Telemedicine Rules from DEA

by Elizabeth E. Hogue, Esq. | Jan 23, 2025 | Clinical, Regulatory, Telehealth

by Elizabeth E. Hogue, Esq.

DEA Issues Three Telemedicine Rules

On January 16, 2025, the United States Drug Enforcement Administration (DEA) announced three new rules to make permanent some temporary flexibilities for telemedicine established during the COVID-19 public health emergency, including new provisions intended to protect patients. The DEA worked with the U.S. Department of Health and Human Services (HHS) to develop the new rules. The DEA made significant revisions to the draft rules proposed on March 1, 2023.

Exemptions

It is important to note that the new rules do not apply to telemedicine visits when patients have already been seen in person by medical providers. After patients have in-person visits with medical providers, any medications may be prescribed through telemedicine indefinitely. Also, if no medications are prescribed during telemedicine visits, the rules about telemedicine do not apply. In other words, patients can always have telemedicine visits with medical practitioners. The rules apply only if patients have never been seen in person by practitioners and controlled medications are prescribed during telemedicine visits.

Rule #1 - Remote Access to Opiod Meds

First, the DEA expanded remote access to buprenorphine, the medication used to treat opioid use disorder, via telemedicine encounters. This change allows patients to receive six-month supplies of buprenorphine through telephone consultations with providers. Additional prescriptions will, however, require an in-person visit to medical practitioners.

Rule #2: Schedule III-V Without In-Person Evaluation

The DEA also issued proposed rules that establish special registrations that allow patients to receive prescribed medications even though they have never had an in-person evaluation from a medical provider. This special registration is available to practitioners who treat patients for whom they will prescribe Schedule III-V controlled substances.

Prescribing Registrations for Schedule II

Advanced Telemedicine Prescribing Registrations are available for Schedule II medications when practitioners are board certified in one of the following specialties:

- Psychiatrists
- Hospice care physicians
- Physicians rendering treatment at long term care facilities
- Pediatricians for the prescribing medications identified as the most addictive and prone to diversion to the illegal drug market
These specialized providers can issue telemedicine prescriptions for Schedule II-V medications.

Call for Public Comment

The DEA seeks public comment on the following issues related to the proposed rules, including whether:

- Additional medical specialists should be authorized to issue Schedule II medications
- Special registrants should be physically located in the same state as patients for whom Schedule II medications are prescribed
- To limit Schedule II medications by telemedicine to practitioners whose practice issues less than 50% of prescriptions by telemedicine.

Online Registration

The DEA will also require online platforms to register with the DEA if they facilitate connections between patients and medical providers that result in prescription of medications. In addition, the DEA will also establish a national prescription drug monitoring program (PDMP) so that pharmacists and medical practitioners can see patients’ prescribed medication histories.

Rule #3: Exemption for Dept of Veterans Affairs

Finally, the DEA will exempt U.S. Department of Veterans Affairs (VA) practitioners from requirements for Special Registrations. After patients receive in-person medical examinations from VA practitioners, the provider-patient relationship is extended to all VA practitioners who engage in telemedicine with the patients.

Final Thoughts

Prescribing controlled substances is essential for some patients, including hospice patients. Practitioners must have the option to prescribe using telehealth.

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Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

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

©2025 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in The Rowan Report. One copy may be printed for personal use: further reproduction by permission only. editor@therowanreport.com

Care at Home Coming to Medicaid?

by Elizabeth E. Hogue, Esq. | Jan 16, 2025 | Advocacy, Regulatory

by Elizabeth E. Hogue, Esq.

Brown v D.C. Decision is Another Boost for Care at Home

In Olmstead v. L.C., the U.S. Supreme Court decided that unjustified segregation of disabled persons constitutes discrimination in violation of Title II of the Americans with Disabilities Act.

The Court said that public entities must provide community-based services to disabled persons when such services are:

- Appropriate;
- Unopposed by disabled persons; and
- Reasonable accommodations taking into account resources available to public entities and the needs of other disabled individuals receiving services from the entity.

This decision gave a tremendous boost to the provision of home and community-based services of all types. Since Olmstead was decided in 1999, there have been more court decisions that require services to be provided at home based on this opinion.

