The SUPPORT for Patients and Communities Act (“the Act” or “the SUPPORT Act”), signed into law by President Trump on October 24, 2018, is intended to combat the growing opioid crisis in the United States. The Act aims at preventing opioid addiction and misuse and enhancing access to care for those who have substance use disorders.

A key aspect of the Act is the expanded Medicare coverage of telehealth services to beneficiaries in their home (see Section 2001 of the Act). Currently, and historically, Medicare has restricted coverage of telehealth services to beneficiaries who reside within certain geographic rural areas and who seek such services at specific “originating sites” (patient beneficiary’s home is not included in the current Medicare definition for “originating site”). The Act amends 42 U.S.C. § 1395m(m) to eliminate these coverage restrictions for “an eligible telehealth individual with a substance use disorder diagnosis for purposes of treatment of such disorder or co-occurring mental health disorder, as determined by the Secretary [of Health and Human Services].” With this amendment in place, health care providers may now be reimbursed for providing eligible substance use disorder services to Medicare beneficiaries in their homes via telehealth. Although the Act does not provide for any “facility fee” reimbursement for telehealth services provided to beneficiaries in their homes, the Act requires reimbursement be provided to physicians and other health care practitioners furnishing these services at the same rate as they would otherwise receive if providing the same services in-person.

It is important to note that while Section 2001 of the Act takes effect on July 1, 2019, it authorizes the Secretary of the U.S. Department of Health & Human Services (“Secretary”) to implement these amendments immediately by creating a final interim rule.  The Act also mandates that the Secretary report on the impact of this legislation on: (1) the health care utilization (and in particular, emergency department visits) related to substance use, and (2) “health outcomes related to substance use disorders,” including opioid overdose deaths. The Act provides $3 million to the Centers for Medicare & Medicaid Program Management Account in order to carry out these reporting requirements, which must be completed within five years.

Another key aspect of the Act mandates that the U.S. Attorney General (“Attorney General”) promulgate final regulations that specify (1) “the limited circumstances in which a special registration under this subsection may be issued” and (2) “the procedure for obtaining a special registration.” Under 21 U.S.C. 831(h), as amended by The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”), this special registration would allow health care providers to prescribe controlled substances via telemedicine when legitimately necessary, including when an in-person evaluation is not possible. As discussed in one of our recent TechHealth Perspectives blog posts, despite the statutory mandate in the Ryan Haight Act passed more than eight years ago, the Attorney General has not yet issued any regulations or guidance on how to obtain this special registration. The Drug Enforcement Administration (“DEA”), the federal agency delegated authority to promulgate these regulations by the Attorney General, has also not promulgated any regulation or other guidance addressing special registration. The SUPPORT Act gives the Attorney General until October 24, 2019, to promulgate its final regulations on this matter.

Epstein Becker & Green plans to discuss the Act’s numerous provisions in greater detail in future Client Alerts.

Throughout the campaign season and the first months of Donald Trump’s presidency, the current Administration has voiced a commitment to furthering telehealth advancement. For example, during the campaign, then-candidate Trump emphasized the importance of telehealth tools in reforming the U.S. Department of Veterans Affairs (“VA”). More recently, both U.S. Department of Health and Human Services Secretary Tom Price and Centers for Medicare and Medicaid Services Administrator Seema Verma stated in their confirmation hearings that they were interested in promoting the use of telehealth technology. On Thursday, August 3, 2017, VA Secretary Dr. David Shulkin, joined by President Trump, took steps towards fulfilling this commitment, announcing three telehealth initiatives aimed at improving access to and quality of care for veterans.

First is a forthcoming regulation that Secretary Shulkin referred to as “Anywhere to Anywhere VA Healthcare.” Under current law, VA practitioners may provide in-person health care services in any state, as long as they are licensed in one state, without needing additional professional licensure. This proposed regulation would expand the ability to engage in multistate practice to VA practitioners who are providing telehealth services. Anywhere to Anywhere VA Healthcare, if enacted, would authorize VA practitioners to serve veterans using telehealth technologies, regardless of the locations of the provider or the patient, as long as the VA practitioner maintains a valid professional license in good standing in at least one state.

The second telehealth initiative discussed during last week’s announcement is an app titled “VA Video Connect” that allows veterans to connect with health care providers via secure and web-enabled video on their smartphones or computers. Currently, VA Video Connect is being used by 300 VA providers in 67 hospitals, and the VA intends to roll-out the app nationwide over the course of the next year. The third telehealth initiative discussed is another app, titled “Veteran Appointment Request App” or “VAR App.” The VAR App enables veterans to use their smartphones, tablets, or computers to schedule or modify appointments at VA facilities. The VAR App is currently available at some VA locations, but now the VA has planned a nationwide roll-out.

Last week’s announcement of these telehealth-focused initiatives was met with praise from many, including leading telehealth advocacy organizations such as the American Telemedicine Association and Health IT Now. The VA has long been at the forefront of telehealth progress, including being an early adopter of telehealth technology, piloting telehealth programs as early as the 1990s, and pioneering much of the progress being made in telehealth care coordination. As the largest telehealth program in the country, the VA continues to be a leader in the telehealth space. Last year alone, 700,000 veterans received telehealth services through the VA. For more information about the VA Telehealth Program, visit VA Telehealth Services.

