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Avoiding Confusion Over State Licensing Laws as CMS Further Loosens Telemedicine Restrictions

The Centers for Medicare & Medicaid Services (CMS) continues to loosen the conditions for participation in Medicare, as well as specific reimbursement requirements, to ensure facilities and practitioners are able to practice at the top of their license and across state lines without jeopardizing Medicare reimbursement. Unfortunately, as demonstrated when CMS took similar actions over the past few weeks in response to the Coronavirus (COVID-19) pandemic, headlines tend to overlook one fundamental component of the applicable regulatory regime: state law requirements. Unlike the Veterans Affairs Administration’s (VA's) action a few years ago, which preempted state licensing law for purposes of implementing a VA telemedicine program, the Department of Health and Human Services has limited its actions during the COVID-19 pandemic to modifications of federal regulations and rules.  Secretary Alex Azar, in a letter to the Governors, instead encouraged the states...

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DOJ Continues Telemedicine Enforcement in Q2 2019

During the second quarter of 2019, DOJ continued its focus on enforcement activity in telemedicine. As reported in prior editions of the Quarterly Roundup, telemedicine is an expanding field, causing DOJ to pay particular attention to the industry. In April 2019, DOJ indicted the owner and operator of 1stCare MD and ProfitsCentric with one count of conspiracy to pay and receive kickbacks. The defendant’s arrest and federal indictment is part of a nationwide law enforcement action, as reported in the Q1 2019 Quarterly Roundup, that targeted 24 defendants involved in alleged extensive healthcare fraud schemes focused on telemedicine and durable medical equipment (DME) marketing. These schemes allegedly resulted in losses amounting to more than $1.2 billion. The indictment alleges that from 2016 to 2019 the defendant defrauded HHS in its administration and oversight of Medicare by conspiring with others by paying and receiving kickbacks and bribes in exchange...

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CMS Innovation Center Proposes Telehealth Solutions in ET3 Model

As part of its efforts to provide patient-centered care and reduce costs for Medicare beneficiaries, the Centers for Medicare and Medicaid (CMS) have developed an Innovation Center model for ambulance care teams: Emergency Triage, Treat, and Transport (ET3). As part of this model, the agency has proposed two potential telehealth offerings: 1) An individual who calls 911 may be connected to a dispatch system that has incorporated a medical triage line to be screened for eligibility for medical triage services prior to ambulance initiation, and 2) telehealth assistance via audiovisual communications technologies with a qualified provider once the ambulance arrives. Key participants in the ET3 model will be Medicare-enrolled ambulance service suppliers and hospital-owned ambulance providers. In addition, to advance regional alignment, local governments, their designees or other entities that operate or have authority over one or more 911 dispatches in geographic...

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Expanded Telemedicine Services Presented as Means to Address Opioid Crisis in New Legislation

Last week, President Trump signed the SUPPORT for Patients and Communities Act (SUPPORT Act), a bipartisan piece of legislation designed to tackle the opioid crisis by, among other approaches, increasing the use of telemedicine services to treat addiction. Several key provisions are summarized below. The package includes provisions to expand public reimbursement for telemedicine services that focus on addiction treatment. Specifically, the legislation removes Medicare's originating site requirement for substance abuse treatment provided via telemedicine, meaning that health professionals can receive Medicare reimbursement even if the patient is not located in a rural area. In addition, the Centers for Medicare and Medicaid Services (CMS) has been directed to issue guidance to states regarding possible ways that Medicaid programs can receive federal reimbursement for treating substance abuse via telemedicine. The legislation explicitly identifies services...

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The RUSH Act – Another Advancement in Telehealth Acceptance?

As previously noted in our Digital Health Mid-Year Review, 2018 has seen greater acceptance of telemedicine within the Medicare program. Both regulatory and statutory changes have expanded reimbursement opportunities and, consequentially, opportunities for the deployment of telemedicine technologies. As we noted then, however, improvement in the Medicare reimbursement environment for telemedicine services has been tied to a policy goal of not increasing utilization unnecessarily. We noted in our Mid-Year Review that Congress appears to be following MedPac’s recent guidance that Congress “should take a measured approach to further incorporating telehealth into Medicare by evaluating individual telehealth services to assess their capacity to address. . . cost reduction, access expansion, and quality improvement.” The recently introduced Reducing Unnecessary Senior Hospitalizations Act of 2018 (the RUSH Act), seems to deviate from MedPac's suggested...

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Bipartisan Budget Act of 2018 Includes Significant Changes in Medicare, Other Federal Health Programs

On February 9, 2018 after a brief shutdown, Congress passed and President Trump signed the Bipartisan Budget Act of 2018, a two-year budget agreement that includes funding for the operation of the federal government until March 23, 2018. The law includes significant health care policy changes impacting Medicare, Medicaid and other federal health agencies. In addition to raising federal spending caps enacted in the Budget Control Act of 2011, this legislation includes additional spending for health care priorities. Here we break down some of the changes affecting telehealth. Expanded Access to Telehealth Stroke Services The new law expands, beginning in 2019, the ability of patients presenting with stroke symptoms at hospitals or mobile stroke units to receive a timely telehealth consultation with a neurologist in order to determine the best course of treatment. The provision eliminates the current geographic restriction that limits originating sites to rural...

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‘Patterns’ in Opioid Crisis: DEA to Examine Prescription Drug Data

On January 30, Attorney General Jeff Sessions announced a surge of Drug Enforcement Administration (DEA) agents and investigators over the coming month and a half, focused on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of opioid drugs. The DEA will examine distribution and inventory data reported to the DEA by prescription drug manufacturers and distributors for "patterns" and "outliers" for further investigation. Read the full On the Subject.

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The Way Forward for Telemedicine

A lot of us have argued that one of the floodgates for telemedicine has been reimbursement. If states and the Federal government more liberally reimbursed or required reimbursement for telemedicine service, we argue then a significant barrier to broader telemedicine will be removed. This is a valid argument, and the potential flurry of activity on Capitol Hill as of this writing (September 20, 2017) gives many hope that Medicare reimbursement for telemedicine may be greatly expanded soon. Alas, another problem persists. A spate of recent surveys and reports on utilization demonstrate that awareness should be viewed as a similar sort of barrier. It is, of course, a generalization to say this, but consumers are largely unaware of the benefit being made available to them, or are unaware of the appropriate uses of a telemedicine service. It would be foolish to speculate as to the reasons why, but a recent trend may help to erode this barrier. When it comes to...

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False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments in violation of the False Claims Act. Read the full article.

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Round Two: Significant Telehealth Expansion Re-Proposed in Bipartisan Senate Bill

On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early 2016 and referred to the Senate Committee on Finance. As we previously reported on February 29, 2016, this iteration of the proposed bill also focuses on promoting cost savings and quality care under the Medicare program through the use of telehealth and remote patient monitoring (RPM) services, and incentivizing such digital health technologies by expanding coverage for them under the Medicare program—albeit using different terminology. Chiefly, the CONNECT Act of 2017 serves as a way to expand telehealth and RPM for Medicare beneficiaries, makes it easier for patients to connect with their health care providers and helps reduce costs for patients and providers. As with the previous iteration, the CONNECT Act of 2017...

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