Support for Olmstead

One recent decision is Brown, et al v. District of Columbia (Brown v D.C.) that was decided on December 31, 2024. The Court decided that the District of Columbia violated the rights of D.C. residents with disabilities under the Americans with Disabilities Act (ADA) and the Rehabilitation Act. According to the Court, D.C. failed to inform nursing facility residents who receive Medicaid that they could leave nursing facilities and receive home health services in their communities and failed to assist them to do so. The D.C. government also failed to help them access community-based services and housing options needed to transition back to the community.

The Court recognized that individuals living in nursing facilities often need help learning about and applying for available community services to help them transition out of the institution and into their own homes. Even when residents learn about services, navigating the complicated Medicaid-funded long-term care program can cause confusion and anxiety that sometimes causes facility residents to lose hope that they can live in their own homes again.

Consequently, the decision applies to

“All persons with physical disabilities who, now or during the pendency of this lawsuit: (1) receive DC Medicaid-funded long-term care services in a nursing facility for 90 or more consecutive days; (2) are eligible for Medicaid-covered home and community-based long-term care services that would enable them to live in the community; and (3) would prefer to live in the community instead of a nursing facility but need the District of Columbia to provide transition assistance to facilitate their access to long-term care services in the community.”

Brown v D.C. Says That D.C. Must

- Develop and implement a working system of transition assistance for [nursing home residents that], at a minimum
  - informs DC Medicaid-funded residents, upon admission and at least every three months thereafter, about community-based long-term care alternatives to nursing facilities
  - elicits DC Medicaid-funded nursing facility residents’ preferences for community or nursing facility placement upon admission and at least every three months thereafter
  - begins DC Medicaid-funded nursing facility residents’ discharge planning upon admission and reviews at least every month the progress made on that plan
  - provides DC Medicaid-funded nursing facility residents who do not oppose living in the community with assistance accessing all appropriate resources available in the community
- Ensure sufficient capacity of community-based long-term care services for [residents] under the EPD, MFP, and PCA programs and other long-term care service programs, to serve [residents] in the most integrated setting appropriate to their needs, as measured by enrollment in these long-term care programs.
- …[D]emonstrate [its] ongoing commitment to deinstitutionalization by, at a minimum, publicly reporting on at least a semi-annual basis the total number of DC Medicaid-funded nursing facility residents who do not oppose living in the community; the number of those individuals assisted by [DC] to transition to the community with long-term care services [described above]; and the aggregate dollars [DC] saves (or fails to save) by serving individuals in the community rather than in nursing facilities.

Final Thoughts on Brown v D.C.

As indicated above, there continues to be a clear mandate for Medicaid Programs to provide services to individuals in the community, which is a significant impetus to provide services to patients in their homes. This mandate, however, does not directly address practical aspects of implementation, such as reimbursement at appropriate rates for providers or availability of staff to provide services at home. Nonetheless, the Olmstead and Brown cases provide an important basis for further development of in-home services of all types to meet the needs of disabled persons.

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

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

©2025 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in The Rowan Report. One copy may be printed for personal use: further reproduction by permission only. editor@therowanreport.com

Case Management and Discharge Planning

by Elizabeth E. Hogue, Esq. | Nov 21, 2024 | Admin, Clinical

by Elizabeth E. Hogue, Esq.

Case Management & Discharge Planning to Reduce Length of Stay

By the Numbers

Many hospitals are laser-focused on reducing length of stay in order to enhance patient experiences and boost financial performance. A recent study by KFF shows that the average adjusted expense per patient day at hospitals in 2022 was $3,025.

Kenneth Kaufman, managing director of Kaufman Hall, observed in a blog post earlier this year that reductions in length of stay can produce dramatic increases in savings. Mr. Kaufman pointed out that if a hospital with 425 beds that has an average length of stay of six days achieved a reduction in length of stay of one day, the hospital would save at least $20 million in operating expenses per year.

Step Up to the Plate

An increasing number of healthcare leaders are now advocating for discharge planners/case managers to play a key role in care coordination, including reductions in length of stay.

Perhaps healthcare managers have lost sight of the fact that discharge planners/case managers have been required to fulfill this role for quite some time based on Conditions of Participation (CoPs) of the Medicare Program for discharge planning. According to 42 CFR 482.43 Condition of participation: Discharge planning, discharge planners/case managers are required to:

- Identify patients who need discharge planning early in their inpatient stays
- Evaluate patients in need of discharge planning to identify the need for post-hospital services, including the availability and accessibility of these services
- Regularly re-evaluate patients’ conditions to make needed changes in discharge plans
- Provide necessary medical information to implement discharge plans

The use of discharge planners/case managers to manage length of stay is not new and isn’t based on potential reductions in length of stay with resulting savings and increased revenue. Rather, case management is a discipline that is well-defined by standards of care published and periodically revised by the Case Management Society of America (CMSA).

