Tag: medicaid

The 80/20 Rule is Here: CMS Finalizes HCBS Care Worker Payment Requirements

In May 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a series of rule changes intended to help promote the availability of home and community-based services (“HCBS”) for Medicaid beneficiaries. Chief among these proposals was a new rule that would require HCBS agencies to spend at least 80% of their Medicaid payments for homemaker, home health aide, and personal care services on direct care worker compensation (the “80/20 Rule”). Intended to help stabilize the HCBS workforce, the proposal faced immediate backlash from HCBS providers and Medicaid agencies, who expressed concern that the 80/20 rule would harm HCBS providers by mandating specific allocations to worker compensation and bogging down providers and Medicaid agencies with burdensome reporting requirements.

After reviewing thousands of comments, CMS released an advance copy of the final rule this week. Defying stakeholder anticipation that the 80/20 Rule would be relaxed, or updated to provide more flexibility for providers, CMS finalized the 80/20 Rule largely as originally proposed, including the following key requirements:

  • HCBS providers must spend at least 80% of Medicaid payments on direct care worker compensation;
  • HCBS providers will have six years (increased from four) from the effective date of the final rule to demonstrate compliance with the 80/20 Rule;
  • States must begin collecting and tracking data on direct care worker compensation within four years of the effective date of the final rule; and
  • States are permitted to establish different standards for smaller HCBS providers and to establish hardship exemptions – in both cases based on objective and transparent criteria.

Under the broad mandate of the 80/20 Rule, there are a number of key definitions that HCBS providers must consider as they evaluate these new requirements:

Direct Care Workers

Because the 80/20 Rule was adopted largely to stabilize the HCBS workforce, a key component is whose compensation qualifies for inclusion. CMS’s proposed definition encompassed almost any person with a role in providing direct care to patients (e.g., RNs, LPNs, individuals practicing under their supervision, home health aides, etc.). Under the final 80/20 Rule, CMS clarified that “direct care workers” also include those whose role is specifically tied to clinical supervision (e.g., nurse supervisors).

Compensation

Compensation of direct care workers means:“[s]alary, wages, and other remunerations as defined by the Fair Labor Standards Act and implementing regulations; [b]enefits (such as health and dental benefits, life and disability insurance, paid leave, retirement, and tuition reimbursement); and [t]he employer share of payroll taxes for direct care workers delivering services authorized under section 1915(c) of the Act.” CMS clarified that “compensation” also includes:

  1. Overtime pay;
  2. All forms of paid leave (e.g., sick leave, holidays, and vacations);
  3. Different types of retirement plans and employer contributions; and
  4. All types of benefits: CMS intentionally used the phrase “such as” to indicate the list of benefits was non-exhaustive, and indicated technical guidance to states on this subject is forthcoming.

Excluded Costs

CMS expressed concern that HCBS providers would include training costs for direct care workers as “compensation,” and that calculating compensation in this way could result in negative outcomes, such as diminished training opportunities. To address these concerns, CMS created the concept of “excluded costs,” which are excluded from the percentage calculations under the 80/20 Rule. See § 441.302(k)(1)(iii) (“costs that are not included in the calculation of the percentage of Medicaid payments to providers that are spent on compensation for direct care workers.”). Excluded costs are limited to:

  1. Costs of required direct care worker training;
  2. Direct care worker travel costs (mileage, public transportation subsidy, etc.); and
  3. Personal protective equipment costs.

Medicaid Payments

CMS largely adopted its expansive view of what qualifies as a “Medicaid Payment” for purposes of 80/20 Rule calculations. CMS clarified that the 80/20 Rule encompasses both standard and supplemental payments and applies regardless of whether HBCS services are delivered through fee-for-service or managed care delivery systems. CMS also declined to create a formal carve-out for value-based care or pay-for-performance arrangements, despite recognizing their value.

What Comes Next?

HCBS providers and state Medicaid agencies have six years to sort out their compliance with the 80/20 Rule (though data tracking and reporting begins after year three). On the provider side, this means carefully evaluating the business and economic impacts of compliance with the 80/20 Rule and monitoring CMS and state-level guidance on implementation as it develops over time. For multi-state providers, this process becomes even more complicated, as there is a high likelihood that states will choose to implement the 80/20 Rule in different, and potentially contradictory, ways.

Providers also need to work with the state agencies to address the adequacy of HCBS rates generally. CMS recognized the important role that the underlying rates play in HCBS sustainability but declined to mandate specific payment rates or methodologies. As a result, positive momentum on the rates themselves must come from state initiatives.

© Polsinelli PC, Polsinelli LLP in California
For more news on Healthcare Provider Regulations, visit the NLR Health Law & Managed Care section.

Out with the Old? Not So Fast! A Quick Review of 2023 Highlights

2023 has brought many updates and changes to the legal landscape. Our blog posts have covered many of them, but you may not remember (or care to remember) them. Before moving on to 2024, let’s take a moment to review our top five blog posts from the year and the key takeaways from each.