Capitol BuildingAs requested by Congress as part of an appropriations bill signed into law late last year, this month, the Department of Health and Human Services (HHS) released a report highlighting its e-health and telemedicine efforts.  The report makes for interesting reading, and while there are no significant surprises in the report, it offers a clear snapshot of some of the agency’s thinking regarding virtual care.

The first thing I noted in the report is the agency’s view that “telehealth holds promise as a means of increasing access to care and improving health outcomes.”  This is important because it has not always been clear whether the agency views telehealth quite in the same favorable way as other stakeholders increasingly do.  The other thing I noted was the agency’s view that the various alternative payment methods currently being tested may facilitate expansion of telehealth.

Among other things, the report details some of the policy challenges faced by telehealth stakeholders:

  • Significant variability in telehealth coverage from one payer to another.
  • State licensure requirements for clinicians and the administrative burden such requirements impose on clinicians.
  • Credentialing and privileging.
  • Gaps in access to affordable broadband.

HHS indicates that many reforms are currently being tested or implemented to address these challenges. For example, in the area of reimbursement, the agency notes that it is currently testing more expansive telehealth coverage through its Next Generation ACO Demonstration, and highlights MACRA’s incentives for physicians to use telehealth.  The report references the agency’s new rule that permits the use of telehealth modalities to provide Medicaid home health services.

The report also provides an overview of telehealth-related federal activity including:

  • The number of telehealth grants administered by HRSA and SAMHSA.
  • The establishment of the Federal Telemedicine Working Group (comprised of 26 agencies and departments such as USDA and the FCC) to facilitate telehealth education and information sharing.
  • ONC developing an inventory of federal telehealth activities.
  • AHRQ providing an evidence map of the available research regarding telehealth.
  • The continued great telehealth work being done within the VA and reasons why that model may not be scalable.

Overall, the report is an illuminating but relatively unsurprising take on agency thinking.  In particular, two nuggets stood out. First, the agency appears to view chronic disease management as a particularly good fit for telehealth.  In recounting that almost half of all adults have at least one chronic illness and that chronic disease accounts for 75 percent of all health expenditures, the report concludes that telehealth “appears to hold particular promise for chronic disease management.” It goes to reason that any expansion of telehealth under Medicare will probably first focus on chronic disease management. Second, HHS signaled the importance of Medicare Advantage in any telehealth expansion effort, by including a proposal in the President’s budget request for FY 2017 to expand the ability of MA organizations to provide telehealth by eliminating otherwise applicable Part B requirements that certain services be provided only in-person.

By Brandon Ge and Alaap Shah

The Department of Health and Human Services (“HHS”) is taking laudable steps to improve notices of privacy practices (“NPPs”) and make them more clear, understandable, and user-friendly. Under the HIPAA Privacy Rule, individuals are entitled to a receive an NPP informing them of how their health information may be used and shared, as well as how to exercise their health privacy rights. Health plans and health care providers must develop and distribute NPPs that clearly explain these rights and practices. Unfortunately, to date NPPs have been poorly designed, hard to navigate and unclear with regard to patient rights or company obligations regarding use and disclosure of health information.

Privacy is just as much about protecting patients’ rights to data as it is about protecting data. The HIPAA Omnibus Rule, CLIA Rule, and others are designed to improve patient access to their medical records, empowering them to actively manage their health. The digitization of medical records, in the form of electronic health records, personal health records, patient portals, and the like, facilitates patient engagement in healthcare if used properly.  However, ineffective NPPs create barriers for patient understanding their rights.

NPPs that clearly convey patients’ privacy rights are critical in enabling patients to take a more active role in healthcare. Conversely, if patients do not understand NPPs, then they won’t have a good sense of their privacy rights, including their right to access their health information. Some critiques regarding NPPs include that they are frequently lengthy and include legalese that the general public has difficulty understanding.  To remedy these concerns, some suggest simplifying language and “layering” the notice—that is, including a short summary of the individual’s rights as a first layer and including a longer, more detailed explanation as a second layer—would go a long way toward improving the readability of NPPs.

In an effort to address criticisms of NPPs, last month, the Office of the National Coordinator for Health Information Technology (“ONC”) collaborated with the HHS, Office for Civil Rights (“OCR”) to develop model NPPs that clearly convey the required information to patients in an accessible format. Covered entities can customize these model NPPs and then display them and distribute them to patients.

ONC and OCR have also thrown down the gauntlet and established the Digital Privacy Notice Challenge, which will award $15,000 to the creators of the best online NPP (second place wins $7,000 and third place gets $3,000). The challenge calls for designers, developers, and privacy experts to use the model notices as a baseline and create an online NPP that is clear, effectively informs patients of their privacy rights, and is easily integrated online. Once submissions are finalized, the public will have two weeks to vote on the best submission.

The submission period ends on April 7, 2014, and winners will be announced in May or June of 2014.

Does your organization think it has what it takes to win this challenge?

 

Follow Alaap Shah on Twitter: @HealthITLawyers