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CMHC PULSE

Cardio Metabolic Health Congress – Official Blog

Asian Pacific Heritage Month: Increased Sensitivity to Statins in East Asian Patients

 

 The month of May is celebrated as Asian Pacific Heritage Month, which spotlights the vast influence and contributions of Asian Americans and Pacific Islanders to the culture and history of the United States. As part of the yearly campaign, CMHC is bringing awareness to specific cardiometabolic clinical considerations relevant to the Asian Pacific patient population, such as varying statin tolerability.

 Statins are among the most prescribed class of medications by U.S. clinicians. In addition to the 28% of the United States adult population already undergoing statin treatment, an estimated 15 to 20 million individuals are candidates for statin prescriptions based on cardiometabolic risk factors. However, the efficacy, tolerability, and safety of these therapies has been under investigation, especially in cases of demographics potentially vulnerable to adverse medication-related events.

To better inform clinical decisions, the American Heart Association released a comprehensive statement  based on an examination conducted by Newman et al. of the safety and tolerability of statin therapies.

The study evaluated the impact of the medication class on population sub-groups, in particular those at an increased risk of adverse outcomes including elderly patients, children, pregnant women, and individuals of East Asian heritage.

 The AHA’s statement highlights varying tolerability levels found in East Asian patients, who exhibit an increased sensitivity to statin medications, indicating the need for caution in prescription and dosage instructions. Furthermore, it presents clinical practice lessons providers should be aware of when developing treatment strategies involving statins for various patient groups.

 

Increased Sensitivity in East Asian Population

Patients of East Asian heritage are a unique population in terms of tolerance and dosing requirements for statin medications. Prior pharmacokinetic trials have found greater plasma concentrations of certain statins as well as their active metabolites in the East Asian population. Although first believed to be a result of lower body mass in the group, the difference is caused by pharmacogenetic factors – including variances in the metabolism of statins by enzymes and their disposition by membrane transporters.  According to the AHA’s statement, Chinese patients in particular appear to have an increased susceptibility to simvastatin-induced myopathy.

 The general East Asian patient population is typically prescribed lower doses of statins due to either increased sensitivity to the medications or an increased therapeutic response compared with Western patient groups. Currently, prescribing guidelines for rosuvastatin and simvastatin recommend lower doses be used in this demographic as evidence implicates that this group may experience increased reactivity to statin therapies. As such, physicians are encouraged to monitor doses for this subgroup of patients and adjust dosing accordingly to mitigate the risk of common side effects which tend to be muscle-related symptoms.

 Adverse Muscle-Related Symptoms

 A primary patient complaint in relation to statin medications is the presence of muscle-related symptoms without a rise in creatine kinase. While few medications have been associated with adverse effects on skeletal muscle, all types of statins have been implicated as causing myopathy however; these symptoms tend to be bilateral, symmetrical, and only present in skeletal muscle.

 Muscle-related symptoms range from statin-associated muscle symptoms (SAMS), myalgias, myopathy, and in rare cases rhabdomyolysis – a severe form of myopathy with serum enzyme elevations greater than 40 times the upper threshold.

Several risk factors for adverse muscular symptoms have been identified, including hypothyroidism, preexisting muscle disease, renal impairment, as well as East Asian heritage.

Data collected from large-scale, long-term scientific trials has been used to evaluate all of the currently available statin therapies at their maximum recommended doses, revealing an excess risk of myopathy of 0.1%. Research indicates that this risk is highest during the first year of statin treatment, after dosage increases, and with the addition of a known interacting medication however, overall risk remains relatively low.

 Clinical Precautions

 Patients of East Asian descent presenting with adverse muscle-related symptoms must be seriously evaluated and closely monitored. “Most drugs that carry rare but serious adverse risks often precipitate less-serious effects of the same nature in much more frequent fashion (anticoagulants and bleeding events are a good example of this); statins and muscle symptoms are no exception,” Newman and colleagues caution.

 In cases of muscle-associated complaints, clinicians should feel comfortable excluding myopathy on the basis of a physical exam and laboratory measures – in which creatine kinase is within <10 upper limit of normal – and re-challenging with the same statin at a lowered dose or frequency, or with a different statin near previous dosage levels.

 The widespread prevalence of vascular diseases in the national population often requires appropriate medical intervention, including the treatment of patients with statin therapies. However, the risks and relevant clinical precautions need to be taken into consideration when evaluating potential and existing patients for statin treatment, especially in cases of vulnerable groups. The increased sensitivity observed in the East Asian population further underscores the importance of factoring in patient ethnicity when developing treatment plans as well as the need for an increased awareness of potential variations in therapeutic responses. Clinicians must remain cognizant of the potential for overall greater sensitivity to statin medications in patients of East Asian descent.

 

Medicare COVID-19 Telemedicine Fact Sheet for Cardiologists

Requiring an urgent shift to digital medical services, the current COVID-19 outbreak has disrupted the contemporary healthcare model forcing federal agencies to temporarily amend guidelines in an effort to ease the transition to telemedicine. Regulations continue to change and insurance coverage for medical services has greatly expanded to promote the growing use of digital healthcare services, which are rising in popularity at a tremendous rate assisted by new policies and a widespread loosening of restrictions aimed at furthering access to care.

Effective March 6, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded access to Medicare telehealth services for their beneficiaries on a temporary, emergency basis while the federal government lessened HIPAA rule enforcement policies as part of the battle against the COVID-19 crisis. These and other policy changes help to offer a safe, alternative model of care for Medicare program participants, many of whom belong to the vulnerable demographic facing increased risk of serious coronavirus illness.

