Health Care and Bioscience Regulatory Compliance

Walter & Haverfield attorneys have served as compliance counsel for a variety of business entities and provider types in a variety of settings. The attorneys in the Regulatory Compliance Group have worked extensively with health care organizations to conduct internal investigations and design compliance strategies. We structure contracts, negotiate transactions and develop corporate compliance programs for providers desiring to manage risks associated with the use and disclosure of health information, billing and referral relationships. Our clients include: hospitals, eye care facilities, rehabilitation centers, mental health practices, physicians, medical imaging and surgery centers, manufacturers, DME suppliers, intensive and primary care, cardiology, anesthesiology, radiology, general surgery, emergency medicine, and HIV clinic settings.

Bioscience Regulatory Compliance Attorneys

The attorneys in the Regulatory Compliance Group have worked extensively with health care and bioscience organizations to conduct internal investigations and design compliance strategies.

Representative projects include:

Structured dozens of fraud and abuse compliance plans and policies for health care providers, suppliers, and third party billing companies.
Resolved technology issues, telemedicine licensure, regulatory, reimbursement and contractual issues for high technology manufacturers, distributors, and providers.
Developed programs to meet the rigors of HIPAA medical privacy and security rules, including training materials, compliance policies, and related forms.
Successfully handled self-reporting and designed corrective action plans for providers.
Regularly structure arrangements designed to comply with the antikickback statute and the Stark laws and submitting advisory opinion requests under both statutes.
Successfully coached numerous health care clients in governmental investigations of compliance and voluntary disclosures.
Successfully defended several health care providers in Medicare and Medicaid billing fraud audits.
Counseled dozens of physician groups on development of ancillary services in compliance with Stark and other regulatory requirements.
Assisted numerous clients with state law issues regarding medical records, licensing, self-referrals, and kickbacks.
Assisted various clients to comply with group purchasing organization and discount safe harbor issues related to discounts and rebates in supply chain and between referral sources.
Strategized compliance initiatives with numerous business attorneys, in-house counsel, and hospital executives on Medicare, Medicaid, IRS, Federal Trade Commission, Department of Health, Department of Insurance and other agency regulations.
Counseled hospitals and physicians on National Practitioner Data Bank and reporting issues.
Prepared comments for associations on Medicare rules.
Drafted antitrust compliance plan for independent practice association and negotiated "messenger model" with FTC for single-specialty physician IPA.
Handled labels and advertising claims for FDA regulated products to comply with regulations.

Recent News

In his article, "AMCNO Participates in Privacy Summit," published in the November/December, 2011 issue of Northern Ohio Physician, J. Ryan Williams summarized the topics covered at the October privacy summit convened by the Ohio Health Information Partnership, and outlined the Academy of Medicine of Cleveland and Northern Ohio's position on the issue of "patient consent" to the sharing of electronic health information.

On Wednesday, September 21, 2011, J. Ryan Williams spoke at the CMBA Health Care Law Section Meeting in Cleveland, Ohio. The topic of Ryan's presentation was "Cloud Computing: Health Information Technology, Privacy and Security."

July/August 2011 - In the July/August issue of Northern Ohio Physician, Ryan Williams summarized recent events in the medical community's efforts to establish a health information exchange system in Ohio in his article, "Update on the Ohio Health Information Partnership HIE and Patient Consent Issue."

On July 20, 2011, Amy S. Leopard was honored by Crain's Cleveland Business as a member of its "Women of Note Class of 2011." An annual tradition for Crain's, the "Women of Note" listing is designed to recognize "Northeast Ohio's outstanding female business leaders who bring passion, dedication and strength to the region's professional landscape."

In the May/June, 2011 issue of Northern Ohio Physician, J. Ryan Williams discussed the OHIP's "opt-in framework" for patient consent in his article, "The Ohio Health Information Partnership (OHIP) Position on Patient Consent Under Review." In this piece, Ryan noted that electronic exchange of health information could be impacted by the OHIP's opt-in framework, due to its potential implications for physicians and health care providers.

