UHC Issues Details about How Labs Register Tests

Labs, AP groups testing UHC’s 45 million members will need to comply with new Test-Registry Protocol

CEO SUMMARY: As of January 1, UnitedHealthcare will require all clinical laboratories and anatomic pathology groups to register every type of test before labs can bill for those tests. Not only is the COVID-19 pandemic disrupting normal activity, but the administrative burden UHC is imposing will be substantial for all of UHC’s in-network labs and pathology groups, as well as for the insurer itself. Delays or confusion in getting the payer to review and approve all registration requests could disrupt labs’ ability to submit claims and get paid for these tests.

WHENEVER A PRIVATE PAYER WITH TENS OF MILLION OF MEMBERS makes radical changes in how clinical laboratory tests are coded, billed, and paid, it is a major development for the entire clinical laboratory industry. That is certainly true for UnitedHealthcare’s (UHC) new Test-Registry Protocol.

Early indications are that this will be a comprehensive effort to fundamentally change how the health insurer works with both clinical laboratories and anatomic pathology groups to manage claims for diagnostic tests.

90-Day Implementation Delay

When UnitedHealthcare announced the details of its Test-Registry Protocol on March 9, it said implementation of the program would begin on Oct. 1, 2020. On July 20, however, UHC said that it would delay the start 90 days, until Jan. 1, 2021.

The program will be all-encompassing. First, most of UnitedHealthcare’s commercial, Medicare Advantage, and Community Plan networks will need to participate. Second, the in-network clinical laboratories and anatomic pathology (AP) groups will be required to register each type of test they perform, said UHC.

In the announcement July 20, UHC said its new Test-Registry Protocol requires all in-network labs (including some hospital laboratory outreach services) and AP groups to register each individual test they use before they can bill for those tests.

The program also affects all claims using the place-of-service code 81, UHC added. Also affected are outpatient hospital labs using place-of-service codes 19 and 22, and all testing services using revenue codes 300 through 319 and 971.

‚ÄúWe may deny claim submissions for¬†[included] laboratory services that aren‚Äôt¬†registered and don‚Äôt include a test code¬†on the laboratory services claim,‚ÄĚ warned¬†UHC, the nation‚Äôs largest health insurer¬†with 45 million members.

The deadline to register tests is Dec. 1, meaning all labs and AP groups must register every type of test (including AP services) that a freestanding or outpatient lab would bill by that date, UHC said.

‚ÄúFor each test, every lab would need to¬†register its own unique identifiers (or test¬†codes) by Dec. 1,‚ÄĚ explained Ann Lambrix,¬†VP of Client Services at Vachette Practice¬†Management, consultants in Sylvania,¬†Ohio. ‚ÄúOnce registered, the test code will¬†need to be submitted on claims labs and¬†AP groups send to UHC, starting on Jan.¬†1. UHC will deny claims that lack the new¬†test codes.‚ÄĚ

UHC will deny payment requests from all in-network labs that do not follow the new procedure for any test claims included in the program, the insurer added. UHC provides guidance on how the claim submission should incorporate the test code.

List of Excluded Tests

Clinical lab directors and anatomic pathologists should note that some tests are excluded, including the following laboratory test services:

‚ÄĘ Those requiring notification or prior¬†authorization through UHC‚Äôs Genetic¬†and Molecular Lab Testing Notification/Prior Authorization process;

‚ÄĘ Those requiring placement of the¬†National Institutes of Health Genetic¬†Testing Registry ID under UHC‚Äôs¬†molecular pathology reimbursement¬†policy;

‚ÄĘ Those test services that outpatient physician¬†office laboratories submit, such¬†as place-of-service billing code 11; and

‚ÄĘ Those test services for which UHC is¬†not the primary payer.

Some Exceptions Allowed

Also, some exceptions are allowed. Test codes will not be required for capitated laboratory services when a capitated lab provider does the test for a member in a capitated plan, nor for laboratory testing done on a hospital inpatient or for patients treated on an emergency or urgent-care basis, UHC said.

Lambrix recommended that labs begin working to comply with the test-registry requirements. “Lab managers will want to leave themselves some time so that if the lab or UHC has questions about their tests, they’ll be able to work through those questions to ensure the lab can comply with the appropriate deadlines for registering the test codes.

Denial of Claims

‚ÄúIf claims do not include the new test¬†codes, UHC will start denying claims (as of¬†January 1, 2021),‚ÄĚ she added.¬†For UHC, the Test-Registry Protocol¬†allows the insurer to fill a gap in how lab¬†tests are identified throughout the industry,¬†the company said.

