CMS-10573 Supporting Statement 6-13-2019

Supporting Statement – Part A

Reform of Requirements for Long-Term Care Facilities (CMS-10573)

A. Background

The purpose of this package is to request Office of Management and Budget (OMB) approval of the collection of information requirements for the reform of the requirements for Long-Term Care (LTC) facilities. LTC facilities are required to meet these requirements in order to participate in the Medicare and Medicaid Programs.

According to Centers for Medicare & Medicaid Services (CMS) data, as of June 2018, there were 15,639 LTC facilities in the United States. For this rule, LTC facilities include skilled nursing facilities (SNFs) as defined in section 1819(a) of the Social Security Act in the Medicare program and nursing facilities (NFs) as defined in 1919(a) of the Act in the Medicaid program. SNFs and NFs provide skilled nursing care and related services for residents who require medical or nursing care, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. In addition, NFs provide health-related care and services to individuals who because of their mental or physical condition require care and services (above the level of room and board) which can be made available to them only through institutional facilities, and is not primarily for the care and treatment of mental diseases. SNFs and NFs must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident and must provide to residents services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care which describes the medical, nursing, and psychosocial needs of the resident and how such needs will be met and which is updated periodically.

Under the authority of sections 1819 and 1919 of the Act, the Secretary propose to reform the requirements that SNFs and NFs must meet to participate in the Medicare & Medicaid programs. These requirements would be set forth in 42 CFR 483 subpart B as Requirements for Long Term Care Facilities. The requirements apply to an LTC facility as an entity as well as the services furnished to each individual under the care of the LTC facility, unless a requirement is specifically limited to Medicare or to Medicaid beneficiaries. To implement these requirements, State survey agencies generally conduct surveys of LTC facilities to determine whether or not they are complying with the requirements.

Ordinarily, we would be required to estimate the public reporting burden for information collection requirements for these regulations in accordance with chapter 35 of title 44, United States Code. However, sections 4204(b) and 4214(d) of Omnibus Budget Reconciliation Act of 1987, P.L. 100-203 (OBRA '87) provide for a waiver of Paperwork Reduction Act (PRA) requirements for some regulations. At the time that the 2016 LTC rule (81 FR 68688) published, we believed that this waiver still applied to those revisions and updates we made to existing requirements in part 483 subpart B. However, we have since learned that this may not be the case. Accordingly, we provide burden estimates for the new information collection requirements finalized in the 2016 LTC rule, as well as revisions and updates we made to existing requirements in part 483 subpart B.

B. Justification

1. Need and Legal Basis

The information collection requirements for which we are requesting OMB approval are listed below. These requirements are among other requirements which are based on criteria prescribed in law and are standards designed to ensure that each LTC facility safely and effectively delivers care to all residents. The information collections requirements described herein are needed to implement these health and safety standards requirements for all Medicare and Medicaid participating LTC facilities. We believe many of the requirements applied to these LTC facilities will impose no burden since a prudent institution will self-impose them in the course of doing business.

Sections 1818 and 1919 of the Act (42 U.S.C. 1395i–3 and 42 U.S.C. 1396r, respectively) specify certain requirements that a LTC facility must meet to participate in the Medicare and Medicaid programs. In particular, sections 1819(d)(4)(B) and 1919(d)(4)(B) require that a skilled nursing facility or nursing facility must meet such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary many find necessary. In addition, sections 1128I(b) and (c) and section 1150B of the Act require that each LTC facility establish a compliance and ethics program, and a quality assurance and performance improvement (QAPI) program, and implement requirements to ensure reporting of suspicions of a crime.

Under the authority of sections 1819, 1919, 1128I(b) and (c), and 1150B of the Act, the Secretary proposes to establish in regulation the requirements that an LTC facility must meet to participate in the Medicare and Medicaid programs.

2. Information Users

The primary users of this information will be State agency surveyors, CMS, and the LTC facilities for the purposes of ensuring compliance with Medicare and Medicaid requirements as well as ensuring the quality of care provided to LTC facility residents. The ICRs specified in the regulations may be used as a basis for determining whether a LTC is meeting the requirements to participate in the Medicare program.

3. Use of Information Technology

Long term care facilities may use health information technologies (HIT) to store and manage records, consistent with statutory and regulatory requirements for record keeping and confidentiality. Use of certified HIT technology is encouraged but not required, as some facilities, particularly small or rural facilities, may not have electronic capacity at this time. Facilities are free to take advantage of any technology advances they find appropriate for their needs.

4. Duplication of Efforts

This information collection does not duplicate any other effort and the information cannot be obtained from any other source.

5. Small Businesses

This information collection does affect small businesses. However, the requirements are sufficiently flexible for facilities to meet them in a way consistent with their existing operations.

6. Less Frequent Collection

CMS does not collect this information directly from long term care facilities on a scheduled basis. Facilities are expected to collect and maintain their own records in a timely fashion and to be able to provide necessary records to State or Federal surveyors when needed to demonstrate compliance with the long term care requirements for participation. With less frequent collection, CMS would not be able to assess or ensure compliance with the requirements.

7. Special Circumstances

There are no special circumstances for collecting this information.

8. Federal Register/Outside Consultation

The 60-day Federal Register notice of the Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities proposed rule (CMS-3260-P) published on July 16, 2015 (80 FR 42168). The 30-day Federal Register notice of the final rule (CMS-3260-F) published on October 4, 2016 (81 FR 68688).

9. Payments/Gifts to Respondents

There are no payment or gifts to respondents.

