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!