Healthcare Compliance Will Be a Challenge in Post-PHE World

September 20, 2022 - The COVID-19 public health emergency (PHE) declaration was accompanied by several waivers and flexibilities that made it easier for healthcare providers to care for patients amid a global pandemic.

Expanded telehealth coverage, Stark Law waivers, and 1135 waivers are key flexibilities that have helped healthcare organizations maintain quality of care and increase capacity, according to Jody Erdfarb, a partner in Wiggin and Dana’s Healthcare Department.

However, as the end of the PHE looms, providers must prepare for post-pandemic compliance.

The PHE is currently set to expire on October 15, 2022, but another 90-day extension is expected as HHS has not yet given providers a 60-day notice. Many waivers and flexibilities will expire with the PHE, leading to significant practice management changes for healthcare providers.

Providers can get ahead of these changes by preparing for a post-PHE world as soon as possible.

“Every indication from every agency is [to] start getting ready now,” Erdfarb told RevCycleIntelligence in a recent interview. “And even though it’s difficult to add something else to your plate for these providers who are still dealing with COVID-19 and its aftermath in the financial and operational effects, they don’t have a choice. You need to start preparing now.”

Providers must prepare for reduced telehealth coverage, as most of the telehealth flexibilities will end with the PHE.

During the PHE, CMS allowed patients to receive telehealth services from any provider who is eligible to bill for Medicare Part B services.

The HHS Office for Civil Rights (OCR) issued an enforcement discretion that allowed providers to use telehealth in good faith even if their platforms or software did not follow HIPAA rules. The Office of Inspector General (OIG) also issued an enforcement discretion that waived coinsurance and deductibles associated with telehealth services.

In March 2022, CMS announced that telehealth waivers and flexibilities would expire 151 days after the PHE ends.

“The important thing for providers to remember is that that’s only five months,” Erdfarb pointed out. “It’s pretty much around the corner since people expect the PHE to expire sometime at the beginning of 2023.”

“You need to start thinking about your service delivery platforms and your business models now in order to ensure the continuity of care for patients and the viability as a business model for healthcare providers.”

Meanwhile, the OCR and OIG enforcement discretions are set to expire immediately after PHE ends. OCR released a special notice to help providers prepare for the end of the HIPAA-related enforcement discretion.

“It’s really important for telehealth practitioners or those that were not formerly telehealth practitioners but have adopted that model in their current service delivery to take a look closely at the rules that were in place prior to the pandemic and to those new changes that were enacted since then and to make sure that they’re compliant,” Erdfarb stressed.

“If they’re not compliant, they need to become compliant or they risk being subjected to investigation and subject to False Claims Act liability, which is very serious in the healthcare world.”

In addition, the United States Drug Enforcement Administration (DEA) allowed telehealth to substitute for an in-person medical evaluation before prescribing certain controlled substances—a flexibility that will end with the PHE.

Providers should also keep an eye on state laws, as some states introduced interstate licensures during the PHE that are being phased out.

Another major flexibility that is tied to the PHE is the Stark Law waivers. According to OIG, the Stark Law “prohibits physicians from referring patients to receive ‘designated health services’ payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies.”

CMS issued a blanket waiver allowing for financial arrangements that would otherwise be illegal under the Stark Law, as long as the arrangement was necessary for COVID-19-related purposes.

“That was a big deal and allowed hospitals and health systems to move with agility to increase their capacity in ways that they weren’t able to do before,” Erdfarb shared. “A lot of healthcare providers relied on those to make things happen quickly in real-time. And those are going to expire—so far, we haven’t heard otherwise—at the end of the public health emergency.”

Once this waiver expires, providers must reassess any hospital-physician arrangements made during the PHE to ensure they meet Stark Law compliance.

Whereas most of the healthcare industry has pushed for continued telehealth waivers, there are differing opinions on the Stark Law, Erdfarb noted.

“There are a lot of healthcare lawyers who do not like the Stark Law at all and feel that it’s way too prohibitive in terms of what providers can do,” she said. “But there’s a whole other school of thought that believes that the Stark Law is vital in order to curb fraud and abuse.”

With public health officials and Congress on its side, the Stark Law will return to its pre-pandemic state, and healthcare providers must start prioritizing compliance once again to avoid penalties.

When the COVID-19 PHE was declared, HHS waived around 200 federal regulatory requirements under Section 1135 of the Social Security Act. Some of these waivers will expire at the end of the PHE, while others have been extended.

“For example, nursing home reporting of COVID-19 infections was enacted during the COVID-19 pandemic as part of HHS’s authority. But that’s been extended until 2024 because they think that that’s really good and important,” Erdfarb mentioned.

However, CMS has already rescinded other PHE regulatory provisions related to nursing homes as they led to safety and quality issues.

CMS released a roadmap and individual fact sheets for healthcare providers explaining the status of each 1135 waiver.

“In order to figure out for every practitioner type which of those waivers are going to remain in place and for how long, every practitioner and provider is encouraged to take a look at this CMS blanket waiver roadmap and the fact sheets so that they can track which of the requirements are going to stop being in effect and which have been extended,” Erdfarb said.

Reverting to pre-pandemic policies will likely be a difficult task for providers. Many healthcare organizations experienced high staff turnover just as these waivers went into effect in March 2020.

“For some healthcare providers, this is not going to be like unwinding and undoing what they did, but almost like putting into place new laws. Even though these laws aren’t new, they’ve been on the books for years. They’ve just been waived,” Erdfarb explained.

“Because there was such a huge staff turnover, a lot of going back to the way things were is going to require almost like orientation and training because these are new staff that don’t know any different from the way that it’s been done during the pandemic.”

She noted that there is still an opportunity for advocacy to extend PHE waivers or make them permanent. Congress is currently considering several bills that aim to solidify telehealth policies past the PHE. Submitting comments on CMS proposed rules may also allow providers to push for waiver extensions.

However, regardless of any potential extensions, the most important thing providers can do is be aware of the changes that are to come and ensure they are prepared to comply with the post-PHE policies.

“Healthcare practitioners should develop teams now within their organization to start doing this analysis and downloading these fact sheets and thinking through what they need to change, which policies need to be revisited so that they can be ready,” Erdfarb emphasized.