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New Laws Expand Telehealth in California

California Governor Gavin Newsom recently signed into law two bills that expand the delivery of telehealth services in the state. In particular, the legislation:

  • Permits providers to prescribe medications without a synchronous interaction
  • Requires payment parity of telehealth services under commercial plans
  • Loosens restrictions on Medicaid coverage of store-and-forward services.

California healthcare providers and commercial health payers should consider the following key takeaways from these laws.

Remote Prescribing

Assembly Bill No. 1264 (codified at Cal. Bus. & Prof. Code § 2242(a)) took immediate effect on October 11, 2019. This provision alters the standard for prescribing, dispensing and furnishing dangerous drugs (including any prescription medication):

  • Such drugs may be prescribed, dispensed and furnished as long as there is an “appropriate prior examination and a medical indication.”
  • The law specifies that the appropriate prior examination “does not require a synchronous interaction” (e., real-time communication) and can be administered via telehealth as long as the provider abides by the appropriate standard of care.
  • The provision expressly identifies certain asynchronous technologies, including questionnaires and self-screening tools, that are permissible methods for conducting the prior examination.

Previously, the law required an “appropriate prior examination” but gave no detail regarding what that examination entailed. The new provision provides clarity and enables providers to use innovative solutions such as dynamic questionnaires when prescribing medications to patients.

Payment Parity

Although California previously required certain insurers (including commercial payers and Medi-Cal managed care plans) to cover telehealth services, it did not specify that telehealth services have to be reimbursed at the same rate as in-person care. Assembly Bill No. 744 changed that with its addition of two new statutes: Cal. Health & Safety Code § 1374.14 and Cal. Ins. Code § 10123.855. These new provisions do not require reimbursement parity for Medi-Cal managed care plans, however.

These statutes incorporate the following provisions for contracts that are issued, amended or renewed on or after January 1, 2021:

  • Commercial payers must reimburse services appropriately delivered through telehealth “on the same basis and to the same extent” as the services are reimbursed when provided in person.
  • Insurers and providers retain the ability to negotiate reimbursement rates, but healthcare services that are the same, “as determined by the provider’s description of the service on the claim,” will be reimbursed at the same rate, whether provided in person or through telehealth.
  • Telehealth services offered by an out-of-network provider do not need to be covered by a health plan or insurer, unless required under other provisions of law.
  • Insurers can establish copayment or coinsurance requirements for telehealth services if they do not exceed the copayment or coinsurance for in-person services. However, cost sharing is not required for telehealth services.
  • Telehealth reimbursement does not need to be separated from other capitated or bundled risk-based payments.
  • Insurers cannot limit coverage only to corporate telehealth service providers.

Medicaid Coverage of Store and Forward

Previously, Medi-Cal only permitted certain services to be delivered via store [...]

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Vetting Relationships for Telemedicine Collaborations

As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration, finding the right partner is crucial for success, particularly at the highly-scrutinized intersection of healthcare and technology. This post explores the factors to address when evaluating service providers and vendors for your next telemedicine collaboration.

Service Provider Evaluation

  • Ask around “town” – What is the collaborator’s reputation? What independent feedback is provided in references?
  • Determine if the service provider’s stage in the organizational “life-cycle” and its affiliated relationships are the best fit for the strategic goals of your partnership (e.g. should you partner with an early-stage company or a longstanding organization?)
  • Assess the capabilities of potential collaboration partners for meeting your organization needs, and pressure test their ability to come up with back-up options, should the need arise throughout the course of the collaboration.
  • Determine whether collaborator has state specific and service specific policies and procedures governing the provision of telemedicine services, including: (more…)



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Telemedicine Collaborations and Partnerships: Key Considerations for Success

Telemedicine collaborations, whether between technology companies and providers, health systems and patients, or other creative partnerships we have yet to see in the industry, can present numerous benefits to our healthcare delivery system and patient outcomes. However, such collaborations present a variety of regulatory, logistical and operational concerns that should be strategically addressed from the ideation stage of the collaboration onward.

