In the News

Who Should Get a COVID Vaccine This Year?

Reuters | By Michael Erman

(Reuters) - The U.S. drug regulator authorized updated COVID-19 vaccines from Pfizer and its partner BioNTech as well as from Moderna on Monday as the country prepares to start an autumn vaccination campaign as soon as this week. A third vaccine from Novavax remains under review.

The U.S. Food and Drug Administration approved the shots for those aged 12 and above, and authorized them for emergency use in children aged 6 months through 11 years. Advisers to the U.S. Centers for Disease Control and Prevention are set to meet on Tuesday to discuss recommendations on who should get the vaccines this year. CDC Director Mandy Cohen said last month she expects the shots to be given annually, but not all doctors agree everyone needs them each year.

How is this year's vaccine different from last year?

Pfizer with BioNTech, Moderna and Novavax all have created new versions of their COVID-19 vaccines. Unlike last year's booster shot that included the original strain of the virus and the then-dominant Omicron variant, this year's shot targets only XBB.1.5, the predominant variant through most of 2023.

The companies have said their retooled vaccines have been shown in early testing to work against newer Omicron subvariants now circulating, including the highly mutated BA.2.86.

Should seniors, the immunocompromised and pregnant people get the shot this year?

There is broad consensus among doctors that these groups should receive at least an annual COVID-19 vaccine to protect against the virus because of their elevated risk of severe disease, hospitalization and death. For instance, the British government's vaccine committee said only adults 65 and older and some of these other categories will be offered the shot as they are the most likely to benefit…

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HHS Announces Stronger Protections for Those with Disabilities

Home Care Insider

The Department of Health and Human Services (HHS) has issued a proposed rule that would update, clarify, and strengthen the statute that prohibits discrimination on the basis of disability in programs and activities that receive Federal financial assistance or are conducted by a Federal agency.

The proposed rule provides greater protections for people with disabilities in federally funded health and human services programs and helps ensure that people with disabilities are not subjected to discrimination in any program or activity receiving funding from HHS simply because they have a disability.

Specifically, the proposed rule:

  • Ensures that medical treatment decisions are not based on biases or stereotypes about individuals with disabilities, judgments that an individual will be a burden on others or beliefs that the life of an individual with a disability has less value than the life of a person without a disability;
  • Clarifies obligations for web, mobile, and kiosk accessibility;
  • Establishes enforceable standards for accessible medical equipment;
  • Clarifies requirements in HHS-funded child welfare programs and activities;
  • Prohibits the use of value assessment methods that place a lower value on life-extension for individuals with disabilities when that method is used to limit access or to deny aids, benefits, and services; and
  • Clarifies obligations to provide services in the most integrated setting appropriate to the needs of individuals with disabilities.
 

Home Health Agencies Fail to Report More than 50% of Falls Leading to Major Injuries, OIG Finds

McKnight’s Home Care | By Adam Healy
 
Home health agencies neglected to report 55% of falls leading to major injuries and hospitalizations on their Outcome Assessment Information Set (OASIS) assessments, according to a study conducted by the U.S. Office of Inspector General.
 
OIG analyzed hospital claims for Medicare home health patients and identified those that included a fall. This was compared to the home health provider’s OASIS assessments and its fall rate report on Care Compare. OASIS falls reporting was worse among young home health patients, along with those who identified as Hispanic, Black and Asian. Of 39,900 falls identified that resulted in major injury, 85% led to a bone fracture and 11% led to “head injury with altered consciousness,” according to the report.
 
For-profit home health agencies came up worse than other agencies in reporting Medicare home health patients’ falls. During the one-year period examined between 2020 and 2021, for-profit agencies failed to report 56% of falls. That compares to the failure to report falls among nonprofit agencies (52%) and government-run agencies (38%).
 
A major red flag was the lack of reporting about a hospitalization related to the fall on the OASIS assessment, OIG found. 
 
“For many Medicare home health patients who fell and were hospitalized, there was no OASIS assessment at all associated with the hospitalization, which raises additional concerns about potential noncompliance with data submission requirements and its impact on the accuracy of information about falls with major injury on Care Compare,” the report said.
 
Noncompliant OASIS reporting would lead to incomplete or misleading fall rate statistics on Care Compare, OIG noted.
 
“These patient assessments are used by CMS to monitor and provide public information about home health care quality,” said Ann Maxwell, deputy inspector general for evaluation and inspection, in the report. “Due to this high rate of non-reporting, Care Compare may not provide accurate information about the incidence of these falls.”
 
OIG found that that home health agencies with the lowest Care Compare major injury fall rates reported falls less often than agencies with higher Care Compare fall rates. This indicated “that Care Compare does not provide the public with accurate information about how often home health patients fell.”
 
OIG made four recommendations to the Centers for Medicare & Medicaid Services to remediate the issue of non-reporting. These recommendations included taking steps to ensure falls are reported in OASIS assessments and using other data sources to develop more accurate reporting measures. 
 
In a letter to OIG, CMS Administrator Chiquita Brooks-LaSure concurred with the inspector’s recommendations.
 
“CMS understands the importance of providing accurate quality information to home health agencies and the public,” Brooks-LaSure said. “CMS will explore opportunities to help promote the completeness and accuracy of the home health agency reported OASIS data used to calculate the falls with major injury quality measure, including additional OASIS outreach and educational opportunities.”

 

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.

 
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