10. Confidentiality

We do not pledge confidentiality of aggregate data. We pledge confidentiality of resident-specific data in accordance with the Privacy Act of 1974 (5 U.S.C. 552a).

11. Sensitive Questions

There are no questions of a sensitive nature associated with this information collection.

12. Burden Estimates (Hours & Wages)

In analyzing information collection costs, we rely heavily on wage and salary information. Unless otherwise indicated, we obtained all salary information from the May 2017 National Occupational Employment and Wage Estimates, United States by the Bureau of Labor Statistics (BLS) at https://www.bls.gov/oes/current/oes_stru.htm. Furthermore, where applicable, the wage information for each occupation were pulled from the BLS industry category “nursing care facilities (skilled nursing facilities). Based on this information, we have calculated the estimated hourly rates in this proposed rule based upon the national mean salary for that particular position increased by 100 percent to account for overhead costs and fringe benefits. The raw wage and salary data from the BLS do not include health, retirement, and other fringe benefits, or the rent, utilities, information technology, administrative, and other types of overhead costs supporting each employee. HHS department-wide guidance on preparation of regulatory and paperwork burden estimates states that doubling salary costs is a good approximation to these overhead and fringe benefit costs.

The table that follows presents the BLS occupation code and title, the associated LTC facility staff position in this regulation, the estimated average hourly wage, and the adjusted hourly wage (with a 100 percent markup of the salary to include fringe benefits).

TABLE 1—SUMMARY INFORMATION OF ESTIMATED HOURLY WAGES

Occupation Code	BLS Occupation Title	Associated Position Title in this Regulation	Mean Hourly Wage ($/hour)	Adjusted Hourly Wage (with 100% markup for fringe benefits & overhead) ($/hour) (rounded to nearest dollar)
29-1141	Registered Nurses	Registered Nurse, Infection Preventionist	$31.59	$63
11-9111	Medical and Health Services Managers	Director of Nursing	$44.59	$89
11-9111	Medical and Health Services Managers	Administrator	$44.59	$89
21-1022	Healthcare Social Workers	Social Worker	$24.48	$49
43-9061	Office Clerks, General	Office Assistant	$15.71	$31
29-1062	Family and General Practitioners	Physician	$95.54	$191
23-1011	Lawyer	Attorney	$68.22	$136
31-1014	Nursing Assistant	Nurse Aide	$13.20	$26
11-9051	Food Service Manager	Director of Food and Nutrition Services	$29.97	$60
29-1031	Dietitian	Dietitian	$27.98	$56
37-1010	First-line Supervisor of Building Grounds, Cleaning and Maintenance Worker	Facility Manager	$19.28	$39

A. §483.10 Resident Rights

§483.10(c)(2) Notification of Changes to Care Plan

Existing regulations require that a resident, to the extent practicable, participate in the development of his or her care plan and be informed of the need to significantly alter treatment. We believe that the involvement and notification will include an opportunity to see the care plan. Periodic review after development of the care plan is also already required.

Section 483.10(c)(2) provides that the resident has the right to sign the care plan. This demonstrates his or her participation in and review of his or her care planning and that participation is evident to care-givers, surveyors, and other interested parties.

We estimate that it will take a registered nurse, no more than an additional 2 minutes per resident, to obtain a resident signature. We estimate that this may occur up to four times per year per resident. Based on an estimated 1,333,745 residents per year, the resulting burden hours are 177,832 (1,333,745 X .1333). The cost is $11,203,416 ($63 hourly wage for RN x 177,832 hours).

§483.10(f)(4)(v) through 483.10(f)(4)(vi) Visitation Policy

Section 483.10(f)(4)(vi)(G) requires facilities to have written policies and procedures regarding the visitation rights of residents. The policies and procedures must address any clinically necessary, safety related, or reasonable restrictions or limitations that may be placed on the visitation rights of residents. In addition, residents must be informed of their visitation rights.

The burden associated with this activity is the time necessary to develop such policies. We assume that an administrator and director of nursing will mainly be involved in discussions related to the development of this policy and the time of an office assistant to document the policy. We estimate that it will take a total of 2.5 hours to develop this policy (1 hour administrator ($89), 1 hour director of nursing ($89), and 30 minutes office assistant ($16.5)). This results in an estimated cost of $194 and a total cost of $3,026,147 for all 15,639 facilities.

§483.10(g)(17) Notification of Medicaid Eligibility

Existing regulations require facilities to provide notice to a resident of their Medicaid eligibility. Section 483.10(g)(17) requires facilities to provide an additional notice to residents who are not eligible for Medicaid at admission, when they do become eligible. This means some residents will require both a notice at admission and a second notice. As the notice of Medicaid eligibility is already required once, the additional burden is associated with providing the notice an additional time.

We anticipate that this will affect only a subset of residents (those eligible but not yet receiving Medicaid). Thus, based on a data analysis by AHCA, approximately 64 percent of LTC facility residents are already Medicaid recipients (that is, Medicaid is the payor of record), 14 percent are covered by Medicare, and 22 percent have another payor. Of those, only the 36 percent who are not receiving Medicaid may require the second notice of Medicaid eligibility. We assume that a portion of those will require ongoing care and become eligible for Medicaid. We also assume that some of those residents will apply for Medicaid at or shortly after admission or as a result of the first notice and not require the second notice. Based on these assumptions, we estimate that 20 percent of LTC facility residents (slightly more than half of those not already receiving Medicaid) will actually require a second notice of Medicaid eligibility.

We anticipate that a social worker will track a resident’s status of Medicaid eligibility and provide the notice. We estimate that this will require an additional 5 minutes per resident of a social worker’s time to provide the notice and communicate with the resident.

