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Services for Healthcare Providers
Supporting Digital Health Innovators
The rapidly developing and evolving digital health and healthcare information technology market represents tremendous opportunities but also poses significant risks. Our mission is to provide the support that digital health innovators need to break the barriers and mitigate uncertainties to advance and prosper.
MDRXLaw attorneys bring a thorough understanding of health law to the vibrant and dynamic field of healthcare information technology and digital health. Our multi-disciplinary approach to emerging and traditional healthcare legal and regulatory challenges, informed by years of transactional and litigation experience, makes us a valuable partner to any company operating at the point of convergence of technology, health care, medical devices and pharmaceuticals.
We share your vision of the future of healthcare where digital health, artificial intelligence, and instant information exchange among healthcare providers will play as important a role as top-notch medical knowledge and skills and stellar patient care. We are at the forefront of digital health issues and counsel clients in the following areas:
Our Services
We deliver the following services to our digital health clients:
As the healthcare industry continues to evolve, new trends emerge. Many healthcare players consolidate, providers become more specialized in the types of health care services they offer, and regulatory and compliance obligations grow exponentially. We can help to advance your business forward, with new and creative types of business arrangements and every other type of transactional support you need, as you shift with the broader industry.
At Sauchik & Giyaur, P.C., our team is at the forefront of these developments, providing regulatory, corporate and financial support to healthcare companies in all types of transactions, including mergers, acquisitions and divestitures, joint ventures and strategic partnerships, investments, managed care contracting, refinancings/restructurings, operational matters, management and employment issues, and other integrated delivery systems and contractual relationships.
This key guidance is provided to a wide array of companies, including hospitals, surgery centers, home health and durable medical equipment providers, long-term care facilities, pharmacies, imaging facilities, behavioral health and substance abuse facilities, optometry, wellness and rehabilitation providers, allied and ancillary services providers, medical groups/physician networks, and private equity/banking entities.
Our transactional attorneys negotiate, draft, and counsel on successful implementation of many types of healthcare agreements and arrangements, including:
- Clinical Trial Agreements
- Confidentiality Agreements and NDAs
- Time-Share Lease Agreements
- Hospital-Physician Group Coverage Agreements
- Hospital-Physician Joint Venture Agreements
- Hospital Service Agreements
- Lease Agreements
- Management Services and Office Share Agreements
- Service and License Agreements
- Medical Director - Practice Agreements
- Professional Services Agreement
- Managed Care Agreements
- Shared Research Services Agreements
- Ambulatory Surgery Center Agreements
- Operations Policies and Procedures
- Employment Agreements
- Employment Handbooks
- HIPAA and Information Technology-Related Agreements
- Records Management and Retention Agreements
- Non-Solicitation and Non-Disclosure Agreements and Policies
- Agreements Related to Long-Term Care Facilities
- Patient Contract Forms, Agreements, and Consents
- Vendor and Marketing Agreements
Arrangements in the healthcare industry constantly evolve, become more complicated, and acquire new faucets. As the level of legal expertise that is needed to successfully navigate a business transaction increases, so does our commitment to providing the best legal counsel to our clients seeking to engage in compliant, efficient, and business-savy healthcare transactions.
PBM AUDIT DEFENSE - ALL STATES*
Most on-site and desktop audits can be resolved with better outcomes if experienced counsel is engaged early in the process. Ideally, audit preparation should begin way before an audit notice is received, through the process of ongoing collaboration between counsel and the pharmacy. The preparation process should include compliance and best practices review, developing and implementing effective policies and procedures, as well as record-keeping and risk assessment.
Unfair and abusive practices by PBMs, their third-party contractors, and health plans can be neutralized through various situation-appropriate and assertive approaches. Counsel who is well-versed in the process, if engaged at the early stages of an audit, can assist in many different ways. Strong and appropriate responses to commonly encountered audit scenarios will help the pharmacy to avoid pitfalls and successfuly complete an audit. When unfavorable findings are inevitable, experienced counsel can help to avoid large recoupments, termination, and possibly referrals to law enforcement and administrative agencies.
Through years of defending audits and other actions by CVS Caremark, OptumRx/Catamaran, Argus, Express Scripts, Humana, Horizon, Envision Rx, Prime Therapeutics, ProcareRx, Medimpact, Navitus, and others, our attorneys have developed numerous succesful approaches to the full range of issues that arise in PBM audits:
Audits frequently focus on matching the purchase history of a pharmacy with the number of claims submitted. These types of audits present mutliple, particularly complicated challenges to unrepresented clients. Your chances of successfully completing an invoice shortage audit are much higher with proper coordination among counsel, pharmacy, PBM personnel, wholesalers, and PSAOs. We represent pharmacies in connection with all types of invoice shortage audits. In cases of unfavorable audits, we can raise multiple post-audit challenges and employ strategies we have developed through representing hundreds of pharmacies to minimize the impact.
Compounding pharmacies are especially susceptible to frequent audits. They often focus on the propriety of using certain ingredients or formulations in compounds, and on whether the pharmacy correctly billed for the compounds. Invoice shortage audits also often accompany compounding audits. An experienced PBM audit attorney not only familiar with the legal aspect of a PBM audit, but also with practical and business aspects of the compounding practice, can help the pharmacy to properly navigate many critical issues that can end up costing the pharmacy hundreds of thousands of dollars in disallowed claims.
