To our Valued Partners:

BLA Partners, LLC d/b/a Aspenti Health™ & BLA of Massachusetts, LLC d/b/a Aspenti Health™ (collectively, “Aspenti”) maintain an active compliance program that reflects our commitment to conduct business in compliance with all federal, state and local laws. As a participant in federally funded healthcare programs, Aspenti provides this annual notice to providers to distribute information and education regarding laboratory compliance, billing and coding guidelines, and to inform our provider clients on the responsibilities we share.

This annual notice specifies current Medicare/Medicaid program requirements and Aspenti policies. Please carefully review the information.

Aspenti must rely on you, our provider clients, for the following key compliance elements:

MEDICAL NECESSITY

Medicare will only pay for tests that meet the Medicare coverage criteria and are medically necessary for the diagnosis or treatment of the individual patient. Criteria to establish medical necessity for drug testing must be based on patient-specific elements identified during the clinical assessment and documented by the provider in the patient’s medical record. Tests used for routine screening of patients without regard to their individual need are not usually covered by the Medicare Program, and therefore are not reimbursed. As a participating provider in the Medicare Program, Aspenti, has a responsibility to make a good faith effort to ensure all tests requested are performed and billed in a manner consistent with all federal and state law regulations. As the ordering physician or practitioner, you are responsible for documenting medical necessity in the patient’s medical record (including physician/practitioner signature) and for providing appropriate diagnostic information in the form of ICD-10 codes to the highest level of specificity to Aspenti. The Office of Inspector General takes the position that a physician or practitioner who orders medically unnecessary tests for which Medicare or Medicaid reimbursement is claimed may be subject to civil penalties under the False Claims Act, or other civil, criminal, and administrative sanctions and remedies available under law. These requirements are specified in each Aspenti Treatment Plan Profile that is signed by the provider and filed with Aspenti.

Recent policy changes and Health Plan actions, including increased use of post-payment audits, has encouraged Aspenti to more aggressively enforce long-standing policies that patients’ medical records must include documentation of medical necessity for each of the tests ordered. In cases where testing patterns or data indicate a risk that services may not meet the criteria for medical necessity established by the Centers for Medicare & Medicaid Services’ (CMS), Aspenti may request additional information from providers. It is important for providers to be mindful that applying the same testing profile to every patient, without reflection of their individual needs, may result in medically unnecessary testing.

DISCLOSURE OF EXCLUSIONS FROM FEDERAL HEALTHCARE PROGRAMS

Under federal law, no payment will be made by any federal healthcare program for any items or services furnished, ordered, or prescribed by an excluded individual or entity. Under the CMS rules, providers must not employ or contract with individuals or entities excluded from participation in any health care program or debarred by the U.S. General Services Administration (GSA). CMS does not permit payments under the plan for services furnished by an individual or entity who is excluded from participation. CMS has further advised states that they should require providers to search the

U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) website monthly to capture exclusions and reinstatements. Professionals who are required to be licensed shall notify Aspenti in writing within (5) days of receiving any written or oral notice of any adverse action, including, without limitation, exclusion from participation in any federal or state health care or procurement programs, any filed and served malpractice suit or arbitration action; any adverse action by a Licensing Board taken or pending; any adverse action which has resulted in the filing of a report with a Licensing Board; any revocation of DEA license; a conviction of any felony or any crime of moral turpitude; or any action against any certification under the Medicare or Medicaid programs.

List of Excluded Individuals/Entities (LEIE): The OIG established a program to exclude individuals and entities who have been found to have violated federal law and/or regulations. The effect of an OIG exclusion from Federal healthcare programs is that no Federal healthcare program payment may be made for any items or services (1) furnished by an excluded individual or entity, or

(2) directed or prescribed by an excluded physician or practitioner (42 CFR 1001.1901). This payment ban applies to all methods of Federal program reimbursement, whether payment results from itemized claims, cost reports, fee schedules or a prospective payment system (PPS). Any items and services furnished by an excluded individual or entity are not reimbursable under Federal health care programs. In addition, any items and services furnished at the medical direction or prescription of an excluded person are not reimbursable when the individual or entity furnishing the services either knows or should know of the exclusion. This prohibition applies even when the Federal payment itself is made to another provider, practitioner or supplier that is not excluded.

System for Award Management (SAM) is the Official U.S. Government system that consolidated the capabilities of Central Contractor Registration/Federal Agency Registration, Online Representations and Certifications Application and the List of Parties Excluded from Federal Procurement and Non- procurement Programs (EPLS). The GSA maintains a single comprehensive list of individuals and firms excluded by Federal government agencies from receiving federal contracts or federally approved subcontracts and from certain types of federal financial and nonfinancial assistance and benefits. The EPLS was originally created for information and use by Federal agencies.

Medicaid State Sanction Data: Many states maintain their own database of individuals and entities they sanction. Several call for or require health care entities to screen against this list. This is in addition to, not in lieu of, screening against the Federal sanction information.

