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Frequently Asked Questions

Frequently Asked Questions are used to provide additional information and/or statutory guidance not found in State Medicaid Director Letters, State Health Official Letters, or CMCS Informational Bulletins. The different sets of FAQs as originally released can be accessed below.

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Can provider-controlled settings with Memory Care Units with controlled-egress comply with the new Medicaid HCBS settings rule? If so, what are the requirements for such settings?

Yes, but only if controlled-egress is addressed as a modification of the rules defining home and community-based settings, with the state ensuring that the provider complies with the requirements of 42 C.F.R. 441.301(c)(4)(F), 441.530(a)(vi)(F) and 441.710(a)(vi)(F). Any setting using controlled-egress should assess an individual that exhibits wandering (and the underlying conditions, diseases or disorders) and document the individual's choices about and need for safety measures in his or her person-centered care plan. The plan should document the individual's preferences and opportunities for engagement within the setting's community and within the broader community.

Settings with controlled-egress should be able to demonstrate how they can make individual determinations of unsafe exit-seeking risk and make individual accommodations for those who are not at risk. Should a person choose a setting with controlled-egress, the setting must develop person-centered care plans that honor autonomy as well as minimize safety risks for each person, consistent with his or her plan goals. For example, spouses or partners who are not at risk for exit-seeking and who reside in the same setting should have the ability to come and go by having the code to an electronically controlled exit. Technological solutions, such as unobtrusive electronic pendants that alert staff when an individual is exiting, may be used for those at risk, but may not be necessary for others who have not shown a risk of unsafe exit-seeking. Importantly, such restrictions may not be developed or used for non-personcentered purposes, such as punishment or staff convenience.

In situations where a setting uses controlled-egress on an individual basis to support individuals who wander or exit-seek unsafely, consistent with our regulations, the person-centered plan must document the individual's:

  • Understanding of the setting's safety features, including any controlled-egress,
  • Choices for prevention of unsafe wandering or exit-seeking
  • Consent from the individual and caregivers/representatives to controlled-egress goals for care
  • Services, supports, and environmental design that will enable the individual to participate in desired activities and support their mobility
  • Options that were explored before any modifications occurred to the person-centered plan

Regulations require the person-centered plan to be reviewed at least annually with the Medicaid beneficiary and his or her representative, to determine whether it needs revision. If a secured memory unit is no longer necessary to meet the individual's needs, the individual must be afforded the appropriate services in that setting to integrate into the community and exercise greater autonomy as well as being offered the option of a setting that does not have controlled egress.

To assure fidelity in complying with the regulations defining home and community-based settings, Memory Care Units should attempt to implement as many options as possible that are outlined within this guidance regarding staffing, activities and environmental design to assure optimal community integration for HCBS beneficiaries.

Note that the regulations provide that Medicaid beneficiaries receiving services in home and community-based settings must be free from coercion and restraint. Consistent with this, home and community-based settings should not restrict a participant within a setting, unless such restriction is documented in the person-centered plan, all less restrictive interventions have been exhausted, and such restriction is reassessed over time.

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FAQ ID:94976

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What are some promising practices that HCBS settings use to serve people who are at risk of unsafe wandering or exit-seeking?

Person-centered planning is at the core of all promising practices. That said, there are staff, activity, and environmental design approaches, as described below, which could be part of an individual's person-centered plan in response to unsafe wandering and exit-seeking. These promising practices have been compiled from industry and governmental sources and are offered as suggestions as they do not constitute requirements for HCBS services or providers.

Staffing:

  • Ensure that staff have adequate training in person-centered planning and unsafe wandering or exit-seeking, including how to effectively engage and participate with individuals in both planned and spontaneous activities as well as strategies for addressing the underlying needs and preferences that may motivate wandering or exit seeking.
  • Support individuals to move about freely with staff who help individuals walk or leave the room safely (e.g., providing a walking companion).
  • Ensure adequate staffing for activities outside the facility.
  • Ensure staff regularly escorts individuals to locations and activities outside of the setting as outlined in the person-centered services plan.
  • Provide flexible supervision to assure adequate support from resident to resident and from time to time for the same resident dependent upon need.

Activities:

  • Prevent under-stimulation by offering activities that engage the beneficiary's interest. Activities could include music, art, physical exercise, mental stimulation, therapeutic touch, pets, or gardening.
  • Provide a wellness program to help people exercise, have a healthy diet, manage stress, improve balance and gait, and stimulate cognition.
  • Support mobility through engaging activities, such as dog walking, gardening, yoga, and dance.
  • Develop daily meaningful activities and minimize passive entertainment, such as television watching.
  • Make available easily accessible activities, such as playing cards, reading books and magazines.
  • Encourage interaction with others.
  • Ensure that family and friends have unrestricted access to the individual if she or he wants this, and to the setting itself.