VAX REQUIREMENT SACKED IN TN: MEDICARE PROVIDERS LOSE EXEMPTION FROM COVID-19 LAWS

Our most read blog of 2023 covered the federal COVID-19 vaccination requirement that applied to certain healthcare employers, which was lifted effective August 4, 2023. (Yes, in 2023 we were still talking about COVID-19). However, keep in mind that state laws may still apply. For example, Tennessee law generally prohibits employers from requiring employee vaccination, with an exception for entities subject to valid and enforceable Medicare or Medicaid requirements to the contrary (such as the federal vaccine requirement). However, now that the federal vaccine requirement is gone, there is no exception for these Medicare or Medicaid providers, and they are likely fully subject to Tennessee’s prohibition.

INTERPRETATION OF AN INTERPRETER REQUEST? 11TH CIRCUIT WEIGHS IN ON ACCOMMODATION OF DEAF EMPLOYEE

In this blog post, we covered a recent Eleventh Circuit case in which the court addressed ADA reasonable accommodation requests . The employee requested an accommodation, and the employer did not grant it—but the employee continued to work. Did the employee have a “failure to accommodate” claim? The Eleventh Circuit said yes, potentially. The court clarified that an employee still must suffer some harm—here, he needed to show that the failure to accommodate adversely impacted his hiring, firing, compensation, training, or other terms, conditions, and privileges of his employment. So, when you are considering an employee’s accommodation request, think about whether not granting it (or not providing any accommodation) could negatively impact the employee’s compensation, safety, training, or other aspects of the job. Always remember to engage in the interactive process with the employee to see if you can land on an agreeable accommodation.

POSTER ROLLERCOASTER: DOL CHANGES FLSA NOTICE REQUIRED AT WORKPLACES

If your business is subject to the FLSA (and almost everyone is), you probably know that you must provide an FLSA poster in your workplace. In this blog post, we reported that there is an updated FLSA “Employee Rights” poster that includes a “PUMP AT WORK” section, required under the Provide Urgent Material Protections (PUMP) for Nursing Mothers Act (more information on the PUMP Act here).

HOLIDAY ROAD! DOL WEIGHS IN ON TRACKING FMLA TIME AGAINST HOLIDAYS

In this now-timely blog post from June 2023, we discussed new guidance on tracking FMLA time during holidays. The DOL released Opinion Letter FMLA2023-2-A: Whether Holidays Count Against an Employee’s FMLA Leave Entitlement and Determination of the Amount of Leave. When employees take FMLA leave intermittently (e.g., an hour at a time, a reduced work schedule, etc.), their 12-week FMLA leave entitlement is reduced in proportion to the employee’s actual workweek. For example, if an employee who works 40 hours per week takes 8 hours of FMLA leave in a week, the employee has used one-fifth of a week of FMLA leave. However, if the same employee takes off 8 hours during a week that includes a holiday (and is therefore a 32-hour week), has the employee used one-fourth of a week of FMLA leave? Not surprisingly, the DOL said no. The one day off is still only one-fifth of a regular week. So, the employee has still only used one-fifth of a week of FMLA leave. Review the blog post for options to instead track leave by the hour, which could make things easier.

OT ON THE QT? BAMA’S TAX EXEMPTION FOR OVERTIME

Alabama interestingly passed a law, effective January 1, 2024, that exempts employees’ overtime pay from the 5% Alabama income tax. In this blog post, we discussed the new exemption. It is an effort to incentivize hourly employees to work overtime, especially in light of recent staffing shortages and shift coverage issues. The bill currently places no cap on how much overtime pay is eligible for the exemption, but it allows the Legislature to extend and/or revise the exemption during the Spring 2025 regular session. If you have employees in Alabama, be sure to contact your payroll department or vendor to ensure compliance with this exemption.

As always, consult your legal counsel with any questions about these topics or other legal issues. See you in 2024!

© 2023 Bradley Arant Boult Cummings LLP
For more news on 2023 Legal Landscape Updates, visit the NLR Labor & Employment section.

Feds Announce More Aggressive Enforcement of Poor Performing Nursing Homes

In February of 2022, during his State of the Union Address, President Biden announced an action plan to improve the safety and quality of care in the nation’s nursing homes.[i] On October 21, 2022, Centers for Medicare and Medicaid Services (CMS) announced new requirements to help with oversight of facilities selected to the Special Focus Facilities (SFF) Program.[ii]

The SFF Program was created to help and oversee the poorest performing nursing homes in the country and improve nursing homes that have a history of noncompliance.  The goal is to improve safety and quality of care. The facilities selected for the SFF Program must be inspected no less than once every six months and if severe enforcement is needed, it is at the discretion of the state surveyors. The main objective for the SFF Program is for facilities to show exponential improvement, graduate from the program, and then maintain compliance and better quality of care and safety.

The new CMS requirements, outlined below, are aimed at facilities that continuously fail to improve and remain in the SFF Program for a prolonged period of time. Health and Human Services Secretary Xavier Becerra stated, “Let us be clear: we are cracking down on enforcement of our nation’s poorest-performing nursing homes. As President Biden directed, we are increasing scrutiny and taking aggressive action to ensure everyone living in nursing homes gets the high-quality care they deserve. We are demanding better because our seniors deserve better.”

