Tuesday, February 9, 2016

Exact Science's Cologuard; Payers; Lawsuits; Colon Screening Policies

Exact Sciences markets the FDA-approved colon cancer screening test based on stool DNA analysis.  It is endorsed by the American Cancer Society (ACS) guidelines and by a Medicare NCD.  However, for many health plans, it is not a required benefit, as it is not endorsed by the US Public Services Task Force.  Based on several recent news stories, the manufacturer sues Humana, on the basis that Kentucky law (and some other states) use ACS guidelines as a state-based standard of coverage.

Update (February 23): Parallel lawsuit against North Carolina BCBS; trade press here, lawsuit PDF here, Genomeweb here

Colon cancer screening is a well-recognized form of cancer screening, although the use of colonoscopy as a mainline screening test is not common outside the U.S.   Medicare law allows screening tests by (1) fecal occult blood testing, by (2) sigmoidoscopy, by (3) colonoscopy, or by (4) other tests approved by the Medicare agency through the National Coverage Determination process.

There have been at least two efforts to create a new colon cancer screening benefit by the NCD process.  The first was virtual colonoscopy or CT colonography.   I clearly recall the public policy meeting held at CMS in November 2008: radiologists felt the procedure was invaluable, ready for prime time, and a major public health benefit.  Gastroenterologists felt the procedure was risky, involved unsafe radiation doses, and should by no means become a Medicare benefit.  (Meeting page here, including transcript.  Subsequent CMS decision memo, here.)

More recently, CMS and FDA conducted parallel review of the Exact Sciences Cologuard test, which is based on DNA (10 human DNA biomarkers) combined with fecal hemoglobin.  FDA approved the test, and CMS released a favorable coverage decision the same day (here).   So CMS now covers (1) occult hemoglobin tests, (2) sigmoidoscopy, (3) colonoscopy, and (4) Cologuard.

Medicare fee for service contractors and Medicare Advantage plans will follow the NCD favorable to Cologuard.   However, private health plans are not required to follow a CMS decision.   The American Cancer Society has taken the same position as the FDA and CMS, and recommends screening by Cologuard.  (ACS also includes CT colonography as an endorsed screening method).

Here's where the policy gets interesting.  Both federal law and state law can mandate the modes of colon cancer screening testing.

  • State law.  Some state laws reference ACS guidelines for health plans regulated by that state.
  • Federal law.  The US Public Services Task Force did not give a clear endorsement to the test in late 2015 (here).   This is important because federal law, the Affordable Care Act, requires most health plans to cover USPSTF endorsed screening tests within a year or two.

The Trade Press on the Lawsuit

On February 3, 2016, the Wisconsin Business Journal released a story that Exact Sciences is suing Humana over unpaid claims (here).   The actual lawsuit is available online here.   Additional press in the Louisville News (here) and Healthcare Dive (here).

As often, Medicare is inconsistent

Medicare has a physician quality metric, to which payment penalties are attached, which the physician can only fulfill if the patient is colon cancer screened by fecal occult blood testing, sigmoidoscopy, or colonoscopy - NOT by the Cologuard DNA test.

That is, the enactment of the CMS NCD did not lead to a matching revision of the CMS quality performance metric for the doctor.   There are four ways for a CMS screening colorectal test to be performed, but only 3 ways for a doctor to get credit for his patient's screening.

I believe this is because the quality metric - PQRS Metric 113 - is not owned by CMS, but is part of the National Quality Forum (NQF) library of metrics for use by all US payers.   CMS may feel that having a physician metric inconsistent with the NCD is less of a problem that creating its own physician PQRS metric that differs from the national standard.  The National Committee for Quality Assurance (NCQA), a 501(c)(3) not for profit, is the "steward" of the colorectal cancer screening metric (here).

Extra Credit: Medicare Nerd Puzzler

Medicare's coverage of the test is inconsistent in another way, although it probably only matters to hard core Medicare nerds.

Question: CMS would pay handsomely for a colonoscopy in the hospital outpatient setting, but will it pay for a Cologuard sample (the actual sample) were taken in the hospital outpatient setting?

Rule:  Recall the new principle that clinical chemistry tests in the hospital outpatient setting [*] are bundled and not paid separately.  So... at first blush, Medicare would pay $80 payment for the hospital outpatient office visit where the test is ordered but no payment for the $400 test under the Date of Service bundling rules.  True or False?

Answer:  The bundling rule for hospital origin specimens seemingly would lead into a policy nerd arguments over whether the fecal sample was taken in the buildings of the hospital, or at a porta potty in the parking lot but not architecturally part of the hospital buildings.  In reality this line of argument won't arise for two reasons.  (ONE) Since Cologuard kits are normally sent to the patient's home address by Exact Sciences, the kits would not be stocked at the hospital clinic in the first place [**].   The Cologuard tests on a home sample escapes hospital outpatient bundling rules ... unless CMS adapts to the bundling rules someday to apply to tests ordered in a hospital outpatient setting.  (TWO)  Cologuard is a DNA-based MAAA or "multi analyte assays with algorithm" test.  Under current rules for 2016, these are exempt from outpatient bundling, as are germline genetic tests, so a line item payable is allwoable, but however the test claim would have to be submitted by the hospital for a hospital origin specimen.

[*] This Medicare bundling might also apply where a patient sample is taken in a physician office which has been bought up by a hospital network and re-registered as a hospital "outpatient clinic."
[**] Thanks for feedback on this point by staff at Exact Sciences.