Environmental design:

  • Eliminate overstimulation, such as visible doors that people use frequently; noise; and clutter.
  • Create pictures on walls that can be sensory in nature to give individuals a place to stop and experience through sight or touch.
  • Manage shift changes so that individuals do not see significant numbers of staff coming and going through the exit/entrance door at the same time.
  • Use signage to orient the individual to the environment, such as indicating where toilets and bedrooms are, and assuring that there are places for individuals to sit and rest in large spaces within a setting that allow for safe wandering.
  • Disguise exit doors using murals or covering door handles as safety codes permit.
  • Use unobtrusive technological solutions, such as installing electronic coding lock systems on all building exits, or having individuals who wander or exit-seek unsafely wear electronic accessories that monitor their location.
  • Include lockable doors on each individual's room unless the resident's person-centered plan documents that such an arrangement is unsafe, following the requirements of the rule on individual modifications. Alternative features designed for safety, such as doors on living units that are not lockable or secure exits, should be used only when they are part of the resident's person-centered plan, after less intrusive methods have been tried and did not work, as provided in the rule.
  • Ensure unrestricted access to secured outdoor spaces and a safe, uncluttered path for people to wander, which has points of interest and places to rest.
  • Identify quiet, public spaces for individuals to sit, observe and rest while simultaneously being part of the community, and may include items that are used to soften the senses or help with removing sensory stimulation.
  • Enable people to leave the premises when they are not at risk of doing so unsafely. For example, wearable technologies can give people the ability to leave the setting or can limit the unsafe exiting of residents whose person-centered plans document that they are at risk of doing so.
  • Using tools and technology to monitor an individual's activities to promote optimal independence and personal autonomy, but assuring that such resources are not used in place of adequate supervision.
  • Ensure that Medicaid beneficiaries who may wander or exit-seek unsafely carry identification with their name and the service provider's location and contact information,
  • Create a back-up plan or lost-person plan that describes roles and responsibilities when an individual has exited in an unsafe manner.
  • Evaluate each lost-person incident to make revisions to person-centered care plans or to environmental design as necessary.

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FAQ ID:94981

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How can residential and adult day settings promote community integration for people who are at risk of unsafe wandering or exit-seeking? What are some examples of promising practices for implementing the community integration requirements of the regulations defining home and community-based settings and simultaneously assuring the safety of individuals who exhibit these behaviors?

All settings must facilitate and optimize Medicaid beneficiaries to live according to their daily routines and rituals, pursue their interests, and maximize opportunities for their engagement with the broader community in a self-determined manner, as outlined in the individual's person-centered service plan. The plan must reflect clinical and support needs as identified through an assessment of functional need, and document the individual's preferences for community integration and how these preferences will be addressed in the setting they have chosen.

Settings can support community integration, in accordance with each individual's person-centered plan by strategies and practices such as:

  • Finding out during initial assessments what individuals desire in terms of community engagement and educate them about how the setting's capabilities will meet the individual's needs and preferences. This should be done before the individual makes a decision about services and settings to allow the best fit between the person and place.
  • Documenting the factors the person identifies as important in a community such as proximity to and involvement of family, connections to communities of faith, specific cultural resources and activities, and others.
  • Recording individual preferences for community integration in the person-centered plan and how the setting will support those preferences (e.g., participating in their faith community, attending a favorite club, Sunday breakfast at the local diner, interests in volunteering or in working, etc.) as well as the transportation needed to achieve desired outcomes, recognizing that many of these activities are leveraged through natural supports and thus would not require Medicaid-funded resources.
  • Providing individuals with opportunities to engage others in their settings through activities, outings, and socialization opportunities.
  • Providing sufficient staff and transportation to enable individuals' participation in their activities of choice in the broader community. These could include opportunities for work, cultural enjoyment, worship, or volunteering. The person-centered service plan may also include provider-facilitated opportunities to engage in desired activities in the broader community.
  • Ensuring that visitors are not restricted, and individuals can connect to their virtual communities of choice through social media noting that this alone does not substitute for community activities and integration.
  • Ensuring that individuals have opportunities to visit with and go out with family members and friends, when they want this. Providing an inviting environment and flexible schedules and service times (e.g., meals, medication administration) can encourage family and friends' participation in the life of the residential setting and support their efforts to maintain individuals' connections to the external community.
  • Reviewing at least annually whether any parts of the person-centered plan need change. It is important to note that the modifications requirement within the regulations defining home and community-based settings also applies to anyone in a residential or nonresidential setting, and thus the person-centered plan needs to document what services and supports should be made available to allow people to live where they want and do what they want during the day to assure maximum integration with the broader community. For more information on the HCBS rule requirements on person-centered planning, please refer to CMS' previous FAQs on this topic.

All settings, including those in rural communities and those in low density suburban areas, are encouraged to provide adequate transportation opportunities to meet beneficiaries' desires for meaningful community engagement and participation in typical community activities.