CMS announced the following revisions to the SFF Program:

  • Effective immediately, CMS will use escalating penalties for violations for deficiencies cited at the same level in subsequent surveys. This can include possible discretionary termination from Medicare and/or Medicaid funding for facilities that are cited with immediate jeopardy deficiencies on any two surveys while participating the in the SFF Program.
  • CMS will consider facilities’ efforts to improve when considering discretionary termination from Medicare and/or Medicaid programs.
  • CMS will impose more severe escalating enforcement remedies for SFF Program facilities for noncompliance and no effort to improve performance.
  • Increased requirements that nursing homes in the SFF Program must meet to graduate from the SFF Program.
  • For three years after graduation from the SFF Program, CMS will ensure nursing homes consistently maintain compliance with safety requirements by continuing to closely monitor these facilities.
  • CMS is offering more support resources to facilities selected for the SFF Program.

Additionally, the Biden administration released a fact sheet with the steps they are taking to in improve the quality of nursing homes. [iii] Some of the steps mentioned include more resources to support union jobs in nursing home care, establishing minimum staffing requirements, incentivizing quality performance through Medicare and Medicaid funding, and enhanced efforts to prevent fraud and abuse.

  1. https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/…
  2. https://www.cms.gov/files/document/qso-23-01-nh.pdf
  3. https://www.whitehouse.gov/briefing-room/statements-releases/2022/10/21/…

Article By Thomas W. Hess, Kelly A. Leahy, Sydney N. Pahren, and Bryan L. Cockroft of Dinsmore & Shohl LLP

For more health law and managed care legal news, click here to visit the National Law Review.

© 2022 Dinsmore & Shohl LLP. All rights reserved.

Medicare Advantage: OIG Report Finds Improper Denials

On April 27,2022, the Office of Inspector General of the Department of Health and Human Services (OIG), Office of Evaluations and Inspections, issued a report on the performance of Medicare Advantage Organizations (MAOs) in approving care and payment consistently with Medicare coverage rules. In its review, OIG found that 13% of MAO denials of prior authorization requests should have been approved and that 18% of payment requests from providers were improperly denied. OIG also made a number of recommendations to the Center of Medicare and Medicaid Services (CMS) with respect to its oversight of MAOs.

Purpose and Method of the Study

OIG undertook the study to assess whether MAOs are appropriately providing access to medically necessary services and making payment to providers consistently with Medicare coverage rules. Since CMS pays MAOs principally by capitation, MAOs have a potential incentive to increase their profits by denying access to care of beneficiaries or by denying payments to providers. CMS’s annual audits of MAOs have indicated some persistent problems related to inappropriate denials of service and payment. As enrollment in Medicare Advantage continues to grow, OIG viewed it as important to ensure that medically necessary care is provided and that providers are paid appropriately.

OIG conducted the review by randomly selecting 250 denials of prior authorization requests and 250 payment request denials by 15 of the largest MAOs during a week in June of 2019. OIG had coding experts review the cases and had physician reviewers examine the medical records. Based on these reviews, OIG estimated the rates at which MAOs issued denials of services or payment that met Medicare coverage rules and MAO billing rules. OIG also examined the reasons for the inappropriate denials and the types of services involved.

Standards

MAOs must cover items and services included in fee-for-service Medicare, and may also elect to include additional items and services. MAOs are required to follow Medicare coverage rules that define what items and services are covered and under what circumstances. As the OIG states in the Report, MAOs “may not impose limitations – such as waiting periods or exclusions from coverage due to pre-existing conditions — that are not present in original Medicare.” In following Medicare coverage rules, MAOs are permitted to use additional denial criteria that were not developed by Medicare when they are deciding to authorize or pay for a service, provided the clinical criteria are “no more restrictive than original Medicare national and local coverage policies.” MAOs may also have their own billing and payment procedures, provided all providers are paid accurately, timely, and with an audit trial.

MAOs utilize prior authorization requests before care is furnished to manage care and payment requests from providers to approve payment for services provided. Beneficiaries and providers may appeal such decisions, and beneficiaries and providers are successful in many of the appeals (for a one-time period, as many as 75% of the appeals were granted).

Findings

Prior Authorization Denials

In the study, OIG found that 13% of prior authorization denials were for services that met Medicare coverage rules, thus delaying or denying care that likely should have been approved. MAOs made many of the denials by applying MAO clinical criteria that are not part of Medicare coverage rules. As an example, a follow-up MRI was denied for a beneficiary who had an adrenal lesion that was 1.5 cm in size, because the MAO required the beneficiary to wait one year for such lesions that are under 2 cm in size. OIG’s experts found such a requirement was not contained in Medicare coverage rules and was therefore inappropriate. Rather, the MRI was medically necessary to determine if the lesion was malignant.

OIG also found instances where MAOs requested further documentation that led to a denial of care when it was not furnished, as such additional documentation was not required to determine medical necessity. OIG’s reviewers found that either sufficient clinical information was in the medical record to authorize the care or the documentation requested was already contained in the medical record.

