Ober, Kaler, Grimes & Shriver, A Professional Corporation  
Ober|Kaler Health Law Alert - Fall 2006




In this Issue

From the Chair

Guide to Terms

Congratulations

Ober|Kaler in Print

Legislation
DRA Changes in Medicaid Long-Term Care Eligibility

DRA Efforts to Combat Medicaid Fraud

OIG Activity
OIG Advisory Opinions

Open Letter Promotes Compliance, Self-disclosure

Hospitals
Two Major DSH Decisions

DME
Power Mobility Devices Subject to New Payment Rules

Durable Medical Equipment Suppliers Beware

Compliance
Compliance Guidance for PHS Research Award Recipients

Privacy
HHS Recognizes Value of Measured Approach to Enforcement in HIPAA Final Rule

Reimbursement
CMS Publishes Inherent Reasonableness Final Rule

FCA
Bisig Widens Avenues of Recovery for FCA Relators

Enforcement
Miami Hospital Excluded for Noncompliance with CIA

Litigation/ADR
Florida Fraud Statute Scrutinzed Anew on Appeal

Attorney Fee Recovery Under EAJA

Antitrust
Efficiencies and Justifications for Physician Network Joint Contracting

Employment
Recent Developments Affecting Employee Benefit Plans

 



Health Law Group

Sanford V. Teplitzky, Chair

Melinda B. Antalek

William E. Berlin

Christi J. Braun

Marc K. Cohen

Thomas W. Coons

John J. Eller

Joshua J. Freemire

Leslie Demaree Goldsmith

Carel T. Hedlund

S. Craig Holden

Leonard C. Homer

Thomas K. Hyatt

Julie E. Kass

Paul W. Kim

John F. Lessner

William T. Mathias

Robert E. Mazer

Carol M. McCarthy, Ph.D.

John J. Miles

Christine M. Morse

Patrick K. O'Hare

Leon Rodriguez

Martha Purcell Rogers

Laurence B. Russell

Donna J. Senft

Ray M. Shepard

Steven R. Smith

Howard L. Sollins

E. John Steren

Chiarra-May Stratton

Emily H. Wein

James B. Wieland

Editorial Assistant:
Michele Vicente, Paralegal

 

Power Mobility Devices Subject to New Payment Rules

Over the past few years, CMS has focused attention on power operated vehicles (POVs) and power wheelchairs, collectively power mobility devices (PMDs). CMS's initial concerns were in response to a 350 percent increase in Medicare payments for power wheelchairs between 1999 and 2003. CMS reacted by instituting Operation Wheeler Dealer — an initiative targeting fraudulent practices in the sale of power wheelchairs — in 2003. In 2004, CMS announced a more comprehensive initiative focusing on coverage, payment, and coding for PMDs. As part of this initiative, CMS issued a National Coverage Determination for mobility assistive equipment (MAE). Effective in 2005, this NCD established an algorithm to be used by physicians in determining which item of MAE, ranging from canes to POVs, if any, is necessary to address a beneficiary's specific mobility deficit.

Most recently, on April 5, 2006, CMS issued a final rule establishing new payment requirements for PMDs. Via implementation of section 302(a)(2) of the MMA, CMS has created regulations that expand the scope of prescribers authorized to issue a prescription for a PMD, eliminate the certificate of medical necessity (CMN) requirement, and create different documentation requirements. These payment requirements, as summarized below, became effective June 5, 2006. 71 Fed. Reg. 17,021 (Apr. 5, 2006).

Authorized Prescribers
CMS claims that it initially limited the scope of authorized prescribers of POVs to certain specialists due to its concern with the potential danger to which a POV could expose a beneficiary. CMS now states that in recognition of the technological advances that have made POVs safer for individual use, it will allow physicians, physician assistants, nurse practitioners, and clinical nurse specialists to prescribe POVs as well as all PMDs. Though physical therapists and occupational therapists may not prescribe a PMD, they may file a claim for payment for their evaluation services.

Certificates of Medical Necessity No Longer Required
A written prescription and supporting medical record documentation will substitute for a CMN. CMS determined that the CMN has not dependably accomplished its original purpose as it has not: served to appropriately document the clinical needs for a PMD, served to ensure that beneficiaries always received appropriate equipment, or served as an effective deterrent to fraud and abuse. CMS believes a treating physician or other treating practitioner is in the best position to evaluate and document a beneficiary's need for a PMD.

Face-to-face Examinations and Supporting Documentation Required
Under the new rule, a physician, or other prescriber, must perform a face-to-face examination of the Medicare beneficiary for whom the prescriber issues a written prescription for a PMD. The examining practitioner will receive payment for the examination through an appropriate evaluation and management (E&M) code for the service level provided.

In addition to the written prescriptions, the prescribing practitioner will be required to prepare parts of the Medicare beneficiary's medical record for submission to the PMD supplier. Such documentation must support the medical necessity of the PMD. CMS has established an add-on G-Code in recognition of the additional work and resources required to prepare and submit the medical record documentation supporting the PMD prescription. The DME supplier must receive the PMD prescription and supporting documentation within 45 days after the face-toface examination.

Commenters to the final rule asked for further clarification as to what medical record documentation will be required to support the medical necessity of a PMD prescription. CMS declined to elaborate on the documentation requirement and stated that it could not create an all-inclusive list of documents or information needed to document a clinical condition properly so as to meet the requirements for payment. CMS also stated it could not provide a comprehensive list of documentation that it may request during an audit. CMS's only guidance on this issue was that it will not be the form, volume, or amount of documentation, but rather the substantive content of the medical record documentation that matters.

One commenter asked whether DME suppliers would be subject to any liability if the supplier agrees with the physician or practitioner's medical necessity documentation for a PMD and later the DMERC decides differently. CMS essentially said, "Yes," and explained that a supplier is responsible for obtaining medical record documentation sufficient to meet the coverage criteria for payment. CMS further stated that suppliers should ensure that their staffs have the necessary training and expertise to carry out such responsibilities. If the information does not support the medical necessity of the PMD, the supplier is liable for the dollar amount involved unless a properly executed advance beneficiary notice of possible denial has been obtained. Such commentary suggests that CMS is encouraging suppliers to employ clinical personnel with knowledge in the use of PMDs.

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