Category Archives: CMS


The Department of Health and Human Services (“HHS”) and The Centers for Medicare and Medicaid Services (“CMS”)

As part of the Biden-Harris Administration’s Nursing Home Reform initiative, and because Federal nursing home staffing laws have not been updated since 1987, HHS and CMS have announced a proposed rule amendment to 42 CFR parts 438, 442, and 483 to ensure safe and quality care in long-term care facilities.  This focuses on the proposed amendments to 42 CFR 483 regarding minimum nurse staffing requirements.

  • Minimum Staffing Standards for Long-Term Care Facilities (42 CFR 483)
  • The proposed rule establishes minimum nurse staffing standards in nursing homes as follows:
    • Minimum nurse staffing standards of 0.55 hours per resident day (“HPRD”) for Registered Nurses (“RN”s).
    • HHS evaluated State nurse staffing requirements and noted that the proposed RN requirement is higher than every State and only lower than the District of Colombia based on September 2022 data.
    • Minimum of 2.45 HPRD for Nurse Aides (“NA”s).
    • HHS noted that the proposed NA staffing requirement also is higher than every State and only lower than the District of Colombia based on September 2022 data.
    • A requirement to have an RN onsite 24 hours a day, seven days a week.
  • HHS expects facilities to staff above these minimum baseline levels to address the specific needs of their unique resident population based on the facility assessment and resident acuity levels.
    • Federal regulations currently require LTC facilities to use the services of an RN for at least 8 consecutive hours a day, 7 days a week (§483.35(b)(1)).
    • The LTC facility must also designate an RN to serve as the Director of Nursing (“DON”) on a full-time basis (§483.35(b)(2)).
  • These Federal requirements specify a number of hours that these licensed nurses and other nursing personnel must be available; however, there is no requirement that those hours be specifically dedicated to direct resident care.
  • To meet these proposed new standards HHS estimates that approximately three quarters of nursing homes would have to strengthen staffing in their facilities in order to comply.  HHS is proposing options for exemptions and a staggered implementation of the proposed requirements to alleviate challenges due to the nursing workforce.
  • HHS is seeking public comments regarding the proposed rules, including viable alternatives to the proposed staffing standards that will ensure safe and quality care for the over 1.2 million residents receiving care in Medicare and Medicaid-certified LTC facilities each day.
  • Florida’s minimum staffing requirements.
  • The Florida minimum staffing requirements include “direct care staff” as defined in F.S. 400.23 (3)(a)1. a. “Direct care staff” means persons who, through interpersonal contact with residents or resident care management, provide care and services to allow residents to attain or maintain the highest practicable physical, mental, and psychosocial well-being, including, but not limited to, disciplines and professions … in the categories of direct care services of nursing, dietary, therapeutic, and mental health. The term does not include a person whose primary duty is maintaining the physical environment of the facility, including, but not limited to, food preparation, laundry, and housekeeping.
  • It must be noted that Federal rule §442.43(a)(2) defines “Direct Care Worker” in a somewhat similar fashion; however, these direct care workers are not included in the proposed minimum nurse staffing numbers.
  • Pursuant to F.S. 400.23(3)(b), the minimum staffing requirements are as follows:
    • A minimum weekly average of 3.6 hours of care by direct care staff per resident per day.
    • A minimum of 2.0 hours of direct care by a certified nursing assistant per resident per day. A facility may not staff below one certified nursing assistant per 20 residents. (It must be noted that Florida revised the CNA standard from 2.45 to 2.0 in April 2022.)
    • A minimum of 1.0 hour of direct care by a licensed nurse per resident per day. A facility may not staff below one licensed nurse per 40 residents. (It must be noted that Florida’s requirements only specify “licensed” nurse (which would include RNs and LPNs) rather than specifying an RN as required by the proposed Federal rule (which HHS purposefully proposed so that facilities do not have the flexibility to decide between types of licensed nurses to meet the minimum)).
    • Nursing assistants employed under s. 400.211(2) (reflected in Federal rule §483.35(d)(1)) may be included in computing the hours of direct care provided by certified nursing assistants and may be included in computing the staffing ratio for certified nursing assistants if their job responsibilities include only nursing-assistant-related duties.
    • Certified nursing assistants performing the duties of a qualified medication aide under s. 400.211(5) may not be included in computing the hours of direct care provided by, or the staffing ratios for, certified nursing assistants or licensed nurses.
  • Additionally, Rule 59A-4.108, Florida Administrative Code, requires the following with regard to nursing services in nursing homes:
    • There shall be a DON who shall be responsible and accountable for the supervision and administration of the total nursing services program.
    • The DON must designate one licensed nurse on each shift to be responsible for the delivery of nursing services during that shift.
  • Effect of Proposed Federal Rule to Florida LTC Facilities
  • To meet the proposed requirement that the facility have an RN on duty 24 hours a day 7 days a week:
    • HHS has estimated that Florida will require an additional 8 nurses in rural areas and an additional 21 nurses in urban areas to meet this requirement.
    • To meet the proposed requirement of 0.55 HPRD for RNs:
    • HHS has estimated that Florida will require an additional 51 RNs in rural areas and an additional 390 RNs in urban areas.
    • To meet the proposed requirement of 2.45 HPRD for NAs:HHS has estimated that Florida will require an additional 23 NAs in rural areas and an additional 414 NAs in urban areas.
  • Comment Submission for the CMS Proposed Rule.
  • There are varying staffing models that are available and different approaches that HHS could have adopted for the proposed minimum nurse staffing requirement such as separate requirements for RNs, LVNs/LPNs, and NAs or defining requirements for licensed nurse staffing, that is, combining RNs and LVNs/LPNs or creating standards for NAs only.  Alternatively, HHS could have adopted non-nurse staffing requirements such as social workers, therapists, feeding assistants and other non-nurse staffing types in the minimum staffing requirement.
  • Ultimately HHS chose the comprehensive 24/7 RN and 0.55 RN and 2.45 NA HPRD requirements to strike a balance between ensuring resident health and safety, while preserving access to care, including discharge to community-based services.
  • HHS welcomes comments, and specifically on the following questions:
    • Does your facility, or one you are aware of, have an RN onsite 24 hours a day, 7 days a week? If not, how does the facility ensure that staff with the appropriate skill sets and competencies are available to assess and provide care as needed?
    • If a requirement for a 24 hour, 7 day a week onsite RN who is available to provide direct resident care does not seem feasible, could a requirement more feasibly be imposed for a RN to be “available” for a certain number of hours during a 24 hour period to assess and provide necessary care or consultation provide safe care for residents? If so, under what circumstances and using what definition of “available”?
    • Should the DON be counted towards the 24/7 RN requirement or should the DON only count in particular circumstances or with certain guardrails? Please explain why or why not.
    • Are there alternative policy strategies that we should consider to address staffing supply issues such as nursing shortages?
    • The comment period is open for a sixty-day period that expires on November 6, 2023.  More information on how to submit comments or to review the entire rule, can be found at this link:

