By Greg Freeman
EXECUTIVE SUMMARY
Hospitals with hospital at home programs should consider legal and compliance risks since public health emergency has ended. Multiple regulatory issues are involved.
• Federal and state agencies may change rules that affect these programs.
• Compliance may become more challenging.
• Hospitals should start working now to create a plan.
Risk managers may need to consider the legal risks of hospital at home programs, which deliver an inpatient level of care in a patient’s home, now that the COVID-19 public health emergency (PHE) has ended.
Hospital at home programs now require providers and payors to carefully navigate competing state and federal requirements, which were designed for a traditional inpatient hospital admission, says Brett R. Friedman, JD, partner with Ropes & Gray in New York City. Recently, Friedman returned to the firm after a period with the New York State Department of Health, where he ran the Medicaid program. In that time, he oversaw an increase in the number of hospital at home programs.
CMS implemented the Acute Hospital Care at Home initiative, providing flexibility to allow hospitals to expand their capacity to provide inpatient care in an individual’s home during the PHE. Although CMS ended many PHE waivers, CMS extended the Acute Hospital Care at Home initiative through Dec. 31, 2024. Hospitals can continue to apply to participate in the initiative through that date.1
However, the end of the PHE means federal and state agencies will be looking at changes to requirements that may have been relaxed during the pandemic. Those could affect hospital at home programs. It is uncertain what CMS will do at the end of 2024.
“Now, we’re left with these really cool, incredibly innovative programs that keep patients out of a facility, but where they receive a facility level of care. They are now in what is a legal gray area, and we’re asking if these programs can continue to operate,” Friedman says. “How important are these federal waivers to their ongoing compliance? How do you continue the success of these programs that rapidly expanded during the pandemic?”
Multiple Compliance Areas
Hospitals are beginning to sort through the potential compliance issues with continuing their hospital at home programs, says Devin Cohen, JD, partner with Ropes & Gray in Boston. Along with the Medicare Conditions of Participation, hospitals running these programs will need to sort through state professional licensure requirements, Drug Enforcement Administration rules, and HIPAA.
“It’s interesting to see that as the public health emergency came to a close, we didn’t really see what I would call a carpet pulled out from under anyone. But we did see a number of different considerations that have to be planned proactively in order to address how to move forward for the remainder of 2023 and plan strategic growth models in ‘24,” Cohen says.
Hospital leaders should watch the alteration of any rules related to hospital at home programs, Cohen advises. The strongest value driver of hospital at home is the delivery of care on site in a manner that incentivizes better quality and lower costs, but Cohen notes it requires proactively overseeing that on-site care.
“You must have the processes in place to ensure remote care is handled with sufficient oversight, that family member counseling is conducted in accordance with best practices, and that there is a process in place to ensure there are solutions and safeguards for interoperability and hardware difficulties,” Cohen explains. “With HIPAA, there has been quite a bit of flexibility since 2020, with the Office for Civil Rights using its enforcement discretion for noncompliance. With the end of the PHE, we will have to watch closely how that changes.”
Will Require Substantial Effort
Friedman says hospitals wishing to continue hospital at home programs or create new ones will need to devote a lot of effort to planning and oversight. The hallmark of these programs is a value-based care or value-based payment arrangement that allows the hospital to serve a patient more efficiently and safely in his or her home instead of a more expensive facility.
“Then, you have to be able to convince a third-party payor, like a Medicare Advantage plan, that this is the right way to go. The next challenge is navigating some of the compliance challenges that go along with it, namely those interlocking regulatory regimes,” Friedman says. “The first step is to plan it out, determine whether this is a program that the hospital’s going to want to continue because there’s value in success, and then [find] your regulatory structure and your payors to further that initiative going forward. If there is no appetite in the hospital, the fear is that so many of these promising programs will just wither and die.”
Some hospitals might be caught by surprise or not fully understand the importance of planning for the near future, Friedman notes. Federal support is just one of many programs in which certain hospitals participated during the pandemic, as they tried to move care out of facilities into the home. Despite the success of the programs, none of them are particularly large. That raises the possibility an institution operating a successful hospital at home program will continue without addressing these risks.
“It’s successful, but it’s not their biggest priority, or even their second-biggest priority, coming out of the pandemic. Patients remain in the program and are not discharged,” Friedman says. “They undergo a regulatory foot fault, or they haven’t adequately had time to plan and implement the necessary transitional efforts to go from the pandemic to post-pandemic environment, and they’ll suddenly find themselves out of compliance.”
REFERENCE
1. Barsky TA, Carani A. Hospital at home programs extended, but final push is needed. Crowell Health Solutions. Jan. 25, 2023.
SOURCES
• Devin Cohen, JD, Partner, Ropes & Gray, Boston. Phone: (617) 951-7322. Email: [email protected].
• Brett R. Friedman, JD, Partner, Ropes & Gray, New York City. Phone: (212) 596-9044. Email: [email protected].
Hospitals with hospital at home programs should consider legal and compliance risks since public health emergency has ended. Multiple regulatory issues are involved.
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