They Were Already on Base

Hospital leaders may marvel at their discovery of discharge planning/case management as a tool to assist patients and manage revenue, but the fact is that case management/ discharge planning has been required for some time in order to maintain certification by the Medicare Program.

While newfound support is welcome, the role and contributions of case managers/discharge planners is long-standing and well known, especially among patients and post-acute providers. Perhaps now hospital leaders will share appreciation of the value of case management/discharge planning more often.

# # #

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

©2024 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in Healthcare at Home: The Rowan Report. One copy may be printed for personal use: further reproduction by permission only. editor@therowanreport.com

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

Fraud Soup

by Elizabeth E. Hogue, Esq. | Oct 31, 2024 | Clinical, Regulatory

by Elizabeth E. Hogue, Esq.

Everyone in the "Fraud Soup" Together

Perhaps you remember the CEO of a hospice in the Dallas area, Novus Health Care Services, who texted staff members urging them to administer drugs to patients to avoid exceeding per patient spending caps. He then sent texts praising them when patients passed away from the drugs he had urged them to administer: “Good job!” There were also accusations of recruiting ineligible patients and falsifying documentation. Ever wonder what happened to him and other staff members?

Well...Here's the Scoop!

Sixteen individuals from the hospice were indicted and at least eleven of them pled guilty.
Thirteen individuals involved in these activities were sentenced to a combined eighty-four years in prison.
The most recent sentence of four years in prison was imposed on the hospice’s marketing director.
The CEO of the Hospice was sentenced to thirteen years in prison.
Two Medical Directors decided to go to trial instead of pleading guilty. They were sentenced to thirteen years and ten years in prison.
A nurse involved in these activities was sentenced to eight and a half years in prison.
An LVN who received a text from the CEO saying “good job” after she administered drugs to a patient who then passed away was sentenced to eight years in prison.

A triage nurse was sentenced to seven years in prison.
The Director of Operations was sentenced to five and a half years in prison.
A Medical Director who pleaded guilty received a sentence of four years and nine months.
The VP of Patient Services was sentenced to three years in prison.
The VP of Marketing was sentenced to two years and nine months in jail.
A nurse was also sentenced to two years and nine months in prison.
An owner of a lab and home health agency was also sent to jail for eighteen months because she allowed the CEO to access potential patients’ confidential medical information in exchange for using services provided by her companies.

Far-Reaching Effects

Can you imagine the effect on professionals who surely also lost their licenses and their families? Not to mention patients and their families!

The lesson in this heartbreaking story is that fraud enforcement is not limited to owners and upper management. Enforcers will dump everyone who engaged in inappropriate conduct into the “fraud soup.” Therefore, when providers refuse to engage in fraudulent conduct, they are not only protecting themselves, but everyone else involved.

# # #

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

©2024 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in Healthcare at Home: The Rowan Report. One copy may be printed for personal use: further reproduction by permission only. editor@therowanreport.com

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

Patient Preference by Race or Nationality

by Elizabeth E. Hogue, Esq. | Oct 10, 2024 | Admin, Clinical, CMS, Regulatory

This article provides updated information about a discrimination case filed against a home care agency by the EEOC. The Rowan Report published the initial press release and article last year.

by Elizabeth E. Hogue, Esq.

What to do When Patients Don't Want Caregivers of Certain Races or Nationalities

The Equal Employment Opportunity Commission (EEOC) sued ACARE HHC, Inc.; doing business as Four Seasons Licensed Home Health Care Agency in Brooklyn, New York. The EEOC claimed that the Agency removed home health aides from work assignments based on their race and national origin to accommodate clients’ preferences in violation of the Civil Rights Act of 1964 [EEOC v. ACARE HHC d/b/a/ Four Seasons Licensed Home Health Care, 23-cv-5760 (U.S. District Court for the Eastern District of New York)].

This case recently settled, and Four Seasons will pay a whopping $400,000 in monetary relief to affected home health aides! The Agency must also update its internal policies and training processes related to requirements of the Civil Rights Act, stop assigning home health aides based on clients’ racial or nationality preferences, and provide semi-annual reports to the EEOC about any reports or complaints received about discrimination.