Early-Stage Considerations

The strategy behind the collaboration should be developed with an eye towards the duration of the relationship and the development of mutually beneficial goals and objectives that are clear and measurable. Each party should be transparent about their capabilities and strategic vision at the outset of the collaboration talks to avoid any surprises or disappointments deeper in the future. Questions for potential collaboration partners include:

  • Is this an experimental partnership or a long-term plan?
  • What do I bring to the table? How can this partner supplement or support my capabilities?
  • How will this relationship be branded and marketed? Do I need greater visibility than my partner, or will we come together under a new brand?
  • Do we have the IT infrastructure and vendor relationships in place to execute this collaboration? If not, how will secure what we need?
  • Do we have the resources to meet the regulatory requirements of the partnership?
  • How will we measure the success or failure of the collaboration?

Considerations in the RFP Stage

After the initial strategy discussions have taken place, the proposal period raises its own series of considerations. After ensuring that the arrangement proposed can address the goals and objectives of the collaboration, regulatory and transactional issues take center stage. Rights and responsibilities of each party, reporting and compliance mechanisms, fees, credentialing, licensing and privacy compliance and liability issues, to name a few concerns, are addressed at this point in the process. Fees structures and compliance with the evolving federal and state laws regulating telemedicine providers are particularly complex issues that should be addressed at this point.

Questions to address regarding fees include:

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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 for doctors’ orders for DME for Medicare beneficiaries. Prosecutors also alleged that the defendants, 1stCare MD and ProfitsCentric, through their network of doctors, generated thousands of doctors’ orders for DME absent a pre-existing doctor-patient relationship and a physical examination, and that the orders were based solely on a short telephone conversation. The indictment alleges that these activities resulted in the submission of approximately $40 million in fraudulent Medicare claims for DME.

Further, in July 2019, DOJ indicted a New York-based anesthesiologist for her alleged role in a $7 million telemedicine conspiracy to fraudulently bill Medicare, Medicare Part D plans and private insurance plans, resulting in more than $3 million in payments on those claims.[51] According to DOJ, the indictment resulted from investigative work by the Criminal Division’s Medicare Fraud Strike Force, a joint initiative of DOJ and HHS. Eastern District of New York prosecutors charged the anesthesiologist with one count of conspiring to commit healthcare fraud by misusing telemedicine channels under agreements with unidentified companies to prescribe DME and drugs to more than 3,000 Medicare beneficiaries. The indictment alleges that, from January 2015 to May 2018, the anesthesiologist and other providers allegedly received kickback payments from unidentified companies for improper telemedicine encounters. The indictment alleges that the anesthesiologist “prescribed and ordered DME and prescription drugs for beneficiaries who were not examined or evaluated by a licensed physician.” The prosecutors alleged that the prescriptions flowing from the alleged telemedicine encounters were for DME and drugs that were neither medically necessary nor the result of genuine physician-patient relationships.

PRACTICE NOTE: Given DOJ’s recent criminal enforcement related to telemedicine, telemedicine companies should closely review their compliance with the federal and state laws that may be implicated through a telemedicine practice. Further, DOJ’s focus on individual accountability is particularly important with respect to telemedicine, given its interest in pursuing criminal actions against physicians.

This blog post was originally published in McDermott’s Health Care Enforcement Quarterly Roundup | Q2 2019. Click here to view the full report. 




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Dash to Digital Health? How the Regulatory Sprint to Coordinated Care Could Expand Access to Care

Certain long-standing laws, such as the civil monetary penalty provision prohibiting patient inducements, have hampered providers’ ability to fully leverage remote patient monitoring and other telehealth tools. Many stakeholders are hoping that developments in the Regulatory Sprint to Coordinated Care will begin the rulemaking process to enable greater access to digital health and virtual care products.