Payment Denials

OIG found in the study that 18% of payment denials fully met Medicare coverage rules and MAO payment policies. As a result of these denials, payment was delayed or precluded for services that should have been paid.

OIG found that common reasons for these inappropriate payment denials were human error in conducting manual reviews (for example, the reviewer not recognizing that a skilled nursing facility (SNF) was an in-network provider), and inaccurate programming.

OIG also found that advanced imaging services (including MRIs and CT scans), stays in post-acute facilities (including SNFs and inpatient rehabilitation facilities), and injections were the services that were most prominent in the inappropriate denials that should have been authorized for care and payment in accordance with Medicare coverage rules.

OIG Recommendations

Based on the study, OIG recommended that:

  • CMS should issue new guidance on both the appropriate and inappropriate use of MAO clinical criteria that are not contained in Medicare coverage rules. In particular, OIG recommended that CMS should more clearly define what it means when it states that MAO clinical criteria may not be “more restrictive” than Medicare coverage rules.

  • CMS should update its audit protocols to address issues identified in the report such as MAO use of clinical criteria and/or examine particular service types that led to more denials. OIG suggests CMS should consider enforcement actions for MAOs that demonstrate a pattern of inappropriate payment denials.

  • CMS should direct MAOs to identify and address the reasons that led to human errors.

CMS reviewed the OIG report and concurred with each of OIG’s recommendations. Those recommendations can affect future coverage decisions as well as utilization of prior authorization tools. AHIP, a national association of health care insurers, challenged the OIG’s sample size as inappropriate to support the agency’s conclusions, and defended prior authorization tools.

Takeaways

Given CMS’s concurrence with the report’s findings, we recommend that MAOs track these issues over the next several months in advance of CMS’s Final Rate Announcement for CY 2024.

MAOs should also be aware of potential False Claims Act (FCA) exposure in this area. FCA exposure can arise when a company seeks and receives payments despite being out of compliance with the basic terms for its participation. If an MAO knew it was denying claims that should be paid because they would be covered under traditional Medicare, but the MAO was still collecting full capitation, it is possible that a whistleblower or the government may pursue FCA liability. This risk warrants attention because whistleblowers can bring qui tam suits under the FCA, with resulting high costs for defense and potentially high penalties if a violation is proven (or settled to avoid further litigation). That said, an FCA suit based on this theory would raise serious questions, including whether any non-payment actually met the FCA’s “knowingly” standard (which includes reckless disregard), or whether any non-payment met the materiality threshold necessary to demonstrate a violation of the FCA.

Article By Alexis Finkelberg Bortniker, C. Frederick Geilfuss II, Matthew D. Krueger, Maureen F. Kwiecinski, and Kinal M. Patel at Foley & Lardner LLP

For more health law and managed care news, click here to visit the National Law Review.

© 2022 Foley & Lardner LLP

CMS Removes All Nursing Home Visitation Restrictions as COVID-19 Cases Decrease

In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here.

Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times. CMS explained its decision to allow visitation is based upon data which shows approximately 86% of residents and 74% of staff are fully vaccinated, and the number of new COVID-19 cases each week in nursing homes has dramatically decreased.

Under the new guidance, nursing homes cannot limit the frequency and length of visits for residents, the number of visitors, or require advance scheduling of visits as mandated under the previous guidance. However, CMS is still directing nursing homes to follow infection-control policies and procedures. Visitors who have tested positive for COVID-19, have symptoms of COVID-19, or currently meet the criteria for quarantine, should not enter the facility. Nursing homes should still screen all visitors before entry.

Although not required, CMS is encouraging nursing homes in counties with substantial or high levels of community transmission to offer testing to visitors, if feasible. Nursing homes should also educate and encourage visitors to become vaccinated. Visitors should still wear face coverings and social distance at all times while in the nursing home. Nursing homes should stay diligent in their infection-control efforts.

Article By Sydney N. Pahren and Timothy Cahill of Dinsmore & Shohl LLP

© 2021 Dinsmore & Shohl LLP. All rights reserved.

CMS Requires COVID-19 Vaccine for Health Care Workers at all Facilities Participating in Medicare and Medicaid

On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022.

The vaccine rule that was also released on Nov. 4, 2021 by the Occupational Safety and Health Administration (OSHA) does not apply to employees of health care entities who are covered under the CMS IFR. However, employees of health care providers who are not subject to the CMS IFR may be subject to the OSHA vaccine rule if the facility has more than 100 employees. For more information on the OSHA vaccine rule, please click here.

Justification for the Rule

CMS cited a number of reasons for the IFR, including the risk unvaccinated staff pose to patients, reports of individuals foregoing health care due to concerns of contracting COVID-19 from health facility staff, disrupted health care operations due to infected staff, and low vaccination rates among health care staff.

