Home Health & Hospice Week

CMS devotes time to insulin pen circumstances in regulation.

Medicare may be gearing up to boot your claims based on insulin injections if they don’t include certain diagnosis codes on a limited list.

The Centers for Medicare & Medicaid Services is putting insulin injection-based claims under heavy scrutiny following a report on the topic last year from the HHS Office of Inspector General. The OIG found fraud and abuse problems related to claims containing diabetes diagnoses and outlier payments for insulin injections.

CMS fears that home health agencies are furnishing visits for insulin injections that aren’t medically necessary, according to the 2015 prospective payment system proposed rule published in the July 7 Federal Register. CMS worked with a contractor to come up with a list of the diagnoses that would help prove a patient’s eligibility for insulin injections. The list contains nearly 165 diagnoses.

“Although we are not proposing any policy changes at this time, we are soliciting public comments on whether the conditions in Table 28 represent a comprehensive list of codes that appropriately indicate that a patient may not be able to self-inject and the use of insulin pens in home health,” CMS says of the list.

CMS devotes a large portion of its insulin injection provision to discussing the benefits of insulin pens, and the likelihood that patients who are prescribed insulin pens may not require assistance with them.

Criteria Yes, List No

Many commenters on the rule express support for some kind of process to make sure patients are eligible for insulin injection assistance. “Allina Health supports the development of reasoned guidelines for determining when a patient is capable of self-injecting insulin,” says the Minneapolis-based health system in its comment letter.

The Hospital & Healthsystem Association of Pennsylvania “recognizes that daily nursing visits to administer insulin are not the most effective way to care for diabetic patients,” the trade group notes in its letter. “We agree that identifying selected diagnoses could provide additional information to help support the identification of patients with impairments in dexterity, cognition and vision that may cause them to be unable to self-inject insulin, and therefore be eligible for skilled nursing assistance with injections.”

But commenters that addressed the issue were nearly unanimous in rejecting CMS’s list of diagnoses to prove coverage. “We would not support a future proposal to use a list of this nature as the sole means of establishing coverage eligibility for this service,” Allina tells CMS in its letter. “Our documentation of medical necessity of the services would support the reason to order and provide the service.”

The list CMS includes in the rule is “too prescriptive and limited,” says expert Lisa Selman-Holman with Selman-Holman & Associates and CoDR — Coding Done Right in Denton, Texas.

For example: ICD-9-CM code 362.01 (Background diabetic retinopathy [mild damage to the retina due to diabetes]) is on the list, but no other ICD-9-CM codes for diabetic retinopathy such as 362.06 (Severe non-proliferative diabetic retinopathy [advanced stage of damage to the retina due to diabetes]) are, HAP says. “Similarly, while some ICD-9-CM codes for cataracts, including the code for unspecified cataract, are on Table 28, related codes representing specific cataracts and legal blindness are not,” the association adds.

And “CMS should be clear that some of the diabetic manifestations contribute to the patient’s inability” to self-inject, Selman-Holman tells CMS.

Off-list: “Any future policy using a list such as that in Table 28 should allow providers to treat patients with conditions outside of the list, if medical necessity for this service is comprehensively documented in the medical record,” HAP urges.

Sometimes patients may be unable to self-inject for reasons not represented by diagnosis codes, says Kate Jones, Chief Clinical Officer for Home Health and Hospice for national chain Amedisys Inc. “We … encourage CMS to consider the range of clinical reasons for which a patient may not be able to self-administer,” Jones says in her letter. “For example, a prior amputation or a cognitive deficit from a prior stroke.”

Any guidelines CMS develops “should be evidence-based and tested in real-life circumstances rather than in a clinical and practical vacuum,” exhorts Genesis VNA in Iowa.

Multiple commenters urge CMS to use the National Coverage Decision process to implement new insulin injection coverage guidelines.

Consequences: Arbitrary eligibility decisions can be deadly in these cases, commenters insist. “The denial of a needed insulin injection can place the life and safety of the Medicare patient at significant risk and significantly increase the potential for otherwise avoidable costly emergent care and inpatient admissions,” warns John Beard of Alacare Home Health & Hospice in Alabama, in his comment letter.

Note: The PPS proposed rule is at www.gpo.gov/fdsys/pkg/FR-2014-07-07/pdf/2014-15736.pdf. The section on insulin injections starts on p. 38401 (p. 37 of the 56-page PDF file). The final rule is expected out very soon.