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. This is the first of a three-part series.)
As we predicted, the Guidelines for Prescribing Opioids for Chronic Pain (Center for Disease Control, March 2016) have been widely adopted as a de facto rule by other federal agencies, insurers, state regulators and prescribers without regard for either unique patient history and characteristics or empirically gathered evidence of effectiveness. 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 Guidelines generated by the Center for Disease Control.
In accordance with newly released rules, new thresholds for opioid doses will be established for Part D program users at 90 mg morphine equivalent units (MME) and again at 200 mg. Any prescription at or above the 90 mg level will trigger a “safety edit” requiring pharmacists to talk with the prescribing doctor about the appropriateness of the dose. If satisfied with the explanation, the pharmacist may then override the edit and fill the prescription. Insurers will be encouraged to implement safety edits, at a much higher dose of 200 MME or more. Continued utilization above these limits will require an appeal and review. The new policy requires all new opioid prescriptions to be limited to no more than 7 days’ supply. Insurers will be incentivized to identify beneficiaries at high risk of addiction (possible ‘over utilizers’) and to require them to use selected prescribers or pharmacies. The reduction of insured Part D plan users in total opioid prescribing units over a 3-year period will become a quality evaluation factor for insurers contracted by CMS.
In 2014, one in four Americans (1:4) has multiple chronic conditions, those that last a year or more and require ongoing medical attention or that limit activities of daily living. Chronic conditions also include many rare diseases (occurring on average, at a rate of 1: 200,000 occurrences in the population), progressive illnesses that arise from a variety of causes, occur alone or together with other disease processes, and include conditions that arise from accidents and injuries. In 2017, the number has risen to three in four Americans aged 65 and older. This high prevalence has several underlying causes: the rapidly growing population of older adults, the increasing life expectancy associated with advances in public health and clinical medicine, and the high prevalence of some risk factors, such as tobacco use and physical inactivity. As a person’s number of chronic conditions increases, his or her risk for dying prematurely, being hospitalized, receiving conflicting advice from health care providers, and encountering iatrogenic harms from treatment encounters increases. These factors are magnified in areas with limited access to routine healthcare resources.
Beneficiaries who are residents of a long-term care facility, in hospice care or receiving palliative or end-of-life care, being treated for active or cancer-related pain are excluded from these interventions. This determination is made through the insurer’s use of disability utilization reviews (DUR) of medical necessity criteria that is often not well understood by either physicians and patients. Given advances in care, the distinction of active treatment for cancer from other forms pain care is a distinction without a functional difference when it comes to treatment of pain. As this regulation moves into place, it will be important for affected persons and their physicians to plan now for transition to uninterrupted care provided in accordance with changed conditions. Who is affected by this discussion?
- Persons with one or more identified chronic illnesses
- Persons with substance use, misuse, or abuse issues
- Persons who have complex prescribing routines that utilize multiple drug classes
- Persons who are underserved and do not have reliable health care relationships
- Family members, friends, care partners
- Policy makers, regulators, insurers, contractors to insurance plans
A patchwork of state rules regarding eligibility for palliative or hospice care services and the influence of state prescribing regulations has led to widespread confusion about what kind of patients meet criteria for integrated and coordinated palliative care services that are generally devised as a way to assist persons with multiple chronic conditions to achieve services appropriate to their needs. Where do you stand in relationship to this rule? The answer to this is “it depends.” It depends on your combination of diseases, your history of treatment, the documentation that is in your medical records, and the willingness of your physician(s) to process the necessary adjustments that will protect both your rights to care and their right to treat you.
Now is the time to prepare by conducting a review of your personal medical records in order to determine whether your care coordination needs meet medical necessity criteria for uninterrupted prescribing regimens and palliative care. If you have a prescription history of long term use of opioids (90 MME or greater for more than 3 months in the last year) alone or in combination, it is likely that your insurer will flag your case for a disability utilization review (DUR). You will want to be prepared for this eventuality by addressing the items that follow. Understanding the new terminology, you will hear is the first step.
