Recent Case Demonstrates Pitfalls of Getting Referrals from ALFs/ILFs

Elizabeth E. Hogue, Esq. (Republished with advance written permission)

Getting more referrals from assisted living facilities (ALFs) and independent living facilities (ILFs) seems to be a crucial piece of the puzzle for many types of post-acute providers; including home health agencies, hospices, private duty agencies, and HME companies. As the number of years in which they have been in business increases, ALF’s and retirement communities are more eager to assist their residents to “age in place.” This means that they often view availability of services from post-acute providers as essential to allow them to achieve this goal. 

While providers compete aggressively in the marketplace, they cannot lose sight of the fact that the healthcare industry is highly regulated. With ever-increasing emphasis on fraud and abuse compliance, providers cannot afford to violate the law. A recent case involving Watermark Retirement Communities illustrates this point.

Watermark, which manages seventy-nine retirement communities nationwide, has agreed to pay $4.25 million to resolve claims that it violated the False Claims Act by soliciting and receiving a kickback from a national home health company in order to facilitate referrals from Watermark facilities. Regulators alleged that the home health company purchased two of Watermark’s home health agencies in Arizona in order to induce referrals of Medicare beneficiaries living in Watermark residential communities. The arrangement included eight Watermark facilities in five states, including Arizona, Connecticut, Delaware, Florida, and Pennsylvania, where the two companies had overlapping operations. 

Enforcers alleged that Watermark caused the home health company to submit false claims for payments to the Medicare Program for services provided to Medicare beneficiaries referred as a result of the kickback transaction from January 1, 2014, through October 31, 2020. The home health company previously paid $17 million to resolve allegations of violations of the False Claims Act for paying a kickback to Watermark.

This suit was initiated by a former director of strategic growth for the home health company who filed a qui tam, or whistleblower, case under the False Claims Act. The former employee or relator will receive a total of $3,765,000 from the settlements with Watermark and the national home health company.

Part of the difficulty that post-acute providers may face in establishing relationship with ALFs and ILFs is that owners and managers of these types of facilities may be uneducated about fraud and abuse. They may have erroneously concluded that fraud and abuse prohibitions apply only to providers enrolled in the Medicare Program. They may not realize that the prohibitions apply to all state and federal health care programs; including Medicaid and Medicaid waiver programs, the VA, and TriCare; which may include payments for the types of services they provide.

Executives at ALFs/ILFs may also have lost sight of the fact that, as this case illustrates, both those who offer kickbacks and recipients of kickbacks may be held responsible. In a press release about this case on August 31, 2023, U.S. Attorney Philip Sellinger said, “Today’s resolution demonstrates that the Department is committed to holding accountable not only those who offer kickbacks but also those who receive them.”

Therefore, when post-acute providers establish relationships with ALFs and ILFs they must be prepared to provide more than a little education about fraud and abuse prohibitions in order to help ensure compliant arrangements. 

©2023 Elizabeth E. Hogue, Esq. All rights reserved.

No portion of this material may be reproduced in any form without the advance written permission of the author.

Home Palliative Care Can Improve Quality of Life for Heart Failure Patients, Study Reveals

McKnight’s Home Care | By Adam Healy
 
Not only does home-based palliative care improve heart failure patients’ quality of life, it can do so immediately, according to new research in BMC Palliative Care.
 
To conduct the study, researchers surveyed 100 patients with heart failure aged 65 years and older using questionnaires to record their demographic information and determine their quality of life. Quality of life was measured by patients’ responses to questions regarding their health, socioeconomic, psychological and family satisfaction, according to the study.
 
These patients received palliative care in three types of settings: primary, specialty and home-based palliative care. Primary palliative care was found to be the least effective in improving patients’ quality of life. Specialty palliative care was better, particularly in improving peoples’ socioeconomic satisfaction, according to survey findings. The most effective form was home-based palliative care, which led to the greatest observed quality of life improvements in the shortest amount of time.
 
This is due in part to the holistic approach home-based palliative caregivers were able to take with patients. Palliative care in the home “takes more comprehensive care of the person, taking into consideration symptoms and signs related to accompanying co-morbidities, such as stroke, renal dysfunction, pulmonary disorders, anemia, and even cancer,” according to the study.
 
In addition to improving quality of life, palliative care lessened patients’ future symptoms of heart failure and reduced hospital admissions, the study found. 
 
Other recent research has explored the effectiveness of in-home palliative care services. A 2022 study found that palliative care performed in the home reduces patients’ risk of dying in the hospital, while other research showed that home-based palliative care may be able to help patients live longer.
 
In June, senators introduced the Expanding Access to Palliative Care Act, which seeks to create a demonstration program providing Medicare coverage for community-based palliative care services.

Popular Nasal Decongestant Doesn't Actually Relieve Congestion, FDA Experts Say

Associated Press | By Matthew Perrone

WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.

Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in popular versions of Sudafed, Allegra, Dayquil and other medications sold on pharmacy shelves.

"Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine," said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.

The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.

Does evidence show a benefit?

If the FDA follows through on the panel's recommendations, Johnson & Johnson, Bayer and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter versions of the pills or to nasal sprays and drops that contain phenylephrine, which are not under review.

This week's two-day meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also challenged the drug's effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.

That was also the recommendation of FDA's outside experts at the time, who met for a similar meeting on the drug in 2007.

This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn't show a benefit for the drug.

"I feel this drug in this oral dose should have been removed from the market a long time ago," said Jennifer Schwartzott, the patient representative on the panel. "Patients require and deserve medications that treat their symptoms safely and effectively and I don't believe that this medication does that."…

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Moderna Says Updated COVID Vaccine is Effective Against Newer Variant

Reuters | By Patrick Wingrove

WASHINGTON — Moderna on Wednesday said clinical trial data showed its updated COVID-19 vaccine will likely be effective against the highly mutated BA.2.86 subvariant of the coronavirus that has raised fears of a resurgence of infections.

The company said its shot generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86, which is being tracked by the World Health Organization and the U.S. Centers for Disease Control and Prevention.

"We think this is news people will want to hear as they prepare to go out and get their fall boosters," Moderna's head of infectious diseases Jacqueline Miller said, adding that the data should also help reassure regulators.

The CDC has previously indicated that BA.2.86 may be more capable of causing infection in people who previously had COVID or were vaccinated with previous shots. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the dominant variant through most of 2023 and the target of the updated shots.

Moderna said it had shared the new finding on its vaccine with regulators and submitted it for peer-review publication. The retooled shot has yet to be approved by the U.S. Food and Drug Administration but is expected to be available later this month or in early October.

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