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.

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.

Acquisition of Ambulatory Surgery Center by Regional Health System

Client: Regional Health System

Dinsmore represented a regional health system acquiring a Medicare-certified multi-specialty ambulatory surgery center. The transaction included drafting and negotiating the Membership Interest Purchase Agreement, non-competition agreements, and related real estate purchase agreements.

Acquisition of Physician Practices by a Regional Health Care System

Client: Regional Health System

Stacey has experience representing buyers and sellers in these types of transactions. Most recently Dinsmore represented a regional health system acquiring two specialty physician practices. We advised the client through all aspects of the transaction, including drafting and negotiating the asset purchase agreement, various management agreements, clinical services agreements, physician employment agreements, and affiliated real estate transactions.

Negotiate Service Line and Co-Management Agreements

Client: Health Care Providers

Stacey has experience representing hospitals, surgery centers, and specialty practices in the drafting, negotiation, and compliance monitoring of these types of arrangements.

Comprehensive Compliance Review of Physician Practice Enterprise

Client: Physicians Group

Stacey completed a comprehensive effectiveness review of the enterprise’s compliance program and practices, from corporate governance, audit and monitoring, compliance education, communication and documentation, and corrective action plans. The review compared the enterprise’s policies, practices, and documentation to the OIG’s standards for an effective compliance program. The final report included recommendations and practical next steps for how to improve the enterprise’s overall compliance processes.

Private Equity Acquisition of Medical Device Manufacturer

Client: Medical Device Manufacturer

Dinsmore represented a closely-held international medical device manufacturer selling a controlling interest to a private-equity company. We advised the client through all aspects of the complex transaction including negotiating the purchase agreement, new governance structure, executive compensation, and non-compete agreements.

Obtained Reversal of Stayed License Decision

Client: A physician

The 10th District Court of Appeals reversed a decision of the Franklin County Court of Common Pleas, which affirmed the State Medical Board of Ohio and remanded the case back to the board for further proceedings. The court determined that the board did not act in accordance with law when it imposed a “stayed” license suspension without affording our client, a physician, an opportunity to be heard, and without determining the “threshold” question of whether, when the three day examination was ordered, the board had “reason to believe” the physician was impaired “because of habitual or excessive use of drugs or alcohol.” Upon remand by the court, the board chose to take no action against the physician and dismissed the case.

Obtained Reversal of Ohio Board of Nursing Order

Client: A nurse

The court reversed in part a decision of the Ohio Board of Nursing affecting our client, a nurse. The court stated the board found no evidence our client had an alcohol problem, and that the board erred by imposing monitoring conditions requiring our client to abstain from the ingestion of alcohol. The court ordered the Nursing Board Order be modified to remove this requirement.

Obtained Reversal of Medical Board Decision

Client: A physician’s assistant

The Franklin County Court of Common Pleas reversed a decision of the State Medical Board of Ohio which suspended a physician assistant’s license after she tested positive on a single EtG test, notwithstanding four years of sobriety demonstrated through negative alcohol screens and direct monitoring from multiple physicians and the Ohio Physician’s Health Program. The court found placing primacy reliance on an EtG test is inappropriate and scientifically unsupported at this time, as the EtG test is highly sensitive to even inadvertent, low-level alcohol exposure, which can provide an unreliable result. The court found that the board erred by relying on the EtG test alone and reversed the decision of the board.

Successfully Obtained Employment Relief for Physician Client

Client: A Physician

We represented an Ohio physician in obtaining the first federal equivalent of an Ohio Certificate of Qualification for Employment issued by an Ohio court and for which there is no federal law or district case law. Obtaining this relief precludes Ohio Medicaid from relying on the client’s prior conviction for health care fraud as a basis to permanently exclude the client from enrollment in Ohio Medicaid. Physician has been successfully re-enrolled, and is a provider for Ohio Department of Medicaid.

Bond Counsel for $1.16 Billion Health Care Financing

Client: Bon Secours Mercy Health, Inc.