Telemedicine and COVID-19

Throughout the COVID-19 crisis, innovative uses of telemedicine technology have been driving routine care, keeping vulnerable demographics safe, and expanding access to medical services across the country.

In an interview with Diagnostic and Interventional Cardiology CMS Administrator Seema Verma explained some of the adjustments:  “These changes allow seniors to communicate with their doctors without having to travel to a healthcare facility so that they can limit risk of exposure and spread of this virus. Clinicians on the frontlines will now have greater flexibility to safely treat our beneficiaries.”
Further information about the newly implemented guidelines for patient care and their implications on telehealth services during the COVID-19 outbreak are outlined below.

Expanded Access to Telehealth Services

1135 Waiver

As part of the effort to expand access to telemedicine, the 1135 waiver was introduced lessening prior restrictions for both patients and healthcare providers. Before the introduction of the waiver, Medicare reimbursed telehealth visits on a limited basis, for example, when a patient was receiving care in a designated rural area or when they received a service within a healthcare facility. Under the new 1135 waiver, the following changes have taken effect:

•   Office, hospital, and other telehealth visits will now be covered and reimbursed for the same amount as in-person visits.
•   A wider range of providers is now able to offer telehealth services across the nation, including nurse practitioners, psychologists, and licensed social workers.
•   Medicare beneficiaries can now receive a wider variety of services through telemedicine – such as evaluation and management visits, mental health counseling, and preventative health screenings.
•   The HHS Office of Inspector General is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid for by federal healthcare programs.

Virtual Services

As part of the expanded Medicare telehealth program, healthcare professionals can provide a variety of digital medical services, including telehealth visits, virtual check-ins, and e-visits. The specific requirements and guidelines for each type of service are outlined below.

Telehealth Visits

Access to telehealth visits has been temporarily expanded for the course of the COVID-19 outbreak; Medicare beneficiaries may now use digital technologies for office, hospital visits, and other services previously rendered in-person. Recent CMS regulation updates regarding telehealth visits include:

•   Online visits will be paid at the same rate as regular, in-person visits.
•   A wider range of practitioners can now be reimbursed for providing telemedicine services – including physicians, nurse practitioners, physician assistants, midwives, anesthetists, psychologists, clinical social workers, registered dietitians, as well as nutritional professionals.
•   However, to guarantee reimbursement, medical providers must use an interactive audio and video system permitting real-time communication to conduct telehealth visits.
•   The requirement for an established patient-provider relationship has been removed or the duration of the public health emergency per new CMS guidelines, further details can be found below.
“The Department of Health and Human Services (HHS) is announcing a policy of enforcement discretion for Medicare telehealth services furnished pursuant to the waiver under section 1135(b)(8) of the Act.  To the extent the waiver (section 1135(g)(3)) requires that the patient have a prior established relationship with a particular practitioner, HHS will not conduct audits to ensure that such a prior relationship existed for claims submitted during this public health emergency,” a statement from the CMS explains.

Virtual Check-ins

Recently implemented changes also allow Medicare beneficiaries in all areas of the country to attend brief virtual check-ins with their healthcare providers – or the use of technology-based services for brief communications. Policy updates related to online check-ins include:

•   Medicare will cover virtual check-ins with established patients to reduce the need for face-to-face appointments.
•   Brief virtual visits can now be conducted using a wider range of technologies; medical practitioners may bill for check-in services provided via telephone, audio/video communication, secure text messaging, email, as well as patient portal systems.
•   However, medical services may not be related to a medical visit that has occurred within the previous 7 days or result in a medical visit within the following 24 hours, or the soonest available appointment.
•   Patients must give verbal consent prior to receiving virtual check-in services.
•   Patients can submit video and image content using store and forward systems; physicians should interpret received patient data within 24 business hours.

E-Visits

The CMS’ updated guidelines now allow established Medicare patients in all types of locations to have online, non-face-to-face, patient-initiated interactions with their providers using online portals. However, these services can only be rendered under the following conditions:

•   E-visit services can only be reported to Medicare if the billing practice has an established relationship with the patient.
•   E-visits must be initiated by patients. However, practices may educate patients on the availability of these services.
•   These communications can occur over a 7-day period, only after the patient provides verbal consent to obtain telehealth services.
•   These services may be billed using CPT codes 99421-99423 and HCPCS codes G2061.
Additional information regarding relevant billing codes for e-visits and other virtual care services can be found on the CMS’ website.
 
HIPAA Regulation Enforcement During COVID-19

Along with the coverage changes outlined above, the HHS Office for Civil Rights has lessened restrictions and waived penalties related to HIPAA compliance. This applies to health care providers serving patients in good faith via virtual communication technologies during the COVID-19 pandemic. Further information on the latest HIPAA regulation policies has been published by the HSS and can be accessed here.

While the CMS already offers flexibility to states wishing to implement telehealth services, the latest developments signal an important step forward in the direction of widespread telemedicine availability – despite the temporary nature of federal guidelines. As a growing number of emerging technologies aims to optimize the process of delivering remote care and patient health monitoring, the strategic expansion of telehealth can be expected to continue and its prevalence in cardiometabolic care to increase further.

As the COVID-19 outbreak continues to evolve, healthcare policies and guidelines can be expected to change; medical professionals are encouraged to stay up-to-date on the latest clinical guidance to ensure compliance and limit potential liability risks.