To identify each test on a claim today, every lab and AP group must use Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes. But UHC wants more information on each test from every lab and AP group in its networks.

‚ÄúIn the absence of industry-standard¬†ways to identify the specific test being¬†performed, requiring test registration is a¬†reasonable alternative that achieves needed¬†test transparency,‚ÄĚ UHC explained. ‚ÄúOften,¬†a procedure (CPT or HCPCS) code alone¬†on the claim does not sufficiently describe¬†the actual testing being ordered and performed.¬†Rather, it describes procedures for¬†which the lab bills.‚ÄĚ

Transparency is lacking, UHC¬†explained, when a physician orders a test¬†using a single corresponding procedure¬†code, such as 80061 for a lipid panel and¬†other times the same code is used when¬†a physician orders a panel when doing¬†a broader assessment for a patient, said¬†UnitedHealthcare. ‚ÄúOne lab offers a ‚Äėdiabetes¬†comorbidity assessment‚Äô that contains¬†80061 plus three other CPT codes,‚Ä̬†UHC noted.

As of Jan. 1, test claims, ‚Äúmust contain¬†your laboratory‚Äôs unique test code,‚Ä̬†and ‚Äúeach test code on a claim must¬†match a corresponding laboratory test¬†registration provided in advance to¬†UnitedHealthcare,‚ÄĚ the insurer said. Labs¬†will need to add the new test codes to four¬†types of claim forms:

‚ÄĘ CMS-1500,

‚ÄĘ UB-04 or CMS 1450,

‚ÄĘ HIPAA 5010 837 Professional, and

‚ÄĘ HIPAA 5010 837 Institutional.

‚ÄúWhen a laboratory test CPT code or¬†HCPCS code is billed, a corresponding¬†test code with a matching test registration¬†will be required for each claim line submitted,¬†or we‚Äôll deny the claim,‚ÄĚ UHC said¬†in its most recent UHC announcement¬†about the program, dated July 16.

Included in the UHC announcement¬†is a list of frequently-asked questions¬†(FAQs). In one answer, UHC defines theterm ‚Äúlaboratory test code‚ÄĚ as a ‚Äúlaboratory‚Äôs¬†unique identifier that a physician¬†would use to order a test (either independently¬†or as a part of their EMR‚Äôs¬†integration with the lab or the lab‚Äôs LIS¬†implementation).‚ÄĚ

Certain AP Services

One problem for UnitedHealthcare‚Äôs¬†in-network AP groups is that applying¬†test codes to certain AP services‚ÄĒsuch as¬†biopsies‚ÄĒcould be troublesome because¬†pathologists do not always know how¬†many samples they may collect. ‚ÄúAlso,¬†each patient‚Äôs case is different, whether¬†a pathologist is collecting a breast biopsy¬†or a prostate biopsy or any other sample,‚Ä̬†noted Lambrix.

For these reasons, there is some confusion¬†about how outpatient pathology¬†labs would follow the new Test-Registry¬†Protocol requirements. ‚ÄúThere‚Äôs still a¬†question about how UHC will recognize¬†the test codes for surgical or cytology specimens,‚Ä̬†Lambrix explained.

“The question applies when an outpatient pathology lab has a separate pathology group directing the hospital laboratory and performing the professional interpretation of the pathology or cytology specimens for hospital outpatients.

‚ÄúUHC has confirmed that place-of-service¬†(POS) 22 (outpatient laboratory)¬†is included in this program,‚ÄĚ she added.¬†‚ÄúAlso, UnitedHealthcare has confirmed¬†that those anatomic pathology groups only¬†billing the professional component must¬†register their ‚Äėtest/order code‚Äô and include¬†that code when submitting claims. The¬†question for these types of laboratories¬†is how UHC will recognize the test/order¬†code for a surgical or cytology specimen,¬†and how UHC will want these test/order¬†codes registered.

‚ÄúMy concern is that some pathology¬†groups may not know that this program¬†affects them,‚ÄĚ Lambrix warned. ‚ÄúBut, if¬†they are participating with UHC and bill¬†POS 19, 22, or 81, then this protocol definitely¬†affects them.

