On July 15, 2004, the Departmentof Health and HumanServices'Centers for Medicareand Medicaid Services (CMS)announced a change in the CoverageIssues Manual (CIM). The change wasfrom the statement "obesity is not consideredan illness"to "obesity may becaused by medical conditions such ashypothyroidism, Cushing's disease,and hypothalamic lesions or can aggravatea number of cardiac and respiratorydiseases as well as diabetes andhypertension."So, basically, Medicarechanged the perception of obesityfrom not being a disease to being aneffect or a worsening factor of a disease.This article will discuss the reasoningbehind the change inperception and how thischange will affect coverage inthe Medicare population.
The National Health andNutrition Examination Survey(NHANES) from the period1999-2002 found that an estimated65% of US adults areeither overweight (body massindex [BMI] 25.0-29.9) or obese(BMI ≥30). These results weredramatically greater than thoseof NHANES II, during the period1976-1980, when only 47%of US adults fell into the categoryof overweight or obese.When looking specifically atobesity, 31% of US adults werefound to be obese during 1999-2002—an increase from 15% in 1976-1980.Two alarming factors are associatedwith these statistics: the number ofpeople and the rate ofincrease.
With the increase in obesitycomes an increase indisease state complicationsassociated with obesity. In2003, these complicationswere estimated to produce$123 billion of all UShealth care costs. Becauseof these dramatic costs andincreased population percentages,CMS officialshave decided to makechanges that may open thedoor for scientific researchin this area.
What Do These ChangesMean for Research?
The impact Medicare hason obesity research is presentedin this statement from the policyrevision: "Program payment maynot be made for treatment of obesityunrelated to such a medical conditionsince treatment in this context has notbeen determined to be reasonable andnecessary."The key words in this statementare "reasonable"and "necessary."Only research can determinewhether treatment is "necessary"toimprove quality of life and reduce complicationsand whether it is "reasonable"to conserve health carerelatedcosts. Beneficiaries will be able torequest a review of scientific evidenceto determine whether treatments forobesity will be covered. In the past,this review of medical necessity wouldnot have been executed. It is importantthat the medical sciences supply theresearch needed to support theserequests. Changes in Medicare coveragedepend exclusively on the scientificevidence needed to support them.
What Do These Changes Mean forMedicare Coverage?
In the past, Medicare and Medicaidprograms covered sickness related to oraggravated by obesity, such as type 2diabetes, cardiovascular disease, severaltypes of cancer, and gallbladder disease.Before the revision to the policy,weight-loss medications and obesitytreatments were not covered. Since therevision, the deficit in coverageremains the same. Medicare coveragehas not changed, because obesity stillis not recognized as an independent illness.Until research is presented thatwill prove obesity to be an illness thatrequires intensive treatment, the coveragewill remain as it is. Medicare officialswill review clinical data using thecoverage-determination procedureestablished in 1999 and modified bythe Medicare Prescription Drug,Improvement and Modernization Actof 2003. CMS Chief Medical OfficerSean Tunis, MD, has revealed that theMedicare Coverage Advisory Committeeplans to begin discussing the evidenceon obesity-related surgical proceduresthat may reduce the risk ofcardiovascular and other illnesses.
When Should Changes in MedicareCoverage of Obesity Be Expected?
There will be no immediate effectsfrom the change in the CIM relating toobesity. The process from beneficiaryrequest to scientific review will be atime-consuming one. An example of thetime line for change can be seen byreviewing the request that was made forthe revision in the CIM that has beendiscussed in this article. The initialrequest for the revision was submitted inSeptember 2001. The request wasreviewed throughout the next 3 years,until action finally was taken in July2004. As this was the time line for makingchanges that did not affect Medicarecoverage, one can imagine how long itwill take to implement changes that willdramatically change the coverage policy.
How Will Changes in ObesityCoverage Affect Pharmacy?
If Medicare policy makers decide tocover obesity treatment in the future,pharmacists have the ability to begreat providers in this area. Pharmacistsalready are actively counselingpatients on obesity in relation to heartdisease, cholesterol, diabetes, hypertension,and other illnesses. Pharmacistsanswer many questions on a dailybasis about OTC and prescriptionmedications for the treatment of obesity.The education and experience ofa pharmacist provide patients with theoptimal source of information regardingdiet, exercise, and medication.
Beyond the vast knowledge of obesitytreatments a pharmacist can offer,the accessibility of a pharmacist couldprove to be the most important toolfor a patient fighting obesity. As difficultas it is to lose weight, imagine howdifficult it would be to do it alone orwithout a support system to guide onethrough the difficult times. A pharmacistcould serve as the patient's supportsystem on a daily basis, while providingthe medical expertise needed totreat obesity. What other health careprofessional has the ability to providethis day-to-day accessibility?
Medicare coverage for the treatmentof obesity will be a great opportunityfor pharmacists to be compensated forclinical services that they may alreadybe offering in their practice or wouldlike to offer if compensation is secured.It is important for pharmacists to beaware of the changes in Medicare policyand to be willing to adapt their practicesto serve these needs.
Dr. Downing is a clinical coordinator forKerr Health Care Center, Raleigh, NC.