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Digital Delivery of Healthcare Services After COVID-19

The idea of keeping people healthy at home has become more relevant than ever during the COVID-19 public health emergency. The expansion of telemedicine during the pandemic is expected to serve as a catalyst that will permanently change the way providers deliver care and patients engage with their health. Joined by leaders from Cricket Health, Livongo and BehaVR, we discussed factors driving the shift towards expanding digital delivery of healthcare services and the challenges – technological, regulatory and cultural – that impact such expansion. Click here to listen to the webinar recording, and read on for highlights from the program.

To learn more about the “Around the Corner” webinar series and attend an upcoming program, click here.

Audience Perspective

This poll shows that 40% of digital health consider regulatory obstacles to be their biggest challenge.

Program Insights

  • A redoubled focus on preventative care will be key to bring about effective digital health delivery. The current US healthcare delivery system, built mainly on reimbursable, episodic care, is consistently indicted for being a “sick care” system, not a “healthcare” system. Patients, especially patients with chronic healthcare conditions such as diabetes, hypertension, behavioral health and acute kidney disease, need constant, real-time support and guidance, and need their providers to have access to accurate, actionable information to manage these conditions between real-time encounters. Digital health will play a vital role in this effort.
  • New care modalities open the door to structural changes, which will need to keep pace with the healthcare system. How emerging care modalities are integrated into and affect the healthcare system are still in development, and raise a variety of concerns, from staffing and technology needs to privacy safeguards. As the healthcare system adapts to these changes, the regulations that govern care delivery, licensing, and accreditation will need to adjust as well.
  • Positive regulatory changes have been implemented during the pendency of the national pandemic emergency, but those or similar regulatory changes must continue, and gain momentum and reach, for lasting changes to occur. The actions taken by regulators during the COVID-19 public health emergency show that the government can swiftly respond to new ideas and paths to care. However, these actions are temporary, and it will take time to implement lasting change. While there is an appetite to make some common-sense changes permanent, other areas, such as multi-state professional licensing, will likely take more time due to their complexity.
  • Reimbursement models based around episodic care are a major hurdle to the adoption of on-going remote monitoring and other digital health tools. Panelists agreed that when reimbursement structures are aligned with value-based care, such that providers are reimbursed for the outcomes and on-going care management they provide, digital health tools become a critical part of the provider’s toolbox. In the meantime, [...]

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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 to take action themselves to similarly loosen state laws to ensure maximum utilization of resources.  The states have been doing so, in some instances since early March, with different approaches. These differences stem from a large number of variables that are implicated by state licensure laws.

Key Takeaways: The practical implication for the provider community is that new standards for Medicare need to be adopted in harmony with existing state laws requirements, which, unfortunately, are not uniform across the country.  Nevertheless, nearly every state has taken action to loosen cross-border licensing restrictions for healthcare professionals and have modified other rules and regulations to help protect healthcare workers, maximize their numbers and help them practice at the highest level of their experience and training.  There is a national movement in this direction, but it remains a patchwork.

For a deeper dive into telemedicine regulations during the COVID-19 pandemic, visit our Coronavirus Resource Center, which features articles, webinar recordings and videos on the telemedicine issues you need to know.




Digital Health Business Strategy: A Careful Balance

When it comes to market success for digital tools in the health sector, business strategy can be far more complex than in other industries. Understanding customer-driven market trends is important, but healthcare’s complexity can camouflage customer demand and its regulatory ecosystem adds layers of additional considerations.

Customer Demand and Digital Solutions

The convenience, competitive pricing, answers-at-your-fingertips responsiveness and hyper-personalization delivered by top technology brands and their integration into other industry sectors has created an expectation for digital health solutions that deliver the same experience.

In some instances, consumers are finding the solutions. For example, telemedicine is gaining momentum as consumers discover that digital interactions with high-quality providers are oftentimes more convenient and less expensive than face-to-face encounters. Other tools are providing access to prescriptions, better health condition management solutions, better information sharing enabling smoother transitions among care settings, and more efficiency in everything from hospital operations to scheduling appointments to identifying in-network care options.

When it comes to business strategy, however, digital health solutions need to recognize that consumer pressures are frequently at odds with existing incentives within care delivery systems and, perhaps legal and regulatory requirements. Accordingly, it is critical not just from a compliance perspective but also from a business strategy perspective to navigate the healthcare industry’s unique market and regulatory dynamics.

Balancing Demand with Reality
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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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Health Care Enforcement Roundup: Increased FCA Enforcement Against EHR Companies

The federal government has offered substantial incentives to providers to adopt and use certified electronic health record (EHR) technology. As of October 2018, the federal government had paid over $38 billion in EHR incentive payments through the Promoting Interoperability Program (formerly, the Meaningful Use Program). Other federal health care program policies also encourage use of certified EHR technology through enhanced payments or avoidance of decreased reimbursement. These EHR-related payment policies, however, have triggered increased oversight and enforcement attention on EHR vendors who have allegedly misrepresented the capabilities of their EHR software and allegedly paid kickbacks to customers.