We estimate that it will cost $4.08 per resident who require the additional notice, for a total cost of $1,089,225 to provide these notices to the applicable residents across all 15,639 facilities (($49 hourly wage for a social worker x (.08333) of an hour) x (.20 estimate percent of all LTC facility residents who will require a second notice x 1,333,745 LTC facility residents)). We note that the actual per facility cost will vary significantly according to facility size and resident mix.

§483.10(j) Grievances

Facilities are required to establish a grievance policy to ensure the prompt resolution of all grievances. Facilities must notify residents, individually or through postings, of their right to file grievances orally (meaning spoken) or in writing; the right to file grievances anonymously; the contact information of the grievance official with whom a grievance can be filed, that is, his or her name, business address (mailing and email) and business phone number; a reasonable expected time frame for completing the review of the grievance; the right to obtain a written decision regarding his or her grievance; and the contact information of independent entities with whom grievances may be filed. In addition, facilities are required to maintain evidence demonstrating the results of all grievances for a period of no less than 3 years from the issuance of the grievance decision.

We assume that an administrator and the grievance official (social worker) would mainly be involved in discussions related to the development of the grievance policy and the time of an office assistant to document the policy. We estimate that it would take a total of 5 hours to develop this policy (3 hours of the grievance official’s time to develop the overall policy ($144), 1 hour of an administrator’s time to review, provide input, and approve the policy ($89), and 1 hour of an office assistant’s time to document the policy and post the policy ($31)). This results in an estimated cost of $264 and a total cost of $4,128,696 for all 15,639 facilities. Annualized over 3 years, this one time burden comes to 26,065 hours per year ((15,639 responses/3 years)*5 hours)

We believe that maintaining records of grievance decisions is a usual and customary practice that does not impose burden upon facilities and would not be subject to the PRA in accordance with the implementing of regulations of the PRA 5 CFR 1320.3(b)(2).

B. §483.15 Admission, Transfer, and Discharge Rights

§483.15(c)(4)

Existing regulations require facilities to notify the resident and the resident representative before a facility transfers or discharges the resident. Section 483.15(c)(4) requires facilities to also send the notice to the Office of the State Long-Term Care Ombudsman.

Since the notice is already created for the resident, the additional paperwork burden associated with this requirement is the need to print a copy of the notice and send it to the Office of the State Long-Term Care Ombudsman or, if a secure means of electronic transmission is available, sending a notice electronically.

We estimate that this activity will require 5 minutes for an office assistant to address and mail the notice (.08333 hours at a cost of $31). Furthermore, we estimate that the need to send the notice to the Ombudsman’s office will apply primarily to residents who are involuntarily discharged from the facility and not include residents who request the transfer or who are transferred on an emergency basis to an acute care facility. Therefore, we estimate that this notice may need to be sent to the Office of the State Long-Term Care Ombudsman for one third of all LTC facility residents. This results in a cost of $1,473,047 ((($.10 (cost of copy) + $.63 (cost of pre-stamped envelope based on USPS retail) + $2.58 (5/60 of an office assistant hourly wage ($31))) x 444,582 (1/3 of 1,333,745 LTC residents))).

Per facility costs will vary significantly according to facility size and number of transfers out of each facility.

C. §483.21 Comprehensive Resident-Centered Care Planning

§483.21(a) Baseline Care Plan

Section 483.21(a) requires facilities to develop and implement a baseline care plan for each resident that includes the instructions needed to provide effective and person-centered care of the resident that meet professional standards of quality care.

We believe that facilities are currently developing some type of interim care plan for residents, prior to developing the comprehensive care plan required at 483.21(b), in order to provide residents with the necessary and appropriate care upon admission into the facility. Furthermore, we expect that the information necessary to complete the baseline care plan will be readily available or accessible through discussions and follow-up upon admission.

Therefore, we believe that the need to formally document a baseline care plan and gather the required information adds an incremental increase to the current duties and staff time necessary of a RN. We estimate that this activity will add an additional 1 hour to the staff time of a RN at a cost of $985,257 ($63 (hourly wage of a RN) x 15,639 facilities).

§483.21(b)(2)(ii)

Existing regulations require a comprehensive care plan for each resident to be developed by an interdisciplinary team (IDT) that include the attending physician, a RN with responsibility of the resident, the resident or a resident representative, and other appropriate staff or professionals in disciplines as determined by the resident’s needs or as requested by the resident.

Section 483.21(b)(2)(ii)(C) and (D) require a nurse aide with responsibility of the residents and a member of food and nutrition services staff to also participate on the IDT. Facilities have removed our requirement for a social worker to participate on the IDT. We believe that this requirement will add to the current duties of each of these staff members. We expect that communications about the status of a resident are a part of standard job duties and anticipate that these staff members are already regularly discussing resident needs and their plans of care. When assessing the amount of additional burden associated with this requirement, we believe that this requirement will produce an incremental increase in the staff time necessary to participate on the IDT. We do not specify the type of communication the IDT must use. IDT members may use electronic communication as well as informal discussions to participate in IDT meetings.

Therefore, we estimate that participation on the IDT will add an additional one hour of staff time to the duties of a nurse aide and a member of food and nutrition services. While we do not require that a dietitian participate on the IDT, for purposes of estimating the cost we use the salary of a dietitian to represent the participation of a member of food services. We estimate that this activity will cost $66,684,696 ($26 Nurse Aide hourly wage + $56 Dietitian hourly wage x 52 hours (1 hour per week x 52 weeks) x 15,639 facilities).

