Health Care Industry

Experience

Helped a Pharmacy Chain Recover Underpayments

Client: Pharmacy chain

Bryan represented a Pennsylvania-based pharmacy chain in its recovery of nearly $800,000 in systematic underpayments by a national pharmacy benefits management (PBM) organization. He reviewed the chain’s provider agreements, applicable state and federal law, and advised the chain on proper exercise of its contractual rights. He also supported streamlining of the chain’s claims identification and verification procedures to prevent future underpayment occurrences.  

Advised a Pharmacy Chain on DSCSA Compliance

Client: Pharmacy chain

Bryan advised a Pennsylvania-based pharmacy chain, which was licensed as a pharmacy, wholesaler and manufacturer, on its compliance obligations imposed by the Drug Supply Chain Security Act. He developed appropriate procedures for identification of DSCSA issues and manners in which DSCSA discrepancies could be resolved with upstream and downstream supply chain partners.

Successfully Defended a Medicaid Managed Care Organization

Client: Medicaid and Medicare MCO (

Bryan successfully defended a Medicaid Managed Care Organization (MCO) in over 200 claims denial appeal procedures before Medicare Administrative Law Judges (ALJ) and the secretary of the Department of Human Services in Pennsylvania. He also developed reporting metrics and case-based training for the MCO to improve utilization review and quality review procedures, and to bolster compliance with various federal and state insurance regulations.

Assist with Acquisitions of Ambulatory Surgery Centers

We provide ongoing counsel for a hospital group in the acquisition of controlling interests in single- and multi-specialty ambulatory surgery centers.

Conducted the Sale of Multiple Assisted Living Facilities

We assisted our client with the sale of nine nursing home/assisted living facilities. Our client wished to leave the nursing home industry, and we negotiated and prepared the sale/purchase transaction documents.

Successfully Argued Against a CON for a Client’s Competitor

Our client, a nursing facility, was concerned that a project proposed by a competing facility would adversely affect their business. The competitor’s facility would have been less than a mile from our client, and the surrounding area already includes multiple nursing facilities. We successfully appealed the decision to grant a Certificate of Need (CON) to the competitor during an Ohio Department of Health administrative hearing.

Successfully Argued for a Nursing Home’s Right to Transfer a Resident

We successfully won an administrative hearing before the Ohio Department of Health granting our client, a nursing home, the right to discharge or transfer a resident. The facility proposed the discharge because it believed the resident was a threat to other residents and to staff.

Assisted Client in Securing Certificate of Need for Essential Health Services

Client: Health System

We successfully represented a health system in connection with its certificate of need (CON) application to establish Primary Therapeutic Cardiac Catheterization (Primary PCI) services at its Beckley, West Virginia hospital. Primary PCI is a life-saving cardiac catheterization procedure offered to heart attack patients that this client was not able to offer at its southern West Virginia hospital without approval by the West Virginia Health Care Authority. We were successful in helping the client secure the CON following the administrative hearing and post-hearing brief.

Internal Investigation Conducted on Behalf of Pharmaceutical Company

Client: A Pharmaceutical Company

Conducted an internal investigation on behalf of a commercial pharmaceutical company arising from an employee whistleblower complaint. Allegations included inappropriate promotional activities, false claims, HIPAA violations, and kickbacks. The investigation included interviewing multiple employees, reviewing relevant documents, and preparing a findings memorandum with corrective action recommendations.  

Internal Investigation Conducted on Behalf of Medical Device Company

Client: A Medical Device Company

Conducted an internal investigation on behalf of a medical device company arising from two employee whistleblower complaints alleging health regulatory and compliance violations. Allegations included pre-approval promotion, inappropriate promotional activities, and a detrimental lack of a corporate compliance program. The investigation included interviewing multiple employees, reviewing relevant documents, preparing a findings memorandum with corrective action recommendations, and assisting the company in implementing several corrective action recommendations. 

Counseled a Pharmaceutical Company on Compliance Program Development and Implementation

Client: A Pharmaceutical Company

Advised a clinical-stage pharmaceutical company regarding its transition to commercial stage, including the development and implementation of a corporate compliance program. This included training company executives on compliance and regulatory matters, drafting and reviewing compliance policies and procedures, reviewing promotional materials, advising on implementation of a transparency tracking/reporting program consistent with federal and state laws, and advising on compliance and regulatory matters. 

