BETHESDA, MD 21 Dec 2015—In issuing the Medicare Part B payment policies for 2016, the Centers for Medicare and Medicaid Services (CMS) has preserved the centralized service–billing option for pharmacists' work in anticoagulation clinics and made the payment policy for biosimilars analogous to the one for multiple-source drugs.
And, according to an expert on payment for pharmacists' services, CMS has signaled openness to the idea of recognizing ambulatory care pharmacists' clinical labor as part of the direct cost of operating physician practices.
Centralized service billing. ASHP and other members of the public, through letters submitted to CMS, persuaded the agency not to remove one specific sentence from the regulation about physicians billing Medicare for any service furnished incident to their professional services.
CMS had proposed removing the sentence as a means of clarifying which physicians could bill Medicare for an incident-to service.
The agency had expressed the viewpoint that only the physician or other practitioner directly supervising the auxiliary personnel providing the incident-to service could bill Medicare for that service.
To make this point clear in the regulation, CMS had proposed removing the following sentence: "The physician . . . supervising the auxiliary personnel need not be the same physician . . . upon whose professional service the incident to service is based."
But as ASHP pointed out, removal of that sentence could be detrimental to anticoagulation clinics and other ambulatory care practice sites that use centralized billing.
Anticoagulation clinics typically have one physician or other practitioner who serves as the supervising professional and whose identification appears on bills to Medicare, ASHP stated. That healthcare provider, however, might not be the one who ordered the anticoagulation service.
The relevant regulation now states that the physician or other practitioner supervising the auxiliary personnel need not be the same healthcare provider "who is treating the patient more broadly."
Payment for biosimilars. Despite numerous objections to CMS's proposal for the calculation of a biosimilar's payment amount in the Part B program, the agency declared the calculation a done deal.
In brief, there is one average sales price payment limit for all biosimilars whose marketing application relies on the same reference product's biologics license application.
ASHP did not comment on the calculation but did ask CMS not to rush to a decision.
The agency countered that healthcare providers and suppliers need certainty on the payment policy before additional biosimilars come to market in the wake of filgrastim-sndz (Zarxio, Sandoz), the first FDA-approved biosimilar, which became available in September 2015.
Physician practice expense direct costs. CMS did not ignore the suggestion that the agency consider pharmacists to be "active qualified health care providers" in the calculation of physician practice expense (PE) direct costs.
Pharmacists Brian J. Isetts of Minnesota, Betsy Shilliday of North Carolina, and Larry L. Georgopoulos and Melanie A. Dodd of New Mexico made the suggestion after CMS, this past July, discussed the method by which the agency determines PE relative value units (RVUs).
CMS responded: "Commenters did not suggest that the labor costs of pharmacists are a typical resource cost in furnishing any particular physicians’ service."
"It's like I can see déjà vu all over again," said Isetts, a professor at the University of Minnesota College of Pharmacy in Minneapolis and a 2011–13 health policy fellow at the CMS Innovation Center.
Isetts and Daniel E. Buffington of Florida had led the Pharmacist Services Technical Advisory Coalition's 2006 surveys that provided evidence to the Current Procedural Terminology (CPT) Editorial Panel on the widespread availability of pharmacist-provided medication therapy management (MTM) services. By year’s end, the editorial panel approved three codes—99605, 99606, and 99607—for those services.
"We have to demonstrate first of all that this is becoming more of a typical service with primary care physicians for [Medicare Part B] beneficiaries," Isetts said of pharmacists' participation in physicians' services.
And by "typical," he said, CMS means occurring more often than not.
Then there is the matter of the next sentence in CMS's response: "When such costs are typically incurred in furnishing such services, we do not have any standing policies that would prohibit the inclusion of the costs in the direct PE input database used to develop PE RVUs for individual services, to the extent that inclusion of such costs would not lead to duplicative payments."
That rules out the services that pharmacists provide in physician practices as part of transitional care management, chronic care management, or the annual wellness visit, Isetts said.
"What they're really doing for us here . . . is they're laying out an outline for a type of a white paper response back to them, with evidence and details," he said.
If CMS were to decide to include pharmacists' clinical labor in the calculation of PE, Isetts said, then the agency may request that the CPT Editorial Panel conduct an analysis to gather data. On the basis of the data, the editorial panel may then make a recommendation as to whether pharmacists' clinical labor should be added to the calculation of PE.
Seemingly independent of the pharmacists' suggestion, three gastroenterology organizations urged CMS to ask the American Medical Association/Specialty Society Relative Value Update Committee "to survey codes 99605-99607, Medication therapy management provided by a pharmacist."
The purpose of this survey, according to the American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy, would be to gather data "so that these services can be appropriately valued and utilized by physicians who wish to provide coordinated care management services to those elderly, frail, and complex patients who require a village of health care professionals to coordinate and optimize their care."
Services incident to physicians' services. CMS did not change its stance on CPT code 99211 being the highest level of evaluation and management (E&M) visit paid to a physician for services furnished by a pharmacist incident to that physician’s service.
A CMS spokesperson stated that for Medicare Part B payments, "The highest level that can be paid to the physician for auxiliary services, such as those services furnished by a pharmacist incident to a physician [service], is a Level 1 E&M visit (CPT code 99211), which would be paid at 100% of the rate."
The spokesperson cited the Medicare Claims Processing Manual, chapter 12, section 30.6.4: "When evaluation and management services are furnished incident to a physician's service by a nonphysician employee of the physician, not as part of a physician service, the physician bills code 99211 for the service."
Pharmacists who speak with a physician practice's billing personnel about incident-to services, said Gloria Sachdev, a consultant who teaches at Purdue University College of Pharmacy in Indiana, must use the appropriate lingo.
"Make sure you say, 'I'm going to be functioning as auxiliary personnel, I will meet all the incident-to criteria, here they are,'" she said.
That type of statement, Sachdev explained, suggests to billing personnel that a pharmacist wants the practice to bill an E&M code and not an MTM code.
An E&M code is associated with a payment from Medicare, whereas an MTM code is not.