Don’t Let CMS Add You to Its Lists

Have you received a letter from the Department of Health and Human Services (“DHS”) or the Centers for Medicare and Medicaid Services (“CMS”) informing you that they intend to exclude you from one or more federal payors (e.g., Medicare) or that they intend to add you to their preclusion list? If so, you need to act timely and appropriately to ensure you protect your rights. Being excluded or precluded from federal payor programs can have long-lasting consequences, both directly with the federal government and with the State of Florida.

What is Exclusion?

Exclusion applies to people and entities who participate in any federal payor programs, such as Medicare, Medicaid, Tricare, or other reimbursement programs funded by the federal government. Exclusions are governed by 42 U.S.C. § 1320a–7. This statute sets forth 21 reasons that DHS or CMS can use as a basis for exclusion from participation in federal payor programs. These reasons range from things like having a criminal conviction related to patient abuse or being a part of prohibited kickback scheme to failing to make adequate disclosures or defaulting on student loans.

Once an individual or entity is excluded, they will be added to the List of Excluded Individuals/Entities (“LEIE”) which is publicly available here. Exclusion also prohibits any other health care entity that is participating in a federal payor program from employing the excluded individual in any position involving management, administration, or patient care services. As a practical matter, most health care institutional providers such as hospitals, nursing homes, and other large companies will not employ individuals who are on the federal exclusion list.

The length of the exclusion will depend upon the reason for the exclusion, any aggravating factors, and any mitigating factors. For example, exclusion due to an individual’s criminal conviction related to patient abuse mandates a statutory five-year minimum exclusion (unless certain exceptions are met).

What is Preclusion?

Preclusion is similar to exclusion in that it bars an individual or entity from participating in the Medicare Advantage program. Thus, private insurers and managed care plans are precluded from paying individual practitioners on the preclusion list for services provided to their Medicare Advantage Plan enrollees. Further, unlike exclusion, preclusion extends its reach to include individual health care providers who may not even be enrolled in any federal payor programs. For example, a physician who is not enrolled in Medicaid or Medicare but has a contract with a private Medicare Advantage insurance plan may still be placed on the preclusion list, preventing payment for patients who have that insurer. The grounds for being added to the preclusion list are set forth in 42 C.F.R. § 422.2 and include reasons such as being excluded from Medicare and having a felony conviction in the past 10 years that CMS “deems detrimental to the best interests of the Medicare program.” Like exclusion, the length that an individual or entity can be placed on the preclusion list vary based on the details and the reason for being placed on the list. For example, a person placed on the preclusion list due to a felony conviction will be placed on the preclusion list for a “10-year period, beginning on the date of the felony conviction.” 42 CFR § 422.222(5).

Unlike exclusion, the preclusion list is not publicly available for viewing. However, CMS will notify private insurers informing them that an individual or entity was added to the preclusion list – which will almost inevitably lead to that individual or entity having those private insurance contracts cancelled.

The Importance of Timely and Fully Responding to a Notice

Preclusions and exclusions can have wide-reaching, long lasting consequences. In addition to the immediate effect – not being able to bill to the federal payor(s) at issue – being precluded or excluded can affect your ability to participate in Florida’s Medicaid program and can cause private insurers to cancel their contracts.

Beyond the payor issues, this can also affect your professional/facility license. See e.g., Florida Statute § 408.815(1) (providing for the revocation and/or denial of a renewal license for a health care facility that is “currently excluded, suspended, or terminated from participation in the state Medicaid program, the Medicaid program of any other state, or the Medicare program.”).

Due to these wide-reaching consequences, it is important that you timely and fully respond to any notice informing you or your facility that they may be excluded or precluded. Timely responding is a strict requirement. Failure to timely respond will almost always constitute a waiver of your right to challenge the preclusion or exclusion. Further, your response needs to include ALL of the information, defenses, and arguments you intend to make. Failure to raise an issue can constitute a waiver of that issue later in your appeal.


Being added to the LEIE or Preclusion List is a serious issue that can haunt you and your career for a long-time. If you have been informed that DHS or CMS seeks to add you to either of these lists, you should contact an attorney at Smith & Associates to discuss your rights and options.