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“Don’t confuse me with the facts; my mind is already made up.” This is how William Malm, the senior manager at Craneware, describes the two recent notifications by two Medicare Administrative Contractors (MACs) who have made up their minds that they need to enter the realm of risk assessment and quality of care: a territory where they do not belong.

My investigation of this was inspired by denials of outpatient ureteral stents by CGS, the Jurisdiction 15 MAC. In January, CGS posted to its website the results of its probe audit of outpatient claims for ureteral stents, CPT code 52332. The MAC reported an astounding 89-percent error rate on 99 reviewed claims, noting lack of medical necessity in the majority of cases. Realizing that most patients would not agree to ureteral stent placement unless there was a clear indication that it was necessary, I asked CGS for details of the rationale for the denials and was told that only denied hospitals can get that information.

Fortunately, two loyal Monitor Monday listeners contacted me and provided details of their denials, noting that their claims were denied for lack of a urinalysis or urine culture in the medical record. Then on Feb. 10, perhaps in response to my inquiries, CGS released “Cystourethroscopy with Insertion of Indwelling Ureteral Stent (CPT Code 52332): Documenting Urinalysis to Support Medical Necessity,” offering a detailed explanation of their documentation requirements to determine medical necessity. This included the requirement for “documentation of urinalysis (or urine culture or dipstick) results performed prior to the procedure, including treatments, if needed to treat identified infection.”

In its narrative, CGS relates that patients who undergo endourologic manipulation with untreated bacteriuria are more likely to have infectious complications, increasing lengths of stay and cost of care. Apparently, in an effort to confuse readers and equate medical necessity with risk assessment, CGS also posted as a reference an article by Nina Youngstrom in Report on Medicare Compliance that covers the medical necessity requirements for total joint replacement, which include an adequate trial of conservative, non-operative management.

While requesting documentation that a patient has a urinary tract obstruction and therefore has medical necessity for a ureteral stent is appropriate, the presence or absence of untreated bacteriuria has absolutely nothing to do with the medical necessity of the stent. If the patient requires an intervention, it is the duty of the physician and patient to assess the risks and benefits of proceeding with that medically necessary intervention; it is not the decision of the MAC. To apply this to joint replacement, if a patient with end-stage osteoarthritis has exhausted all conservative measures, meets the medical necessity requirements, and desires joint replacement, the MAC cannot indicate that it will not pay for the surgery because the patient has diabetes, systolic heart failure, morbid obesity, and chronic kidney disease and therefore is at higher risk of complications and a longer length of stay.

CGS also makes reference to clinical practice guidelines from the American Urologic Association (AUA), noting that pre-operative identification and treatment of urinary tract infection reduces the risk of complications, but the AUA guidelines do not note that urinary tract stenting is contraindicated in the presence of urinary tract infection or bacteriuria (nor do they indicate that stenting is medically unnecessary in the presence of either condition). Whether the patient has a urinary tract infection or not, if the patient meets the medical necessity guidelines for a ureteral stent the claim should be approved.

In the other aforementioned case of blurring the distinction between medical necessity of care and quality of care, Palmetto GBA, the Jurisdiction 11 MAC, has proposed LCD DL35782, “Skilled Nursing Services for Observation and Assessment: Monitoring of Potentially Inappropriate Medications Listed in the Beers Criteria.” As background, the Beers Criteria were established in 1991 by a consensus panel of experts; they contain lists of medications that pose potential risks outweighing potential benefits for people 65 and older. The criteria have been updated through the years, with the most recent update being issued in 2012 under the auspices of the American Geriatrics Society. The guidelines divide medications into three categories: potentially inappropriate medications and classes to avoid in older adults; potentially inappropriate medications and classes to avoid in older adults with certain diseases and syndromes that the drugs listed can exacerbate; and finally, medications to be used with caution in older adults. Throughout the guidelines it is noted that the medications included in these categories are “potentially inappropriate,” and the word “contraindicated” is used only once, referring to the use of androgens for men with prostate cancer. The intentions of the criteria, as cited in the guidelines, include improving the selection of prescription drugs by clinicians and patients, evaluating patterns of drug use within populations, educating clinicians and patients on proper drug usage, and evaluating health outcomes, quality of care, costs, and utilization data.

