Health Law Blog - Healthcare Legal Issues

Archive for January, 2018

New TEP Report Posted On Quality Measures for Long-Term Care

Tuesday, January 23rd, 2018

Development and Maintenance of Quality Measures for Long-Term Care – Hospital Quality Reporting Program (LTCH QRP)

Personal Care Agency FraudThe technical expert panel (TEP) has published a new summary report covering the Development and Maintenance of Quality Measures for Long-Term Care Hospital Quality Reporting Program.  The new report related to a meeting of the TEP that was held on Tuesday, March 28, 2017 focusing on   current LTCH QRP quality and resource use measures.  The objective was to report on existing measures and to make recommendations for future measures.

The new TEP Report can be accessed on the  TEPs webpage.

Other reports on that page include:

  • Claims-Only and Hybrid Hospital-Wide (All-Condition, All-Procedure) Risk-Standardized Mortality Measures
  • Development of the Hospice Quality Reporting Program HEART Comprehensive Patient Assessment Instrument
  • Quality Measure Development: Supporting Efficiency and Innovation in the Process of Developing CMS Quality Measures
  • Development of Outpatient Outcome Measures for the Merit-based Incentive Payment System (MIPS)
  • Development and Maintenance of Quality Measures for Skilled Nursing Facility (SNF) Quality Reporting Program (QRP)
  • Development and Maintenance of Post-Acute Care Cross-Setting Standardized Patient Assessment Data
  • Inpatient Psychiatric Facility (IPF) Outcome and Process Measure Development and Maintenance
  • Quality Measure Development (QMD): Dual Enrollees, Managed Long-Term Services and Supports (MLTSS), and Medicaid Innovation Accelerator Program (IAP).
  • Task: Technical Expert Panel: Medicaid Innovation Accelerator Program (IAP)-Substance Use Disorder, Beneficiaries with Complex Needs, and Physical-Mental Health Integration
  • Hospital Inpatient and Outpatient Process and Structural Measure Development and Maintenance (Hospital-MDM)
  • Development and Maintenance of Quality Measures for Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

 

Medicare’s New Low Volume Settlement Process

Tuesday, January 23rd, 2018

Expressions of Interest Can Lead to Medicare Settlement for Eligible Appellants

The Centers for Medicare and Medicaid Services recently announced that beginning February 5, 2018, it will begin accepting what it terms as “expressions of interest” for a limited settlement from providers who have fewer than 500 appeals pending at the Office of Medicare Hearing and Appeals and the Medicare Appeals Council.  The option is made available to certain Medicare fee-for-service providers, physicians and suppliers.  The new administrative settlement process will be to settle portions of pending appeals that involve $9,000 or less total billed amounts.  The trade-off would be a timely partial payment of 62% of the net new amount that is approved by Medicare.

Providers and suppliers who meet qualifications can commence the process by submitting an Expression of Interest (EOI) using the process established by CMS.

Eligible appellants include Medicare Part A and Part B providers, physicians, and suppliers that have less than than 500 appeals pending.  Some appellants are ineligible for participation in the program.  Ineligible appellants include beneficiaries, enrollees, their family members, or estates. State Medicaid Agencies, Medicare Advantage Organizations (Medicare Part C), those that filed for bankruptcy or expect to file for bankruptcy, some appellants who may have had False Claims Act problems or other program integrity issues.

The details of the program and various forms and guidance are included on the CMS website.  Medicare Low Volume Appeal Program

Gainsharing Arrangement Addressed in New Advisory Opinion

Thursday, January 11th, 2018

 OIG Advisory Opinion 17-09

OIG Advisory Opinion Gain SharingThe Office of Inspector General (“OIG”) recently released a new advisory opinion (Advisory Opinion 17-09 – January 5, 2018), addressing a gainsharing arrangement between a group of neurosurgeons and a health center.  Under the proposed arrangement, a neurosurgery group agreed to implement measures to reduce the costs associated with a defined scope of surgical procedures.  As part of its agreement with the health center, the neurosurgeons were to participate in a portion of the cost savings that resulted from the implementation of the measures.

The OIG has historically issued around a dozen Advisory Opinions addressing gainsharing arrangements.  However, the OIG had not issued an advisory opinion in the gainsharing area since the passage of the Medicare Access and CHIP Reauthorization Act (known as MACRA) in 2015.  That law made modifications to Civil Monetary Penalty provisions that are applicable in the gainsharing area by removing some of the impediments to gainsharing arrangements that previously existing in the Civil Monetary Penalty laws.

Gainsharing arrangements have emerged as a way to align the economic interests of hospitals and physicians in efforts to work together to reduce cost and enhance quality of care.  A gainsharing arrangements provides doctors with economic incentives to adhere to practices that reduce the hospital’s costs associated with defined procedures or treatment courses.  Under traditional fee-for-service reimbursement, a financial incentive is created for physicians to provide more service to maximize reimbursement.  A properly structured gainsharing arrangement creates incentives for appropriate levels of service and rewards physicians for efficiencies and quality outcomes.  Interests are aligned because the facility and the physician, who is often the engine driving the level of care, share in the savings.

