Medical Necessity and Qualitative Drug Screening

MDL-02 Medical Necessity and Qualitative Drug Screening: A Survey of Payer Coverage Determination and Medical Policies Presented by Jennifer Bolen, JD

Disclosures  Ms. Bolen serves as a consultant on a variety of issues, including billing

and coding for clinical laboratory services, for the following clinical laboratories:

 Alere Toxicology, AFTS Laboratories, Andor Laboratories, Peace Health

Laboratories, Physicians Pharmaceutical Corp. , ReCept Pharmacy  Numerous individual physician-owned and CLIA-waived, CLIA-certified laboratories.

 Grant/Research Support  Alere Toxicology, AFTS Laboratories  Honoraria  ReCept  Speaker’s Bureau  Alere Toxicology, AFTS Laboratories, Andor Laboratories, Physicians Pharmaceutical Corp. , ReCept Pharmacy

Learning Objectives  Distinguish between National and Local Coverage Determinations

which define medical necessity for Qualitative Drug Testing;  Perform a search for applicable coverage determinations using the

CMS Coverage Database;  Cite the gaps between coverage for qualitative drug testing and

professional standards recommending drug testing in pain management; and  List critical documentation issues pertaining to medical necessity

for drug testing in the medical record and communications with government and commercial payors/plans.

Important Resources  CMS Medicare Coverage Database http://www.cms.gov/medicare-

coverage-database/overview-andquick-search.aspx  Various Commercial Payor Websites  Common Sense

Key Definitions  National Coverage Determination (NCD)  Local Coverage Determination (LCD)  Medical Policy  Medical Necessity  Other

National Coverage Determination (Official Definition)  National Coverage Determinations (NCDs) originate from the

Centers for Medicare & Medicaid Services (CMS) Central Office and apply to all Medicare jurisdictions.

 The impetus for NCD development can come from different

sectors, such as provider groups and beneficiary advocate groups, often working through legislative channels.

 The basis for most NCDs can be found in the Coverage Issues

Manual (CIM) and the National Coverage Determinations Manual(external link).

 At time of slide creation, there were no NCDs for Qualitative Drug

Screening/Testing.

Local Coverage Determination (Official Definition)  A Local Coverage Determinations (LCDs) is a policy created by Medicare

Administrative Contractor (MAC). The Benefit Improvement Protection Act (BIPA) §522 created Local Coverage Determinations (LCDs) that consist only of reasonable and necessary information.

 LCDs are carrier developed coverage policies, pertaining to services or items

not addressed in NCDs or program manuals.

 LCDs contain coding and utilization guidelines as well as descriptive passages.  LCDs sometimes contain some CMS language as well, which would be

italicized. LCDs are developed for various reasons, some of which are:  To define the appropriate use of new technologies.  To address services with an abuse history or potential.  High volume, high dollar services.

 All LCDs, current and under development from all Carriers in the country are

available on the CMS Coverage Database

Critical Elements of an LCD  Type of Entity Publishing the LCD  Jurisdiction  Effective Date  Indications and Limitations of Coverage and/or Medical

Necessity  Coding Information  General Information, including documentation requirements

Current LCDs for Qualitative Drug Screening From the CMS Medicare Coverage Database: the official resource for these items

Using the CMS Coverage Database 1. http://www.cms.gov/medicare-

coverage-database/overview-andquick-search.aspx

2. Walking through a search 3. Examining identified coverage

determinations

First Coast Service Options (FCSO) Example Type: MAC-B Jurisdiction: Florida/Puerto Rico/U.S. Virgin Islands LCD #: L30574 Discussion

National Government Services (NGS) Example Type: MACB (NGS also has Carrier and FI LCDs)

Example Jurisdiction: New York (Queens) (this contractor has significant other jurisdictions)

LCD #: L28145 Discussion

Trailblazer Example Type: MACB Example Jurisdiction: Texas LCD #: L31690 Discussion

Novitas Solutions (formerly Highmark) Example Type: MACB Example Jurisdiction:

Pennsylvania LCD #: L32050 Discussion

CGS Administrators Example Type: MACB Example Jurisdiction: Ohio LCD #: L31893 Discussion

Wisconsin Physician Services (WPS Medicare) Example Type: J5-MACB Example Jurisdiction: Iowa and

other states LCD #: L32450 (on or after 7/16/12) Discussion

WPS – FINAL WILL COME OUT AFTER SLIDES SUBMITTED.

Recent Draft LCDs Various Jurisdictions

Palmetto GBA  Example Type: MACB  Example Jurisdiction: Nevada (also has

Northern CA, Southern CA)  DRAFT LCD #: DL-32597  Discussion

Palmetto GBA  Example Type: MACB  Example Jurisdiction: North Carolina

(also has SC, VA, WV)  DRAFT LCD #: DL-32552  Discussion

Common medical necessity themes between the various LCDs and Draft LCDs  1. Medical necessity has limits for coverage

purposes.  2. Medical necessity MAY NOT parallel regulatory

requirements and thus requires an advocacy plan.  3. At time of slide submission, Palmetto GBA is the

only contractor with a DRAFT (soon to be final) LCD that incorporates current clinical literature on patient risk evaluation into the medical necessity coverage process.

Medical Necessity Hot Topics  LCD instructions on coding of qualitative

drug testing  LCD application to coding qualitative drug

testing with chemistry analyzers that provide semi-quantitative test results  LCD application to coding of confirmation

testing

Translating these “medical necessity” LCDs to Frontline Reality  Understand how to document medical necessity  Understand how laboratory forms can help or

hurt you  Understand limitations of laboratory personnel

in terms of giving advice in this area  Understand importance of overall policy

planning and review in this area

Summary  Lots of focus on the healthcare system and

costs of healthcare services

 Relatively easy for payors to target

overpayments

 Documentation is the key!

Contact Information Jennifer Bolen, JD jbolen@legalsideofpain.com

THANK YOU!