Colorado State Regulations.

        History of Regulation In 2008, the General Assembly passed Senate Bill 08-153 (SB 153), which required home care agencies to be licensed by the Health Facilities and Emergency Medical Services Division (Division) in the Colorado Department of Public Health and Environment (CDPHE) and charged the Colorado State Board of Health (Board of Health) with adopting rules for the licensing program. The purpose of regulation was to address a growing concern regarding the provision of care by home care agencies, specifically improper patient care and criminal activity.

        Although individuals could be prosecuted for fraud or abuse of patients, privately funded home health agencies could not be removed from the marketplace since they were not regulated, and serious problems were found in home care agencies that were certified as Medicare and Medicaid providers.

        The bill required home care agencies to ensure that their employees were adequately trained and vetted. Senate Bill 153 also required home care placement agencies1 (placement agencies) to register with the Division. It required placement agencies to perform criminal history record checks in order to refer individuals to provide skilled health and personal care services2 in the home, and they were also required to provide a disclosure to consumers concerning the duties and employment status of the individual providing services.

        In 2010, the General Assembly passed Senate Bill 10-194 (SB 194), which placed a moratorium on the licensure requirement for Community Centered Boards (CCBs) and agencies that provide services to persons with developmental disabilities. This moratorium expired in March 2011. Senate Bill 194 also exempted qualified early intervention service providers for children with developmental disabilities. In 2012, the General Assembly passed House Bill 12-1294, which impacted the regulation of all health facilities in Colorado. Specifically, it required the Board of Health to establish different requirements appropriate to the various types of home care agencies, such as those that are substantially funded through Medicare or Medicaid and Providers of All-Inclusive Care for the Elderly.

            a)    Home care placement agencies provide referrals for home care attendants, for a fee, and do not employ or contract with home care attendants.

            b)    Personal care services include, but are not limited to, getting in and out of bed, walking or mobility, bathing, using the toilet, and dressing.

Summary of Current Laws

        Licensing Home care agencies are required to be licensed by the Division in order to provide skilled home health services and personal care services to consumers in their homes.

        The Board of Health housed in CDPHE is charged with adopting rules for licensing home care agencies.

A home care agency is defined as

        Any sole proprietorship, partnership, association, corporation, government or governmental subdivision or agency […], not-for-profit agency, or any other legal or commercial entity that manages and offers, directly or by contract, skilled home health services or personal care services to a home care consumer in the home care consumer’s temporary or permanent home or place of residence. A residential facility that delivers skilled home health or personal care services which the facility is not licensed to provide shall either be licensed as a home care agency or require the skilled home health or personal care services to be delivered by a licensed home care agency.

Skilled home health services are defined as

        Health and medical services furnished to a home care consumer in the home care consumer’s temporary or permanent home or place of residence that include wound care services; use of medical supplies including drugs and biologicals prescribed by a physician; in-home infusion services; nursing services; home health aide or certified nurse aide services that require the supervision of a licensed or certified healthcare professional acting within the scope of his or her license or certificate; occupational therapy; physical therapy; respiratory care services; dietetics and nutrition counseling services; medication administration; medical social services; and speech-language pathology services. “Skilled home health services” does not include the delivery of either durable medical equipment or medical supplies.

Personal care services are defined as

        Assistance with activities of daily living, including but not limited to bathing, dressing, eating, transferring, walking or mobility, toileting, and continence care. It also includes housekeeping, personal laundry, medication reminders, and companionship services furnished to a home care consumer in the home care consumer’s temporary or permanent home or place of residence, and those normal daily routines that the home care consumer could perform for himself or herself were he or she physically capable, which are intended to enable that individual to remain safely and comfortably in the home care consumer’s temporary or permanent home or place of residence.5

1.  § 25-27.5-103(1), C.R.S
2.  § 25-27.5-104(1), C.R.S.
3.  § 25-27.5-102(3) (a), C.R.S.
4.  § 25-27.5-102(7), C.R.S.
5.  § 25-27.5-102(6), C.R.S

        The Colorado State Board of Health (Board of Health) is vested with the authority to adopt rules for home care agencies and placement agencies. The Board of Health sets the minimum standards for the operation of home care agencies. The Division licenses two types of home care agencies:

• Class A agencies provide skilled healthcare services (e.g., medication administration, injections, intravenous therapy, and wound care), personal care services (e.g., getting in and out of bed, walking or mobility, bathing, using the toilet, and dressing), and other services such as homemaker and companion services.
• Class B agencies provide personal care services and other services such as homemaker and companion services. However, they are not licensed to provide skilled healthcare services.