Aides Removed from Assignments

According to the EEOC, Four Seasons routinely responded to patients’ preferences by removing African American and Latino home health aides based on clients’ preferences regarding race and national origin. Aides removed from their assignments would be transferred to new assignments, if available, or, if no other assignments were available, would lose their employment altogether. The lawsuit asked for both compensatory and punitive damages, and for an injunction to prevent future discrimination based on race and national origin. The EEOC says that “Making work assignment decisions based on an employee’s race or national origin is against the law, including when these decisions are grounded in preferences of the employer’s clients.”

As many providers know, patients’ preferences for certain types of caregivers are common. Experienced managers have been asked by patients not to provide caregivers who are, for example, “foreign.” Such requests should generally be rejected, especially when they involve discrimination based upon race, national origin, religion, or any other basis commonly used to treat groups of people differently. Legally and ethically, providers should not engage in such practices.

Exception to the Rule

There is one exception to this general rule that occurs when patients ask for caregivers of the same sex as the patient based upon concerns about bodily privacy. It is then acceptable to assign only same-sex caregivers to patients who have made such requests.

Risk Management

In addition to concerns about discrimination, providers must also be concerned about risk management when they honor such requests. Especially in view of increasing staff shortages, limitations on available caregivers may mean that patients’ needs cannot be met by staff members who are acceptable to patients. In view of staffing shortages, the fewer caregivers who are permitted to care for certain patients, the more likely it is that patients’ needs will go unmet. Unmet patient needs are, in turn, likely to significantly enhance the risk associated with providing care to patients.

Preferences at Home

Perhaps the pressure to honor patients’ requests is at its greatest when patients receive services at home. Patients who will accept any caregiver assigned to them in institutional settings somehow feel that they have the right to decide who may provide services in their homes. On the contrary, with the exception noted above, staff assignments should be made without regard to client preferences for services rendered at home, just as assignments are made in institutional settings.

Agency Response

How should managers respond when patients tell them not to assign any “foreign” nurses to them? First, they should explain that the organization does not discriminate and that to avoid assignments based on cultural or racial background may constitute unlawful discrimination. Then staff should explain that if limitations on caregivers were acceptable, the provider may be unable to render services to the patient at all because they may not have enough staff. The bottom line is that staff will be assigned without regard to patient preferences in order to prevent discrimination and to help ensure quality of care.

Patients’ requests and managers’ responses must be specifically documented in patients’ charts. Documentation that says patients expressed preferences for certain caregivers or rejected certain types of caregivers is too general. Specific requests and responses of management must be documented.

Monitoring the Patient

After patients have expressed what may amount to prejudice against certain groups of caregivers, managers must follow up and monitor for inappropriate behavior by patients directed at caregivers who are not preferred. Managers should be alert to the potential for this problem and should follow up with patients and caregivers to help ensure that caregivers are receiving the respect they deserve. Follow-up activities and on-going monitoring should also be specifically documented.

From the EEOC

“Employers cannot make job assignment decisions based on a client’s preference for a worker of a particular race or national origin. It is imperative for employers to have policies, training and other safeguards in place that help prevent a client’s prejudices from influencing their employment decisions.”

-EEOC Representative

Final Thoughts

Caregivers are a scarce commodity. Providers cannot afford to lose or alienate a single caregiver based upon discrimination or inappropriate behavior by patients.

# # #

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

©2024 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in Healthcare at Home: The Rowan Report. One copy may be printed for personal use: further reproduction by permission only. editor@therowanreport.com

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

Home Health in a Post-Chevron World

by Elizabeth E. Hogue, Esq. | Sep 27, 2024 | Admin, Advocacy, Audits, Regulatory

by Elizabeth E. Hogue, Esq.

The "Wicked Witch" Chevron is Gone

On June 28, 2024, the U.S. Supreme Court overturned a decision of the Court in 1984 often referred to as “Chevron.” The Chevron case said that Courts must defer to administrative actions that are reasonable interpretations of ambiguous statutory language.

In Loper Bright Enterprises v. Raimondo, however, the U.S. Supreme Court abandoned the decision in Chevron and said that:

- The “deference that Chevron requires of courts reviewing agency action cannot be squared with” the Administrative Procedure Act (APA). The APA “specified that courts, not agencies, will decide ‘all relevant questions of law’ arising on review of agency action…even those involving ambiguous laws – and set aside any such action inconsistent with the law as they interpret it.”
- The framers of the U.S. Constitution envisioned that the final “interpretation of the laws” would be “the proper and peculiar province of the courts.”
- The views of the executive branch should inform the judgment of the judiciary, not supersede it.
- “Chevron’s presumption is misguided because agencies have no special competence in resolving statutory ambiguities. Courts do.”