§483.21(c) Discharge Planning Process

Existing regulations require facilities to develop a discharge summary when the facility anticipates that a resident will be discharged.

Section 483.21(c)(1) requires facilities to develop and implement a discharge planning process that focuses on the resident’s discharge goals, the preparation of residents to be active partners and effectively transition them to post-discharge care. This includes identifying the discharge needs of each resident and developing a discharge plan, regular re-evaluation of residents to identify changes and subsequent updates/revisions to the discharge plan, as needed, involvement of the IDT in the ongoing process of developing the discharge plan, and documenting that a resident has been asked about their interest in receiving information regarding returning to the community.

For residents who are transferred to another SNF or who are discharged to a HHA, IRF, or LTCH, §483.21(c)(1)(viii) requires facilities to assist residents and their resident representatives in selecting a post-acute care provider by using data that includes, but is not limited to SNF, HHA, IRF, or LTCH standardized patient assessment data, data on quality measures, and data on resource use. The facility also must ensure that the post-acute care standardized patient assessment data, data on quality measures, and data on resource use is relevant and applicable to the resident’s goals of care and treatment preferences.

We assume that facilities already have in place some type of discharge planning process. This requirement formalizes the process and adds some activities, such as providing residents with data to assist them in selecting a post-acute care facility, which we do not anticipate facilities have actively been engaged in. Facilities will need to review any existing discharge plans to determine whether they align with these requires. In addition, any residents without discharge plans will need to have their discharge goals and needs assessed and have a subsequent plan developed.

For purposes of establishing a formal discharge planning process and reviewing/updating resident discharge plans we estimate that this will require a total 20 hours staff time from the administrator (2 hours at $89), the DON (4 hours at $89), a social worker (3 hours at $49), the IDT (physician (2 hours at $191), nurse aide (1 hour at $26), food and nutrition staff (1 hour at $56), and a RN (4 hours at $63)), and an office assistant (2 hours at $31) to document the formal process. This results in an estimated cost of $22,896,087 ($1459 x 15,693 LTC facilities).

We expect that a social worker will be responsible for compiling the standardized data, reviewing the resident’s preferences/goals, and pulling data that applies to these preferences/goals and that this will require 1 hour of their time. We note that this activity will only be required for those residents who are transferred to another SNF or discharged from the LTC facility. We are unable to determine the average number of residents who are transferred to another SNF or discharged from a LTC facility annually. We believe that a conservative estimate is that if there are an estimated 1,333,745 residents per year in LTC facilities, possibly a third of these residents are discharged or transferred to another SNF on an annual basis. Therefore, we estimate that this requirement will cost $21,784,518 ($49 social worker hourly wage x 1 hour staff time x 444,582 residents discharged or transferred to another SNF annually).

The total cost for developing the discharge planning process is $44,680,605 ($22,896,087 + $21,784,518).

D. §483.25 Quality of Care

Section §483.25(n)(2) states that the facility must review the benefits and risks of bed rails with the resident or resident representative and obtain informed consent prior to installation. The burden associated with this requirement is the time it would take to review the benefits and risks with the resident or the resident representative. We estimate that it would take a registered nurse 10 minutes at a cost of $10.50 ($63 RN hourly wage x .16666) to discuss this information with the resident or resident representative. The total cost per facility would be $14,004,323 ($10.50 per resident x 1,333,745 residents per year in LTC facilities).

E. §483.55 Dental Services

Section 483.55(a)(3) and 483.55(b)(4) states that a facility may not charge a resident for the loss of or damage to dentures when the loss or damage is the responsibility of the facility. As such the facility must have a policy identifying those circumstances when the loss or damage of dentures is the facility’s responsibility. The burden associated with this requirement is the time it would take to develop a policy for such circumstances. We estimate that it would take an Administrator and the Director of Nursing one hour each to develop a policy that can be incorporated with the existing SNF/NF policies. The total cost per facility would be $178. The cost for all 15,639 facilities would be $2,783,742.

F. §483.60 Food and Nutrition Services

Under the food safety requirements at CFR 483.60(i)(3), facilities are required to have a policy regarding use and storage of foods brought to residents by family and other visitors to ensure safe and sanitary storage, handling, and consumption of the food. Since the facility staff would assist the resident with storing or reheating the food, it is important for a facility to have guidelines or policies to ensure safe food handling and consistent application of food handling practices. We estimate that it would take the facility’s administrator and dietitian or nutrition professional a total of 3 hours to develop a policy to ensure safe handling and consumption of food brought in by family and other visitors. We estimate that the combined one-time cost for all 15,639 facilities would be $3,143,439 (1 hours for the administrator at $89; 2 hours for a dietitian at $56 x 2=$112). Annualized over the 3 year approval period, this one time burden comes to 15,639 burden hours annually at a cost of $1,047,813 (15,639 annual responses*$201/hr)

Section 483.60(c)(4) requires facilities to have menus that reflect the cultural and ethnic needs of residents. We expect that facilities will have their menus updated by a qualified dietitian or other clinically qualified nutrition professional in the course of routine reviews and updates. Additional time will include the dietitian or other clinically qualified nutrition professional reviewing the facility assessment for pertinent factors and reviewing and updating the menus. We anticipate this will require 1 to 4 hours, on average 2 hours, depending on the size of the facility and complexity of resident needs. Based on this information, we estimate that it will cost $1,751,568 ($56 dietitian hourly wage × 2 hours × 15,639 facilities) for all LTC facilities to comply with this requirement.