        References: DORA (Department of Regulatory Agencies).

When is Skilled Care required?

        1. General prohibitions:

            a)    Broken skin or inactive skin problems, wound care.

            b)    Use of prescription ointments, stocking, exercise.

            c)    When client is not independent with eating, chewing, swallowing, or at risk of chocking and aspiration.

            d)    Medications, suppositories.

            e)    Catheters, enemas.

            f)     Respiratory care, except to move mask to shave client.

            g)    When client’s condition: Requires reports to nurse. Involves circulatory problems, loss of sensation.

        2. When is personal Care appropriate?

            a)    As a medical condition improves and less assistance is required for functional mobility.

            b)    Companionship needs.

            c)    When client fully trained with adaptive equipment.

            d)    When client fully trained, only needs stand by assist.

            e)    Client does not required skilled transfer.

            f)     Medication reminding, assistance OK when pre-poured /prepared, well labeled and complete instructions re time.

         (Use list 6CCR1011-1 section7, section 8).

8.489.20 GENERAL PERSONAL CARE RULES

        .21   – Personal care services shall include unskilled personal care as defined under INCLUSIONS for each personal care task listed in Section 8.489.30.

.22  – EXCLUSIONS AND RESTRICTIONS

1. Personal care services shall not include any skilled personal care, which must be provided as home health aide services or as nursing services under non-HCBS programs. These services as defined under EXCLUSIONS for each personal care task listed in Section 8.489.30, shall not be provided as personal care services under HCBS, regardless of the level of the training, certification, or supervision of the personal care employee.
2. Personal care staff shall not perform tasks that are not included under INCLUSIONS for each personal care task listed in Section 8.489.30, or tasks that are not listed. For example, personal care staff shall not provide transportation services and shall not provide financial management services. Clients, family, or others may choose to make private pay arrangements with the provider agency for services that are not Medicaid benefits, such as companionship.
3. The amount of personal care that is prior authorized is only an estimate, including estimated travel time. The prior authorization of a certain number of hours does not create an entitlement on the part of the client or the provider for that exact number of hours. All hours provided and reimbursed by Medicaid must be for covered services and must be necessary to meet the client’s needs.
4. Personal care provider agencies may decline to perform any specific task, if the supervisor or the personal care staff feels uncomfortable about the safety of the client or the personal care staff, regardless of whether the task may be included in the INCLUSIONS section for the task.
5. Family members shall not be reimbursed to provide only homemaker services. Family members must provide relative personal care in accordance with SECTION 8.485.200, LIMITATIONS ON PAYMENT TO FAMILY. Documentation of services provided must indicate that the provider is a relative.

8.489.30 SPECIFIC PERSONAL CARE TASKS

        .31 – The specific personal care tasks shall be authorized and provided according to the following rules:

A. BATHING Inclusions:

        Bathing is considered unskilled only when skilled skin care, skilled transfer, or skilled dressing, as described under EXCLUSIONS, is not required in conjunction with the bathing.

Exclusions:

        Bathing is considered skilled when skilled skin care, skilled transfer or skilled dressing is required, as described under EXCLUSIONS for skin care at 8.489.31,B,2, XCLUSIONS for transfers at 8.489.31,K,2, or EXCLUSIONS for dressing at 8.489.31,G.2.

B.  SKIN CARE Inclusions:

        Skin care is considered unskilled -only when skin is unbroken, and when any chronic skin problems are not active. Unskilled skin care must be of a preventive rather than a therapeutic nature, and may include application of non-medicated lotions and solutions, or of lotions and solutions not requiring a physician’s prescription; rubbing of reddened areas; reporting of changes to supervisor, and application of preventive spray on unbroken skin areas that may be susceptible to development of decubiti. Unskilled skin care does not include any of the care described under skilled skin care in the EXCLUSIONS section below.

Exclusions:

        Skin care is considered skilled when there is broken skin or potential for infection due to a chronic skin condition in an active stage. Skilled skin care includes wound care, dressing changes, application of prescription medications, skilled observation and. reporting, but does not include use of sterile technique.

C.  HAIR CARE Inclusions:

        Hair care is considered unskilled only when skilled skin care, transfer, or skilled dressing, as described under EXCLUSIONS -, is not required in conjunction with the hair care. Hair care under these limitations may include shampooing with non-medicated shampoo or shampoo that does not require a physician’s prescription, drying, combing and styling of hair.