What Does it Mean for Providers?

The short answer is that we don’t know yet. It is unclear how the new standards of the Loper Bright decision will be applied and affect health care providers. The Supreme Court said that the recent Court decision does not call past cases into question that were based on Chevron, but existing regulations are not insulated from challenges. It is likely that several providers will “swing for the fences” for favorable rulings based on Loper Bright!

One possible “candidate” for disruption is the reliance of administrative law judges (ALJs) on Chapter 8 of the Medicare Program Integrity Manual. This section offers an overview of use of inferential statistics and statistical sampling to estimate overpayments in Medicare audits. Chapter 8 of the Manual is only nine pages long. ALJs routinely use this section of the Manual to hamper providers’ ability to mount a compelling defense that challenges auditors’ methods using widely accepted standards within the statistical community. Challenges to this practice based on Loper Bright may prevent ALJs from reliance on these sections of the Manual.

Another possible target is the use of sub-statutory and even sub-regulatory guidance from the Centers for Medicare and Medicaid Services (CMS) and the Medicare Administrative Contractors (MACs) by fraud and abuse enforcers to make determinations about illegal conduct, especially under the False Claims Act (FCA). Defendants arguably now have a better chance to challenge the basis of claims of illegal conduct in light of Loper Bright.

The story of Loper Bright has not been written by any means. Surely providers should use this significant change in the law to their benefit whenever possible.

# # #

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

©2024 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in Healthcare at Home: The Rowan Report. One copy may be printed for personal use: further reproduction by permission only. editor@therowanreport.com

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

Cat on a Hot Tin…Keyboard?

by Elizabeth E. Hogue, Esq. | Aug 9, 2024 | Admin, Clinical, Regulatory

by Elizabeth E. Hogue, Esq.

HIPAA Violation

HIPAA violation: Trent James Russell was convicted in federal Court on charges of obtaining another person’s health care information in violation of the Health Insurance Portability and Accountability Act (HIPAA). Russell was employed by an organ transplant organization. As a transplant coordinator, he had access to electronic medical records at George Washington University Hospital in Washington, DC.

Justice Ginberg

In January of 2019, Russell accessed the medical records of U.S. Supreme Court Justice Ruth Bader Ginsburg even though Justice Ginsburg had not been referred as a possible organ donor. He took a screenshot of the records and then posted them on a message board called “4chan.” Ginsberg’s records quickly appeared on Twitter and YouTube, including her name and the exact dates and times when she received radiology, oncology, and surgical treatments at the Hospital between 2014 and 2018.

Hospital officials traced the search of Ginsburg’s records to one of Russell’s home computers. As soon as Russell was identified as a suspect, his access was denied by the Hospital. His request to have access restored was also denied.

The Cat Made me Violate HIPAA Laws

Russell initially told federal agents that his “cats had run across his keyboard.” He later characterized this statement as a “nervous joke.” Russell said that he had no idea how his computer searched terms that produced the Justice’s records and that “everyone makes typos.”

Online users who viewed Ginsberg’s records promoted various antisemitic conspiracy theories. One theory was that Ginsburg had died in late 2018 and that democrats were hiding her death in order to deny President Trump an opportunity to appoint her replacement. A search of Russell’s computer also revealed a search for the term “dirty jew.”

An FBI agent said that she found an image on Russell’s hard drive that mimicked a poster for the film “Weekend at Bernie’s.” The caption said “Weekend at Ginsburg’s” and showed leaders of the U.S. House of Representatives propping Ginsburg up from both sides in a morbid play on how the movie characters covered up Bernie’s death so that they could use his beach house.

Ignorance of HIPAA Law is not a Defense

But, he didn’t even have that. The Chief Executive Officer of the transplant organization at the time the access occurred testified that coordinators like Russell had “no business being inside the chart” of patients who had not been referred to the organization. The CEO said that Russell was certainly aware of this prohibition because of numerous agreements he signed with his employer and the extensive training he received.

Lessons Learned

There are several important takeaways from this case. First, it is important to note that Russell had extensive training about the requirements of the HIPAA Privacy Rule. He also agreed to comply with these requirements. The temptation is great, but employees must be reminded not to succumb. In addition, practitioners should take note of the fact that Russell was criminally prosecuted. Since he was convicted, he faces up to twenty-two years in prison and fines in the tens of thousands of dollars. Serious business!