We served as bond counsel for Bon Secours Mercy Health, Inc., one of the nation’s 20 largest health care systems, with respect to the issuance of several series of bonds totaling $1.16 billion in aggregate principal amount. As bond counsel, we assisted with each step of the financing process, which involved the public offering of municipal tax-exempt and corporate taxable bonds involving issuers in three states. The bonds were issued in April of 2020 and enabled the financing or refinancing of health care facilities in Ohio, South Carolina, and Virginia while also contributing to the re-opening of the capital markets for health care borrowers during the COVID-19 pandemic. These combined bond deals were selected by The Bond Buyer as its 2020 Deal of the Year in the Health Care Financing Category.

Successfully Obtained Relief for Ohio Physician

Client: A physician

We represented an Ohio physician in obtaining the first federal equivalent of Ohio Certificate of Qualification for Employment issued by a U.S. District Court in Ohio and for which there is no federal law or district case law. Obtaining this relief precludes Ohio Medicaid from relying on the client’s prior conviction for health care fraud as a basis to permanently exclude the client from enrollment in Ohio Medicaid.

Counseled Client through Licensure Process

Client: Licensed medical marijuana cultivator

After securing a provisional license to cultivate medicinal cannabis, our client sought to amend its original application plans after a local industrial park association retracted prior structural approval for facility plans. The Ohio Department of Commerce rejected proposed amendments to the applicant’s facility plans and moved to revoke the client’s provisional license. We negotiated with the association and the department and resolved the matter through revised structural plans that satisfied association bylaws, as well as other corrective actions and remedies approved by the department by way of a consent agreement and dismissal of the proposed revocation action. The client has since been granted a full license to cultivate and is successfully operating in northeast Ohio.

Assisted Client with Business Development

Client: Cannabis company

As medical marijuana is a relatively new and evolving health care modality, clinical resources and data remains scarce. We advised a cannabis start-up company focused on developing knowledge and aggregating the best data and information to provide patient education services, therapeutic product selection, and guidance regarding dispensary offerings. This company’s goal is to help medical marijuana patients find the best product to treat their individual and unique health conditions. We assisted the company with everything from business plan development, corporate governance, regulatory implications, and telehealth compliance.

Counseled Treatment Center through Investigation

Client: Addiction treatment center

On behalf of a multi-office Ohio addiction treatment center, we handled the fraud and abuse investigation and subsequent negotiations with federal authorities who were reviewing the client’s receipt of free drug screening equipment from one of the largest laboratories in the country.  We successfully persuaded the United States Department of Justice to decline bringing criminal or civil charges, and the matter was eventually resolved with minor civil penalties paid to the United States Department of Health and Human Services / Office of Inspector General and avoidance of any administrative sanctions, including exclusion from participation in public health programs.

Counseled Health Care System on Medical Marijuana Guidelines

Client: A health care system

On behalf of a hospital system and its employed physicians, we prepared various informed consent forms, internal policies, and procedural manuals for use by licensed providers who have obtained a Certificate to Recommend Medical Marijuana from the State Medical Board of Ohio and are seeking to utilize medical marijuana as a potential treatment modality. We also advised the hospital system on navigating state and federal guidelines and avoidance of potential compliance issues and violations.

Counseled Cultivator with Application

Client: Pure OH LLC

Our client, a marijuana cultivator applicant, submitted an application to the Ohio Department of Commerce seeking a provisional license to cultivate medicinal cannabis. The application process is extensive and applicants are graded against one another, with the top 12 companies selected for licensure. Despite scoring higher than six of the 12 companies granted licensure, the department notified our client it was proposing denying its application due to alleged deficiencies in its proposed security plan – one of five operational plans each applicant must satisfy. Through the administrative hearing process, we were able to demonstrate that a higher, corrected score for the security plan section was warranted, leading the department to reverse the proposed denial and instead grant our client’s application. This case represented the first successful administrative appeal by an applicant seeking a provisional cultivator’s license as a result of challenging its original score issued by the department.

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 (FCA) 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 multi-million dollar Medicare overpayment to less than $15,000.

Specific 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 (FCA) 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.