March 2022
CMS issued a Medicare Learning Network (MLN) Fact Sheet which provides updated language to documentation signature requirements for physicians and non-physician practitioner, specifically using electronic signatures. According to MLN905364, electronic signatures must be authenticated, safeguarded against misuse and identifiable as an electronic signature rather than a typed signature. It must also represent the provider […]
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On February 23, 2022, a federal judge in Texas ruled that the independent dispute resolution process implemented by the U.S. Department of Human and Health Services (HHS) within the No Surprises Act violated the Administrative Procedure Act. The Administrative Procedure Act oversees the process by which federal agencies develop and issue regulations and includes requirements […]
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The U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers regarding recommendations for lifelong surveillance of abdominal aortic aneurysm (AAA) patients treated with endovascular repair (EVAR). The recommendations include regular imaging surveillance within 30 days of EVAR and annually thereafter which “may help identify adverse events such as endoleaks, device migration, loss […]
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February 2022
FDA Issues Guidance on Patient Participation in the Design and Conduct of Device Studies The U.S. Food and Drug Administration (FDA) issued two final guidance documents that provide recommendations for utilizing patient perspectives in medical device clinical studies. The first is Patient Engagement in the Design and Conduct of Medical Device Clinical Studies. As outlined […]
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On February 11, the World Health Organization (WHO) released the international Classification of Diseases (ICD), 11th revision, coding set for WHO member countries to implement worldwide. According to their press release, 35 countries are already using ICD-11 for recording and reporting mortality and morbidity statistics. Included in this version are approximately 17,000 codes, with over […]
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Bipartisan legislation was introduced to begin the process of modernizing health privacy laws. The Health Data Use and Privacy Commission Act would establish a commission to assess the current state of health data privacy and the Health Insurance Portability and Accountability Act (HIPAA) in an effort to address longstanding technology and security challenges posed by […]
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January 2022
According to InsideHealthPolicy, the Centers for Medicare and Medicaid (CMS) formally announced that it will give 60 days’ notice before it ends the COVID Public Health Emergency (PHE) and its related regulatory flexibilities, which is currently set to end mid-January. The Department of Health and Human Services (HHS) will not state how long it plans […]
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The Centers for Medicare and Medicaid Services (CMS) has published an updated list of approved telehealth services for calendar year (CY) 2022. Updated as of January 5, 2022, the List of Telehealth Services for Calendar Year 2022 contains information to provide clarification on which codes are temporarily added to the list due to the public […]
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Due to the COVID PHE, the Centers for Medicare and Medicaid Services (CMS) created the Acute Hospital Care at Home (AHCaH) Initiative, launched in November of 2020. This program allows Medicare-certified hospitals to treat patients with inpatient-level care at home. Hospitals have to submit a waiver of the Hospital Conditions of Participation, which require nursing […]
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The Bureau of Consumer Financial Protection issued a compliance bulletin and policy guidance to remind debt collectors of their obligation to comply with the Fair Debt Collection Practices Act’s (FDCPA) prohibition on “false, deceptive, or misleading representations or means in connection with the collection of any debt and unfair or unconscionable means to collect or […]
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