# # #

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

©2024 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in Healthcare at Home: The Rowan Report. One copy may be printed for personal use: further reproduction by permission only. editor@therowanreport.com

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

Managed Care Plans: How to Meet Their Needs

by Elizabeth E. Hogue, Esq. | Aug 1, 2024 | Clinical

by Elizabeth E. Hogue, Esq.

What do Managed Care Plans Really Want from Providers of Services to Patients in Their Homes?

Medicare Managed Care Plans have a long history of disinterest in provision of services to patients in their homes. Despite the fact that they are mandated to provide the same services that enrollees in Medicare fee-for-services receive, they just haven’t done it. Common practices among Plans of draconian, untimely preauthorization processes and doling out authorizations for visits a few at a time make it clear that Plans have seen no real value in services to patients at home.

OIG Investigates

Plans, of course, should have been very interested in services at home. These services save money and keep patients at home where they want to be. Services at home are just generally a beautiful thing!

At the same time, it’s fair to say that the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), the primary enforcer of fraud and abuse prohibitions, has Medicare Managed Care Plans in its crosshairs. A key area of concern for the OIG is that Medicare Managed Care Plans make visits to patients in their homes looking for additional diagnoses so that the Plans will receive more money per patient. The OIG is especially critical of this practice because review of medical records of patients who received visits at homes and whose acuity increased as a result never received any care for these new diagnoses.

Managed Care Plans in the News

The Wall Street Journal recently reported that between 2018 and 2021 Plans received $50 billion for diagnoses added to members’ charts, at least some of which resulted from visits to patients in their homes.

After years of disinterest, Plans are now quite interested in at home services. Is it possible that Plans’ newfound interest is related to a desire to increase revenue through home visits? It appears so. Take, for example, comments by the CEO of UnitedHealth Group, Andrew Witty, during an investment call on July 16, 2024.

Managed Care Plan Responds

UnitedHealth Group CEO Andrew Witty

Mr. Witty reported to investors that staff made more than 2.5 million home health visits to Plan members in 2023. “As a direct result, our clinicians identified 300,000 seniors with emergent health needs that may have otherwise gone undiagnosed,” Mr. Witty said. “They connected more than 500,000 seniors to essential resources to help them with unaddressed needs.”

Former UnitedHealth employees told The Wall Street Journal that home visits were used to add diagnoses to patients’ records. They said that clinicians used software during visits that offered suggestions about what illnesses patients might have.

It now looks like it’s possible that at-home care is being hijacked by Medicare Advantage Plans to help Plans engage in practices that the OIG views as questionable.

Please say it ain’t so!

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

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

Federal Regulations for Adult Protective Services

by Elizabeth E. Hogue, Esq. | Jul 26, 2024 | Regulatory

by Elizabeth E. Hogue, Esq.

Dept of Health & Human Services Final Rule

On May 7, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule establishing the first federal regulations for Adult Protective Services (APS). The regulations took effect on June 7, 2024. The entire rule is at https://acl.gov/apsrule.

One goal of the new regulations is to promote high quality APS that better meet the needs of adults who experience or are at risk of maltreatment and self-neglect. Another goal is to improve consistency in services among the states.

APS services have historically been funded by state and local governments. There has been wide variation in APS services and practices between and even within states. New regulations, along with recent funding from HHS to state APS programs, now make it possible to improve consistency.

The APS final rule:

- Establishes a set of national minimum standards for the operation of APS programs that all state APS systems meet
- Requires APS systems to ensure that planning and delivery of all services respect the fundamental right of adults to make their own life choices and that services are driven by the person receiving them
- Establishes stronger protections for clients subject to, or at risk of, guardianship. Specifically, APS must consider guardianship only when there are not alternatives.
- Requires responses within 24 hours of screening cases that are life-threatening or likely to cause irreparable harm or significant loss of income, assets, or resources
- Requires APS to provide at least two ways, at least one of which must be online, to report maltreatment or self-neglect 24 hours per day, seven days per week
- Requires robust conflict of interest policies to support ethical APS practice
- Establishes definitions for key APS terms to improve information sharing, data collection, and program standardization
- Promotes coordination and collaboration with state Medicaid agencies, long-term care ombudsmen, tribal APS, law enforcement, and other partners.