Despite these clear guidelines, Palmetto, under the guidance of Dr. Harry Feliciano, the MAC’s medical director, has proposed in this LCD to deny payment for home health care and skilled nursing services if a patient is taking a medication on one of these lists. The proposed LCD notes that “the existing scientific evidence and clinical consensus against using the Beers Criteria potentially inappropriate medications render the skilled nursing visits conducted for observation and assessments related to Beers Criteria potentially inappropriate medications not reasonable and necessary to the treatment of an illness or injury.” So Palmetto is making the great leap by indicating that because a treatment may potentially expose a patient to an increased risk, it will not pay for home care services by a nurse to monitor for that risk.

The Medicare home health benefit covers skilled nursing visits for otherwise eligible home health beneficiaries “where there is a reasonable potential for change in a patient’s condition that requires the skilled nursing personnel to identify and evaluate the patient’s need for possible modification of treatment or initiation of additional medical procedures until the patient’s clinical condition and/or treatment regimen has stabilized.” Certainly patients who require medications included in the Beers Criteria fit this description, even more so than patients without such medications; they are at high risk and such a patient requires close monitoring for potential side effects and adverse effects. But Palmetto is proposing the exact opposite, indicating that these high-risk patients cannot receive home nursing care because the MAC has inappropriately decided that “potentially inappropriate” and “use with caution” is the same as “never use.”  If a patient is prescribed such a medication, Palmetto is insisting, skilled nursing care in the home will not be covered. The most recently issued guidelines indicate that “thoughtful application of the criteria will allow for closer monitoring of drug use, application of real-time e-prescribing and interventions to decrease ADEs in older adults, and better patient outcomes.” Palmetto application of the criteria is to thoughtlessly deny home nursing care to the patients most in need of it.

The practical application of this LCD, if adopted, is also worrisome. Since self-administered medications are covered under Medicare Part D, Palmetto will not have access to a patient’s prescription history to determine if a medication is new or old (nor will it be able to determine what prior medications were tried prior to use of a medication from one of the lists). The Beers Criteria also exclude patients receiving palliative care, and no one with the MAC would have any knowledge of whether the patient is receiving such care. Palmetto will also have no way to know if the nursing services are being ordered to monitor that particular medication (in which case nursing would not be covered) or another medication on the patient’s medication list (in which case nursing would be covered). It is also unclear what a home care agency should do if it receives a referral for a patient who is taking a potentially inappropriate medication – refuse the referral? Call the doctor and question his or her medical judgment and request a medication change? Or accept the patient and not monitor the use of that one medication in any way? If it chooses the latter and the patient develops a complication from one of those medications, is the nurse forbidden from notifying the physician, or do they notify the physician and risk denial of payment for the whole episode of care? And how will Palmetto determine which claims to deny? There is no indication on the claim forms which medication the nurse is monitoring. Will they request medication lists from the home care agency and deny if any potentially inappropriate medication is on the list?

The mission of the MACs is to process Medicare claims and ensure that services paid for by Medicare are medically necessary as defined by the Social Security Act. Both CGS and Palmetto are going beyond this and trespassing into the territory of the quality improvement organizations (QIOs), which are tasked with ensuring that Medicare recipients receive high-quality care. If the treatment, be it a ureteral stent or home nursing to monitor a patient receiving a potentially inappropriate medication, is medically necessary, the MAC should pay the claim. If it has a concern about the quality of the care provided to the beneficiary, it should refer the case to the QIO. 

The Palmetto LCD is posted for comment and I would encourage readers to submit feedback pointing out the many flaws inherent in such a proposal. I would also hope that the Centers for Medicare & Medicaid Services (CMS) and the QIOs read this and kindly ask the MACs stop playing in the quality sandbox and stick to medical necessity.

You can find the proposed LCD with address for comment by clicking here.

About the Author

Ronald Hirsch, MD, FACP, CHCQM is vice president of the Regulations and Education Group at Accretive Physician Advisory Services at Accretive Health. Dr. Hirsch’s career in medicine includes many clinical leadership roles at healthcare organizations ranging from acute care hospitals and home health agencies to long-term care facilities and group medical practices. In addition to serving as a medical director of case management and medical necessity reviewer throughout his career, Dr. Hirsch has delivered numerous peer lectures on case management best practices and is a published author on the topic. He is a member of the American Case Management Association and a Fellow of the American College of Physicians.

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