Health Care MarketTrends | January 2019, Issue 1

31 January 2019 Health Care MarketTrends Publication
Authors: Alexis Finkelberg Bortniker Adria Warren Christopher J. Donovan Judith A. Waltz

How Oncology Can Benefit from Digital Technology

Welcome to Foley’s new health care MarketTrends newsletter. Each edition, we will focus on a different aspect of health care and highlight key trends in the industry. In this first issue, we focus on the intersection of oncology and digital health.

Digital health technology has immense potential to reform the health delivery system in oncology through improved information access, faster development of strategies to more effectively treat cancers, reduced costs of otherwise expensive treatments, and improved overall health care experiences for cancer patients. Recent surveys indicate that clinicians are increasingly recognizing the benefits of telemedicine. In 2017, Foley reported that 76 percent of survey respondents offered or planned to offer telemedicine services, whereas just three years prior, 87 percent of respondents did not expect their patients to be using telemedicine services.

Since then, oncology practices have taken further steps to leverage digital health in support of tumor boards, supportive and diagnostic care consultations, and treatment planning. One study recently published in the Journal of Oncology Practice, a journal of the American Society of Clinical Oncology, demonstrated promising cost savings through reducing ER incidents using digital health platforms for symptom management and triage pathways. The most recent data available from the Centers for Medicare and Medicaid Services (CMS) reported a 28 percent increase in reimbursement for telehealth services under the Medicare program. And changes to reimbursement – including the new Medicare Virtual Check-Ins effective on January 1, 2019 – will continue to impact adoption.

While telemedicine has gained momentum, legal and regulatory hurdles remain and cannot be discounted. Among those are coverage requirements that may drive choice of treatment modalities. For example, there exists an applicable Medicare telemedicine requirement that a patient/practitioner communication occur via a real-time interactive audio and video telecommunication system. Telemedicine licensure requirements also vary from state to state, and differing state medical practice standards may also complicate things for physicians who want to practice across state lines.

Market Intelligence

It is not uncommon that technology advancements outpace legal and regulatory developments. Nevertheless, oncology practices are seeing the value that digital health affords their organizations by helping to improve communication among the care team by breaking down information silos. Privacy and security, prescribing authorities, malpractice coverage, and physician practice requirements (e.g., restrictions on advertising, state rules on the corporate practice of medicine) are all areas to which oncology providers beginning to use telemedicine should be attentive. All of these areas are covered by both federal and state requirements.

Connected care, which allows doctors to monitor patients remotely, has the potential to not only increase patient engagement, but also to drive down skyrocketing health care costs by limiting the number of in-office visits. Remote patient monitoring is increasingly embraced in the oncology field with the introduction of technologies such as wearables and mobile health apps. In addition to being faster and more convenient, remote monitoring also helps in connecting the care team by improving the transmission of information among caregivers, patients, and clinicians. Recent clinical trials have shown that remote monitoring has improved overall cancer symptoms and impacted survival rates.

The American Society of Clinical Oncology reported in Clinical Cancer Informatics that the benefits of using digital health also include expedited drug development via better assessment of treatment outcomes.

Even cancer diagnoses have an app: an imaging device that can be connected to an iPhone has the potential to make ultrasounds used to locate tumors more portable and accessible. This type of real-time cancer diagnosis will likely garner more attention in 2019.

Artificial Intelligence has entered into the oncology patient care realm. For example, Google’s new AI algorithm is said to detect cancer metastases with 92 percent accuracy. AI is still in its infancy, but is expected to impact overall cancer detection and cancer care delivery.

Recent Legal Developments for Oncology Providers

CMS’ Oncology Care Model (OCM) is going strong and continues to affect organizations as they are moving toward accepting risk. OCM brings care transformation to the next level by aligning financial incentives with performance accountability for cancer patients. Results to date suggest that organizations implementing the model are on their way to higher quality and more coordinated care at lower costs. That said, more than half way through the model, it is yet to be seen if an increased number of practices will actually move to accept the associated two-sided risk (i.e., that they may lose money on the model as well as gain from it).

On December 12, 2018, the U.S. Department of Health and Human Services Office for Civil Rights filed a Request for Information focusing on HIPAA requirements that limit or discourage coordination of care that does not assist in protecting the patient’s privacy. The RFI signals a potential overhaul of HIPAA that would impact cancer centers and their business associates, including those supporting oncology digital health initiatives.

Ongoing legislative and regulatory efforts to expand site-neutrality for Medicare payments have settled in for the long haul and will most likely affect outpatient oncology clinics, which are often provider (hospital)-based and historically eligible for higher payments. The most recent reductions, part of the outpatient prospective payment system (OPPS) final rule, effective January 1, 2019, will apply a uniform downward adjuster to clinic visits (the most common hospital outpatient services billed to Medicare) at all off-campus settings, including those that had been considered grandfathered. The payment reduction will be phased in over two years. The American Hospital Association, the Association of American Medical Colleges, and 38 individual hospitals are currently challenging the site-neutral payment plan through two separate lawsuits, asserting that the actions violate the clear intent of Congress and will impose significant harm on affected hospital outpatient departments and their patients.

Meanwhile, the Trump administration considers site-neutrality a topic for future legislative or regulatory attention, and has recommended that Congress establish site-neutral payment policies based on the anticipated clinical needs and risk factors of the patient, rather than the site of service. This portends an ongoing expansion of site-neutrality through Medicare, possibly extending through the states to Medicaid. There is an open question as to whether commercial payers will follow suit.

The 340B drug provisions introduced in the 2018 and 2019 OPPS final rules also impact oncology clinics that serve low-income populations by limiting the financial benefits of the 340B program (reducing reimbursement from average sales price (ASP) plus 6 percent to ASP minus 22.5 percent) for any participating hospital outpatient oncology departments, whether or not grandfathered by site-neutrality rules. These reductions have also been challenged in the courts, and on December 27, 2018, a federal district court ruled that the Department of Health and Human Services (HHS) had exceeded its authority and granted a permanent injunction on the 2018 cuts. The court has not yet decided how this injunction is to be applied.

Where We Are Going

The Association for Community Cancer Centers (ACCC) 45th Annual Meeting & Cancer Center Business Summit (AMCCBS) is scheduled for March 20 through 22. Representatives from Foley, in conjunction with the ACCC and the CCBD Group, as well as oncology leaders from across the country, will address the intersection of business, quality, technology, and policy.

From connected care to real-time cancer diagnoses, technological innovation is transforming an industry. One focus of this year's AMCCBS summit is technology and, more specifically, how oncology can benefit from new digital health innovation in the health care space. We will also look at the regulatory and legal impacts of new technologies on cancer care delivery.

For those looking to deep dive into areas of interest, take a look at the pre-conference workshops and the drill-down sessions. We encourage you to review the agenda and join us for this informative event.

For a complete listing of where we are going, click here.

Foley Resources

  • We invite you to subscribe to Health Care Law Today, Foley’s Health Care Blog. Health Care Law Today provides timely updates on health care legal issues. Subscribers receive the most recent information on health care policy, digital health and telemedicine, M&A activity, health care regulatory actions, and much more.
  • 2019 Health Care Industry Outlook provides insight on key developments in health care and the effects they are expected to have on the industry.
  • Foley’s 2017 Telemedicine and Digital Health Survey reflects a surging demand for telemedicine-based offerings among providers and patients, as well as a broader acceptance of the technology by other major players in the health care industry.