Exclusions:

        Hair care is considered skilled when skilled skin care, skilled transfer, or skilled dressing, as described under EXCLUSIONS for skin care at 8.489.313,2, EXCLUSIONS for transfers at 8.489.31,K,2, or EXCLUSIONS for dressing at 8.489.J 1,G,2, is required in conjunction with the hair care.

D.  NAIL CARE Inclusions:

        Nail care is considered unskilled only when skilled skin care, as described under EXCLUSIONS, is not required in conjunction with the nail care; and only in the absence of any medical conditions that might involve peripheral circulatory problems or loss of sensation. Nail care under these limitations may include soaking of the nails, pushing back cuticles, and trimming and filing of nails.

Exclusions:

        Nail care is considered skilled when skilled skin care, as described under EXCLUSIONS  for skin care at 8.489.31,B,2, is required in conjunction with the nail care; and in the presence of medical  conditions that may  involve  peripheral  circulatory  problems  or loss of sensation.

E.  MOUTH CARE Inclusions:

        Mouth care is considered unskilled only when skilled skin care, as described under EXCLUSIONS, is riot required in conjunction with the mouth care. Mouth care under these limitations may include denture care and basic oral hygiene.

Exclusions:

        Mouth care is considered skilled when skilled skin care, as described under EXCLUSIONS for skin care at 8.489.31, B ,2, is required in conjunction with the mouth care; or when there is injury or disease of the face, mouth, head or neck; or in the presence of communicable disease; or when the client is unconscious; or when oral suctioning is required.

F.   SHAVING Inclusions:

        Shaving is considered unskilled only when skilled skin care, as described under EXCLUSIONS, is not required in conjunction with shaving; and only an electric razor may be used.

Exclusions

        Shaving is considered skilled when skilled skin care, as described under EXCLUSIONS for skin care at 8.489.31, B ,2, is required in conjunction with shaving.

G.  DRESSING Inclusions:

        Dressing is considered unskilled only when skilled skin care or skilled transfer, as described under EXCLUSIONS, is not required in conjunction with the dressing. Unskilled dressing may include assistance with ordinary clothing; application of support stockings of the type that can be purchased without a physician’s prescription; application of orthopedic devices such as splints and braces, or of artificial limbs, if considerable manipulation of the device or limb is not necessary, and if the client is fully trained in the use of the device or limb and is able to instruct the personal care staff.

Exclusions:

        Dressing is considered skilled when skilled skin care or skilled transfer, as described under EXCLUSIONS for skin care at 8.489.313, 2 or EXCLUSIONS for transfers at 8.489.31,0, is required in conjunction with the dressing. Skilled dressing may include application of ant embolic or other pressure stockings that can be purchased only with a physician ‘s prescription; application of orthopedic devices such as splints and braces, or of artificial limbs, if considerable manipulation of the device or limb is necessary, or if the client is still learning to use the device or limb.

H.   FEEDING Inclusions:

        Feeding is considered unskilled only when skilled skin care or skilled dressing, as described under EXCLUSIONS, is not required in conjunction with the feeding, and when oral suctioning is not needed on a stand-by or other basis. Unskilled feeding includes assistance with eating by mouth, using common eating utensils, such as forks, knives and straws.

Exclusions:

        Feeding is considered skilled when skilled skin care or skilled dressing, as described under EXCLUSIONS for skin care at 8.489.313,2 or EXCLUSIONS for dressing at 8.489.31,0,2, is required in conjunction with the feeding, and when oral suctioning is needed on a stand-by or other basis. Syringe feeding is also considered skilled. Feeding is skilled if there is a high risk of choking that could result in the need for emergency measures like CPR or Heimlich maneuver.

I. AMBULATION Inclusions:

        Assistance with ambulation is considered unskilled only when skilled transfers, as described under EXCLUSIONS, are not required in conjunction with the ambulation. In addition, when assisting a client with adaptive equipment, the client must be fully trained in the use of such equipment; and when assisting someone in a cast, there must be no need for observation and reporting to a nurse, and no need for skilled skin care, as described under EXCLUSIONS. Adaptive equipment may include, but is not limited to, gait belts, walkers, canes and wheelchairs.