Scope of Coverage

The requirements of the IFR apply to health care facilities that participate in Medicare and Medicaid and that are subject to Conditions or Requirements of Participation, including but not limited to:

  • Ambulatory surgical centers;
  • Hospices;
  • Hospitals, such as acute care hospitals, psychiatric hospitals, hospital swing beds, long-term care hospitals, and children’s hospitals;
  • Long-term care facilities;
  • Home health agencies;
  • Comprehensive outpatient rehabilitation facilities;
  • Critical access hospitals;
  • Home infusion therapy suppliers; and
  • Rural health clinics/federally qualified health centers.

While the IFR does not directly apply to physician offices, which are not regulated by CMS Conditions or Requirements of Participation, physicians may nevertheless be required to vaccinate as a result of their relationships with other health care entities. For example, the IFR requires hospitals to implement policies and procedures to ensure “individuals who provide care, treatment, or other services under contract or by other arrangement” are fully vaccinated.

Covered Personnel

The IFR requires vaccinations for staff who routinely perform care for patients and clients inside and outside of the facility, such as home health, home infusion therapy, hospice, and therapy staff. CMS’s vaccination requirement also extends to all staff who interact with other staff, patients, residents, or clients, at any location, and not just those who enter facilities. However, staff who provide services 100% remotely—that is, staff who never come into contact with other staff, patients, residents, or clients—are not subject to the IFR vaccination requirements. Additionally, providers and suppliers are not required to ensure IFR vaccination compliance of one-off vendors, volunteers, or professionals, such as (a) those who provide infrequent ad hoc non-health care services (e.g. annual elevator inspectors), (b) those who perform exclusively off-site services (e.g. accounting services), or (c) delivery and repair personnel.

Definition of Full Vaccination

CMS considers “full vaccination” as 14 days after receipt of either a single-dose vaccine (such as the Johnson & Johnson vaccine) or 14 days after the second dose of a two-dose primary vaccination series (such as the Pfizer or Moderna vaccines). At this time, CMS is not requiring the additional (third) dose of mRNA vaccine for moderately/severely immunosuppressed persons or the “booster dose” in order for staff to be considered “fully vaccinated.” Additionally, CMS considers individuals receiving heterologous vaccines—doses of different vaccines—as satisfying the “fully vaccinated” definition so long as they have received any combination of two doses. In order to gauge compliance, CMS is requiring that providers and suppliers track and securely document the vaccination status of each staff member as well as vaccine exemption requests and outcome. The IFR does not specify that weekly testing, masking, and social distancing are an alternative to vaccination, meaning employers must ensure all employees are either (1) fully vaccinated or (2) exempted under a permissible exemption.

Exemptions

The IFR explicitly provides that employers must continue to comply with anti-discrimination laws and civil rights protections which allow employees to request and receive exemption from vaccination due to a disability, medical condition, or sincerely held religious belief or practice. Exemptions should be provided to staff with recognized medical conditions for which a vaccine is contraindicated as a reasonable accommodation under the Americans with Disabilities Act. For exemptions for a sincerely held religious belief or practice, CMS encourages health care entities to refer to the Equal Employment Opportunity Commission’s Compliance Manual on Religious Discrimination. Despite the ability to provide an exemption, CMS states that exemptions may be provided to staff only to the extent required by law, and that requests for exemption should not be provided to those who seek solely to evade vaccination. CMS also notes at length that the Food and Drug Administration considers approved vaccines safe. Accordingly, CMS will likely be unwilling to excuse provider and supplier noncompliance due to employees refusing vaccination based on fears about safety.

Penalties

Although the IFR does not identify specific penalties for non-compliance, CMS is expected to use enforcement tools such as civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement. CMS will utilize State Survey Agencies to review compliance with the IFR through standard recertification surveys and complaint surveys. Noncompliance with the IFR will be addressed through established classification channels of “Immediate Jeopardy,” “Condition,” or “Standard” deficiencies.

Preemption

While CMS recognizes that some states and localities have established laws to prevent mandatory compliance with vaccine mandates, CMS ultimately considers the Supremacy Clause of the United States Constitution as preempting inconsistent state and local laws as applied to Medicare- and Medicaid-certified providers and suppliers.

© 2021 Dinsmore & Shohl LLP. All rights reserved.
For more updates on COVID-19, visit the NLR Coronavirus News section.

CMS Waives Certain Penalties Classes of the Stark Law

On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced it will waive certain penalties classes of violations of the Physician Self-Referral Law, known as the Stark Law. The affected penalties are those listed under Section 1877(g) of the Social Security Act (42 U.S.C. 1877). These blanket waivers are effective retroactively to March 1, 2020.

The Stark Law is a strict liability statute generally prohibiting a physician from making referrals of Medicare- and Medicaid-designated health services to an entity with which the physician or an immediate family member has a financial relationship. Typically, if such a relationship exists between a physician and an entity, then the arrangement must satisfy an express Stark Law exception for the physician to bill for the referred services.

The blanket waivers temporarily allow payments and referrals between physicians and covered entities if the relationship falls into one of the express categories during the COVID-19 pandemic, even if such an arrangement would otherwise not meet a Stark Law exception. The blanket waivers apply to payments and referrals between an entity covered under the Stark Law and (1) a physician, (2) the physician’s organization defined under 42 C.F.R. 411.354(c) or (3) the physician’s immediate family member.