12 Important Definitions
- A Chronic condition (CC) is a human health condition or disease that is not passed from person to person, which is persistent or otherwise long-lasting in its effects, or represents a slow disease progression that develops over time. These diseases are of long duration (more than three months) and include common diseases such as arthritis, asthma, cancer, COPD, diabetes and viral diseases such as hepatitis C and HIV/AIDS. It also includes hundreds of diseases that occur with lesser frequency (see chart). Chronic diseases generally cannot be prevented by vaccines or cured by medication, nor do they just disappear. In your medical records and insurance claims they are coded as ICD-10 codes with related service subcodes (CPTs).
- Multiple Chronic Conditions (MCC) are those chronic conditions that last a year or more and require ongoing medical attention and coordination of medical treatment regimens across one or more body systems, or that limit activities of daily living. These might be expected to occur together as related illnesses – if one occurs, the other is likely to occur.
- The complex patient is one for whom contextual or environmental factors may also be required to be addressed in order for medical care to be effective:
- Medical complexity, including discordant conditions that require multiple medical specialties, management of chronic or intractable pain, potential medication interactions or intolerance, unexplained symptoms and cognitive issues including –
- Socioeconomic factors, such as the unaffordability of medication, family stressors and low levels of health literacy;
- Mental illness, such as depression resulting in poor medication adherence, addiction, and anxiety that confuses the clinical picture; and
- Behaviors and traitsthat might be expected to occur under the stressors of prolonged chronic illness like emotional lability, anger, frustration, increased demands, anxiety, depression, or feelings of hopelessness.
- “Exacerbating factors” are those important facts that surround multiple medical conditions and include considerations like family support, housing and food security, job losses, financial status, geographic location, and independent living status.
- Palliative care is an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. The World Health Organization (WHO) defines palliative care as:
- provides relief from pain and other distressing symptoms;
- affirms life and regards dying as a normal process;
- intends neither to hasten or postpone death;
- integrates the psychological and spiritual aspects of patient care;
- offers a support system to help patients live as actively as possible until death;
- offers a support system to help the family cope during the patient’s illness and in their own bereavement;
- uses a team approach to address the needs of patients and their families, including bereavement counselling, if indicated;
- will enhance quality of life, and may also positively influence the course of illness;
- is applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy, and includes those investigations needed to better understand and manage distressing clinical complications.
- A Disability utilization review (DUR) is a form of administrative case review conducted by your insurer that audits the data that has been collected about you in managing your individual case enrollment in a health plans. It reviews and tracks service utilizations based on ICD-10 and CPT codes and indicators of need represented in case notes, claims made and payment, and monitoring of allowable costs and quality, risk and benefit.
- A Diagnosis related group (DRG) is a case categorization into a diagnosis-related group (DRG). Each DRGhas a payment weight assigned to it, based on the location of services (e.g. inpatient versus outpatient) and the regional average resources used to treat Medicare patients in that DRG. A patient may have case data that falls into multiple DRGs which are weighted for payment differently depending on a number of criteria.
- Medical necessity is a legal concept which refers to the health care services or products provided by a physician to a patient. It is provided for the purpose of preventing, diagnosing, treating an injury or disease in accordance with generally accepted standards of medical practice. According to Medicare.gov, the term medically necessary is defined as “health-care services or supplies needed to prevent, diagnose, or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.” In any of those circumstances, if your condition produces debilitating symptoms or side effects, then it is also considered medically necessary to treat those. Medicare defines “medical necessity” as services or items reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
- The Local coverage determination (LCD) of medical necessity is governed by the contract negotiated between your insurer and the Center for Medicare and Medicaid Services. The LCD must describe the circumstances under which the item or service is reasonable and necessary under the law. Contractors shall consider a service to be reasonable and necessary if your physician determines that the service is:
- Safe and effective; and
- Appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is;
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
- Furnished in a setting appropriate to the patient’s medical needs and condition;
- Ordered and furnished by qualified personnel;
- One that meets, but does not exceed, the patient’s medical need; and
- At least as beneficial as an existing and available medically appropriate alternative.