TEST ORDER REQUISITION

To ensure accurate processing and testing, efficient patient identification, timely reporting of laboratory results, valid laboratory orders must include the following:

Patient’s full legal name, date of birth, reason for each test ordered, date(s) of collection, source (when applicable), and the licensed ordering practitioner’s name and address. Handwritten orders must be signed and dated by the provider. Treatment Plan Profiles may be used if patient specific medical necessity is recorded in the patient’s medical records and the requested tests for the individual date of service are clearly marked on the Test Order Requisition. Signature stamps are NOT acceptable.

Although the provider signature is not required on laboratory requisitions, if signed, the requisition will serve as acceptable documentation of a physician or practitioner order for the testing. In the absence of a signed requisition, documentation of your intent to order each laboratory test must be included in the patient’s medical record and available to Aspenti upon request, as needed.

Documentation must accurately describe the individual tests ordered; it is not sufficient to state ‘labs ordered’.

The pre-printed test order requisition is the tool used to communicate the physician or practitioner’s order to the laboratory, but is NOT considered the valid ‘order’ as defined by Medicare. Upon request by Aspenti or its payers/auditors, ordering providers are required to provide any/all chart documentation (including physician/practitioner signature) that reflect the actual lab order and supports the authenticity and medical necessity of the lab order(s) submitted.

TEST ORDERING

A standard Aspenti test requisition form or Aspenti’s electronic ordering software should be used when ordering tests. This requisition is designed to emphasize provider choice and encourage physicians and practitioners to order only those tests which the provider believes are appropriate and medically necessary for the treatment and diagnosis of each patient. If Aspenti receives a non- Aspenti requisition form or an incomplete Aspenti requisitions form, processing of your test order may be delayed. As necessary, Aspenti will contact providers to have them resubmit the test order on a Aspenti test requisition form or otherwise clarify each specific test being ordered.

Treatment Plan Profile

Recent policy changes from Medicare Administrative Contractors support a growing movement away from providers’ use of non-patient specific testing profiles when ordering laboratory drug testing. We support these efforts to help better ensure that only medically necessary tests are ordered for each patient and we have taken steps to ensure compliance.

Aspenti does not accept “Standing Orders” or the default to a standing order if no order is on the Test Requisition Form. Aspenti has provided all existing and new clients with a Treatment Plan Profile that promotes physician choice for each test offered by Aspenti. Along with the Treatment Plan Profile, Aspenti has enforced requirements for a patient roster to be submitted on a regularly scheduled basis. This ensures that the provider has considered the appropriate testing for the individual patients.

The provider has the choice to order individual tests based on patient-specific medical necessity and must make the decision that a patient is appropriately tested by a Treatment Plan Profile.

Treatment Plan Profiles must contain the physician or practitioner signature and date in addition to the ordering provider’s printed name and NPI Number. Treatment Plan Profiles should only be used in connection with extended treatment by the same ordering provider, and with the same diagnosis code(s). The ordering provider should record the frequency and duration for the order, not to exceed 365 days from the original order date, in the patient’s medical record and treatment plan.

Treatment Plan Profiles are to be reviewed on a regular basis, to be no longer than once per year, and, following the review, Aspenti will require submission of new Treatment Plan Profiles, noting your changes or renewing the Treatment Plan Profile in its current state. Also, you may amend a Treatment Plan Profile at any time. We suggest that the provider keep a copy of their Treatment Plan Profile readily available and in the patient’s medical record when ordering laboratory test services as a reference to help ensure that only medically necessary tests are ordered.

Clinical Consultant

Aspenti’s clinical consultant is available to discuss providers’ testing needs and any questions that providers may have about Aspenti’s testing services. Aspenti’s clinical consultant and Chief Medical Officer, Dr. Jill Warrington, can be reached at 802-863-4105, extension 335.

Verbal Test Orders

Medicare regulations require that all orders for laboratory tests be in writing. If a provider or his/her authorized representative orders a test by telephone or wishes to add a test to an existing order, a written order is required to support the verbal order. In these cases, Aspenti will send a confirmation of the verbal order request to the ordering physician, requesting it to be signed and sent back to the laboratory for its records. Testing will not be performed until a written confirmation or a properly completed Aspenti requisition form is returned to the laboratory.

Advance Beneficiary Notice

If a ‘non-covered’ diagnosis is used, the patient must be notified prior to specimen collection and given the opportunity to sign the Advance Beneficiary Notice (ABN). The ABN must be completed for any Medicare patient where claim denial is suspected based on medical necessity or frequency limitations. The signed, original ABN must be attached to the original lab order prior to submission. Per Medicare rules, requesting the ABN on all Medicare beneficiaries is considered an unacceptable practice.

MEDICARE NATIONAL AND LOCAL COVERAGE DETERMINATIONS

The Medicare Program publishes National Coverage Determination (NCDs) and local Medicare contractors publish Local Coverage Determinations (LCDs) for certain tests. These policies identify the conditions for which the included tests are or are not covered or reimbursed by Medicare with reference to specific diagnostic information. LCDs that apply to qualitative drug screens (presumptive tests), and confirmatory or quantitative drug tests (definitive testing) can be found through the Medicare website at https://www.cms.gov/medicare/coverage/determinationprocess/LCDs.html.