We often encounter situations when our clients face audits due to license-related issues, such as acting outside the scope of their license, shipping to states in which they are not licensed as out-of-state providers, and the like. We have developed a deep understanding of license-related laws and regulations and can help you to avoid and mitigate licensure-related audits, investigations, and possible referrals to authorities.
PBMs often claim that certain prescriptions were written in violation of laws and regulations, and filled without requesting corrections from prescribers. This is when our knowledge of the laws and regulations can, and frequently does, make all the difference.
One of the more common types of audits, they can be effectively dealt with by using our tried and proven strategies and deep knowledge and understanding of the industry.
Sometimes audits implicate issues of PBM credentialling, such as whether correct pharmacy background information was submitted to the PBM; dealing with excluded individuals, initial credentialling due to audits of other entities, and obtaining PBM contracts when the pharmacy was purchased from a previously terminated owner. No matter the challenges, we have effective ways of dealing with them and navigating you through some of the roughest waters when it really matters.
We have successfully dealt with numerous mail-order-related audits implicating issues ranging from confirmation of receipts of medications to engaging in mail-order activities when prohibited by PBM contracts.
Most patient- and physican-denial audits have nothing to do with fraud, waste or abuse. We know how to present these issues to the PBMs and deal with them in an efficient and expeditious manner.
Attorneys at Sauchik & Giyaur, P.C. are highly experienced in healthcare mergers, acquisitions, and affiliations. Using our multidisciplinary approach, we represent healthcare clients in all stages of business arrangements for the healthcare industry. We represent all types of healthcare providers, including long-term care facilities, individual physicians and physician practices, imaging centers, infusion centers, dialysis providers, medical device companies, home health agencies, durable medical equipment providers, ambulatory surgery centers, and other ancillary service providers, in structuring and closing acquisition and other change-of-control transactions. We are intimately familar with the latest legal and regulatory developments and are deeply engaged in helping clients from an aggregate of perspectives.
Our Approach
We have a deep understanding of the complex business issues that our clients face and add value through responsive and creative solutions for navigating the multitude of legal and regulatory issues involved in change of control transactions. Members of our team are experienced in representing both buyers and sellers and affiliation partners through every stage of a transaction, including:
- Initial management consideration, analysis, and conceptualization of a transaction
- Due diligence and regulatory review including regulatory approvals and compliance with federal and state physician-self referral, anti-kickback, medical privacy, and licensing laws
- Board discussions and approvals including strategic planning and special counseling
- Negotiating the transaction agreements
- Analyzing and assisting in the completion and filing of applicable regulatory and reimbursement applications
- Closing of the transaction
- Harmonizing business and legal policies and integrating the target’s business
We work with clients to develop the corporate and contractual structures best suited for them to ensure efficiency and quality of outcomes. We take a team approach to healthcare transactions, working with other specialists engaged by our clients—including financial institutions, accountants and public relations firms—and drawing on the skills of our lawyers to handle antitrust, tax, real estate, corporate compliance, privacy, environmental, employment and labor, litigation, FDA, intellectual property, and public policy concerns.
SPECIALTY PHARMACY REPRESENTATION
The specialty pharmacy industry is undergoing rapid growth and profound transformation. By 2018–2020, 50% of all drugs sold in the United States are expected to be specialty pharmaceuticals, compared with 30% today. These high-cost medications help treat patients with complex conditions such as multiple sclerosis, rheumatoid arthritis, cancer, and hemophilia. Whether taken orally, infused or injected, they typically require special handling, monitoring and specialty expertise that only a limited number of pharmacies are equipped to provide. Yet, the industry is constantly evolving and undergoing profound changes, many of which have significant legal ramifications. Many specialty pharmacies have discovered that expert advice by an experienced law firm, such as MDRXLaw, can add great value to their businesses.
In addition to being a recognized industry leader in the area of pharmacy law and practice, over the years, MDRXLaw has developed an expertise in the area of specialty pharmacy representation. We understand the unique challenges facing specialty pharmacies and other key players in the industry and have the knowledge, experience, and resources to efficiently deliver outstanding results.
We have experience dealing with the wide range of issues facing specialty pharmacy providers, such as:
We assist our clients with issues involving access to preferred networks, leveraging many tools including federal and state any willing provider laws.
We aggressively defend specialty pharmacy providers in connection with audits and investigations by PBMs and governmental payors and fight on behalf of providers in the event of unfair and frequently unlawful attempts by PBMs to terminate our clients' contracts.
We help pharmacy providers with the legal aspects of gaining access to limited distribution drugs in situations when the manufacturer's position is legally unsupportable and practically untenable.
Over the years, we have served as lead counsel in connection with major and notable sales, mergers, and acquisitions in the specialty pharmacy industry. We understand the special challenges and the full range of issues presented in connection with transactions involving specialty pharmacies. We work closely with accounting firms, banks, M&A advisors, private equity companies, consultants, and others to achieve the most desirable financial and business outcomes for our clients.
We understand the challenges presented, and the issues raised, by DIR fees imposed by major PBMs. We are at the forefront of the most recent developments involving this controversial issue, and aggressively advocate on behalf of our clients faced with this extraordinary challenge.
Our understanding and experience in corporate and business matters, in conjunction with our solid regulatory background and knowledge of business realities, allow us to effectively counsel clients on the choice and structure of their business entities to permit smooth and efficient operation.
We have extensive experience counseling clients on proper ways to manage and operate their sales force and other employees in the face of intense regulatory scrutiny and complex business and legal environments in the constantly evolving field of labor relationships.