‚ÄúTherefore, if you are a hospital-based¬†pathology group billing PC only, then I¬†highly recommend that you work directly¬†with UHC on your test/order code registry¬†process,‚ÄĚ she noted. ‚ÄúThat means you¬†should not wait until January to resolve¬†these questions with UHC.‚ÄĚ

Test Identifier

UHC explained that the test identifier¬†‚Äúshould uniquely identify the test offered¬†by the laboratory and correspond to what¬†the physician ordered, whether it was a¬†single test that is ultimately billed as a¬†single procedure code, or a test ‚Äėpanel‚Äô¬†that ultimately bills as multiple procedure¬†codes.‚ÄĚ Most labs define a ‚Äėtest code,‚Äô¬†‚Äėorder code,‚Äô or ‚Äėtest identifier‚Äô to identify¬†each test being ordered, and that code or¬†identifier is distinct from the procedure¬†codes, UHC noted.

Given the complexity of the program,¬†labs should welcome UHC‚Äôs decision to¬†move the start date to Jan. 1, 2021, because¬†it gives labs more time to understand how¬†to comply with the new protocol.¬†‚ÄúPushing the start of this program further¬†out gives labs an additional 90 days¬†to comply with UHC‚Äôs new protocol,‚Ä̬†noted Lambrix. ‚ÄúThat time will allow labs¬†to register their tests, and it gives UHC¬†time to review each test. Then, if UHC¬†has questions when it reviews a lab‚Äôs tests,¬†there still may be time for UHC to answer¬†those questions before it starts to process¬†claims using the new protocols.‚ÄĚ

The fact that UnitedHealthcare’s new Test-Registry Protocol is intended to cover every test a lab performs could result in rejected claims or delayed settlement of claims if UHC has not completed its review of every code a lab submits for review. The Dark Report sent questions to UHC asking for clarifications on some of the issues reported here. As of our press deadline, UHC had not responded.

UHC Review Will Result in Multiple Actions

ONCE CLINICAL LABORATORIES AND ANATOMIC PATHOLOGY GROUPS apply for a unique test identifier under UnitedHealthcare’s test-registry program, the insurer can accept or reject the test for claim filing or require the lab to answer questions about the test. UHC also can deny payment by deciding that a test has expired.

Here are the categories UHC will¬†use when reviewing test identification¬†requests. UHC said that its Test-Registry¬†tool will list the status of a lab‚Äôs test as¬†‚ÄúDraft, Lab Action Required, Pending¬†Review, Released, Denied, or Expired.‚ÄĚ

UHC explained those terms as follows:

‚ÄĘ Draft test registrations are incomplete¬†and require more information¬†from the requesting lab.

‚ÄĘ Lab Action Required means UHC¬†needs further information.

‚ÄĘ Pending Review means UHC is¬†reviewing the application.

‚ÄĘ Released means no further information¬†is required and the lab can¬†submit claims.

‚ÄĘ Denied means the test cannot be¬†billed, but that UHC may include a¬†reason for denial.

‚ÄĘ Expired means a test registration has¬†reached its ‚Äúavailable-through date‚ÄĚ or¬†otherwise expired while under review.

UHC’s Test Registry Has Earlier Antecedents

WHEN UNITEDHEALTHCARE ANNOUNCED ITS NEW TEST-REGISTRY PROTOCOL IN MARCH, the description UHC offered made it seem similar to a molecular diagnostics identification system that Medicare Administrative Contractor Palmetto GBA introduced in 2012. That Medicare effort resulted in nonpayment for certain molecular diagnostic codes under what Palmetto call the MolDx program.

MolDx is similar to a program McKesson developed earlier that has since become the DEX Z-Code Identifier system, which certain payers use to supplement non-specific CPT codes.

The DEX Z-Code Identifier uses a five-character alpha-numeric code for certain molecular diagnostic tests. UHC appears to be applying a similar system to identify almost all clinical lab tests and anatomic pathology (AP) services.

In addition, UHC’s new test registry is similar to a program UHC launched in Florida in 2015 with Beacon Laboratory Benefit Solutions, a subsidiary of Laboratory Corporation of America.

Under that program, clinical labs and AP groups had to apply for approval before they could submit claims for any one of more than 100 molecular tests. Once labs and AP groups received the pre-approval to submit claims for these tests, they could bill as usual if BeaconLBS approved the test for the patient involved.

UHC’s new test registry is different, however, in two significant ways. First, it affects all clinical laboratory and AP services and, second, it is not a pre-authorization review because test claims can still be denied.

Contact Ann Lambrix at 517-486-4262 or alambrix@vachettepathology.com.



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