The Need for Adult Protective Services

HHS points out that at least one in ten older adults who live in communities experience some form of maltreatment each year.

All providers have been involved in situations in which adult protective services are needed. Case managers/discharge planners in hospitals and long-term care facilities are especially likely to encounter and to be expected to assist with situations involving APS.

Providers of services to patients in their homes; including home health agencies, hospices, home medical equipment (HME) companies, and home care or private duty companies; are on the “front lines” with regard to identifying situations in which APS is needed. At least anecdotally, however, providers have received very little assistance and support from APS in situations of abuse and neglect.

Hopefully, providers can look forward to greater assistance in view of enhanced funding and standards.

# # #

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

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

Kickbacks for Referrals are Costly…and Illegal

by Elizabeth E. Hogue, Esq. | Jul 19, 2024 | Admin, Regulatory

by Elizabeth E Hogue, Esq.

Kickback on Kickbacks

Three home health agencies and their parent company in Cincinnati, Ohio, must pay $4,496,330 to resolve alleged violations of the federal False Claims Act by providing kickbacks to assisted living facilities in exchange for referrals of Medicare patients. The settlement resolves allegations that, between 2013 and 2022, the companies provided lease payments and other valuable benefits; including wellness health services, sports tickets, and meals; to numerous ALFs and their residents. The companies then billed Medicare for the services provided to patients referred by the ALFs.

Referrals from ALFs

Getting more referrals from ALF’s and retirement communities seems to be a crucial piece of the puzzle for all types of providers. 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, however, 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.

How can providers get more referrals from ALF’S and retirement communities? What are the potential legal pitfalls that providers must avoid?

The most effective way to maximize referrals from these sources may be to take a multi-pronged approach that includes:

Assigning at least one coordinator/liaison to each referral source on at least a part-time basis

Use of coordinators/liaisons at ALF’s and retirement communities raises issues related to violation of the federal anti-kickback statute. This statute generally prohibits providers from either offering to give or actually giving anything to referral sources in order to induce referrals. Consequently, liaisons and coordinators must be scrupulous about avoiding the provision of free services to ALF’s and retirement communities and/or their residents. Possible violations include “staffing” an office with an RN who responds to requests from residents in their apartments or has “office hours” to address health conditions of residents.

Renting space for coordinators/liaisons to occupy so that providers have a frequent or continuous presence on the premises of referral sources to better serve patients

Renting space from referral sources also involves potential kickbacks, so providers must meet the requirements of the space rental exception or safe harbor. In order to do so, providers must enter into a written lease with the facility/community for a term of least one year. The lease must include the number of square feet providers are renting. Rent must be set in advance at fair market value and cannot take into account either the volume or value of referrals received. Finally, providers may rent only the amount of space that is commercially reasonable or that they actually need.

The OIG has provided significant guidance about these requirements, which providers must master before they establish these types of relationships. Common pitfalls for providers is insistence by ALFs that providers must rent an entire apartment, whether or not they need it, and must pay an amount equal to the residents’ monthly rent, which includes food and other services.

Entering into Preferred Provider Agreements

Preferred Provider Agreements may be verbal or in writing. There may be significant value in reducing these preferred provider relationships to writing. These types of relationships raise issues related to patients’ right to freedom of choice of providers. The common law or court decisions require providers of all types to honor patients’ right to freedom of choice. There are also federal statutes that guarantee this right to Medicare and Medicaid patients. In addition, states sometimes address these issues in applicable statutes and regulations. For this reason, providers should not attempt to use standard or “sample” Agreements, but must adhere to requirements in all of the states in which they use these types of Agreements.

Providing a full range of screenings and educational events for and about common chronic illnesses or community awareness activities

ALF’s and retirement communities often ask providers to conduct educational events and basic screenings for common chronic conditions. Generally, providers may do so if they walk a relatively fine line between engaging in community awareness activities and providing free skilled services to residents that exceed $15.00 in value at a time. At a minimum, such activities must be conducted consistent with a detailed policy and procedure that governs the provision of such services, so that providers do not violate the anti-kickback statute.

Establishing relationships with ALF’s and retirement communities may result in numerous referrals to post-acute providers. Such relationships should be based on standard documents and comprehensive policies, as described above, in order to ensure compliance. Legal representation is essential for the development and implementation of these documents due to the complexity of the issues involved.

Enforcement actions like those described above are avoidable.

Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.

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