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.
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.
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.
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.
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.
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.
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.
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.
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
Counseled a Client During an OIG Audit
Represented a health care provider during an OIG audit regarding alleged Medicare overpayments for medically unnecessary treatments. This involved narrowing the scope of the audit, addressing the OIG demands for documents and information, and guiding the provider through the various levels of appeal, which resulted in a significant reduction of the OIG’s recoupment.
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
Counseled a Client on HIPAA Compliance
Represented a health care information exchange through the necessary implementation of a HIPAA compliance program.
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
Negotiation of Settlement in Misbranding Law Matter
We represented a physician who had been designated as a “target” of a federal grand jury investigation focusing on FDA allegations of misbranding. The client along with other oncologists potentially faced numerous felony charges. We successfully defended the physician, resulting in a plea agreement to a single misdemeanor, favorable resolution of all civil matters including false claims act violations and no debarment of physician.
OIG Voluntary Self-Disclosure for Durable Medical Equipment Company
Provide Ongoing Legal and Compliance Counsel to a Specialty Pharmacy Chain
We serve as outside general counsel for a nationwide retail and specialty pharmacy company headquartered in Pennsylvania. We advise the company on legal and regulatory strategies and work with its leadership, sales and clinical teams to address complex and rapidly-evolving health care regulatory issues.
National Health Care Litigation Counsel for Large Multi-State Provider
Serve as national litigation counsel to a large, multi-state provider, overseeing litigation and serving as lead counsel nationwide. By taking consistent positions on discovery and other issues in every case, clients are better positioned to avoid litigation potholes and arrive at more favorable outcomes.
State Grand Jury Investigation
We represented a physician who had been designated as a “target” of a state grand jury investigation focusing on alleged healthcare fraud and false statements violations. After completion of an internal investigation and meetings with and presentations to the local prosecuting attorney, the investigation against our client was closed with no criminal charges filed and all civil and administrative matters resolved favorably to the client.
Federal Grand Jury Investigation
We represented a physician who had been designated as a “target” of a federal grand jury investigation focusing on alleged anti-kickback violations. After completion of an internal investigation and meetings with and presentations to United States Department of Justice and United States Department of Health and Human Services officials, the investigation against our client was closed with no criminal charges filed.
Merger of Two Surgery Practice Groups
Defended Bio-Tech Company Against False Claims Act Allegations
Represented a San Diego-based bio tech company investigated by the U.S. Department of Justice and more than 30 state attorneys-general for alleged False Claims Act violations. After completing the investigation and suggesting the implementation of new safeguards, presented the findings and affirmative steps to prevent future issues to the government prosecutors and investigators. This significantly mitigated the client’s exposure to penalties and avoided criminal charges altogether.
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