Creating and Managing Your Client s Licensure and Enrollment Program SCOTT SCHARDT FEBRUARY 21, 2018 MARTHA KARAM

Bringing Order to the Chaos To assist our client s in establishing an effective program and process for their licensure and enrollment, we must: 1. Centralize leadership of the program. 2. Identify and communicate with individuals and departments necessary to support the program. 3. Identify and continually update core information necessary for efficient operation of the program. 4. Develop a tool to identify and stay ahead of necessary maintenance actions for the organization s licensure and enrollment.

Bringing Order to the Chaos (Identify the Leader) Program Leader could be different individuals for different organizations, but a health care provider s legal counsel is uniquely situated to lead an organization s licensure and enrollment program. Regulatory nature of the licensure and enrollment process How is a hospital s new practice location enrolled and reimbursed under Medicare pursuant to the provider-based regulations (42 C.F.R. 413.65); is the new location added to the hospital s license or independently licensed? (25 T.A.C. 133.21(g)). Does a change to the BOD of a Texas Non Profit Health Org (501a) require immediate notification to TMB or can it be handled through the entity s biennial recertification with the Board? (22 T.A.C. 177.6) What patient notifications must a home health agency make when voluntarily terminating its license? (40 T.A.C. 97.295) Purview over the legal and ownership structure of the organization. Close relationship with other areas of the organization: administrative, legal, clinical, billing, compliance, IT. (Much of an organization s licensure, enrollment, certification is dependent on the other). Access to the authorized officials and the executive team ABILITY TO ESCALATE THINGS QUICKLY. When issues arise, which they always do, the legal department is in a position to receive the notice first, intimately familiar with the administrative process and can direct the response immediately.

Bringing Order to the Chaos Program leader depends on these team members, and must establish a clear expectation that any issues related to the organization s licenses and enrollments is referred to the program s leadership. L e g a l LEGAL TEAM EXECUTIVE TEAM CLINICAL PRACTICE ADMINS COMPLIANCE QUALITY REIMBURSEMENT/ REVENUE CYCLE

Bringing Order to the Chaos (Members of the Team) Examples of interaction between members of the licensure and enrollment team: Reimbursement and Revenue Cycle: Why are claims being denied? Is a newly constructed hospital facility considered a new hospital for purposes of Medicare capital cost reimbursement? Do the claims with an Out of State Medicaid program justify enrollment? Clinical: Is our physician qualified to serve as Lab Director under our CLIA certificate? Addition of new physicians to organization s Medicare Part B enrollment through the CMS 855R. Compliance: Does the adverse legal event uncovered in our new physician s background check require disclosure or notification under the organization s Medicare/Medicaid filings? Quality: Coordination of licensure and survey/inspection activities. Executive Team: What is the timeframe and process for a license or enrollment involved in a transaction or operations? Organization obtained a new loan from a bank, what disclosures are required? How do we integrate a physician group s surgical center into our existing operations within the transaction timeline?

Bringing Order to the Chaos (Foundational Information to the Program) The Licensure and Enrollment Program leader must continually maintain and update the following information to ensure efficient and accurate administration of the licensure process: Legal entity structure Entity type (Corporation, Partnership, LLC, Government, etc.) Registered Agent, Principal Place of Business Organization dates (e.g. Incorporation, CHOW effective date, etc.)

Bringing Order to the Chaos (Foundational Information to the Program) Ownership and Management Information Entities/individuals with at least a 5% or greater direct or indirect ownership interest in your organization. (Texas DSHS uses a standard of 25% or greater for corporations applying for hospital licensure 25 T.A.C. 133.22(a)(8)(c)) Entities/individuals that have a 5% or greater mortgage or security interest in your organization. Organization that exercises operational or managerial control over your organization. Other Medicare/Medicaid providers or licensed providers in which your organization maintains an ownership interest. (42 C.F.R. 455.104(b)) Corporate Officers Authorized and Delegated Officials (42 C.F.R. 524.510(a)(3)) Directors and Officers: How is your entity organized (partnership, corporation, etc.? Your directors, officers or partners might have to be individually disclosed (e.g. 42 C.F.R. 455.101 person with an ownership or control interest ) Managing Employees

Bringing Order to the Chaos (Foundational Information to the Program) Adverse Legal Events: To whom does the disclosure apply? (disclosing entity, owners, officers/partners, Medicaid 42 C.F.R. 455.106(a)) What actions must be disclosed? (e.g. 42 C.F.R. 1001.101) Is there a lookback period for disclosure? (e.g. certain DADS Home Health Agency License disclosures 40 T.A.C. 97.11(h)(2-3); ASC license disclosures 25. T.A.C. 135.20(b)(1)(H)) Scope of Services (e.g. number of beds, service lines, outpatient/inpatient) Practice Locations (e.g. physical location, outpatient/inpatient, relationship to main provider, administrator, separate licensure) Relationship with Management Company (Legal and ownership structure of management company, effective date of company s relationship with provider, nature of relationship with provider: ownership v. contractual)

Bringing Order to the Chaos (Foundational Information to the Program) Maintaining the actual organizational documents vital to the licensure process. Organizational Documents IRS and Financial Accounts Information Documentation related to disposition of legal adverse events Transaction Documents Provider Rosters Copies of other licenses

Bringing Order to the Chaos (Developing an Effective Licensure Tool)

Ongoing Maintenance 1. Reporting Requirements, Updates, and Changes Generally Texas Medicaid Medicare Consequences of Failures 2. Hypothetical

Ongoing Maintenance 1. What needs to be reported? 2. When does it need to be reported? 3. How does it need to be reported?