Prior to the passage of MACRA in 2015, the OIG expressed suspicion about gainsharing through Special Advisory Bulletins as well as advisory opinions.  This has the effect of chilling the proliferation of gainsharing arrangements because providers were cautious about potential regulatory issues. A major impediment prior to 2015 was the CMP law that restricted hospitals from compensating physicians in order to induce a reduction or limitation on services provided to Medicare and Medicaid beneficiaries.  MACRA clarified that the CMP law was only violated if the payment to the physician is for purposes of reducing services that are medically necessary.  This subtle yet significant change opened the door for the proliferation of gainsharing arrangements.

Coming full circle to Advisory Opinion 17-09, the OIG concluded that the specific gainsharing arrangement described in the opinion would not result in sanctions under the Civil Monetary Penalty rules or the Federal Anti-kickback Statute.  The OIG acknowledged that both the CMP laws and the Anti-kickback had potential implication but that the structural issues of the particular arrangement between the neurosurgeons and the health system would not result in the OIG pursuing sanctions.

By their very nature, Advisory Opinions only apply to the requesting party.  However, we can gain useful concepts from the analysis and conclusions of the OIG relating to the specific facts that formed the basis of their opinions.

Fair market value will always remain an issue in gainsharing arrangements.  The Federal Stark Law, Anti-kickback Statutes, and applicable state laws will require adherence to fair market value standards when payment is made between a referring party and the provider of a service. Advisory Opinion 17-09 provides us with some useful guidance regarding some of the consideration that should go into establishing fair market value and structuring a gainsharing arrangements.  Fair market value concepts in these arrangements are often subtle and must be well thought out to avoid regulatory issues. In addition, concepts of commercial reasonableness, which has emerged as a related but distinct issue impacting payments must be considered in addition to fair market value.

Advisory Opinion 17-09 is worth a review to anyone involved in structuring gainsharing arrangements. By no means should 17-09 be the only guidance that you rely upon because the opinion only touches on a few considerations that were relevant to the structure of the specific arrangement.  Some important factors to keep on your radar when structuring a gainsharing arrangement relate to the determination of baselines that are used to measure cost savings through program implementation.  The frequency and method of calculating available gainsharing amounts is subtle but important for regulatory compliance.  Of course the specific protocols or description of the method for reducing costs should be described in detail, together with a method for determining the level of compliance with those protocols.  Another issue that often arises in these arrangements involves the scope of costs that are allocated to the program.  It is important that costs allocated be reasonable to avoid potential disguised kickbacks.

If you require additional information regarding this article, gainsharing arrangements, or health care issues in general, please contact us through the contact section of this blog.

Ambulatory Surgery Center Compliance Legal Practice

Monday, January 1st, 2018

Ruder Ware has developed an active practice counseling ambulatory surgery center providers and has served as special counsel in several cases involving ambulatory surgery center exclusions.  The firm’s health care and compliance attorneys are knowledgeable on the numerous legal and regulatory requirements that are applicable to ASCs.  The regulations applicable to these entities are complex and nuanced.  The consequences of failing to comply or with taking improper steps to exclude providers can be very costly.

Some of the issues that our health care practice has recently addressed include the following:

  • Counseling ASC’s on the application of the Stark law, Anti-Kickback Statute, and ASC safe harbor issues.
  • Advising and representing providers on issues relating to conditions of participation and governmental surveys.
  • Representing organizations in preparing and submitting self-disclosure to the government.
  • Structuring ASC/Anesthesia Arrangements
  • Development of ASC investment entities.
  • Establishment of ASC compliance programs.
  • Decisions regarding exclusion of “under-performing” providers.
  • Structuring exclusion provisions to minimize risk of violating regulations or enhancing the risk of litigation.
  • Sale and purchase of surgery centers.
  • ASC licensure and governmental approval.
  • Compliance with patient confidentiality and privacy laws.
  • Risk assessment, audits, compliance work plans, staff compliance training.
  • Contractual relationships with outside parties.
  • Ambulatory Surgery Center Lawyers – Ambulatory Surgery Center Lawyers

Ambulatory Surgery Center Attorney

John H. Fisher has practiced health care law for over 25 years.  One of John’s significant areas of expertise involves the regulatory and business aspects of ambulatory surgery centers.  Over the years, John has represented numerous clients on legal and compliance issues related to ambulatory surgery centers.  John consults as a subject matter expert and provider legal backup to other attorneys and law firms from around the country on issues relating to ambulatory surgery centers.  Some of John’s more recent ASC related projects include:

  • Representation of an ASC in connection with the exclusion of non-complying owners.
  • Representation of excluded providers in litigation and settlement.
  • Creating operating documents that comply with ambulatory surgery center safe harbors and other applicable regulatory requirements.
  • Creation of policies and procedures required to gain certification as an ASC.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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