The US Department of Health and Human Services (HHS) launched the Regulatory Sprint to Coordinated Care in 2018 with the goal of reducing regulatory burden and incentivizing coordinated care. As part of this initiative, the Centers for Medicare and Medicaid Services and other agencies are scrutinizing a variety of long-standing regulatory requirements and prohibitions to determine whether they unnecessarily hinder the innovative arrangements policy-makers are otherwise hoping to see develop. While regulations such as the civil monetary penalty prohibition on patient inducements have significant benefits for reducing fraud and abuse, they can also make it difficult for health systems to deploy digital tools that help patients track, monitor and share health data with their providers.

For example, Medicare reimbursement of digital health and virtual care products, while expanded in 2018, is still limited. This means that if a provider wants to use un-reimbursed technology, the provider must either charge the patient separately for the non-reimbursable service or provide the service to the patient for free. The former option is tricky—it can result in surprise charges for patients, and digital health services can be part of a care service plan and difficult to break out separately as a standalone billable service. As a result, many providers would prefer to offer virtual care services to the patient for free, but doing so immediately implicates the civil monetary penalties prohibition. Substantial time, effort and cost is required to evaluate the facts and circumstances, understand the available regulatory guidance and case law, and determine whether the provision of the service—which results in no increase in revenue—could result in governmental scrutiny

This is just one example of how certain long-standing regulations have become a barrier to broad adoption of digital health. If HHS chooses to update these regulations or issue additional guidance, the Regulatory Sprint to Coordinated Care could bring digital health technologies such as telehealth and virtual care products off the sidelines and into the race.

Read more at McDermott’s Regulatory Sprint to Coordinated Care Resource Center




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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 areas where ambulance suppliers and providers have been selected to participate in the ET3 model will have an opportunity to access cooperative agreement funding. As such, both state regulations and CMS regulations will apply to the use of telehealth offerings under ET3. This post explores early-stage questions of ET3 implementation and reimbursement, the intersection of state laws governing telehealth, and what potential participants and telehealth companies should know about the program.

How will CMS support the ET3 model implementation?

The key telehealth development for the ET3 program is that CMS expects to waive the telehealth geographic and originating site rules as necessary to implement the model, including waivers that will allow participants to facilitate telehealth at the scene of a 911 response. Additional information on these waivers is expected to accompany the ET3 Request for Applications (RFA), slated for release this summer. Overall, Medicare coverage requirements provide that the patient must be in an approved originating site at the time of the telehealth visit (e.g., hospital) and must be located within a rural area. CMS has waived these two requirements for other programs, such as the SUPPORT for Patients and Communities Act (the SUPPORT Act) in October 2018, which eliminated the originating site restriction for substance use disorder treatment, because doing so is necessary for these programs to succeed.

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DOJ’s Enforcement Activity Against Individuals: Acute Focus on Telemedicine

DOJ’s focus on individual accountability is particularly important with respect to telemedicine. Telemedicine is a burgeoning field, with a projected market increase of 18 percent annually over the next six years, reaching $103 billion in 2024. In light of this recent surge in profitability, DOJ has begun paying extra attention to telemedicine, with at least one recent HHS-OIG report asserting that more than one-third of all telemedicine claims are improper.

The report’s claim is further supported by a recent increase in telemedicine prosecutions. In April 2019, DOJ announced charges against 24 defendants, including owners of various telemedicine companies, for their alleged involvement in a health care fraud scheme resulting in $1.2 billion in loss. This scheme involved the payment of kickbacks and bribes by durable medical equipment (DME) companies to medical professionals working with telemedicine companies, in exchange for the referral of Medicare beneficiaries. DOJ alleges that the defendants paid doctors to prescribe medically unnecessary DME without ever seeing patients or after only a brief telephone conversation. The prosecution involves charges in at least seven districts across the United States, including New Jersey, Florida, Texas, Pennsylvania, and California. Additionally, DOJ prosecuted several other individuals in connection with unrelated telemedicine schemes in late 2018 (see the agency’s press releases here, here and here). In light of this recent trend, companies should exercise extreme caution and consult with regulatory experts prior to opening telemedicine practices. Companies can expect to see increased scrutiny and further prosecution of telemedicine companies moving forward.

