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Practices  /  Health Care Regulatory

Health Care Regulatory

Practice group · Seven lawyers · Chair, Ruth Abend

Harwell Brandt’s Health Care Regulatory Group is handed the problems a provider has with the agencies that license it, pay it and police it: a Medicare audit, a state inspection that ends in a notice of revocation, a payment to a referring physician that no longer fits the law, a change of ownership that has to clear licensure and Medicare enrollment before the new owner can bill. Seven lawyers represent home health and hospice agencies, personal care homes and assisted living residences, ambulatory surgical facilities, community hospitals, physician practices and medical equipment suppliers. Several of them practiced on the government’s side before they joined the firm.

What the group is handed

  1. Licensure and inspections. The Pennsylvania Department of Health licenses hospitals, ambulatory surgical facilities, home health agencies, hospices and nursing homes under the Health Care Facilities Act. The Department of Human Services licenses personal care homes and assisted living residences. The group answers the inspection, writes the plan of correction, and takes the appeal when a department moves to a provisional license or revocation. Pennsylvania has had no certificate-of-need program since the 1990s, so licensure and Medicare enrollment carry the weight that a need review carries in other states.

  2. Medicare and Medical Assistance payment. Audits by Medicare Administrative Contractors, Unified Program Integrity Contractors and Recovery Audit Contractors, often ending in an overpayment extrapolated from a sample of claims. A Medicare appeal runs through five levels: redetermination, reconsideration, a hearing before an administrative law judge, the Medicare Appeals Council, and federal district court. Medical Assistance audits by the Department of Human Services are appealed within the department to its Bureau of Hearings and Appeals; the Board of Claims has no jurisdiction over those provider claims.

  3. Fraud and abuse. Structuring a provider’s arrangements with physicians and referral sources to fit the exceptions to the federal physician self-referral law and the safe harbors under the Anti-Kickback Statute. When an arrangement has failed to fit, the group conducts the internal review and, where the facts call for it, prepares a submission under the CMS Voluntary Self-Referral Disclosure Protocol or the OIG Self-Disclosure Protocol. An overpayment must be reported and returned within sixty days of being identified, a deadline that federal rules in force since January 2025 suspend for up to 180 days while the provider conducts a timely, good-faith investigation for related overpayments. An overpayment kept past the deadline can become a False Claims Act liability.

  4. Changes of ownership. Due diligence on a target’s licenses, enrollment, billing history and physician arrangements; the Medicare enrollment filings and state licensure notices a change of ownership requires; and the timing between closing and the first claim the new owner can submit. The group handles the employment terms of acquired practitioners, including the one-year limit Pennsylvania now places on most new health care practitioner non-competes, with the Employment Group.

  5. Professional licensing. Defense of physicians, nurses and pharmacists before the State Board of Medicine, the State Board of Osteopathic Medicine, the State Board of Nursing and the State Board of Pharmacy, in proceedings brought by the prosecuting attorneys of the Department of State’s Bureau of Professional and Occupational Affairs.

  6. Patient information. Breach response under HIPAA and Pennsylvania’s Breach of Personal Information Notification Act, and investigations by the Office for Civil Rights of the U.S. Department of Health and Human Services.

How the group works

  1. The deadlines in the first letter. Audit responses, Medicare appeals and licensing appeals each run on a short clock. The first letter to a new client lists every date that applies and what is lost if it passes.

  2. Clinical review before the response. Before a provider answers an audit, the group has the records reviewed by a clinician it retains, so the client knows which claims will hold before arguing for any of them.

  3. The agency’s reading of its own rules. Lawyers who once represented the Department of Health and other agencies read a regulation the way the agency’s counsel will, and tell the client where the agency is likely to hold firm.

  4. Litigation brought in early. When an audit or an inquiry could become a fraud investigation, the group brings in the firm’s Litigation Group before any employee is interviewed. False Claims Act cases in the Eastern District of Pennsylvania are defended by the two groups together.

A lawyer in this group

Nathan Greer

Counsel

Nathan Greer is brought in when a health care provider receives a letter from the government that puts its revenue or its license at risk: a Medicare contractor’s audit ending in an extrapolated overpayment demand, a state inspection followed by a notice of revocation, a compliance officer’s discovery that a physician was paid for two years under an agreement that had expired.

Read the full biography

The lawyers

  • Ruth AbendPartner · Chair
  • David SterlingPartner
  • Monica PatelPartner
  • Nathan GreerCounsel
  • Lauren KesslerAssociate
  • Isaac MorganAssociate
  • Grace LiuAssociate