By Terri Lewis, PhD.
(Editor’s Note: Dr. Terri Lewis has been very critical of the CDC for not requiring data collection about chronicity or context of chronic disease. She has been discussing this issue in a series of reports. This is the second of a three-part series.)
As of April 2, 2018, the Center for Medicare Services has adopted modifications to its program requirements for prescribing of opiate medications in the Part D pharmacy program, implementing the recommendations generated by the Center for Disease Control (Guidelines for Chronic Pain, March 16, 2016). In Part I, I introduced definitions related to this rule change.
What exactly are multiple chronic conditions (MCC) according to the Medicare program?
Medicare tracks hundreds of health conditions that reflect various levels of chronicity. Beneficiaries may have more than one of these chronic conditions listed alone or in combination with other chronic diseases. Some of these conditions are known to occur together. A Medicare beneficiary is considered to have a chronic condition if the CMS administrative data have a claim indicating that the beneficiary received a service or treatment for a specific condition identified in the Medicare Handbook of Diagnosis Review Groups (DRG).
Hundreds of diseases are tracked within this system, but the 19 most frequently billed chronic conditions are tracked through Medicare administrative claims. Data collected about all conditions is collected as administrative data that has important limitations – in particular, their principal clinical insight comes from ICD-10 diagnostic and associated CPT codes that frequently reflect insufficient attention to case development, are of questionable accuracy, completeness, clinical scope, and meaningfulness. This is a limitation of construction of electronic health records systems which yields primarily ‘count’ or frequency data.
Table 1. 19 Most Frequently Reported Chronic Conditions in CMS Claims Data
|Alzheimer’s Disease and Related Dementia||Heart Failure|
|Arthritis (Osteoarthritis and Rheumatoid)||Hepatitis (Chronic Viral B & C)|
|Atrial Fibrillation||Hyperlipidemia (High cholesterol)|
|Autism Spectrum Disorders||Hypertension (High blood pressure)|
|Cancer (Breast, Colorectal, Lung, and Prostate)||Ischemic Heart Disease|
|Chronic Kidney Disease||Osteoporosis|
|Chronic Obstructive Pulmonary Disease||Schizophrenia and Other Psychotic Disorders|
While administrative databases may be useful for descriptive purposes (e.g., exploring variations in regional or demographic treatment patterns), their practical limitations imposed by reliance on this information prevents us from being able to provide credible answers regarding which alternatives offered to patients, treatment technologies, and provider specialties among the available alternatives, work the best for patients. This is because payment for services is not linked to patient outcomes and is compounded by the adoption of an inadequate definition of chronic disease that is hardwired into the data collection system. Importantly, the CDC has adopted a method of disseminating information about chronic disease incidence and prevalence that omits many chronic conditions from its tracking and reporting systems and makes no mention of duration of the disease or symptoms. So, missing from this system is information about-
- complex causality, with identification of the multiple factors leading to disease onset
- a long development period, for which there may be no symptoms in early stages
- transitions in the course of disease states from acute to chronic and terminal to chronic status
- a prolonged course of illness, which contributes to other health complications
- associated functional impairment or disability
- disease burden of associated co-morbidities that involve multiple body systems, mental illness, challenges to behavioral health, oral disease, or functional and psychosocial decline
Given the reliance on the ICD system, variation in adoption of coded definitions across systems and individual users has resulted in the inconsistent collection of patient and public health information that confuses physicians and patients alike and has real implications for those managing chronic diseases or conditions. People with multiple chronic conditions also are at increased risk of poor day-to-day functioning. The failure to gather information within a complete context may cause the process to fail to build a consolidated picture of the chronic disease, its symptom course, and associated and sometimes predictable co-morbidities. For instance, the CDC lists “cancer” as a chronic disease when, in fact, only certain types of cancers (i.e., multiple myeloma) can be viewed in terms of a chronic illness and others are of little long-term consequence. Some forms of cancers have few treatment options and prove fatal in the near term. Some, but not all, cancer-related conditions generate pain that must be addressed in designing care for patients and there is little to distinguish these care protocols from the treatment needs of other non-cancerous chronic diseases in the current tools. When it comes to the basics of managing pain treatment, nothing is more frustrating to patients in the adoption of treatment protocols for complex illness and pain than the ongoing discourse around the term cancer and whether it constitutes a distinction without a difference in pain care. This contributes to care failure and creates excessive administrative time. This is of critical clinical importance in managing multiple chronic conditions at the community level.
Having multiple chronic conditions is also associated with substantial personal and public health care costs and as recent analyses have demonstrated, catastrophic illness is associated with financial harms that are associated with increased stressors and early mortality. Approximately 71% of the total health care spending in the United States is associated with care for the Americans with more than one chronic condition. Among Medicare fee-for-service beneficiaries, people with multiple chronic conditions account for 93% of total Medicare spending. People with multiple chronic conditions face substantial out-of-pocket costs of their care, including higher costs for prescription drugs. Changes to prescribing protocols have real world implications for managing costs in a household with limited income.