Exclusions:

        Assistance with ambulation is considered skilled when skilled transfers, as described under EXCLUSIONS for transfers at 8.489.31,K,2, are required in conjunction with the ambulation. In addition, when assisting a client with adaptive equipment, it is considered skilled if the client is still being trained in the use of such equipment; and assisting someone in a cast is considered skilled there is a need for observation and reporting to a nurse, or if there is a need for skilled skin care, as described under EXCLUSIONS for skin care at 8.489.31,B,2.

J.   EXERCISES Inclusions:

        Assistance with exercises is considered unskilled only when the exercises are not prescribed by a nurse or other licensed medical professional. Unskilled assistance with exercise is limited to the encouragement of normal bodily movement, as tolerated, on the par: of the client. Personal care staff shall not prescribe nor direct any type of exercise program for the client.

Exclusions:

        Assistance with exercises is considered skilled when the exercises are prescribed by a nurse or other licensed medical professional. This may include passive range of motion.

K.   TRANSFERS Inclusions:

        Assistance with transfers is considered unskilled only when the client has sufficient balance and strength to assist with the transfer to some extent. Except for Hoyer lifts, adaptive equipment may be used in transfers, provided that the client is fully trained in the use of the equipment and can direct the transfer step by step. Adaptive equipment may include, but is not limited to, gait belts, wheel chairs, tub seats, and grab bars.

Exclusions:

        Assistance with transfers is considered skilled when the client is unable to assist with the transfer. Use of Hoyer lifts is considered skilled, and use of other adaptive equipment is considered skilled if the client is still being trained in the use of the equipment.

L. POSITIONING Inclusions:

        Positioning is considered unskilled only when the client is able to identify to the personal care staff, verbally, non-verbally or through others, when the position needs to be changed; and only when skilled skin care, as described under EXCLUSIONS, is not required in conjunction with the positioning.  Positioning may include imple alignment in bed, wheelchair, or other furniture.

Exclusions:

        Positioning is considered skilled when the client is not able to identify to the caregiver when the position needs to be changed, and when skilled skin care, as described under EXCLUSIONS for skin care at 8.489.3 I, B, 2, is required in conjunction with the positioning.

M.   BLADDER CARE Inclusions:

        Bladder care is considered unskilled only when skilled transfer or skilled skin care, as described under EXCLUSIONS, is not required in conjunction with the bladder care. Unskilled bladder care may include assisting the client to and from the bathroom; assistance with bed pans, urinals, and commodes; and changing of clothing and pads of any kind used for the care of incontinence. Emptying of Foley catheter bags or suprapubic catheter bags is considered unskilled only if there is no disruption of the closed system; the personal care staff must be trained to understand what constitutes disruption of the closed system.

Exclusions:

        Bladder care is considered skilled whenever it involves disruption of the closed system for a Foley or suprapubic catheter, such as changing from a leg bag to a night bag. Care of external catheters is also considered skilled.

N.   BOWEL CARE Inclusions:

        Bowel care is considered unskilled only when skilled transfer or skilled skincare, as described under EXCLUSIONS, is not required in conjunction with the bowel care. Unskilled bowel care may include assisting the client to and from the bathroom; assistance with bed pans and commodes; and changing of clothing and pads of any kind used for the care of incontinence.

        Emptying of ostomy bags and assistance with other client-directed ostomy care is unskilled only when there is no need for skilled skin care or for observation and reporting to a nurse.

Exclusions:

        Bowel care is considered skilled when skilled transfer or skilled skin care, as described under EXCLUSIONS for transfers at 8.489.31, K, 2, or EXCLUSIONS for skin care at 8.489.3 LB-2. Is required in conjunction with the bowel care. Skilled bowel care includes digital stimulation and enemas. Skilled bowel care may include care of ostomies that are new and care of ostomies when the client is unable to self-direct the care, provided that sterile technique is not required.

0. MEDICATION REMINDING

Inclusions:

        Medication reminding is allowed as unskilled personal care only when medications have been preselected, by the client, a family member, a nurse, or a pharmacist, and are stored in containers other than the prescription bottles, such as medication minders.  Medication minder containers must be clearly marked as to day and time of dosage, and must be kept in such a way as to prevent tampering. Medication reminding includes only inquiries as to whether medications were taken, verbal  prompting  to take medications , handing the appropriately  marked  medication minder  container  to  the client, and opening  the appropriately  marked  medication minder container for the client if the client is physically unable to open the container. Medication reminding does not include taking the medication out of the container.