The blanket waivers must relate to one of the explicitly defined COVID-19 purposes and meet the following conditions:

  1. The providers are acting in good faith to provide care in response to the COVID-19 pandemic.
  2. The financial relationship or referral is protected by one of CMS’s 18 permitted relationships (discussed below).
  3. The government does not determine that the financial relationship creates fraud and abuse concerns.

Defined COVID-19 Purposes

To apply, the blanket waivers must be related to COVID-19 purposes. Such purposes include:

  • “Diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient or individual is diagnosed with a confirmed case of COVID-19;
  • Securing the services of physicians and other health care practitioners and professionals to furnish medically necessary patient care services, including services not related to the diagnosis and treatment of COVID-19, in response to the COVID-19 outbreak in the United States;
  • Ensuring the ability of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;
  • Expanding the capacity of health care providers to address patient and community needs due to the COVID-19 outbreak in the United States;
  • Shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak in the United States; or
  • Addressing medical practice or business interruption due to the COVID-19 outbreak in the United States in order to maintain the availability of medical care and related services for patients and the community.”

Those wishing to use the blanket waivers need not provide advance notice to or receive approval from CMS. Those who rely on a blanket waiver, however, must retain records relating to its use, and the records must be available for the U.S. Department of Health and Human Services to review upon request.

The Blanket Waivers

The blanket waivers do not suspend the entire Stark Law. Rather, they apply only to 18 expressly enumerated relationships. These relationships can be divided into two classes: those that address payments and those that address referrals.

Allowed Payments

  1. Personally Performed Services: Remuneration paid by an entity to a physician above or below the fair market value (FMV) for the physician’s personally performed services to the entity is permitted.
  2. Office Space and Equipment Rental Payments: Remuneration paid by an entity to a physician or by a physician to an entity below FMV for rental of office space or equipment is permitted by the waivers. Rental payments exceeding FMV are not covered.
  3. Purchase of Items or Services: Remuneration paid by an entity to a physician or by a physician to an entity below FMV for the purchased items or services, including use of the entity’s premises, is permitted by the purchase waivers. The purpose of these waivers is to permit parties to rapidly source critical items or services without overpaying for the service.
  4. Additional Incidental Benefits to Medical Staff: Remuneration from a hospital to a physician in the form of medical staff incidental benefits that exceed the $36-per-item limit set forth in 42 CFR § 411.357(m)(5) is protected. This waiver permits a hospital to offer a range of benefits to its medical staff members to facilitate participation in the health care workforce, such as childcare services or clean clothing for the physician while at the hospital.
  5. Nonmonetary Compensation: Remuneration from an entity to a physician in the form of nonmonetary compensation that exceeds the $423 annual limit set forth in 42 CFR § 411.357(k)(1) is permitted. Similar to the medical staff benefit waiver, this waiver allows an entity to provide additional services that would otherwise exceed the limits established by the regulations to facilitate participation in the health care workforce during the COVID-19 pandemic. Currently, it is unclear how this waiver will be assessed when the blanket waiver period ends because the public emergency declaration caused by the COVID-19 pandemic is terminated. More guidance from CMS on the application of this waiver may be issued.
  6. Low-Interest or Interest-Free Loans: Remuneration among individuals and entities in the healthcare industry in the form of a loan, with an interest rate below FMV or on terms that are unavailable from another independent lender, is allowed. Essentially, CMS is attempting to increase cash liquidity within the health care industry to mitigate potential cash flow problems among health care workers and providers during the COVID-19 pandemic.

Allowed Referrals

  1. Referrals by Physician-Owner of a Hospital: Referrals by a physician-owner of a hospital that temporarily expands its facility capacity above the number of operating rooms, procedure rooms and beds for which the hospital was licensed on March 23, 2010 without prior application and approval of the expansion of facility capacity will temporarily not be prohibited by the Stark Law. (In the case of a hospital that did not have a provider agreement in effect as of March 23, 2010, but did have a provider agreement in effect on December 31, 2010, the effective date of such provider agreement applies.)
  2. Referrals by Physician-Owner of Ambulatory Surgical Centers that Temporarily Convert to Hospitals: Referrals by a physician-owner of a hospital that converted from a physician-owned ambulatory surgical center to a hospital on or after March 1, 2020 are permitted provided that:
  • The hospital does not satisfy one or more of the requirements of Section 1877(i)(1)(A) through (E) of the Act.
  • The hospital enrolled in Medicare as a hospital during the period of the public health emergency described in Section II.A of this blanket waiver document.
  • The hospital meets the Medicare conditions of participation and other requirements not waived by CMS during the period of the public health emergency described in section II.A of this blanket waiver document.
  • The hospital’s Medicare enrollment is not inconsistent with the Emergency Preparedness or Pandemic Plan of the state in which it is located.
  1. Referrals by Owners to a Home Health Agency: Referrals are now permitted by a physician of a Medicare beneficiary for the provision of designated health services to a home health agency (1) that does not qualify as a rural provider under 42 CFR 411.356(c)(1) and (2) in which the physician (or an immediate family member of the physician) has an ownership or investment interest.
  2. Referrals for Services at Locations Other than the Health Care Facility: Referrals are now permitted by a physician in a group practice for medically necessary designated health services furnished by the group practice in a location that does not qualify as a “same building” or “centralized building” for purposes of 42 CFR 411.355(b)(2). Also, referrals by a physician in a group practice for medically necessary designated health services furnished by the group practice to a patient in his or her private home, an assisted living facility, or independent living facility where the referring physician’s principal medical practice does not consist of treating patients in their private homes will not violate the Stark Law.
  3. Referrals to Immediate Family Members in Rural Areas: Referrals are now permitted by a physician to an entity with which the physician’s immediate family member has a financial relationship if the patient who is referred resides in a rural area.
  4. Relaxing Compensation Arrangement Written Requirements: Stark Law compensation arrangement exceptions frequently require the arrangement to be in writing. However, referrals are now permitted by a physician to an entity that the physician (or an immediate family member of the physician) has a compensation arrangement that does not satisfy the writing requirements of an applicable exception but satisfies all other requirements of the applicable exception, unless that requirement is waived under one or more of the blanket waivers above.

