Helped a Pharmacy Chain Recover Underpayments
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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