Conducted a Compliance Review and Assessment of a Biotechnology Company’s Corporate Compliance Program

Client: A Biotechnology Company

Assessed the implementation and effectiveness of a biotechnology company’s corporate compliance program, including review of company policies, procedures, guidelines, training materials, risk assessment processes, internal investigation reporting mechanisms and follow-up, and auditing and monitoring activities. Also made recommendations for enhancing the program and assisted with implementation of such recommendations.

Defense of Pharmaceutical Company in False Claims Act Lawsuit

Client: Pharmaceutical Company in False Claims Act Lawsuit

Defended a global pharmaceutical company in a False Claims Act investigation involving five qui tam complaints related to the sales, marketing, and promotional activities for several drugs in the company’s product portfolio. Criminal and civil investigators from multiple federal agencies were involved in the investigation, including the U.S. Attorney’s Office for the District of Massachusetts, U.S. Food and Drug Administration (FDA), Veterans Administration (VA), and Federal Bureau of Investigation (FBI). The matter included document collection from more than 1,800 employees, witness interviews, and presentations to investigators. I negotiated a civil settlement agreement with the Department of Justice, settlement agreement and release with the lead qui tam relator, civil settlement agreements with the National Medicaid Fraud Control Unit team and individual states, and a corporate integrity agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (OIG).

Defense of Clinical Laboratory in False Claims Act Investigation

Client: Clinical Laboratory

Defended a clinical laboratory in civil and criminal investigations by the Department of Justice, U.S. Attorney’s Office for the Northern District of California, Office of Inspector General, Federal Bureau of Investigation, and the California Department of Insurance related to inappropriate sales and marketing activities, phlebotomy payments, and other kickbacks. Civil and criminal investigators declined to intervene in the matter against the company. 

Represented Global Pharmaceutical Manufacturer During Health Care Fraud Investigation

Client: A Pharmaceutical Manufacturer

Defended a foreign-based global pharmaceutical manufacturer in a multi-jurisdiction (federal and state) government investigation of sales, marketing, and research activities. Client was dismissed from the False Claims Act qui tam action, and intervention proceeded against their co-promote partner only.

Represented Skilled Nursing Facility in False Claims Act Investigation

Client: A Skilled Nursing Facility

I defended a skilled nursing facility and its parent company in a False Claims Act matter alleging the submission of false claims for rehabilitation therapy provided by the facility’s contracted rehabilitation therapy provider. Representation included the negotiation of a civil settlement agreement with the Department of Justice. No corporate integrity agreement was required by the Office of Inspector General.

Represented Electronic Health Records Company During Health Care Fraud Investigation

Client: Electronic Health Records Company

Represented an electronic health records and billing vendor in a government investigation by the U.S. Attorney’s Office for the Eastern District of Pennsylvania related to false claims submitted by and on behalf of a client health care professional. The matter was successfully resolved for the client.

Represented Medical Device Company in Connection with Internal Investigation and Self-Disclosure to Government Regulators

Client: A Medical Device Company

Conducted an internal investigation for a medical device manufacturer of a compliance matter reported to the company and its board of directors. Further represented the company in a self-disclosure of the matter to the U.S. Department of Health and Human Services Office of Inspector General (OIG).

Certificate of Need Objections on Behalf of a Nursing Home

We advised a nursing home facility and its related entities through their objection to two related Certificate of Need applications filed by another nursing home facility. After the Certificate of Need applications had been filed, we filed objections with the Ohio Department of Health to challenge the merit of the applications, and a hearing was granted. During the course of the administrative hearings, the parties reached a confidential settlement. The hearings were subsequently dismissed.

Health Care Services Cleared of False Claims Allegations

We represented a health care services business that provided billing services to physicians groups and emergency rooms after a false claims act suit was filed alleging the company had improperly coded and overcharged government health care services, including Medicare and Medicaid, by millions of dollars. We did our own analysis of the company’s records while working closely with the U.S. attorney’s office as well as the U.S. Department of Health and Human Services and found an explanation for the company’s coding and charges. As a result of our investigation no criminal charges were filed and the civil suit was not pursued.

Advised a Large Nursing Home Through a Medicare Audit Appeal

Dinsmore advised a large Ohio nursing home through a three stages of a Medicare audit appeal in connection with physical therapy services. Our attorneys represented the client before an administrative law judge and reduced a million dollar Medicare overpayment to less than $15,000.