Aspenti will also make these LCDs available to any interested provider upon request.

The LCD issued by National Government Services, Inc. (NGS) entitled “Urine Drug Testing (L36037) provides guidance regarding appropriate indications and expected frequency for Urine Drug Testing (UDT). This policy is applicable to laboratories located in NGS’s jurisdiction, which encompasses Vermont, and we believe (and have already seen) many of the same requirements will be adopted by the individual CMS contractors nationwide, and are thus preparing to ensure both our and your compliance with these standards. Aspenti adopted a Compliance Program that reflects the OIG Clinical Laboratory Compliance Program.

CMS National Coverage Policy

Title XVIII of the Social Security Act, Section 1862(a) (1) (A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Code of Federal Regulations (CFR) Title 42, Part 410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his/her license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem.

Medicare regulations at 42 CFR 410.32(a) state in part, that “…diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem.” This, except where other uses have been authorized by statute, Medicare does not cover diagnostic testing used for routine screening or surveillance.

Local Coverage Determination

NGS LCD L36037 is available at https://www.aspenti.com/providers-L36037/.

PATIENT PRIVACY (HIPAA)

Under the Health Insurance Portability and Accountability Act (HIPAA), Aspenti is a health care provider and a covered entity. It is our policy to comply with the letter and intent of the HIPAA privacy and security standards. Our privacy policy is available at http://www.Aspenti.com.

PROHIBITED REFERRALS & INDUCEMENTS

It is the policy of Aspenti to comply with all aspects of the laws and regulations governing physician self-referral, most noticeably the Stark Law. The Stark Law’s self-referral ban states that if a financial relationship exists between a physician (or an immediate family member) and a laboratory (or certain other kinds of healthcare providers), and the relationship does not fit into one of the law’s exceptions, then (a) the physician may not refer Medicare patients to the laboratory and (b) the laboratory may not bill Medicare for services referred by the physician. The kinds of relationships between laboratories and physicians that may be affected by these laws include the lease or rental of space or equipment and the purchase of medical or other services by a laboratory from a referring physician.

Federal Law prohibits offering or paying remuneration-meaning anything of value to induce the referral of tests that are covered by Medicaid, Medicare or other federal health care programs. Any form of kickback, payment or other remuneration that is intended to secure the referral of federal health care program testing business is strictly prohibited and should be reported to the Aspenti Compliance Hotline by calling 781-222-5030.

To avoid false claim submission, please be sure to:

  1. Order only those tests necessary for diagnosis or Each component of a panel must be necessary for the panel to qualify Medicare reimbursement.
  2. Provide a diagnosis for each test
  3. Document this information in the patient’s medical record followed by the ordering physician or practitioner’s
  4. Obtain an ABN from the Medicare patient when the tests do not meet the medical necessity criteria.

 

MEDICARE RATES

Aspenti’s currently provides testing described by the following CPT and HCPS G-codes for 2018:

2018 HCPCS Code Short Description 2018 Medicare Rate
80307 Drug test presumptive chemical analyzer $ 71.83
G0480 Drug test definitive 1-7 classes $ 114.43
G0481 Drug test definitive 8-14 classes $ 156.59
G0482 Drug test definitive 15-21 classes $ 198.74
G0483 Drug test definitive 22+ classes $ 246.92

Definitive Drug Classes & Corresponding 2018 AMA CPT Code

(Any of these may be ordered individually or included in the Definitive codes listed above)

Drug Class 2018 AMA CPT Code
Alcohols 80320
Alcohol biomarkers 80321
Alkaloids, not otherwise specified 80323
Amphetamines 80324-80326
Anabolic steroids 80327-80328
Analgesics, non-opioid 80329-80331
Antidepressants, serotonergic class 80332-80334
Antidepressants, tricyclic and other cyclicals 80335-80337
Antidepressants, not otherwise specified 80338
Antiepileptics, not otherwise specified 80339-80341
Antipsychotics, not otherwise specified 80342-80344
Barbiturates 80345
Benzodiazepines 80346-80347
Buprenorphine 80348
Cannabinoids, natural 80349
Cannabinoids, synthetic 80350-80352
Cocaine 80353
Fentanyl 80354
Gabapentin, non-blood 80355
Heroin metabolite 80356
Ketamine and norketamine 80357
Methadone 80358
Methylenedioxyamphetamines (MDA, MDEA, MDMA) 80359
Methylphenidate 80360
Opiates 80361
Opioids and opiate analogs 80362-80364
Oxycodone 80365
Phencyclidine (PCP) 83992
Pregabalin 80366
Propoxyphene 80367
Sedative hypnotics (non-benzodiazepines) 80368
Skeletal muscle relaxants 80369-80370
Stimulants, synthetic 80371
Tapentadol 80372
Tramadol 80373
Urine pregnancy test (CLIA-waived) 81025

Medicare Clinical Laboratory Fee Schedules showing the maximum Medicare reimbursement for these tests are available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.html.  You should note that Medicaid reimbursement for tests may be equal to or less than the amount that Medicare may reimburse for the tests.