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Navigating The Minefields Of Regulation: Welcome To Skilled Nursing Care

November 10, 2020

To understand the regulatory polypheme that is long-term care, consider the assessment of Jindou Lee, CEO of HappyCo, a San Francisco-based technology-driven property management company. HappyCo serves the long-term care sector and other industries like banking and military housing. Lee offers his views in this recent discussion about the value of electronic record keeping.

“Few industries are as heavily regulated as long-term care facilities,” says Lee. “The Nursing Home Reform Act of 1987 is the main federal statute that all operators must follow, but there are thousands of other codes at the federal, state and local level that must be adhered to so that care facilities can maintain their accreditation, avoid costly penalties, and remain eligible for Medicare payments. While most minor infractions can be easily addressed, larger problems can have a catastrophic effect on a facility’s ability to stay in business.”

Failure to follow the rules can affect nursing homes’ reimbursement, their reputation, their very existence. Add to that, the constant threat of litigation from federal regulators, residents and their families.

And that’s just the healthcare part.

In August 2018, the Labor Department created a new office and two new websites to help nursing homes better comply with new labor laws and regulations. “The department expects more effective compliance assistance will help the department target enforcement resources on repeat and willful violators to level the playing field for America’s job creators who abide by the law,” the department noted.

Indeed, compliance is an issue that affects every nursing home owner-operator, administrator, HR staff and director of nursing every minute of every day.

“There’s plenty of blame to go around and a great deal of confusion,” says Marti Wdowicki, PharmD., Director of Clinical Operations for PharMerica. Some days it seems there are no clear-cut answers to anything.”

And no wonder.

Consider the Patient Driven Payment Model, or PDPM, the first major change in Medicare program participation rules since the unveiling of the prospective payment system in the 1980s. PDPM is so massive, it cannot be found, much less officially presented, in a single document. Instead, the regulation is explained in a series of PowerPoint presentations, FAQs and memorandums on PDPM’s official website and similarly interpreted on a seemingly infinite array of allied health organization and consultants’ websites. There are more than 70,000 codes in the ICD-10 system that drives PDPM.

Five months into its implementation start, regulators were forced to pass a 110-page rule just to explain and amend the original rule.

Other massive, precedent-setting regulations include the Affordable Care Act, which occupied a whopping 2,700 pages in the Federal Register, the 700-page, aptly-named “Mega Rule,” and the rule of
all rules concerning nursing homes – the Omibus Reconciliation Act of 1987 (also known as OBRA or the Nursing Reform Act), which clocked in at an uncharacteristically modest 473 pages.

A brief history of nursing home laws

As an article in the December 1988 issue of Health Care Financing Review explains, two “events” have shaped what the industry is today: OBRA and “the enforcement process that the federal government and its agents, the state survey agencies, must follow in inspecting nursing homes and approving or disapproving them for participation.”

Ask any nursing home what time of year they fear most, and it’s likely going to contain the word “survey.”

“Both sets of regulations are interrelated in the sense that enforcement is impossible without clear measures of compliance, and, similarly, the best compliance measures are useless without a fair, accountable process for enforcing these measures,” the journal summary states.

As the author goes on to explain, this country’s nursing home laws were modeled after hospital regulations and while the so-called “bricks and mortar” rules around safety were fairly clear cut, the rules around outcomes (originally referred to as “adequacy of treatment and services”) were not.
Consequently, a series of “surrogate measures” were cobbled together in lieu of more official sounding things like qualifications, policies, and procedures.

Enforcement of safety rules was easy; enforcement of the other part is not so easy. “Clearly, we could not mandate good results through regulation, and the state-of-the-art was such that the idea of regulating for outcomes was little more than a hope for the future,” authors noted.

In the end – or in this case, the beginning – the establishment of the industry’s survey system “was the first major step in implementing a state-of-the-art, outcome-oriented review of nursing homes.”

Regulation stressors

Regulations can sometimes force providers to bite their lips when massive changes come.

As she was contemplating the moving implementation target of the third and final phase of the Mega Rule, one industry official remarked, “Over the past 30 years, we finally got into a happy balance in terms of interpretation and compliance. With this new rule, some facilities are hesitant to push back against surveyors and interpretations vary widely from state to state.”

Referring to new onerous new hazardous waste disposal rules for nursing homes, Stephen Creasy, PharmD., Director of Clinical Services for PharMerica, added, “Each regulation is from a different organization, has a separate time line for implementation depending upon the state, and has a differing definition of what constitutes hazardous.”

Regulations can also heavily influence what kinds of technology facilities are able to adopt.

“Many states are demanding certain items submitted or reported in a digital form which many providers do not have the capability to complete, and if they do, it is often very time-consuming,” says one IT technology executive. “This will often force a provider to find a technology that will allow them to easily
compile the needed information. This is especially evident in communities that participate in Medicaid waiver programs.”

Other rules often interfere with, and in some cases force providers to disrupt or dismantle previously mandated initiatives that were very costly and time consuming to implement.

For example, providers learned just weeks before PDPM was implemented they would likely have to redesign Quality Assurance and Performance Improvement (QAPI) programs they deployed months before. As one tech vendor told McKnight’s Long-Term Care News, “It is July. The idea that these significant initiatives haven’t been already contemplated for a fall 2019 start date is naïve. Most providers I speak with have QAPI implemented for quite some time. It’s more the fear, and associated resources required, of regulatory penalty that was causing stress.”

Compliance challenges

What makes compliance so challenging?

For one, there are confusing and contradictory regulations, many of which overlap.