- Medical evidence is the documentation in your records that supports your treatment plan. For a service to be considered medically necessary, it must be reasonable and necessary to diagnosis or treat patients identified medical condition(s). When submitting claims for payment, it is the diagnostic codes (ICD-10) reported with the service codes (CPTs) that tells the payer “why” a service was performed. The diagnosis reported can be the determining factor in supporting or not supporting the medical necessity of the procedure. It will be an increasingly important factor in determining whether your pharmacy will fill your prescriptions as the ICD-10 code must match the diagnostic purpose for which the medication is issued. Increasingly states are coding ICD-10 codes into the interstate Prescription Drug Monitoring System (PDMP) so that prescribing practices can be linked to prescriber decisions for care. Medical necessity is based on “evidence based clinical standards of care.”. This means that there is evidence to support a course of treatment based on a set of symptoms or other diagnostic results. Per CMS, medical necessity of a service is the overarching criterion for payment in addition to the individual requirements of a CPT code.
- Social determinants of health and health disparities are the financial, educational, health, social, neighborhood and community environmental factors—and their functional interrelationships—that influence the ability of individuals in their family and community to make progress toward alleviating health stressors. Indicators are examined using a life stages, life space contextual perspective. This approach recognizes that specific risk factors and determinants of health vary across the life span. Health and disease result from the accumulation (over time) of the effects of risk factors and determinants. Intervening at specific points in the life course can help reduce risk factors and promote quality of life and health. While CMS has adopted this perspective and actively promotes it, this language is notably silent in the current CMS policy document adopted on April 2, 2018 for implementation in 2019. As a group of data factors that contribute to understanding and interpreting medical necessity, this information must be gathered at a supplemental level in the medical record in order to support medical necessity criteria for the disability utilization review (DUR).
- Risk versus benefit is a quantifiable analysis of the ratio of potential risk of harm associated with a course of action to possible benefits that might arise from the same or other alternative courses of action. Analysis of these risks is heavily dependent on human factors, values, and culture. A certain level of risk in our lives is accepted as necessary in order for certain benefits to develop.
- A Perverse incentiveis an incentive that has an unintended and undesirable result which is contrary to the interests of the incentive makers. Perverse incentives are a type of negative unintended consequence. For instance, in an effort to prevent overdose and suicide in the population of Medicare users, insurers are incentivized to reduce prescribing. While this benefits the amount of financial outflow from the Medicare system, it perversely incentivizes the contractor to create barriers to care such as step therapies, in order to improve their evaluation for reduced prescribing among its users. Contracted participants may be harmed in the process.
In Part II of this discussion, we will discuss the topic of multiple chronic conditions (MCC), palliative care, and how these definitions affect your right to consideration and appeals under medical necessity criteria. In Part III, I will provide you with recommended steps to review your medical records, and to discuss these records with your physician(s) to be sure that the information that will be needed to continue your care can be found in your records should they be flagged for a disability utilization review (DUR) by your insurer. Let’s all work together – physicians and patients – to make continuation of care as seamless as possible and with as little disruption as we are able to manage.
Center for Medicare Services (2018, Apr 2). Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Final Rule. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/CY2019-Medicare-Advantage-Part-D-Final-Rule.pdf
Center for Disease Control (2016, March 16). Guidelines for Prescribing Opioids for Chronic Pain https://www.cdc.gov/drugoverdose/prescribing/guideline.html
Center for Disease Control. Chronic Disease Overview. (2016). Available from: http://www.cdc.gov/chronicdisease/overview/index.htm
Center for Medicare & Medicaid Services (2012). Chronic Conditions Among Medicare Beneficiaries, Chart Book 2012. [PDF – 4.85 MB] Baltimore, MD: Centers for Medicare & Medicaid Services
HHS. Multiple Chronic Conditions – A Strategic Framework: Optimum Health and Quality of Life for Individuals with Multiple Chronic Conditions. Washington, DC: US Department of Health and Human Services; (2010).
MedicineNet. Definition of Chronic Disease. (2016). Available from: http://www.medicinenet.com/script/main/art.asp?articlekey=33490
National Academies Press (2018). Health Care Utilization as a Proxy in Disability Determination, https://www.nap.edu/catalog/24969/health-care-utilization-as-a-proxy-in-disability-determination#.WsSGWb1JRtk.twitter