§483.70 Administration

G. §483.70 Administration

Section 483.70(e) requires each facility to conduct, document, and annually review a facility-wide assessment to determine what resources are necessary to care for its residents competently during both daily operations and emergencies. Facilities are required to address in the facility assessment the facility’s resident population (that is, number of residents, overall types of care and staff competencies required by the residents, and cultural aspects), resources (for example, equipment, and overall personnel), and a facility-based and community-based risk assessment.

Based on our experience with LTC facilities, we believe that there is already some assessment of the resident population and the resources that would be required to care for that population. However, we do not believe that all facilities perform as thorough an assessment of their resident population or the facility’s resources as is required by § 483.70(e). In addition, we do not believe that most facilities have a formal process that is documented. Therefore we would expect that a facility would spend on average 30 hours developing a formal process to document and analyze a facility-wide assessment. We estimate that the facility’s administrator and director of nursing would primarily be responsible for this task. We estimate that the cost for the administrator would be for 20 hours at an hourly wage of $89; and the director of nursing would spend 10 hours on the activity at an hourly wage of $89. The total cost for an administrator and a director of nursing would be $2,670 (administrator at an adjusted hourly wage of $89 x 20 hours= $1,780 and a director of nursing at an adjusted hourly wage of $89 x 10 hours = $890). This one-time cost for all facilities would be $41,756,130 ($2,670 x 15,639). We also estimate a total of 469,170 burden hours. Annualized over the 3 year approval period, this comes to an annual burden of 156,390 hours at a cost of $13,918,710.

We further estimate that each year it would require an administrator 4 hours to collect and analyze data from throughout the facility; 3 hours for the director of nursing to collect and analyze staffing data; 1 hours for an office assistant to collect and document data; and 2 hours each for a facility manager and a physician to review and provide input. We estimate total facility annual burden hours of 12 hours and a total cost of $1,112 (Administrator: 4 hours at $89 an hour = $356; Director of Nursing: 3 hours at $89 an hours = $267; Office Assistant: 1 hour at $31; Physician: 2 hours at $191 an hour= $382; Facility Manager: 2 hours at $38 an hour = $76) per facility. The total cost for all facilities would be $17,390,568 ($1,112 x 15,639 facilities), or 187,668 hours.

H. §483.75 Quality Assurance and Performance Improvement (QAPI)

Existing regulations require facilities to maintain a Quality Assurance and Assessment (QAA) committee consisting of the director of nursing services, a physician designated by the facility and at least three other members of the facility’s staff. The committee must meet at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary. The committee is required to develop and implement appropriate plans of action to correct identified quality deficiencies.

Section 483.75 requires each facility to have a QAPI program. The burden associated with these requirements is the time and effort necessary to develop, implement, and maintain a comprehensive, data-driven QAPI program designed to monitor and evaluate the ongoing performance of the facility. The facility will need to establish a program to address the key components of the newly implemented standards (program measures, program scope, and program activities). Based on our experience with facilities’ compliance with QAA requirements, we anticipate that they already have some of the resources needed to develop and implement a proactive QAPI program. Also, we expect that many of the information collection requirements (ICRs) will be met through the technical assistance provided to facilities by CMS on the development of best practices, as required by the Affordable Care Act.

Based on our experience with other Medicare providers that have developed QAPI programs, we estimate that, on average, it will take 56 hours for the facility to develop and document a comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all services and programs of the facility, including services provided under contract or arrangement.

We estimate that the facility administrator will be largely responsible for developing the overall QAPI program and will spend approximately 30 hours on this activity; the director of nursing and a registered nurse will each spend approximately 10 hours each to review and provide input on clinical services activities; a physician will spend approximately 4 hours to review the program plan and provide medical direction and input; and one office assistant will spend approximately 2 hours to prepare and distribute draft and final program plans. We estimate that this will require a total of 875,784 burden hours for all 15,639 facilities (56 hours x 15,639 facilities) to develop a QAPI program.

We estimate that the cost for the administrator/coordinator will be $2,670 ($89 x 30 hours). We estimate the cost for the director of nursing will be $890 ($89 x 10 hours). We estimate that the cost for an RN will be $630 ($63 per hour x 10 hours). We estimate that the cost for the physician will be $764 ($191 x 4 hours). We estimate that the cost for an office assistant will be $62 ($31 x 2 hours). The estimated one-time cost for each facility will total $5,016. The total one-time cost for all 15,639 facilities will be $78,445,224. Annualized over the 3 year approval period, this comes to an annual burden of 291,928 hours at a cost of $26,148,408.

We anticipate that the ongoing, annual burden for each facility to collect and analyze data for QAPI activities will be 20 hours and an additional 20 hours to document the improvement activities. We estimate the total annual burden hours for all facilities will be 625,560 (40 hours x 15,639 facilities). We anticipate that the staff time to collect and analyze data and to implement and document improvement projects will be distributed as 14 hours for the administrator (Total cost of $1,246 ($89 x 14 burden hours), 14 hours for the DON (Total cost of $1,246 ($89 x 14 burden hours)), 10 for a RN (Total cost of $630 ($63 x 10 burden hours)), 1 hour for a physician (Total cost of $191 ($191 x 1 burden hour)), and 1 hour for an office assistant (Total cost of $31 ($31 x 1 burden hours)).

Therefore, we estimate that the on-going annual cost for each facility will be $3,344. The total annual cost for all LTC facilities will be $52,296,816

($3,344 x 15,639).