In 2017, DOJ announced a settlement with eClinicalWorks (eCW), an EHR vendor, to resolve an FCA lawsuit originally brought as a qui tam action by a whistleblower. DOJ’s complaint-in-intervention alleged that eCW made material false statements and concealed material facts about the capabilities of its software in connection with the government’s EHR certification process.[1] It also alleged that eCW paid purported kickbacks in connection with certain marketing arrangements (i.e., a referral program, site visit program, and a reference program) with influential customers to induce them to recommend eCW’s EHR software, in violation of the federal Anti-Kickback Statute (AKS).[2]

As part of the settlement, eCW agreed to pay $155 million and to enter into a novel, five-year Corporate Integrity Agreement (CIA) with the HHS OIG. Among other things, the CIA required eCW to engage an independent Software Quality Oversight Organization to assess eCW’s software quality control systems and to regularly report to OIG and eCW on its reviews and recommendations. Further, the CIA required eCW to offer free upgrades and data transfers to its current customers. This was a ground-breaking settlement that raised the question of whether this was the beginning of government and whistleblower attention on (and FCA actions against) EHR vendors. This question was seemingly answered in the affirmative when DOJ announced a second settlement with an EHR vendor in early 2019.

On February 6, 2019, EHR vendor Greenway Health LLC (Greenway) entered into a similar settlement to resolve an FCA case filed by the US Attorney’s Office in Vermont. Interestingly, a whistleblower did not initiate the Greenway case. Rather, DOJ pursued it directly. Like eCW, Greenway faced allegations that its EHR system did not function in the way it represented it during the certification process.[3] One specific allegation was that Greenway provided some customers whose EHR software was improperly calculating certain meaningful use measures (which providers are required to achieve to be eligible for incentive payments) with incorrect calculations in order to enable them to receive incentive payments.[4] According to DOJ, this allegedly caused some Greenway customers to submit false claims to HHS for payment under the Promoting Interoperability Program.

Like in the eCW case, the government complaint against Greenway also alleged that certain payments from Greenway to its customers pursuant to certain reference, referral, and site visit programs [...]

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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.




Telehealth-Related Updates Included in 2019 Medicare Physician Fee Schedule

On November 1, 2018, the Centers for Medicare and Medicaid (CMS) issued final rules for updating the 2019 Medicare Physician Fee Schedule to implement recent telehealth-related legislative reforms. As reported in our Digital Health Mid-Year Report: Focus on Medicare, these changes are expected to have a material impact on the ability of providers to receive payment for delivering telehealth services. Certain key changes are highlighted below:

  • Qualified providers may be reimbursed when providing telehealth services for stroke and kidney disease—even when patients are located in their own homes.
  • Qualified providers may receive a small amount of reimbursement for holding “virtual check-in[s]” with patients and when they evaluate recorded video and images from an established patient. CMS noted that these changes are aimed at allowing providers to help determine whether an in-person visit or additional follow-up is needed. Doing so “increase[s] efficiency for practitioners and convenience for beneficiaries.”
  • CMS also issued an interim final rule related to the recently-signed SUPPORT for Patients and Communities Act, a bipartisan piece of legislation that was passed to combat the opioid crisis. Similar to the Bipartisan Budget Act, the SUPPORT Act removed the originating site requirement for substance abuse and related mental health treatments. There is a 60-day comment period before this rule will be finalized.

Together, these rules represent a substantial expansion of Medicare reimbursement for services provided via telehealth.  For additional guidance on how to interpret and implement these new changes, please contact your regular McDermott attorney.




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 approach. The RUSH Act seeks to avoid hospitalizations through a program that creates financial incentives for providing certain nonsurgical services furnished by hospital emergency departments at skilled nursing facilities that are qualified to provide such services by the Secretary of Health and Human Services The RUSH Act specifically refers to the possibility that some of these services could be provided by licensed practitioners “through the use of telehealth.” Interestingly, the RUSH Act does not specify what telehealth services should be allowable or how they should be reimbursed; rather, the RUSH Act leaves these matters for agency determination.

According to Representative Diane Black (TN), one of the bill’s sponsors, “[t]here are companies who are ready and able to provide this innovative care. . . . These positive disruptors just need Medicare’s payment policies to catch up with the technology. . . giving [nursing homes] the technology-enabled tools needed to lower health care costs and, most importantly, save lives.”

As an observer of this industry, I tend to agree with this claim, but under the approach taken by this bill, that determination will need to be made by the Department of Health and Human Services. Digital health companies looking for a better reimbursement environment are well-advised to focus on the bottom line of federal health policy–lower cost, improved care and increased access.




