1 THE REJUVENATION OF IN-PERSON RETAIL AND CONCIERGE HEALTHCARE DELIVERY MODELS.

The 2020 COVID-19 pandemic has forever changed the way that Americans consume healthcare services. Beyond doubt, a permanent shift to a variety of telehealth offerings has happened. In most markets, however, a need for in-person care that can be delivered efficiently and effectively remains. More than ever, providers must carefully rethink where and how they deliver services. Brick and mortar retailers, healthcare or otherwise, are uniquely positioned to reinvent their business model. Providers that are most engaging, innovative, and efficient, will position themselves as market leaders. An unprecedented amount of regulatory flexibility will allow them to act quickly and compliantly. Healthcare kiosks and mobile providers will no longer face the barriers that limited patient utilization in the past. Those providers that most uniquely position themselves for inperson services will be best suited for long-term success.

2 REGULATORY FLEXIBILITIES BROUGHT ABOUT BY THE COVID-19 PANDEMIC WILL NOT FADE QUICKLY, AND MANY COMPONENTS WILL BECOME PERMANENT.

HHS acted historically as well as quickly in providing billions of relief dollars to healthcare providers at the outset of the pandemic. Since then, however, the agency’s actions have often been confusing and sometimes problematic for providers. Frequently, HHS has changed the rules of the game midstream, flip-flopping positions on important topics such as lost revenue calculations and capital expenditures. This uncertainty has required providers to pivot on relief funding strategies on numerous occasions. Still today, the need for clarity remains regarding how best to go forward. With the new administration and continued pushback by provider advocacy groups, we anticipate that HHS will eventually “get it right”. Eventually, HHS will allow providers much needed flexibility, for example, in the form of calculating lost revenues by any reasonable method, by allowing allocations amongst parent companies and subsidiaries of funding where funding is most needed, and clearly establishing eligibility and reporting standards. It may not be until mid-year that we see these changes, yet recently proposed legislation and discussions from incoming leadership show support for continued PRF funding and flexibility.

3 THE PROVIDER RELIEF FUND WILL SEE INCREASED FUNDING AND MORE CONTINUED CHANGES TO UTILIZATION AND REPORTING STANDARDS

HHS acted historically as well as quickly in providing billions of relief dollars to healthcare providers at the outset of the pandemic. Since then, however, the agency’s actions have often been confusing and sometimes problematic for providers. Frequently, HHS has changed the rules of the game midstream, flip-flopping positions on important topics such as lost revenue calculations and capital expenditures. This uncertainty has required providers to pivot on relief funding strategies on numerous occasions. Still today, the need for clarity remains regarding how best to go forward. With the new administration and continued pushback by provider advocacy groups, we anticipate that HHS will eventually “get it right”. Eventually, HHS will allow providers much needed flexibility, for example, in the form of calculating lost revenues by any reasonable method, by allowing allocations amongst parent companies and subsidiaries of funding where funding is most needed, and clearly establishing eligibility and reporting standards. It may not be until mid-year that we see these changes, yet recently proposed legislation and discussions from incoming leadership show support for continued PRF funding and flexibility.

4 WE WILL CONTINUE TO SEE AN EXPANSION OF TELEHEALTH SERVICES AND OTHER HOME-BASED DELIVERY MODELS.

The industry will see an adoption of many telemedicine and physician/ nonphysician professional supervision requirement flexibilities as they were instituted during the pandemic. Both institutional providers and professionals have an interest in lobbying for a permanent adoption of these flexibilities. These flexibilities aims to maximize their professional time and to broaden health care access beyond hospitals and physician practices. It is predicted that Congressional
action will ensure allowing for continued expansion of telehealth services and other home-based delivery models aimed at limiting need for inpatient care. We will also see tech innovation accelerate as more individuals take advantage of the availability of these telehealth services.

5 THE 340B PROGRAM WILL CONTINUE TO BE IN THE SPOTLIGHT.

In the short term, 340B Covered Entities and advocacy groups will continue to fight against manufacturer restrictions. The fight will occur across multiple fronts, including direct outreach to manufacturers/ government representatives, formal lawsuits, and complaints brought through the recently announced 340B Alternative Dispute Resolution (ADR) process. Creative strategies and operations modifications to maintain 340B savings, including centralized distribution set ups and leveraging of hospital-owned retail pharmacies, can be expected. Manufacturers will continue to push the envelope and put legally dubious limits on when 340B pricing is offered. This will be especially true for contract pharmacy relationships due to HRSA’s questionable authority to enforce existing regulations, most of which were promulgated through informal guidance. As safety net providers are increasingly harmed by this manufacturer activity, the chances will increase that bipartisan legislation is introduced and potentially passed to shore up and better define HRSA’s enforcement authority over the 340B Program.

6 THE SUN-SETTING OF THE INPATIENT ONLY LIST WILL DRIVE HOPD SURGERIES.

The sunset of the inpatient only list is poised to expand the number and types of surgeries that can be performed on an outpatient basis. As hospitals seek to make-up lost revenues, it is expected that more and more surgeries will be performed in the outpatient setting, especially for the nearly 300 orthopedic surgeries removed from the list this year. Hospitals will seek to jump on this windfall to lure more orthopedic surgeons to perform surgeries in the HOPD setting, rather than the ASC, stifling the 9% expected growth rate in ASCs.

7 THE RE-EVALUATION OF THE USE OF POST-ACUTE CARE VENUES WILL CONTINUE.

While many skilled nursing facilities, inpatient rehabilitation facilities, and long-term acute care hospitals closed or limited admissions throughout the public health emergency, the need for these valuable services within the continuum was further highlighted. A number of flexibilities were aimed at the provider’s ability to increase the use of these venues to ease regulatory constraints. It is predicted that these venues will serve as a platform for future change.

8 THE REGULATORY ENVIRONMENT WILL TAKE A FRONT SEAT.

The last four years have brought impactful changes to the 340B Drug program, Conditions of Participation (CoPs), Price Transparency, Medicaid Section 1115 waivers, and other regulatory driven policy directives affecting providers. With a changing of the guard, providers should be keenly following the direction of HHS/CMS under the Biden administration. While the pandemic will be the immediate focus, the second half of 2021, along with how the administration treats policies implemented over the last four (4) years, will set the tone for the provider’s relationship with the Biden administration.

9 BEHAVIORAL AND MENTAL HEALTH SERVICES WILL DEMAND INCREASED ATTENTION.

As the effects of a pandemic and extended isolation continue to manifest, behavioral and mental health providers will continue to become increasingly stretched. Health care providers will be required to expand mental health offerings in innovative ways, such as through telehealth and other digital health offerings. Meanwhile, insurers will be pressured to expand coverage of behavioral health services. Expect to see a surge in mental health applications designed to mitigate specific mental health issues like anxiety, depression, stress, and sleep disturbances.