I. §483.80 Infection Control

Section 483.80 requires a facility to establish, maintain and document an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment with the goal of preventing and controlling infections and communicable diseases. Specifically, §483.80(a)(1) states that the facility must maintain a program for the identification, prevention, control, and investigation of infectious and communicable diseases. §483.80(a) also requires that each facility provide infection control education to staff, patients, and caregivers. Since health care-acquired infections have been a source of significant research, education, and training efforts by both the public and private health care sectors for more than a decade, we believe that all facilities already have infection prevention and control programs. The burden associated with the infection prevention and control program would be the time necessary to document the program. We estimate that each facility (15,639 facilities) will have an RN ($63/hour) spend 1 hour per quarter documenting its infection prevention and control program, for a total of 62,556 hours at a cost of $3,941,028 for a nurse to complete the documentation.

J. §483.85 Compliance and Ethics Program

Section 483.85 requires the operating organization for each SNF and NF to have in operation a compliance and ethics program that would be effective in preventing and detecting criminal, civil, and administrative violations under the Act and promoting quality of care.

For the purpose of determining a burden, we have estimated a burden based on the number of SNF and NF operating organizations. Since it would be the individual facilities that would be surveyed and not the operating organization, operating organizations would need to ensure that the appropriate documentation is available at all of their individual facilities in order to demonstrate compliance with all of the relevant requirements. Therefore, the burden we have assessed for the operating organization would encompass their working with staff at their individual facilities.

We believe that many, if not all, of the operating organizations for SNFs and NFs already have some type of compliance program in operation Therefore, we believe that all of the operating organizations for the SNFs and NFs would need to review their current programs and possibly revise or, in some cases, develop new sections for their programs in order to comply with the requirements in this final rule.

Based on PECOS and CASPER data, for purposes of this regulation, we estimate that there are 6,599 total operating organizations (422 operating organizations with 5 or more facilities, 444 operating organizations with 2 to 4 facilities, and 5,733 operating organizations with single facilities). Based on our experience with SNFs and NFs, we expect that the administrator and the director of nursing would primarily be involved in developing the operating organization’s compliance and ethics program. Thus, in determining the burden for all of the requirements in §483.85, except for §483.85(d), we will analyze the burden based on an administrator and the director of nursing performing the necessary tasks and activities. If the operating organization has a designated compliance officer, we expect that he or she would take the lead in developing the entire program with the assistance of the administrator and the director of nursing as needed or when required. Since we have estimated that the compliance officer and the director of nursing would receive about the same amount of compensation, $89 an hour, and that the necessary activities would require about the same numbers of hours, we believe our estimates would be about the same regardless of whether these tasks and activities were performed by the administrator and the director of nursing or by the compliance officer with the assistance of the administrator and the director of nursing.

We estimate that complying with this requirement would require 10 burden hours from the administrator and 10 burden hours from the director of nursing for a total of 20 burden hours from these individuals at an estimated cost of $1,780 (20 hours x 89 hourly wage). In addition, since we are requiring that compliance and ethics programs should now be mandatory, we expect that facilities would have an attorney review their programs to ensure they are in compliance with the requirements in this rule. The cost of having an attorney review the operating organization's program will vary depending on whether the operating organization has in‑house counsel or has to hire an attorney at a law firm. For the purposes of determining the burden, we will assume that each operating organization has in‑house counsel. We expect that an attorney would need to review the facility's compliance and ethics program, make recommendations, and approve the final program. We estimate this would require 4 burden hours at an estimated cost of $544 ($136 hourly wage x 4 hours).

Based on this data, we estimate it would require a total of 24 burden hours (10 hours for an administrator + 10 hours for the director of nursing + 4 hours for an attorney) for each operating organization to develop a compliance and ethics program that complied with the requirements in this final rule at a cost of $2,324 ($1,780 for the administrator and director of nursing + $544 for an attorney). Therefore, we estimate it would require 158,376 burden hours (24 burden hours for each operating organization x 6,599 operating organizations) at a cost of $15,336,076 ($2,324 for each operating organization x 6,599 operating organizations) for all facilities to comply with this requirement. Since this is a one-time development cost, we have annualized this over the 3 year approval period, for a total of 52,792 hours or $5,112,025 annually.

Each operating organization would also need to develop the policies and procedures necessary to implement the operating organization's compliance and ethics program. The burden associated with this requirement would be the resources needed to review and revise any existing policies and procedures and, if needed, develop new policies and procedures. We estimate that it would require 10 burden hours for each operating organization to comply with this requirement at a cost of $890 ($89 hourly wage for a health services manager x 10 hours). Therefore, we estimate that for all 6,599 operating organizations to comply with this requirement, it would require 65,990 burden hours (10 burden hours for each operating organization x 6,599 operating organizations) at a cost of $5,873,110 ($890 per operating organization x 6,599 operating organizations). Since this is a one-time development cost, we have annualized this over the 3 year approval period, for a total of 21,997 hours or $1,957,703.

In addition to developing the compliance and ethics program, each operating organization would be required to develop training materials and/or other publications to disseminate information about the program to its entire staff, individuals providing services under a contractual arrangement, and volunteers, consistent with their expected roles. We expect that many operating organizations already have some of the materials and/or other publications that would be needed to comply with this requirement. The burden associated with this requirement would be the resources needed to review and revise any existing materials and, if needed, develop new materials to comply with this requirement. Based on our experience with operating organizations, we expect that the compliance liaison (nursing staffs) would be involved in these activities.

We estimate that the compliance liaison would need 8 hours to develop these materials. Thus, we estimate it would require 8 burden hours for each operating organization to comply with this requirement at a cost of $504 ($63 hourly wage x 8 hours). Therefore, based on the previous estimate, for all 6,599 operating organizations to comply with this requirement it would require 52,792 burden hours (8 hours x 6,599 operating organizations) at a cost of $3,325,896 ($504 per operating organization x 6,599 operating organizations). Since this is a one-time development cost, we have annualized this over the 3 year approval period, for a total of 17,597 hours or $1,108,632.