The impact of this CMS regulatory change has offered little consideration to community conditions that affect actual care management. Beneficiaries are justifiably concerned about the impact of conflicts between state regulations, Medicare rules and limitations imposed by insurers. The amount of time necessary to deal with administrative appeals, constraints imposed by availability of insurance coverage (or lack thereof) and for persons who are dually eligible, the integration between Medicare and Medicaid and navigating things like step therapies, is likely to add significant stress to physicians who are working to keep administrative costs low, and users who are unschooled in navigated these changes.
In accordance with the implementation of the Comprehensive Addiction and Recovery Act of 2016 (CARA), Part D sponsors are required to implement drug management programs that result in decreased opioid prescribing volumes. Under such programs, a sponsor can limit at-risk beneficiaries’ access to coverage for frequently abused drugs, including opioids and benzodiazepines, beginning with the 2019 plan year. The clinical guidelines will be used to determine if a beneficiary is potentially at-risk, based on using opioids from multiple prescribers and/or multiple pharmacies. Sponsors will be allowed to limit an at-risk beneficiary’s access to frequently abused drugs to a selected prescriber(s) and/or pharmacy(ies) (“lock-in”), and through the use of beneficiary-specific point-of-sale (POS) claim edits, which are already permitted under the current policy. Part D sponsors may not implement such limitations unless they have engaged in case management consults with the prescribers of these drugs, and beneficiaries can submit prescriber and pharmacy preferences. The final rule exempts beneficiaries who are being treated for active cancer-related pain, are receiving palliative or end-of-life care or are in hospice or long-term care from drug management programs. At-risk determinations, which include prescriber and pharmacy lock-in, will be subject to the existing disability utilization reviews (DUR) and beneficiary appeals process.
So, for the sake of suggesting a path forward, I want to suggest a thought process for establishing the determination of medical necessity documentation that relies on the exchange of appropriate information between the physician and the patient and occurs at the office level. Part III will identify a thought process that operates independently of insurance plans or geography. Because persons with complex chronic conditions should plan on annual reviews of medical necessity there is no time like the present to begin to prepare for this conversation.
Let’s Consider the example of Interstitial Cystitis
Below is the framework for the data capture in the ICD-10 lookup system. IC is a noncommunicable disease located in the N group in the ICD-10. From this information, can you determine anything about severity, or chronicity, or even the impact on one’s daily life for this life changing disease? To what extent does this disease create disability over time? Are there indications for pain management or medications required?
Diseases of the genitourinary system N00-N99 >
Type 2 Excludes
certain conditions originating in the perinatal period (P04-P96)
certain infectious and parasitic diseases (A00-B99)
complications of pregnancy, childbirth and the puerperium (O00-O9A)
congenital malformations, deformations and chromosomal abnormalities (Q00-Q99)
endocrine, nutritional and metabolic diseases (E00-E88)
injury, poisoning and certain other consequences of external causes (S00-T88)
symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (R00-R94)
N00-N08 Glomerular diseases
N10-N16 Renal tubulo-interstitial diseases
N17-N19 Acute kidney failure and chronic kidney disease
N25-N29 Other disorders of kidney and ureter
N30-N39 Other diseases of the urinary system
N40-N53 Diseases of male genital organs
N60-N65 Disorders of breast
N70-N77 Inflammatory diseases of female pelvic organs
N80-N98 Noninflammatory disorders of female genital tract
N99-N99 Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified
As you can see, there are limitations to the way disease information is collected. These limitations have implication for decisions about treatment, prescribing, and chronicity of disease. The lack of contextual information may make the disability utilization review process unnecessarily difficult due to lack of important interpretive information to support the decisions you make with your physician. In Part III we will consider a thought process for gathering the necessary information that must be available in your medical records to support medical necessity for impact of disability, treatment planning and prescribing.
Gerteis J, Izrael D, Deitz D, LeRoy L, Ricciardi R, Miller T, Basu J. Multiple Chronic Conditions Chartbook.[PDF – 10.62 MB] AHRQ Publications No, Q14-0038. Rockville, MD: Agency for Healthcare Research and Quality; 2014. Accessed November 18, 2014.
ICD-10 Codes online lookup. http://www.icd10data.com/ICD10CM/Codes
Multiple Chronic Conditions—A Strategic Framework: Optimum Health and Quality of Life for Individuals with Multiple Chronic Conditions. [PDF – 234.43 KB] Washington, DC: US Dept. of Health and Human Services; 2010. Accessed November 18, 2014