Thursday, April 30, 2020

CMS Blows Open The Rules for COVID Testing; Treating Physician Order Not Required. Serology Covered.

On April 30, 2020, CMS issued a press release covering a range of new (new-new) easier rules for Medicare/Medicaid services, including new easier rules for lab test payment and access. It's paired with the release of a new 279-page interim final rule (IFR).  The activities are justified by Social Security Act §1135, emergency policymaking.

UPDATE:  The Federal Register version of the rule appeared Friday, May 8, 2020.  See 85 FR 27550-27629 (80pp) here.   I have updated pagination in this blog, to the five-digit pagination in the Fed Reg version.

Here's the top line of what's new for the lab industry:

  • On pages 27557-8, "Modified requirements for ordering OCIVD-19 diagnostic laboratory tests," broadens rules for who can "order" test - no longer the "treating physician" but any "healthcare personnel" (within state law).
    • CMS released a 2-page online PDF of all codes containing influenza or RSV or COVID testing, to which this rule is applicable.
    • This is more historic than it looks; they changed a decades-old regulation that only a treating MD can order diagnostic tests, at 42 CFR 410.32.
  • On pages 27598ff, coverage for serology testing is added to CMS regulations.
    • This one test - serology - is now baked into regulations of what is reasonable and necessary under 1861(a)(1)(A), something that CMS admits is normally done via NCD.
    • Serology testing defined as "reasonable and necessary" under broad conditions.
    • To my knowledge, CMS hasn't announced any national price for serology testing.
  • On pages 27602ff, CMS allows 99211 coding and payment for physician office specimen collection for COVID in some cases (circa $20).
CMS also has a six page summary sheet regarding COVID new rules, here.

See trade journal MedTechDive on the new rules here.

See the April 30 press release in full here.  I also cut/paste the lab section of the press release after the break.

For the new collection of COVID rule waivers, see the new April 30/May 8 rules online at Federal Register here.

(Not to be confused with the prior IFR, issued around March 30 and finaled as 85 FR 19230-92, April 6, 2020).

At the CMS homepage for emergency COVID rules and guidance here, see "List of Lab Test Codes for COVID, Influenza, RSV" - diagnoses that could clinically overlap - a wide range of codes "that can be conducted without a practitioner order."  HereThis code list includes the familiar codes U0001-U004 (CMS COVID PCR codes) but also broad CPT codes like "Infectious agent, respiratory, 12-25 targets," 87633.

See also 6-page CMS PDF on emergency lab rules here.

See also 36 page PDF on CMS emergency rulemaking, here.

COVID and related tests; new easier ordering rules; full list is 2pp; sample shown here

In the Fed Reg rule, see Serology in Section V, page 27598ff.  Serology covered as reasonable and necessary "for beneficiaries with current or known prior COVID infection or suspected current or suspected past infection."  Regarding cost justification (part of federal rulemaking), CMS states page 233, "its is unclear" what the costs will be.  Relief from "treating physician" order is codified at 42 CFR 410.32 (page 27620).

NB - I haven't seen a price for serology testing at Medicare.  COVID PCR codes are $50 (U0001-2) and $100 (U0003-4).

Ordering Requirements
Modification of ordering requirements at page 27557ff.  Writing, "We anticipate needing to test many Medicare beneficiaries quickly as part of the rapid expansion of COVID testing capacity to combat the epidemic.  Therefore, the need for a patient to first have a visit with a [treating] physician or practitioner to obtain an order for COVID testing to meet Medicare requirements could present a significant barrier to patients who might otherwise seek a test."  The relaxation applies also to tests for influenza and respiratory syncytial virus (RSV): "because the symptoms...might present the same way."

The rules seem to be that any "healthcare professional" e.g. a "professional" in a pharmacy or drive-by setting can "order" the COVID tests (including up to an 86733 25 pathogen Biofire type test, $416).

Except that it must be "clinically necessary," (not further defined), but claims require only listing of the NPI of the "ordering professional" e.g. professional or pharmacy (pharmacist or pharmacy?).

Regarding CMS's statement that test "must be clinically necessary" -  what kind of records on that "patient" would the pharmacy or for that matter a drive-thru place keep?  So there are still some puzzles.

Other features; CMS allows physician offices to bill 99211 in some circumstances for COVID specimen collection (27602ff).

CMS loosens certain rules pertaining to the DME LCD for continuous glucose monitors (27595ff).

Most features of the 80-page rulemaking emerge from authority at SSA 1135, allowing CMS to waive statutes, regulations, and policies during an emergency.  The waivers would stop the day the emergency stops.

April 30, 2020
Press release

Lab Section of Press Release:

Testing is vital, and CMS’s changes will make getting tested easier and more accessible for Medicare and Medicaid beneficiaries,” Verma said.

Under the new waivers and rule changes, Medicare will no longer require an order from the treating physician or other practitioner for beneficiaries to get COVID-19 tests and certain laboratory tests required as part of a COVID-19 diagnosis.

During the Public Health Emergency, COVID-19 tests may be covered when ordered by any healthcare professional authorized to do so under state law [not necessarily one who is treating the patient - BQ]. To help ensure that Medicare beneficiaries have broad access to testing related to COVID-19, a written practitioner’s order is no longer required for the COVID-19 test for Medicare payment purposes.  [However, the NPI of the ordering professional must be provided - BQ]. 

Pharmacists can work with a physician or other practitioner to provide assessment and specimen collection services, and the physician or other practitioner can bill Medicare for the services.

Pharmacists also can perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory, in accordance with a pharmacist’s scope of practice and state law. With these changes, beneficiaries can get tested at “parking lot” test sites operated by pharmacies and other entities consistent with state requirements. Such point-of-care sites are a key component in expanding COVID-19 testing capacity.

CMS will pay hospitals and practitioners to assess beneficiaries and collect laboratory samples for COVID-19 testing, and make separate payment when that is the only service the patient receives. This builds on previous action to pay laboratories for technicians to collect samples for COVID-19 testing from homebound beneficiaries and those in certain non-hospital settings, and encourages broader testing by hospitals and physician practices.

To help facilitate expanded testing and reopen the country, CMS is announcing that Medicare and Medicaid are covering certain serology (antibody) tests, which may aid in determining whether a person may have developed an immune response and may not be at immediate risk for COVID-19 reinfection.

Medicare and Medicaid will cover laboratory processing of certain FDA-authorized tests that beneficiaries self-collect at home.