Practice Note: DOJ has recently re-emphasized its willingness to exercise significant discretion and reward companies that invest in strong compliance programs. Looking forward, health care companies should maintain detailed and up-to-date documentation of all compliance programs, in case such an FCA case should arise. A lawyer should be consulted if an updated compliance program is needed.

This blog post was originally published in McDermott’s Health Care Enforcement Quarterly Roundup | Q1 2019. Click here to view the full report. 




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Around the Corner in Digital Health: What’s Next for Care Coordination & Reimbursement?

The end of 2018 and the first months of 2019 brought a number of regulatory developments impacting care coordination and the adoption and reimbursement of digital health services. From the Centers for Medicare & Medicaid Services’ (CMS) Regulatory Sprint to Coordinated Care and Pathways to Success initiatives to the updated Physician Fee Schedule, speakers Dale Van Demark and Lisa Schmitz Mazur discuss the rules and regulations that have the potential to enhance or hinder access to digital health solutions and how digital health companies can position themselves for success in this evolving regulatory landscape.

Click here to listen to this episode of the Of Digital Interest podcast. 




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Digital Health Drives Forward – A Roadmap of Regulations

New digital health regulations arose at the federal and state level in 2018, bolstering the existing legal framework to further support and encourage digital health adoption in the context of care coordination and the move to value-based payment. McDermott’s 2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement report – the second in a four-part series – highlighted these developments within the digital health landscape. These efforts brought changes to coverage of telehealth and other virtual care services, as well as information gathering for regulatory reform, and can help bridge the gap between research, funding and implementation as regulations build a framework within which companies can deploy their products, receive reimbursement and demonstrate value to patients. Here we outline digital health developments from the second half of 2018 and how they can help drive digital health forward in 2019. For a closer look at key care coordination and reimbursement developments that shaped digital health in 2018, along with planning considerations and predictions for the digital health frontier in the year ahead, download our full report.

To view the first report in the series, 2018 Digital Health Year in Review: Focus on Data, click here.




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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 provided via a hub and spoke model and in school-based health centers, among others, as those that should be eligible for federal reimbursement.

In another development, the US Drug Enforcement Agency (DEA) is now required to implement regulations regarding a special registration process for telemedicine providers within one year of the passage of the SUPPORT Act. The aim of this process is to expand health providers’ ability to prescribe controlled substances to patients in need of substance use disorder treatment based on a telemedicine consultation, without having to conduct an in-person evaluation first. This special registration process was originally contemplated 10 years ago under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) as one of the seven pathways through which a telemedicine provider could prescribe a controlled substance to his/her patient without having first conducted an in-person evaluation, but the DEA never issued any regulations to effectuate it. At present, the special registration process and requirements (e.g., registration costs, application processing timeline, provider qualifications) are still largely unknown. The answers to these open issues will determine how accessible this new registration pathway will be to substance use disorder providers and, therefore, how impactful it will be in connecting patients in need of substance use disorder treatment with qualified providers.

In addition to these policy reforms, the SUPPORT Act also directs government agencies to conduct additional research into the possible benefits of telemedicine technology for treating substance abuse. Both CMS and the Government Accountability Office (GAO) are tasked with publishing reports concerning the use of telemedicine technology for treating children: CMS is directed to analyze how to reduce barriers to adopting such technology, and GAO is directed to evaluate how states can increase the number of Medicaid providers that treat substance use disorders via telemedicine in school-based clinics. Furthermore, the Department of Health and Human Services must issue a report regarding the impact of using telemedicine services to treat opioid addiction within five years.




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