        These limitations apply to all prescription and all over the counter medications, including pm medications. Any irregularities noted in the preselected medications, such as medications taken too often or not often enough, or not at the correct time as marked on the medication minder container, shall be immediately reported by the personal care staff to a supervisor.

Exclusions:

        Medication assistance is considered skilled care and consists of putting the medication in the client’s hand when the client can self-direct in the taking of medications.

P.    RESPIRATORY CARE Inclusions:

        Respiratory care is not considered unskilled. However, personal care staff may clean or change the tubing for oxygen equipment, may fill the distilled water reservoir, and may temporarily remove and replace the cannula or mask from the client’s face for purposes of shaving or washing the client’s face. Adjustments of the oxygen flow are not    allowed.

Exclusions:

        Respiratory care is skilled care, and includes postural drainage, cupping, adjusting oxygen flow within established parameters, and suctioning of mouth and nose.

Q.   ACCOMPANYING Inclusions:

        Accompanying the client to medical appointments, banking  errands, basic household  errands, clothes shopping, and grocery shopping to the extent necessary and as specified on the care plan is considered unskilled, when all the care that is provided by the personal care staff in relation to the trip is unskilled personal care, as described in these regulations. Accompanying the client to other services is also permissible as specified on the care plan, to the extent of time that the client would otherwise receive personal care services in the home.

        Personal care for the purpose of accompanying the client shall only be authorized when a personal care provider is needed during the trip to provide one or more other unskilled personal care services listed in this Section. Accompanying the client primarily to provide companionship is not a covered benefit.

Exclusions:

        Accompanying is considered skilled when any of the tasks performed in conjunction with the accompanying are skilled tasks. Accompanying does not include transporting the client.

R.      HOMEMAKING

        Homemaking, as described at Section 8.490, HOMEMAKER SERVICES, may be provided by personal care staff, if provided during the same visit as unskilled personal care, as described in these regulations.

S.       PROTECTIVE OVERSIGHT

Inclusions:

        Protective oversight is considered unskilled when the client requires stand-by assistance with any of the unskilled personal care described in these regulations, or when the client must be supervised at all times to prevent wandering.

Exclusions:

        Protective oversight for standby assistance with personal care tasks is considered skilled if any of the tasks performed are skilled tasks. Protective oversight to prevent wandering is considered skilled if any skilled personal care tasks are performed while providing oversight.

.32 – Personal care services as described above may be used to provide respite care for primary care givers, provided that the respite care does not duplicate any care which the primary caregiver may be receiving payment to provide.

8.489.40 CERTIFICATION STANDARDS FOR PERSONAL CARE SERVICES

.41              – Personal care provider agencies shall conform to all general certification standards and procedures at Section 8.487, HCBS-EBD PROVIDER AGENCIES, and shall meet all the additional personal care certification requirements in this section.

.42              – Personal care provider agencies shall assure and document that all personal care staff have received at least twenty hours of training, or have passed a skills validation test, in the provision of unskilled personal care as described above. Training, or skills validation, shall include the areas of bathing, skin care, hair care, nail care, mouth care, shaving, dressing, feeding, assistance with ambulation, exercises and transfers, positioning, bladder care, bowel care, medication reminding, homemaking, and protective oversight. Training shall also include instruction in basic first aid, and training in infection control techniques, including universal precautions. Training or skills validation shall be completed prior to service delivery, except for components of training that may be provided in the client’s home, in the presence of the supervisor.

.43              – All employees providing personal care shall be supervised by a person who, at a minimum, has received the training, or passed the skills validation test, required of personal care staff, as specified above. Supervision shall include, but not be limited to, the following activities:

1. Orientation of staff to agency policies and procedures.
2. Arrangement and documentation of training.
3. Informing staff of policies concerning advance directives and emergency procedures.
4. Oversight of scheduling, and notification to clients of changes; or close communication with scheduling staff.
   1. Written assignment of duties on a client-specific basis.
   2. Meetings and conferences with staff as necessary.
   3. Supervisory visits to client’s homes at least every three months, or more often as necessary, for problem resolution, skills validation of staff, client-specific or procedure­ specific training of staff, observation of client’s condition and care, and assessment of client’s satisfaction with services. At least one of the assigned personal care staff must be present at supervisory visits at least once every three months.
      1. Investigation of complaints and critical incidents.

I.  Counseling with staff on difficult cases, and potentially dangerous situations.

1. Communication with the case managers, the physician, and other providers on the care plan, as necessary to assure appropriate and effective care.
   1. Oversight of record-keeping by staff.