Sale of Majority Equity Position

When Hometown Urgent Care had an opportunity to sell a majority equity position to Ridgemont Capital, a top private equity firm, it turned to Dinsmore to advise on the transaction. We worked with the Ridgemont’s counsel to structure the transaction and negotiate the terms. Hometown and Ridgemont completed the sale in late May 2012. Hometown is one of the Midwest’s largest walk-in urgent care groups, with 25 locations spread across Ohio, Michigan and Kentucky at the time of the sale.

Negotiation of Settlement in Stark Law Matter

Evolving and complex legislation in the health care arena can provide a myriad of challenges for providers, and overcoming the challenges requires effective and efficient legal counsel. We represented Ohio Hospital in negotiating a settlement with the Centers for Medicare & Medicaid Services (CMS) in a matter involving violations of the federal physician self-referral statute, more commonly referred to as the Stark Law. Our client disclosed that some of their arrangements with physicians for electrocardiogram interpretation, medical director services, vice chief of staff services, and hospital services violated Stark Law because they did not meet the requirements of applicable exceptions. We entered into negotiations with CMS, and ultimately settled for an amount that was agreeable to our client.

Cyber Security Defense Verdict In FTC Administrative Action

Successfully defended LabMD at trial before the FTC Chief Administrative Law Judge. LabMD is the medical laboratory whose data security policies, practices and procedures allegedly violated section 5 of the FTC Act. After a lengthy trial the Administrative Law Judge dismissed the complaint. This is a landmark case because it is the first instance in which the FTC has prosecuted a HIPAA “Covered Entity” for violation of consumer privacy without being joined by HHS. It is also the first instance in which the FTC has been forced to take a case to trial involving data security and privacy. Thus this case established the adjudicatory framework for FTC cyber security administrative trials including the standard of proof and elements required to prove section 5 consumer harm in a cyber security case.

Defended a Large Academic Medical Center Physician Practice in False Claims Act Lawsuit

Representation of a large academic medical center physician practice in a False Claims Act lawsuit alleging improper referral arrangements among area hospitals and our physician practice client. The matter resolved for nuisance value with no CIA or other penalty imposed on our client.

Negotiation of Medicaid Enrollment and Payment Issues

Dinsmore represented a home health care company throughout an investigation by the Ohio Attorney General relating to alleged criminal actions of employees. When the investigation ended in termination of the home health company’s Medicaid provider agreement, Dinsmore represented the client in the appeal of the termination order in a three-day public hearing.

Defense of Academic Medical Center in False Claims Act Lawsuit

Representation of an academic medical center in a False Claims Act qui tam lawsuit alleging improper billing practices. The client was operating under a CIA at the time of the representation. The matter was resolved favorably for our client after extensive discovery, with no extension of the length of the CIA and no press release issued by the federal government.

Settlement of a Hospital OIG Voluntary Disclosure matter

Evolving and complex legislation in the health care arena can provide a myriad of challenges for providers, and overcoming the challenges requires effective and efficient legal counsel. We represented an Ohio hospital that disclosed information about improper financial relationships with referring physicians in response to claims of violating the False Claims Act, the Anti-Kickback Statute and the Stark Statute. Our client had a relationship with two physicians – a joint venture with a pain management physician and also an arrangement where our client purchased intraocular lenses at an inflated price from an ophthalmologist. Both relationships were alleged to have violated statutory requirements. We represented the client in negotiating a settlement with the Department of Justice, the Office of the Inspector General and the Ohio Attorney General (collectively “Government”). During the negotiations, our client disclosed that some of their arrangements with physicians for violated the federal Anti-Kickback Statute because they did not meet the requirements of the relevant safe harbors. Criminal charges against our client were declined, and we worked to address the civil and administrative issues to provide a global resolution. We entered into negotiations with the Government and ultimately settled for an amount that was agreeable to our client.

General Representation of a Home Health Care Company

Dinsmore represents a home healthcare company in a variety of matters, including general business, employment law, regulatory compliance and HIPAA-related issues. The firm has also advised this client through a Medicaid audit and a successful overpayment appeal that significantly reduced the home health company’s Medicaid repayment obligation. This client benefited from the firm’s extensive regulatory experience and knowledge of the healthcare industry.

Physician Recruitment Agreements for Group Practice Physician

We advise group practice physicians on the legal and regulatory issues related to physician recruitment agreements. We worked with many clients to negotiate components of the agreements related to income guarantees, loan agreements, and Stark and anti-kickback compliance.