Section 483.85(e) requires that the operating organization for each facility must review its compliance and ethics program annually, and revise its program, as needed.

We expect that the administrator or the director of nursing, or perhaps both, would be responsible for reviewing this program annually to ensure it was up‑to‑date and in compliance with all of the relevant federal and state laws, regulations, and other guidance. We expect that to comply with this requirement would require 5 burden hours from the administrator and 5 hours from the director of nursing for 10 burden hours at a cost of $890 ($89 hourly wage for administrator and director of nursing x 10 hours). Therefore, based on the previous estimate, for all 6,599 facilities to comply with this requirement would require 65,990 burden hours (10 burden hours x 6,599 operating organizations) at a cost of $5,873,110 ($890 for each facility x 6,599 operating organizations).

Based upon the previous estimates, for the first year that this requirement is in effect, it would require 42 burden hours (24 burden hours for developing the program + 10 burden hours for developing policies and procedures + 8 burden hours for developing training materials and/or publications ) at a cost of $3,718($2,324 for developing the program + $890 for developing policies and procedures + $504 for developing training materials and/or other publications) for each operating organization to comply with the ICRs for this requirement. Based on these estimates for all 6,599 operating organizations to comply with these requirements it would require 277,158 burden hours (42 burden hours for each operating organization x 6,599 operating organizations) at a cost of $24,535,082 ($3,718 estimated cost for each operating organization x 6,599 operating organizations). For all subsequent years, we estimate to comply with the ICR requirement to review and, if necessary, revise the operating organization's program annually would require 10 burden hours at a cost of $890. For all 6,599 operating organizations, it would require 65,990 (10 burden hours x 6,599 facilities) burden hours at an estimated cost of $5,873,110 ($890 per operating organization x 6,599 operating organizations).

K. §483.90 Physical Environment

Section 483.90 (i)(5) states that the facility must establish policies, in accordance with applicable Federal, State and local laws and regulations, regarding smoking, smoking areas, and smoking safety that also take into account non-smoking residents. We believe that most facilities already have some sort of smoking policy in place based on Federal, State and local. We estimate that it will take the Administrator (2 hours x $89) and the facilities manager (2 hours x $37) for a total cost of $252 per facility x 15,639 = $3,941,028 for all facilities.

L. §483.95 Training Requirements

General Training Topics (§483.95(a) through 483.95(e))

Section §483.95(a) requires facilities to develop and/or update training materials to include topics on communication, resident rights, facility obligations, abuse, neglect, exploitation, infection control, behavioral health and its QAPI program. We require that these training topics be provided for all new and existing staff; individuals providing services under a contractual arrangement; and volunteers, consistent with their expected roles and that they be able to demonstrate competency in these topic areas. We also expect each facility to keep a record of these trainings. To reduce regulatory burden and create a reasonable requirement we have not specified the amount or types of training that a facility must provide. There are various free online training tools and resources that facilities can use to assist them in complying with this requirement. For example, the Agency for Healthcare Research and Quality (AHRQ) released a set of training modules to help educate LTC facility staff on key patient safety concepts to improve the safety of LTC facility residents (http://www.ahrq.gov/professionals/systems/long-term-care/resources/facilities/ptsafety/). In addition to the web based materials, instructor and student handbooks can be sent to facilities at no additional cost. Therefore, we believe that the cost associated with this requirement will be limited to the staff time required to review and update their current training materials.

Based on our experience with facilities, we expect that all facilities have some type of training program. However, we expect that each facility will need to compare their training programs to their facilities assessments as required at §483.70(e) and ensure they cover the above training topics. We expect that complying with this requirement will require the involvement of a RN and the infection control and prevention officer (ICPO). We expect that a RN will spend more time reviewing, revising and/or developing new sections for the training program. The IP will need to weigh in on the infection control training related topics. We estimate that it will require 17 (8 for the RN ($63/hour), 4 for the Director of Nursing ($89/hour). 2 for the IP ($63/hour), 1 for Administrator ($89/hour) and 2 for Office Assistant ($31/hour) burden hours for each facility to develop a training program at a cost of $1,137. Thus, for all facilities to comply, it will cost an estimated $17,781,543 ($1,137 estimated cost for each facility x 15,639 facilities). We believe that the training will be considered part of regular ongoing training for the staff of each facility.

Compliance and Ethics Program Training (§483.95(f))

We require that SNF and NF operating organizations include as part of their compliance and ethics program an effective way to communicate their program’s standards, policies, and procedures. We believe that all operating organizations would need to develop training materials and/or other publications to comply with the training requirement. This regulation requires higher standards for organizations operating 5 or more facilities, therefore our cost estimates differentiate by organization size. We estimate that training staff in organizations operating 1 to 4 facilities will mainly require the duties of a RN at a cost of $778,302 for all 6,177 facilities (5,733 single facilities operating organizations + 444 facilities in operating organizations with 2 to 4 facilities) x 2 hours x $63 average hourly wage for a RN). For the training in operating organizations with 1 to 4 facilities, we expect that operating organizations will be able to minimize these training costs by including the training on their compliance and ethics program with any current trainings or in-services that they already conduct for their staff. In addition, these facilities could also include this information in publication, print or electronic, that are available to their staff.

