Tag Archives: telemedicine

Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving …

CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other changes to healthcare regulations and policies in response to the COVID-19 public health emergency (PHE). At a high level, the Interim Rule encompasses topics including expansion of telehealth, support for and expansion of COVID-19 testing, allowing certain licensed professionals to practice at the top of their licenses, Medicare payments for teaching hospitals, changes to the Medicare …

CMS Broadens Telehealth Access Across the Board, Including Audio-Only Telephone Services

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period published in the Federal Register on May 8, 2020 (the April 30 Interim Rule) building on previous regulatory waivers and other revisions to regulations issued March 31, 2020 in an interim final rule (March 31 Interim Rule) in response to the COVID-19 public health emergency (PHE). Among other changes, the April 30 Interim Rule further broadens access to patient care provided via telehealth and other communication technology-based services and …

CMS Issues New Interim Final Rule With Sweeping Regulatory Changes in Response to the COVID-19 Pandemic

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (the “Rule”) which sets forth additional regulatory waivers and other changes to healthcare regulations in response to the COVID-19 pandemic. “Today’s actions are informed by requests from healthcare providers as well as by the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act” states CMS in its press release. Spanning 279 pages, the Rule makes sweeping changes for the full spectrum of health care providers. On a high …

Connecticut DCP Issues Guidance for Remotely Refilling Prescriptions

The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an in-person visit due to the COVID-19 pandemic. DCP explains that “practitioners may issue prescription refills for controlled substances using their professional discretion for a patient under their care without seeing the patient in-person within certain parameters.” The parameters are as follows:

  • Schedule-Specific Requirements for Controlled Substance Prescriptions
    • Schedule II prescriptions cannot be refilled; however, practitioners with a pre-existing relationship with a

OIG Issues FAQs on its Policy for Waiver of Patient Cost Sharing Obligations for Telehealth During COVID-19 Public Health Emergency

On March 25, 2020, the Office of Inspector General, Health and Human Services (OIG) issued two frequently asked questions (FAQs), clarifying its March 17th Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak (Policy Statement).…

Rhode Island Issues Emergency Regulations on Off-Label Prescribing for COVID-19, and Guidance on Telehealth and Reciprocal Licensure

Rhode Island has issued important updates for health care providers related to COVID-19, available at https://health.ri.gov/diseases/ncov2019/for/providers/.  Providers should be aware of these updates including, among others, the following described below.…

COVID-19: HHS Issues FAQs on HIPAA and Telehealth to Help Providers Maintain Access to Care During the Pandemic

On March 20, the U.S. Department of Health and Human Services (HHS) issued additional guidance in the form of Frequently Asked Questions (FAQs) on HIPAA and telehealth services to help providers furnish care during the COVID-19 pandemic.

The FAQs follow and provide further information on the Notification of Enforcement Discretion issued by HHS on March 17 (Notification), in which HHS indicated that it would not penalize providers for using popular video chat applications, such as FaceTime and Skype, in good faith to provide telehealth services amid the COVID-19 …

COVID-19: Lamont Authorizes DSS to Expand Access to Telehealth Services for Medicaid Beneficiaries in Response to Coronavirus Pandemic

As part of Executive Order No. 7F issued on March 18, Connecticut Governor Ned Lamont authorized the Commissioner of the Department Social Services (DSS) to “temporarily waive any requirements” set forth in state law, regulations, rules, policies or other directives concerning telehealth as is necessary to enable the Medicaid program “to cover applicable services provided through audio-only telehealth services.”  As a result, DSS will be able to expand Medicaid coverage for telehealth services that are provided by phone, and not just audio-video technology.…

DEA Allows Providers to Prescribe Controlled Substances Without an In-Person Medical Examination During COVID-19 Public Health Emergency

The Federal Drug Enforcement Agency (DEA) issued guidance permitting DEA-registered practitioners to prescribe controlled substances without an in-person medical exam of the patient for the duration of the COVID-19 public health emergency. …

Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

On March 17, the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid Services (CMS) published an announcement, a fact sheet and Frequently Asked Questions.  To further facilitate telehealth services, the Office for Civil Rights (OCR) issued a notification describing certain technologies that would be permitted to be used for telehealth without being subject to penalties under the Health Insurance Portability and Accountability Act regulations (HIPAA). In addition, the Office of Inspector …

2019 Physician Fee Schedule Rule Review: CMS Recognizes “Virtual Check-Ins” and “Store and Forward” Remote Service Offerings

On November 1, 2018, the Centers for Medicare & Medicaid Services issued a final rule that updated payment policies and rates under the Medicare Physician Fee Schedule (PFS). This rule also formalized two types of remote service offerings known as “virtual check-ins” and “store and forwards.” In an effort to increase access for Medicare beneficiaries, CMS has recognized and finalized a code to provide separate payment for communication technology “virtual check-in” service. The purpose of these services are “brief check-ins” using communication technology to evaluate whether or not an office …

Medicare Proposes Revised Telehealth Services and Payments

The Centers for Medicare & Medicaid Services (CMS) recently published a Proposed Rule, primarily intended to modify certain Medicare payment policies.  The Proposed Rule contains several provisions that address the growing use of telehealth. CMS noted that it had received many suggestions regarding the expansion of access to telehealth as well as appropriate pay for the same, in response to its call for comments in the CY 2018 Medicare physician fee schedule (PFS) proposed rule.…

OIG Posts Telemedicine Advisory Opinion

The Office of Inspector General (OIG), Health and Human Services issued an Advisory Opinion allowing an arrangement proposed by a federally qualified health center look-alike (FQHC look-alike) to provide free technology items and services to a clinic run by a county Department of Health (County Clinic), that would facilitate telemedicine encounters (the Arrangement).  Although the OIG found that the Arrangement could potentially implicate the anti-kickback statute (AKS), the OIG concluded that it would not impose administrative sanctions.…

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