mega Rule has been abandoned. Instead, HRSA will be publishing interpretive guidance next year (2015).

Joy Hord

Joy Hord

Joy Hord focuses her practice on regulatory and compliance matters specifically related to the health care industry. Her clients include hospitals, physicians, pharmacies and other health care providers. Ms. Hord also has significant experience representing health care professionals and organizations with business law and transactional issues, such as mergers, acquisitions and joint ventures. Ms. Hord leads Parker Poe’s Health Care Practice, which includes attorneys from the firm’s North Carolina and South Carolina offices.

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