On May 23, 2011, Amy S. Leopard spoke at the NCHICA Academic Medical Center Conference in Chapel Hill, North Carolina. The topic of Amy's presentation was "New Requirements for Business Associates & Subcontractors: New Liabilities for Covered Entities."

On May 6, 2011, at its 2011 Annual Meeting, The Academy of Medicine of Cleveland & Northern Ohio (AMCNO) presented Amy S. Leopard with its "Presidential Citation Award," in recognition of her outstanding legal service to the medical community in Greater Cleveland.

Amy S. Leopard spoke on the topic, "Meaningful Use: Legal Meets Clinical," at the ALHA HIT Conference in Washington, D.C., on April 27, 2011.

In her article titled, "The Road to 'Meaningful Use' EHR Stimulus Payments," published in the September / October 2010 issue of Northern Ohio Physician, Amy S. Leopard discussed the Centers for Medicare and Medicaid Services' final rule regarding what constitutes the "meaningful use" of electronic health records for physicians interested in qualifying for EHR incentive payments.

On August 23, 2010, in an article titled "EMR courtship: Hospitals wooing doctors to stay afloat," posted on-line in the health care publication, amednews.com, J. Ryan Williams cautioned physicians to implement their own "meaningful use" plans before they agree to affiliate their practices with a hospital system.

On April 30, 2010, Ryan Williams appeared as a presenter at the Cleveland Metropolitan Bar Association's 26th Annual Health Care Law Institute. Ryan provided a HIPAA Update" for the attendees.

In the article, "Electronic Health Records Today," which appeared in the online publication, EContent Magazine, Amy S. Leopard spoke about the establishment of "common industry standards and definitions" as a means of maximizing the efficiency of regional Health Information Exchanges (HIEs).

In the article, "Health care providers plan for transition," which appeared in the April 12-18, 2010 issue of Crain's Cleveland Business, Amy S. Leopard discussed provisions of the new health care bill - in particular, the government's plans to better manage care and reduce Medicare costs in the coming years.

In a front-page article published in the March 29 - April 4, 2010 issue of Crain's Cleveland Business, Amy S. Leopard commented on the newly-enacted Patient Protection and Affordable Care Act. In this article, entitled, "Uncertainty surrounds bill's passage," Amy discussed the new law's ramifications for companies offering employer-sponsored health care plans.

On Wednesday, January 20, 2010, Amy S. Leopard gave a presentation entitled, "HITECH Act," on behalf of the Cleveland Metropolitan Bar Association's Health Care Law Section.

In the May 18th, 2009 on-line version of the publication, American Medical News, Ryan Williams discussed the issue of archiving physician-patient e-mail correspondence in the article, "Don't Toss All Your Practice's E-mails in the Virtual Trash."

Recent Publications

March/April 2010

"The Proposed Pathway for Achieving 'Meaningful Use' and EHR Stimulus Payments," by Amy S. Leopard, published in Northern Ohio Physician

March 2010

"Ten Things Lawyers Should Know about the New HITECH Act," by Amy S. Leopard, published in the Cleveland Metropolitan Bar Journal

November/December 2009

In the November/December 2009 issue of Northern Ohio Physician, Amy S. Leopard discussed governmental efforts to define the term "meaningful use," as it applies to implementation of electronic health records, in her article entitled, "'Meaningful Use' for EHR Stimulus Payments - an Update."

May/June 2009

In the magazine, Northern Ohio Physician, Amy Leopard describes how the American Recovery and Reinvestment Act of 2009 (ARRA) stimulus package will encourage the increased use of health information technology by health care providers in the article, "Stimulus Package Promotes Health IT Adoption."

January/February 2009

Amy Leopard's article, "CMS Updates the Stark Physician Self Referral Rule;" Northern Ohio Physician

July 2007

Chair of Walter & Haverfield’s Health Care and Bioscience Regulatory Compliance Group, Amy S. Leopard discusses the importance of a health care provider’s compliance auditing function and its impact upon OIG decisions to grant certificates of compliance agreement (CCAs) in settlements with providers, in the article entitled, “OIG: Compliance Auditing Is Key Factor for CCAs; Huge Settlements Diminish Chances,” published in the July 30, 2007 issue of the Report on Medicare Compliance.