Health Care and FDA: Medicare Reimbursement and Enrollment
At the core of every health care provider’s operations are critical licenses and permits, enrollments with Medicare and Medicaid, credentialing with other payors, and reimbursement models. Without these, even the most sophisticated health care provider’s operations or revenues will come to a grinding halt.
Given the importance of these core assets, our firm has a long history of serving health care clients to obtain, maintain, and transfer state licenses and Medicare and Medicaid enrollments. We provide practical know-how and strategic insight based on years of experience working directly with state and federal regulators, including state licensing bodies, Medicaid agencies, and Medicare contractors. We assist clients throughout all phases of the lifecycle of a facility or service line, including assessing and helping clients meet licensure and enrollment requirements for new facilities or service lines, as well as their reorganization, acquisition, or sale. We also advise clients regarding ongoing compliance in these areas and in the wake of negative licensure and enrollment actions.
Further, enrollment review has become a key government tool in fighting fraud and abuse. As such, the enrollment process is fraught with legal perils, with intense scrutiny placed on the accuracy and timelines of filings, heightened levels of provider screening, and site visits for certain types of providers and suppliers. Failure to understand licensure and enrollment requirements and timing, to fully and accurately complete required forms, and to be adequately prepared for site visits or surveys can lead to delayed or denied licensure and enrollment for even the best-intentioned health care providers, with a negative impact on reimbursement. When this occurs during the opening of a new facility or service line or a large health care transaction, even minor mishaps can have dire financial consequences. Therefore, the assistance of experienced counsel with in-depth knowledge in these areas is imperative.
In addition, we regularly work with clients on complex reimbursement compliance matters advising on core billing compliance rules related to federal health care programs and commercial payors as well as innovative reimbursement models designed to maximize reimbursement while ensuring compliance.
We work with clients to understand their key licensure, enrollment, and reimbursement goals from a structural, timing, and financial perspective. We combine that with an in-depth knowledge of Medicare coverage, reimbursement, and enrollment rules across provider or supplier types. We then develop an implementation strategy that will meet applicable regulatory requirements for the provider or supplier type, address the mechanics of the licensure and enrollment process, and provide the best possible path to minimize the impact of transactions or internal reorganizations on cash flow. We leverage our years of experience in this area to identify creative solutions to implement complex provider or supplier structures and respond to enrollment challenges, with the ultimate objective of providing options that will assist clients in meeting their structural, timing, and financial goals.
We work with clients to address:
- Options that will ensure timely licensure and enrollment, minimizing cash flow delays and reimbursement gaps, taking into account the complex interaction between enrollment requirements and reimbursement and coverage rules applicable to the provider or supplier type.
- Certification survey or site visit requirements and preparation for such onsite survey or review if required.
- Application of special rules to unique provider or supplier types, such as supplier standards and site visit requirements for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers and independent diagnostic testing facilities; Inpatient Prospective Payment System excluded units, long-term care hospitals , inpatient rehabilitation facilities, radiation therapy centers, hospitals-within-a-hospital, and satellite facilities; temporary enrollment moratoria; the home health agency 36-month rule; and maintenance of critical access hospital status.
- Core billing compliance requirements for each provider or supplier type.
We then assist with the implementation of licensure and enrollment plans, including gathering of relevant information and documents, completion of applications, management of deadlines, and resolution of follow-up requests once applications are filed. We have a proven track record of working with state licensing agencies, the Centers for Medicare & Medicaid Services, state Medicaid agencies, and Medicare and Medicaid contractors to see projects—whether transactions, internal restructurings, or new facilities and service lines—through to successful licensure and enrollment. In representing a buyer in a transaction, we work closely with the buyer to obtain an understanding of the seller’s enrollments as part of diligence, assessing buyer’s options post-transaction, and planning and implementing a strategy for buyer’s licensure and enrollments that will minimize cash flow delays and reimbursement gaps.
Likewise, we bring strong relationships with these agencies to obtain timely recommendations on billing and reimbursement compliance. In this regard, we bring specialized knowledge in each of these areas, such as pharmacy Part B coverage under the DMEPOS benefit and other statutory benefits, the provider-based rules, site neutral payment under Section 603 of the Bipartisan Budget Act of 2015, accountable care organization rules, and 340B Program rules. At the heart of this is our in-depth knowledge of how different provider or supplier types are reimbursed by Medicare and related enrollment strategies.
Once successfully licensed and enrolled, we advise health care providers or suppliers on required enrollment and licensure disclosures and assist with reporting changes of information and meeting revalidation and renewal requirements. We also advise and represent clients in the event of adverse licensure or enrollment actions, including formal and informal agency disputes, which may result in delays or even application denials as a result of incomplete or inaccurate disclosures or other breakdowns in the enrollment or licensure process. We bring to bear our experience in resolving such challenges—many through informal processes—to get clients’ plans back on track.