CMS encourages providers to contact CMS with questions regarding the applicability of the blanket waivers. Providers should send any requests to 1877CallCenter@cms.hhs.gov and include the words “Request for 1877(g) Waiver” in the subject line. All requests should include the following minimum information:

  • the name and address of requesting entity
  • the name, phone number and email address of the person designated to represent the entity
  • the CMS Certification Number (CCN) or Taxpayer Identification Number (TIN) of the requesting entity; and
  • the nature of the request.

The contours and applications of these blanket waivers are complex and often require a nuanced understanding of how they are couched into the existing regulatory framework addressing the provision of health care services under the Social Security Act, the Stark Law, and a number of other statutes and regulations.

© 2020 Much Shelist, P.C.

For more on healthcare blanket waivers amidst COVID-19, see the National Law Review Coronavirus News section.

Tennessee-Based Health Services Company Settles FCA Case Alleging Medicaid Fraud For $9.5 Million

The Department of Justice (“DOJ”) announced another False Claims Act (“FCA”) settlement centered around a health services company’s practice of providing unnecessary therapy services to patients in order to receive the maximum amount of reimbursement under Medicare.  The $9.5 million settlement is with Diversicare Health Services Inc, a Tennessee-based company that provides nursing and rehabilitation services at 74 locations throughout the country.  Diversicare’s alleged violations are similar to those in a medicaid fraud case settled by the DOJ for $15.4 million two weeks earlier concerning fraudulent Medicare reimbursements for unnecessary rehabilitation services.

The settlement resolves two separate qui tam FCA lawsuits filed by whistleblowers Mary Haggard and Bryant Fitzmorris, both former Diversicare employees.  Ms. Haggard will receive a whistleblower award of roughly $1.4 million, and Mr. Fitzmorris will receive $145,350.  The FCA allows private citizens who possess inside information of fraudulently billing against the United States Government to initiate a lawsuit on the Government’s behalf to recover those funds.  The citizens, known as qui tam relators, are then entitled to receive a share of any damages that the Government ultimately recovers from the litigation.

The settlement concerned Diversicare corporate policies, in use from the beginning of 2010 through the end of 2015, that specifically instructed its employees to provide patients rehabilitation treatments to receive the highest level of Medicare reimbursement, regardless of the need for, the efficacy of, or risks associated with such treatment.  Specific allegations include “instances of improper co-treatment in order to achieve minute thresholds, repetitive and unskilled exercises that did not match plan of care goals to obtain additional minutes, engaging patients in activities contraindicated by underlying medical conditions, [and] extending patient lengths of stay beyond what was medically indicated.”  In addition to the allegations of improper therapy, it was alleged that Diversicare billed Medicare for therapy services that were never in fact provided.

Additional allegations highlight the fraudulent attempts to maximize Medicare revenue, claiming that Diversicare threatened to undertake, and in some instances took, adverse employment actions against employees who failed to meet set budgetary goals and quotas. Finally, the settlement also resolves allegations of FCA violations regarding Diversicare’s Medicaid billing practices, including its submission of “forged, photocopied, or pre-signed physician signatures” on certifications necessary for Medicaid reimbursement.

Federal regulations governing the disbursement of taxpayer dollars for Medicare and Medicaid exist to both protect the patients receiving treatment, as well as the taxpayers whose dollars fund the programs.  When companies intentionally circumnavigate these regulations in search of higher revenue, they not only rip off the taxpayers but also put vulnerable populations of patients at risk with unnecessary and often dangerous treatments.  In the fiscal year 2019, the United States Government reported that using the FCA, it recovered $2.6 billion of taxpayer dollars fraudulently paid out under health care programs, including for violations such as those alleged against Diversicare.  FCA relators and the Government should continue to utilize this powerful tool to protect Medicare and Medicaid patients, as well as every United States taxpayer.

Copyright Kohn, Kohn & Colapinto, LLP 2020. All Rights Reserved.