We estimate that training staff in organizations operating five or more facilities will require 2 hours of time of a compliance officer (similar to an administrator) conducting the training at the organizational level (422 organizations) at a cost of $75,116 (422 x 2 x $89 = $75,116) and 2 hours of time of a compliance liaison (similar to an RN) at the facility level (9,462 facilities x 2 x $63 = $1,192,212), for a total annual cost of $1,267,328 ($75,116 + $1,192,212).

For all entities combined, this comes to a total annual burden of 32,122 hours, or $2,045,630.

Dementia Management and Abuse Prevention Training (§483.95(g))

Each facility is already required to complete a performance review of every nurse aide (NA) at least once every 12 months, and must provide in-service education based on the outcome of these reviews. Section 483.95(g) requires a facility to include dementia management and abuse prevention in their regular in-service education for all NAs.

Existing regulation at §483.95 already requires that NAs who provide services to individuals with cognitive impairments receive in-service training to address the care of the cognitively impaired. Based on the existing requirements, facilities already conduct training for some NAs on caring for residents who are cognitively impaired. Additionally, existing regulations at §483.95states that NAs must receive in-service training that addresses areas of weakness as determined in their performance reviews and may address the special needs of residents, as determined by the facility staff. Thus NAs receive annual training in dementia management and abuse prevention only if the training is indicated by their performance reviews.

Because this final rule would specifically require facilities to provide dementia management and abuse prevention training to all NAs, each facility would need to review their training procedures and materials to ensure that they are complying with the new requirements. For example, facilities may currently provide the in-service training (as identified from the performance review) utilizing an individual, targeted approach. In this proposed rule, all NAs would be required to receive this training annually, and the facility would need to evaluate whether another format might be more appropriate.

Since we have not increased the time needed to provide this training, we are not adding additional burden for the staff to train the NAs, since the existing requirements for facilities require them to provide in-service training to all NAs at least once every 12 months. We estimate that the burden associated with complying with this requirement would be a one‑time burden due to the resources required to review and, if necessary, modify the existing training materials to apply to all NAs, regardless of identified performance weaknesses. We expect that these activities would require the involvement of a RN or a Licensed Practical Nurse. Based on our experience with facilities, we anticipate that it would take each facility 4 hours to review and modify their existing training materials. Based on an hourly rate of $63 for an RN, we estimate that this would require 62,556 burden hours (4 hours x 15,639 facilities) at a cost of $3,941,028($252 per facility x 15,639 facilities).

The table below summarizes the estimated annual reporting and recordkeeping burden.

ANNUAL REPORTING AND RECORDKEEPING BURDENS

Regulation Section(s)	Number of Respondents	Number of Responses	Burden per Response (hours)	Total Annual Burden (hours)	Total Annual Cost ($)
§483.10(c)(2)	1,333,745	5,334,980	0.0333	177,832	$11,203,416
§483.10(f)(4)(v) through 483.10(f)(4)(vi)	15,639	15,639	2.5	39,098	$3,026,147
§483.10(g)(17)	266,749	266,749	0.08333	22,229	$1,089,225
§483.10(j)	15,639	5,213	5	26,065	$4,128,696
§483.15(c)(4)	444,582	444,582	0.08333	37,049	$1,473,047
§483.21(a)	15,639	15,639	1	15,639	$985,257
§483.21(b)(2)(ii)	15,639	813,228	1	813,228	$66,684,696
§483.21(c)	460,275	460,275	1.64	758,442	$44,680,605
§483.25(n)(2)	1,333,745	1,333,745	0.16666	222,291	$14,004,323
§483.55	15,639	15,639	2	31,278	$2,783,742
§483.60(c)(4)	15,639	15,639	2	31,278	$1,751,568
§483.60(i)(3)	15,639	5,213	3	15,639	$1,047,813
§483.70	15,639	20,852	16.5	344,058	$31,309,278
§483.75(a)	15,639	5,213	56	291,928	$26,148,408
§483.75(b)(2)	15,639	15,639	40	625,560	$52,296,816
§483.80	15,639	15,639	4	62,556	$3,941,028
§483.85(b)	6,599	2,200	24	52,792	$5,112,025
§483.85(c)	6,599	2,200	10	21,997	$1,957,703
§483.85(d)(1)	6,599	2,200	8	17,597	$1,108,632
§483.85(e)	6,599	6,599	10	65,990	$5,873,110
§483.90(i)(5)	15,639	15,639	4	62,556	$3,941,028
§483.95(a) through 483.95(e)	15,639	15,639	17	265,863	$17,781,543
§483.95(f)	16,061	16,061	2	32,122	$2,045,630
§483.95(g)	15,639	15,639	4	62,556	$3,941,028
Totals	4,100,499	8,860,061		4,095,643	$308,314,764

13. Capital Costs

There are no capital/maintenance costs associated with the information collection requirements contained in this rule.

14. Cost to Federal Government

The Federal government will sustain a burden from implementing and enforcing the final rule. Specifically, CMS will need to update the interpretive guidance, update the survey process, and make IT systems changes. We anticipate the majority of the system costs will be incurred between FY17 and FY18. In the final rule, we estimated initial federal start-up costs between $15 and $20 million. Once implemented, improved surveys to review the new requirements were anticipated to require an estimated $15 to $20 million annually in federal costs.

15. Changes to Burden

This is a new information collection requirement.

16. Publication/Tabulation Dates

There are no plans to publish the information collected.

17. Expiration Date

CMS will publish a notice in the Federal Register to inform the public of both the approval and the expiration date. In addition, the public will be able to access the expiration date on OMB’s website by performing a search using the OMB control number.

18. Certification Statement

We have not identified any exceptions.

INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW:

This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law.