Facility and Professional Regulation and Operation

Ober|Kaler’s Health Law Group offers in-depth legal counsel on the many regulatory issues that health care providers encounter. We assist facilities and individual health care professionals in developing and implementing business strategies designed to meet the demands of today’s marketplace, while paying close attention to the issues specific to the health care regulatory environment in which each client operates. Our attorneys guide our clients’ interactions with government agencies and, when necessary, take the helm in pursuing litigation against the government on behalf of our clients.

Comprehensive Health Planning

Ober|Kaler provides comprehensive health planning services to hospitals and other health facilities, as well as to venture participants in Maryland and other states. Such services include:

Determining if a Certificate of Need (CON) is required for a project
Handling applications for CON-required projects
Assisting in health policy development with CON agencies
Helping resolve CON-contested cases
Inter-agency dispute resolution

Ober|Kaler attorneys have been involved in this field since the inception of the federal health planning law and state CON statutes. Our attorneys have achieved success in obtaining approvals allowing clients to initiate new services or programs, and to undertake major as well as minor construction, equipment purchases and advance refunding of existing long-term debt.

Enrollment Certification and Licensure

Ober|Kaler Health Law attorneys have significant experience in assisting clients with Medicare and Medicaid enrollment and certification and in obtaining all appropriate licenses and permits. Through our years of experience in facilitating transactions for various types of providers and suppliers, we have developed close working relationships with many state agencies, contractors and Centers for Medicare & Medicaid Services (CMS).

For both new companies and those that are undergoing acquisitions, mergers or internal corporate reorganizations, we help minimize cash flow delays by coordinating the process of obtaining or maintaining Medicare and Medicaid certification and enrollment. We have developed systems that help our clients prepare CMS 955 enrollment forms for Medicare and identify issues that must be addressed in the enrollment process. Our firm utilizes a systematic approach to ensure that all advance notices and application filing requirements are satisfied and agency approvals to operate are obtained in a timely manner.

Ober|Kaler closely monitors changing laws related to licensure and certification, including transactions that constitute Changes of Ownership (CHOWs) requiring new licenses or certification, ownership and control disclosure requirements, and application processes. Our firm routinely deals with complications created by complex transactions and transactions that are considered to be CHOWs under state laws but not under federal laws.

Our work includes facilitating regulatory compliance and assisting facilities in responding to issues that pose the threat of loss of licensure or certification. In connection with this, we represent all types of facilities, including hospitals, nursing homes, ambulatory surgical facilities, pharmacies and other Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) suppliers, home health agencies, hospices, clinical laboratories, assisted living facilities, continuing care retirement communities, adult day care providers and comprehensive outpatient rehabilitation facilities.

Professional Licensure and Certification

Health care professionals and professional practices can count on Ober|Kaler to help them obtain and maintain licenses and certifications. Our attorneys regularly represent physicians, podiatrists, occupational physical therapists, chiropractors, adult day care providers, dentists, nurse practitioners, physician assistants, and other individuals involved in delivering health care services.

Ober|Kaler assists clients in negotiating regulatory processes not only with agencies responsible for issuing licenses and permits, but also with agencies responsible for Medicare and Medicaid enrollment. Our attorneys stay current in requirements to obtain and maintain Medicare enrollment, including completion of the CMS 855 forms and keeping Provider Enrollment, Chain and Ownership System (PECOS) data current, and assisting enrolled providers who have had billing privileges deactivated or revoked through submission of Corrective Action Plans (CAPs) or appeals.

We provide representation at both the national and state levels with issues related to licensing, scope of practice, professional compliance, hospital privileges, peer review and disciplinary matters. Our experience encompasses state and federal investigations, professional competency hearings, and licensure application and approvals.

Accreditation

In the accreditation arena, Ober|Kaler attorneys are experienced in handling Joint Commission matters. Our extensive background includes assisting a variety of health care facilities in responding to determinations of conditional accreditation, preliminary denials of accreditation and denials of accreditation.

We work with facilities to provide clarification documentation and to appeal agency findings. In addition, we help our clients develop policies and procedures designed to satisfy accreditation standards, work with them to aid in the investigation of sentinel events and identify areas where organizational change is needed.

Emergency Medical Treatment and Active Labor Act (EMTALA) Compliance

Ober|Kaler helps hospital and physician clients handle EMTALA compliance, allegations of violations and corrective action response.

We are experienced in a wide range of EMTALA-related issues, including:

Drafting and amending compliance policies
Developing corrective action plans for submission to CMS
Representing clients in Quality Improvement Organization (QIO) presentations to dispute allegations of poor quality care
Responding to the Office of the Inspector General regarding imposition of civil monetary penalties
Responding to onsite and offsite investigations of possible discrimination conducted by the Office of Civil Rights

Clinical Research

In the area of clinical research, Ober|Kaler provides legal counsel to research sponsors, principal investigators, research sites and registry operators.

We have advised clients on matters that span the research spectrum, including:

FDA and HHS regulatory compliance
HIPAA compliance
IRB development and operation between sites and principal investigator relationships
Sponsor agreements with sites, investigations and CROs
Registry establishment and operation
OHRP and FDA audits and investigations

Our attorneys work closely with in-house counsel and research administrators to develop arrangements that facilitate clinical research within legal and fiscal constraints.

Hospital/Medical Staff Relationship Disputes

Ober|Kaler attorneys are acutely sensitive to the importance of maintaining effective hospital medical staff relationships where legal issues are involved. Our sensitivity results from our effective representation of hospitals and physicians in litigation, including antitrust injunctions and damage claims, “breach of bylaws” litigation and breach of contract cases; and in administrative investigations by the Federal Trade Commission and the Department of Justice that can result when breakdowns in hospital/medical staff relationships occur. At times, these disputes can be particularly venomous.

We have been able to work effectively with medical staff physicians and hospitals in implementing hospital objectives in bylaw revisions, quality assurance programs, utilization reviews, CMS investigations, terminal patient treatment issues, Joint Commission and Accreditation Council for Graduate Medical Education (ACGME) issues, and many other administrative matters.

In addition, Ober|Kaler attorneys have the experience required to help clients address credentialing and privileging matters, medical staff disciplinary proceedings, physician “turf battles” and other medical staff political issues. Our substantial depth also extends to representation of both physicians and hospitals in physician-hospital contract negotiations and disputes.

Insurance

Ober|Kaler’s Health Law Group has direct experience in helping clients with the formation and operation of risk retention groups, purchasing groups, domestic and offshore captive insurance companies and self-insured trusts.

The practice provides management advice designed to improve adverse claim and loss development, guidance concerning existing coverage and future placement, and counsel on structuring specialized stop-loss reinsurance and letters of credit to achieve affordability. In addition, we provide advice concerning regulation coverage issues, including contracts under ERISA jurisdiction and exempt plan organizations.

As leaders in the field, our attorneys have prepared legal issues for state insurance department approval, drafted a position paper on health care coverage and alternative delivery format issues for presentation to the National Association of Insurance Commissioners, and represented health care providers and professional associations in administrative proceedings before the Maryland State Insurance Commission and in litigation.

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