For more Medicaid False Claims Act settlements, see the National Law Review Health Law & Managed Care section.

Medicaid Billing Upcharges Prompts Oklahoma Nurse to Blow the Whistle on Hospital

Oklahoma Heart Hospital (OHH) has agreed to pay $2.8 Million to settle U.S. and Oklahoma government claims that the hospital committed Medicaid Fraud. Jennifferr Baird, a retired registered nurse, filed the complaint, which reported that her former employer, OHH was consistently billing  Oklahoma’s Medicaid insurance program inpatient rates for outpatient procedures – regardless of whether a doctor ordered inpatient care or not.

Ms. Baird’s 2015 complaint, filed under the False Claims Act (FCA) and a similar Oklahoma law because Oklahoma administers its Medicaid program with federal funds. The practice of billing inpatient rates for outpatient service is more commonly known as “upcoding” and is a form of fraud. Specifically, in question was the hospital’s tendency to bill stent procedures at higher inpatient rates, which, according to Ms. Baird, are typically performed on an outpatient basis. According to the prosecutors who investigated the claim, the fraud lasted at least seven years.

Private citizens, like Ms. Baird, play a crucial role in holding healthcare providers accountable for their fraud by acting as whistleblowers on behalf of the government.  These whistleblowers do not go without reward for their assistance. Successful whistleblowers receive up to 25 percent of the settlement amount of the case. “Under the False Claims Act, private citizens, also known as relators, can bring a suit on behalf of the United States and share in any recovery. … [These] relators are awarded 15 to 25 percent of the settlement amount depending on the extent to which the relator substantially contributed to the recovery.”

“Jennifferr did her best to resist the administrators who pushed this fraudulent billing scheme,” said R. Scott Oswald, managing principal of The Employment Law Group. “And she urged everyone she managed to do the same. But when she realized she was fighting a losing battle—and that the true victims were U.S. taxpayers—she appealed to a higher power: The U.S. legal system, which welcomes whistleblowers like her. I am pleased that it delivered.”

While OHH did not admit to fault outright in the matter of overbilling, the hospital operator did agree to settle the case, paying $2.8 million to both U.S. and Oklahoma government coffers.  Additionally, the hospital operator has vowed to follow a new “Corporate Integrity Agreement” that will be enforced by the Inspector General of the U.S. Department of Health and Human Services.

“I’m hopeful that the culture at Oklahoma Heart Hospital now will change,” said Ms. Baird. “The frontline medical team has always been great, but I think some hospital officials cared more about dollar signs than vital signs.”

Unfortunately, Ms. Baird’s “dollar signs and vital signs” sentiment is laced with fact as, historically, there have been many instances where whistleblowers have exposed healthcare providers that were taking financial advantage of the Medicaid system.

 

© 2019 by Tycko & Zavareei LLP
For more on Medicaid-related cases see the National Law Review Health Law & Managed Care page.

The Unknown Future Of The Affordable Care Act

Donald Trump Affordable Care Act

Donald Trump’s victory to become the next president of the United States, and the Republican Party’s continued control of the United States Senate and House, will likely have a significant impact on the future of the Affordable Care Act (ACA). President-elect Trump (Trump) has vowed to immediately dismantle the ACA. To date, Trump has provided only a broad outline of what exactly he plans to replace the law with, such as the following:

  • Eliminating ACA requirements which generally require (1) individuals to maintain health insurance, and (2) employers with more than 50 full time employees to offer affordable major medical plan coverage or run the risk of paying penalties;

  • Eliminating tax subsidies that eligible individuals can use to purchase coverage and/or offset costs under health insurance exchanges;

  • Expanding the use of health savings accounts to pay deductibles, copayments, etc.;

  • Establishing tax breaks to allow taxpayers to deduct premiums they pay for individual health insurance policies;

  • Allowing health insurance across state lines;

  • Allowing states to manage Medicaid funds;

  • Modifying or eliminating the ACA’s “essential health benefits” requirements;

  • Expanding age rating bands (increasing the range of premiums that will be allowed); and

  • “Modernizing” Medicare.

Despite his general opposition to the ACA, Trump has expressed support for ACA rules which prohibit insurers and employer plans from excluding coverage for expenses related to preexisting conditions. However, those prohibitions force insurance companies and employer plans to bear significant costs. The ACA’s employer and individual coverage mandates were intended to make the pre-existing condition exclusions more palatable to payers by forcing healthy individuals into the applicable insurance pools. Consequently, it is unclear how Trump would preserve the pre-existing condition exclusions yet eliminate the employer and individual mandates.

In addition, the ACA contains hundreds of provisions affecting hospitals, corporations, Medicare, health care quality and integrity, the health care workforce, biosimilars, health care prevention and other issues unrelated to what most people think of as “Obamacare.” To date, Trump appears not to have taken any public position on these provisions.

ARTICLE BY Molly R. Berkery, Todd M. Cleary, John E. Donahue, Thomas N. Shorter, Charles G. Vogel & Jed A. Roher of Godfrey & Kahn S.C.

Copyright © 2016 Godfrey & Kahn S.C.