What needs to be reported? Identifying Information provider name, type, addresses, phone numbers, contact Practice Location Information Additions and closures of locations Changes to individual locations Adverse Legal Actions/Convictions convictions, exclusions, revocations, or suspensions Ownership Interest, Managing Control Information Includes officers, directors, managing control, and partnership interests Payment Information Electronic Payment Information, Bank Account information Billing Agency Information

Texas Medicaid HHSC Medicaid Provider Agreement Within 90 days, Provider agrees to keep its application for participation in the Medicaid program current at all times by informing HHSC or its agent in writing of any changes to the information contained in its application, including, but not limited to... federal tax identification number provider licensure certification or accreditation phone number provider business addresses Changes due to a change of ownership or control interest within 30 days All convictions of Provider or Provider s principals within 10 days

Failure to Report Leading to Medicare Revocation 42 C.F.R. 424.535(a)(9) The provider or supplier did not comply with the reporting requirements specified in 424.516(d)(1)(ii) and (iii). 30 days for: 1. A change of ownership including authorized officials and designated officials 2. Any adverse legal action; or 3. A change in practice location. 90 days for all other changes.

March 2016 Proposed Rule Program Integrity Enhancements to the Provider Enrollment Process This proposed rule would also provide CMS with additional authority to deny or revoke a provider's or supplier's Medicare enrollment and expand CMS s reenrollment bar authority CMS would have the authority to impose a reapplication bar of up to three years where a Medicare enrollment application is denied for submission of false or misleading information or where information is omitted in order to obtain enrollment. Change to reenrollment bar: from 3 to 10 years where CMS determines provider is attempting to circumvent reenrollment bar up to 20 years for a second revocation

Is this ever actually enforced? Viora Home Health, CR4369 (Dep t of Health and Hum. Serv., Dept. Appeals Bd. 2015) Between submitting revalidation application and receiving approval or revalidation, address changed and on-site inspection occurred Provider sent letter notifying MAC of it s move, but not the appropriate 855 form The contractors who administer the program on a day-to-day basis are confronted with immense amounts of information and are responsible for processing and organizing that information. It is essential that they receive relevant information in a routinized way.

Is this ever actually enforced? Fares F. Yasin, CR 4425 (Dep t of Health and Hum. Serv., Dept. Appeals Bd. 2015) Physician checked wrong box on 855 form to delete a practice address for an additional practice location Physician described it as an oversight Resulted in Appeal Board upholding a 2 year bar to re-enrollment

Is this ever actually enforced? Daniel H. Kinzie IV, M.D., CR 2112 (Dep t of Health and Hum. Serv., Dept. Appeals Bd. 2010) Physician practicing in Texas failed to notify CMS his California medical license was revoked Physician had not practiced in California since 1960s but held active license Revocation backdated to date his California medical license was revoked

Is this ever actually enforced? Mary S. Stoliker-Diaz, O.T., CR5000 (Dep t of Health and Hum. Serv., Dept. Appeals Bd. 2017) Gap in reimbursement for delay in answering revalidation request Todd G. Anderson, O.D., PLLC CR4990 (Dep t of Health and Hum. Serv., Dept. Appeals Bd. 2017) PECOS system erred, Provider unable to submit online revalidation. MAC assured via phone he would have extension; appeal upheld gap in coverage for reimbursement for not revalidating in time

Consequences of Poor Maintenance Administrative Penalties Civil Liability Criminal Liability Termination Exclusion Internal Losses Transaction Delays

Hypothetical A licensed general acute care hospital learns its CEO is under investigation for a crime. While the crime is being investigated, the hospital wants to evaluate whether there are any notification requirements for their current licensure and enrollment. Where to begin?

Hypothetical

Licensure and Enrollment in a CHOW Insert Licensure Tool Visual

Licensure and Enrollment in a CHOW (Structuring the Transaction) How does the organization s licensure and enrollment impact the transaction structure? Does the transaction constitute a CHOW and require transfer of the organization s Medicare and Medicaid enrollments? (42 C.F.R. 489.18) Partnership Asset Purchase and Transfer of Provider Agreement Merger/Consolidation of Corporations (newly formed corporation) Leasing Impact of transfer and assignment of Medicare/Medicaid Provider Agreements.

Licensure and Enrollment in a CHOW (Structuring the Transaction) Transactions that do not constitute a CHOW and require transfer and assignment of Medicare and Medicaid provider agreements (42 C.F.R. 489.18): Stock/Interest Transfer Merger (Provider Corporation survives) Asset Purchase with no Transfer of Provider Agreement Provider Entity Licensure: DSHS Hospital Licensure (25 T.A.C. 133.24) DSHS ASC Licensure (25 T.A.C. 135.2(9), 25 T.A.C. 135.23(d)) DSHS Freestanding Emergency Medical Center License (25 T.A.C. 131.2(8), 25 T.A.C. 131.28) DADS Home Health License (40 T.A.C. 97.2(25), 40 T.A.C. 97.23) Texas BOP Pharmacy License (21 T.A.C. 291.3(d))

Licensure and Enrollment in a CHOW (Timing of a Transaction) Components of the organization s licensure that may have a significant impact on the timing of the transaction: Certificate of Need Medicare and Medicaid Pharmacy Components that will not effect the timing of the transaction: Hospital/ASC License CLIA Radiation TJC Accreditation

Licensure and Enrollment in a CHOW (Implementing the CHOW) Notice Letters early contact with the agencies. Program Leader directs the process. Regular communication with departments and individuals comprising the licensure team. Utilize your tool for directing the regulatory notifications and submission and completion of applicable filings.

Questions? Contact Us SCOTT SCHARDT MARTHA KARAM (214) 842-6917 (214) 842-6918 Scott.Schardt@rogalinerlaw.com Martha@rogalinerlaw.com