Note that visits by community members have value but do not substitute for community access for Medicaid beneficiaries receiving services in residential and adult day settings.

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FAQ ID:94986

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If a state can prove that they are under the aggregate limits of AAC and PDF and have strong participation by pharmacies, are they required to adopt the AAC and PDF reimbursement methodology at the individual claim level?

All states are required to adopt the AAC and professional dispensing fee methodology; however, it is not required to be adopted at the individual claim level, but in the aggregate. In accordance with the regulatory requirements at 42 CFR 447.512(b), the state is responsible for establishing a payment methodology, that must not exceed, in the aggregate, payment levels that the agency has determined by applying the lower of the AAC plus a professional dispensing fee or the providers' usual and customary charges to the general public. In conjunction with this the state is also responsible to ensure that pharmacy reimbursement is consistent

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with the requirements of section 1902(a)(30)(A) of the Act, which specify that provider reimbursement rates should be consistent with efficiency, economy, and quality of care while assuring sufficient beneficiary access.

FAQ ID:94691

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If a state is already using actual acquisition cost (AAC) as their reimbursement methodology, does the state need to file a State Plan Amendment (SPA) or provide assurances that the current formula meets requirements established in the final rule? Is there a requirement for such states to file a SPA to provide assurance that the state's current dispensing fee amount meets the requirements of the final rule?

If a state is already making payment for prescription drugs under its state plan based on AAC, it may continue to use that methodology. However, if a state decides to change its AAC model of reimbursement, (e.g., the state decides to use the National Average Drug Acquisition Cost (NADAC) instead of a state survey to implement a payment methodology based on AAC), the state must submit a new SPA through the formal SPA process for review.

Additionally, the state should review its currently approved professional dispensing fee (PDF) to determine if, in light of the regulation (42 CFR 447.518), the PDF needs to be revised and a SPA needs to be submitted. The state does not have to submit a new SPA to provide assurance that its dispensing fee is reasonable.

Furthermore, we expect that all states, even those currently operating under an AAC reimbursement methodology, will evaluate their current state plans to determine if a SPA will be required to comply with the reimbursement requirements (including, but not limited to, AAC, PDF, 340B and the federal upper limits (FULs)).

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FAQ ID:94671

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Will there be an annual review of PDFs that are required as part of SPA approvals?

No, CMS will not perform an annual review of PDFs; however, states must consider both the ingredient cost reimbursement and the PDF reimbursement when proposing changes to ensure that total reimbursement to the pharmacy provider is calculated in accordance with requirements of section 1902(a)(30)(A) of the Act.

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FAQ ID:94676

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Will CMS be providing guidance to states to ensure that states include reasonable components in their cost of dispensing survey?

To the extent that a state is conducting a cost of dispensing survey, it should be a transparent, comprehensive, and well-designed tool that addresses a pharmacy provider's cost to dispense the drug product to a Medicaid beneficiary. States have the flexibility to set PDFs, including using national or regional data from another state and we do not require that a state use a specific standard or methodology such as a survey to do so.

Further, states are not required to use a specific formula or methodology such as a cost study or use an inflation update where cost studies are not conducted; however, the burden is on each state to ensure that pharmacy providers are reimbursed in accordance with the requirements in section 1902(a)(30)(A) of the Act. CMS will review each SPA submission against these standards (see 81 FR 5311).

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FAQ ID:94681

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After a state evaluates changing reimbursement to actual acquisition cost plus an increased PDF and the state determines that the total cost of their pharmacy reimbursement will be increased compared to current costs, will CMS allow an adjustment in the PDF that would result in a cost neutral outcome?

The intent of the new reimbursement methodology requirements is not necessarily to result in a cost neutral outcome. The requirements are to more accurately reflect the pharmacy providers' actual prices paid to acquire drugs and the professional services required to fill a prescription. Each state's AAC reimbursement methodology and proposed professional dispensing fee will be reviewed through the SPA process to ensure they are meeting the requirements of this final rule.

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FAQ ID:94686

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If NADAC is updated monthly, and a drug has a price change before the next monthly NADAC file is published, can states backdate NADAC in order to reimburse pharmacy providers correctly?

The NADAC files have weekly updates posted on Medicaid.gov that reflect any price changes that have occurred since the last posted monthly file. States using the NADAC for their AAC reimbursement methodology will have access to the weekly updates of the NADAC to ensure pharmacies are reimbursed with the most updated NADAC pricing.

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FAQ ID:94696

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Please confirm whether the final rule's AAC-based reimbursement policy applies to how states pay for drugs administered by providers in hospital clinic areas as part of hospital outpatient services, whether they are paid as part of the service or separately.

AAC reimbursement requirements for covered outpatient drugs extend to retail community pharmacy providers where drugs are covered by Medicaid under the state's covered outpatient drug pharmacy benefit and are not reimbursed as part of a service. Physician-administered drugs are not required to meet AAC reimbursement requirements.

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FAQ ID:94701

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