Illinois Medicaid Program Expands Telehealth Reimbursement Increasing Access to Behavioral Health and Other Critical Services

In an effort to address the need for increased access to behavioral health services, Illinois has passed a series of bills that meaningfully expand the reimbursement of telehealth services delivered to its Medicaid patients. Illinois’ legislators, telemedicine advocates, healthcare providers and patient advocacy groups collaborated in an impressive effort to develop focused and targeted legislative solutions that effectively balance the need to get critical behavioral health services to patients in need with long-standing concerns that increasing access via telehealth will result in greater health care costs to a state already experiencing severe financial challenges.

Governor Bruce Rauner advised that these “initiatives work together to improve the quality of care and hopefully the quality of life for so many Illinoisans suffering from mental health and substance use disorders.” Supporters of the legislation are optimistic that these changes will further expand telehealth programs in Illinois, continuing the growth experienced in the past several years.

As a result of changes to the Illinois Public Aid Code (305 ILCS 5/5-5.25), the following will receive reimbursement from the Department of Healthcare and Family Services (“Department”) for delivering telehealth services that meet applicable requirements:

  • Clinical psychologists
  • Clinical social workers
  • Advanced practice registered nurses certified in psychiatric and mental health nursing
  • Mental health professionals and clinicians who are authorized by Illinois law to provide mental health services to recipients via telehealth (in addition to psychiatrists and federally qualified health centers)

The Department is also required to reimburse any Medicaid certified eligible facility or provider organization that acts as the originating site (i.e., the location of the patient at the time a telehealth service is rendered), including substance abuse centers licensed by the Department of Human Services’ Division of Alcoholism and Substance Abuse.

In addition to these changes, the Illinois Telehealth Act’s definition of a “Health care professional” (225 ILCS 150/5) has been revised to include dentists, occupational therapists, pharmacists, physical therapists, clinical social workers, speech-language pathologists, audiologists, and hearing instrument dispensers. As a result of this change, these professionals are now explicitly subject to the Illinois Telehealth Act’s requirements.

Finally, the Illinois Insurance Code (215 ILCS 5/356z.22) has been amended to require that any individual or group policy of accident or health insurance that provides coverage for telehealth services also provide coverage for telehealth services provided by licensed dietitian nutritionists and certified diabetes educators to senior diabetes patients. The amended section clearly states that this change is intended to “remove the hurdle of transportation for senior diabetes patients to receive treatment.” While this change is a step in the right direction, Illinois remains in the minority as one of the states without a telehealth coverage and/or payment parity law. The vast majority of states have parity laws that, at a minimum, include a coverage requirement, mandating certain types of payors to approve and reimburse certain telehealth encounters the same as they would in-person medical encounters.

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The Illinois legislators who sponsored the passed legislation will be recognized for their efforts [...]

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Virtual Care Advancement | Outlook on CHRONIC Care Act and Other Federal Legislation

The Senate’s unanimous passage of the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S.870) on September 26th is an encouraging step forward for modernizing telehealth access and reimbursement. The bipartisan, budget-neutral bill aims to improve health outcomes for Medicare beneficiaries living with chronic conditions and includes key provisions expanding access to telehealth. A summary of the key telehealth provisions under the CHRONIC Care Act can be found here.

The bill now moves to the House Subcommittee on Health and may be adopted in its current form or integrated into existing House bills. The House has already advanced three separate bills this year with telehealth provisions similar to those included in the CHRONIC Care Act: expanding telehealth services under Medicare Advantage (HR 3727), expanding telehealth for stroke patients (HR 1148), and expanding the use of telehealth to facilitate the use of home dialysis (HR 3178). With seemingly aligned goals between the two chambers, the House may accept the remaining provisions of the CHRONIC Care Act, or negotiate minor changes and incorporate the CHRONIC Care Act into another priority health care related bill, such as extending federal funding for the Children’s Health Insurance Program, as a vehicle for passage this calendar year.

The recent momentum of federal legislation focused on expanding telehealth services to Medicare beneficiaries signals Congress’ continued consideration of telehealth’s ability to improve patient health and lower the costs of health care delivery. In light of this increased legislative activity, health care providers, commercial payers and telehealth technology companies should be mindful of the following.

  • Consider developing or participating in studies designed to test the efficacy and efficiency (including costs) of telemedicine programs.
  • Continue exploring ways to tailor their care delivery and revenue models to provide telehealth services to Medicare beneficiaries.
  • Offer Center for Medicare and Medicaid Services (CMS) and MedPAC insights and guidance on ways to provide the Federal government agencies overseeing Medicare coverage and payment for telehealth services the best available industry information.
  • Focus operational goals to achieve cost and value goals that are of concern to the government.



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