It’s not uncommon for any sweeping government regulation regarding medication management to involve numerous federal and state agencies from the DEA and EPA to CMS and CDC , as well as a host of state and local entities. Meanwhile, clinicians inside and outside of nursing homes have additional oversight agencies affecting their overall compliance.

Adds Creasy, “Be aware that local and state regulatory bodies can always enforce stricter versions of federal regulations. Tweaks and revisions can definitely occur on a state to state basis.”

Many facilities take a wait-and-see approach to massive regulations, preferring to wait while the dust settles on the myriad revisions and interpretations before landing on a compliance course to plot – an exercise fraught with risk.

Even compliance programs themselves are teeming with regulatory checks and balances. Requirements of Participation rules require nursing centers to have a Compliance and Ethics Program that meets certain requirements, explains the American Health Care Association, which represents the interest of nursing homes.

Confused yet? Consider this language spelled out in a recent National Law Review article:

“Having a designated compliance officer will help nursing facilities meet the mandated requirements and further the purpose of the compliance mandate. The compliance program mandate is intended to help prevent accidental and intentional violations, detect violations when they occur, and correct non-compliance.”

In contemplating the Mega Rule provisions around antimicrobial stewardship, Wdowicki explains the frustration many nursing facilities feel in Mega Rule provisions that on the surface, appear to assume nursing homes have the same deep pockets hospitals do.

“In terms of compliance, antimicrobial stewardship rules reveal one of the other problems having a really good program has to do with prescribers and their ability to make quick decisions,” she says.

“Prescribing clinicians must decide, without the benefit of STAT lab results available in acute care settings, between treating or not treating with antibiotic therapy. No clinician wants to prescribe an antibiotic that results in a life threatening Clostridiodes difficile infection or resistant antimicrobial organism. They also don’t want to be the prescriber that doesn’t prescribe an antibiotic and the patient decompensates quickly and requires hospitalization or worse.”

The frustrations are only amplified by the workforce issues affecting so many post-acute providers today.

“Staff turnover and shortage also complicates the issue,” she adds. “New staff may not identify significant signs or symptoms of infection or be familiar with facility antibiotic stewardship guidelines when communicating with clinicians. Implementing and sustaining additional programs requires additional staff hours – which may not be available. Tracking and trending data that provides accountability and feedback on the success of antibiotic stewardship is also still elusive to many long- term care facilities.”

Going forward

Recent efforts seem to point to a growing distaste for government regulation from a very unlikely source: government itself.

The Trump administration has so far used the Congressional Review Act to repeal more than a dozen rules from the prior administration, saving businesses more than $1 billion each year, according to McKnight’s Senior Living.

The magazine goes on to point out Centers for Medicare & Medicaid Services Administrator Seema Verma’s blog vowing to stem the tide of government regulation such as “unnecessarily time-consuming” documentation for payment and quality reporting; electronic health records that have “distanced” providers from their patients and new payment models that have “added yet another layer of rules and requirements.”

In announcing the delay of PDPM quality measures in October, CMS estimated reducing information collection expectations would save providers about $59 million annually, while other operational reforms could trigger $210 million in annual savings. When combined with relaxed construction standards, CMS projects cost savings of about $616 million over the rule’s first five years.

Navigating the minefields of government policy and rules are not for the faint of heart, and considering the ebb and flow of today’s nursing home workforce, Wdowicki advises providers to “have a vendor partner that’s invested in your success and who understands your difficulties. So when you ask about consultant pharmacists and what they can do to help, one of the biggest things we need to understand from their viewpoint is education can’t be one and done. It has to be repetitive.”

Wdowicki believes regulators should acknowledge the work of long-term care’s “unsung heroes, the people, the operators, the floor staff personnel who are working very hard to make those things work, and has suggested that CMS allow facilities to apply for civil monetary penalty dollars to reward those people and their facilities. “It does take a lot of staff hours, consistency and training to have those programs and sustain them,” she adds, urging providers to identify internal champions to keep big regulation-mandated program working.
“Let’s create change with positive feedback instead of punitive action,” she says. “When surveyors go into a facility, it’s not always bad. They have to recognize there are some really good facilities that are doing some really incredible things. Why not take a proactive approach and say this should be rewarded? These people are doing it right and let’s publish this as a best practice.”

Wdowicki also advises providers to seek external expertise whenever they get stuck.

“I want to give our senior leadership credit. As far as antibiotic stewardship goes, that was answering the bell,” Wdowicki adds. “That was a facility requirement, but because we are a company that understands that, we have systems that sole providers don’t have and the resources to create that kind of program. And even if they do have the resources, recognizing and telling them it may not be the best use of those resources spent developing a complicated program. As a vendor partner that understands there is a problem, we came back internally and created a solution thanks to the work of Stephen Crease.”

In its recent article, “The Future Of Nursing Home Regulation: Time For A Conversation?” Health Affairs ponders the growing significance the outcomes part that shaped early nursing home regulations will have.

“Providers should consider that residents’ frailty and their own record of poor quality shape the demands of the current regulatory system,” the article notes. “Similarly, advocates should consider that most providers aim to do the right thing and that regulatory burden can have real consequences, not just for facilities’ profits but also for their ability to deliver person-centered care. Complete harmony in these discussions may be unlikely; however, the stakes are too high to avoid engagement altogether and foreclose our ability to work together toward a shared vision of high-quality nursing home care.”

Regulation updates are intended to improve the daily operations for all facilities, large and small, and adherence to new guidelines can get overwhelming. A closer partnership between all parts of the healthcare industry will help make our work easier to handle. For more thought leadership content, please feel free to reference our wide variety of Learn Articles provided by PharMerica.