Comment: In regard to §97.1(2), Purpose. A commenter suggested deleting the following phrase in the first sentence: ". including a health care facility licensed under the Health and Safety Code, Chapter 142." The commenter stated, "Chapter 142 of the Health and Safety Code is the HCSSA statute and does not pertain to facilities. Facilities of various types are regulated by other HSC statutes." The commenter also suggested deleting the language "A certified HCSSA must have a license to provide certified home health services," from the last sentence of this paragraph because this is addressed elsewhere in the regulations (see §97.402).

Response: The language suggested for deletion is statutory language taken directly from the HCSSA statute, Health and Safety Code, Chapter 142, §142.002(a). However, the reference to Chapter 142 was inadvertently added and has been removed. The language now reads ". including a health care facility licensed under the Health and Safety Code, .."

Comment: In regard to §97.2(10), Definitions, Assistance with medication. A commenter stated, "The last sentence is vague, particularly in consideration of the intent of the nurse delegation rules relating to delegation of certain medication administration to an unlicensed person by an RN (See §218.8 of the Nurse Practice Act)." The commenter suggested rewording the last sentence for clarity as follows: "Such ancillary aid includes administration of any medication when the client has the cognitive ability to direct the administration of their medication and would self-administer if not for a functional limitation."

Response: DHS agrees and has made the change.

Comment: In regard to §97.2(22), Definitions, Complaint. Two commenters expressed opposition to the definition for complaint. The commenters believe the way the language is written an agency would be required to include human resources (HR) issues that are not client-related, such as inappropriate sexual behavior among staff members and other employment issues that are meant to be confidential. The commenters believe that placing these types of complaints in the Complaint Log contradicts requirements of HR and employment laws. One commenter stated, "The federal OIG's compliance program requirements for certified home care agencies, for example, call for the agency's compliance policies and procedures to provide protection and confidentiality in its reported (i.e., complaints of) or suspected cases of fraud and/or abuse." One commenter requested that the definition be limited to those involving clients and care issues. Another commenter suggested limiting this definition to the issues now covered and discussed under §97.250, which sets forth how an agency must handle all "complaints" subject to the stated definition. One commenter believes that the language in this section limits the agency's complaint investigation responsibilities to those complaints made by a client or the client's family or guardian or the client's health care provider regarding treatment or care that is (or fails to be) furnished or regarding the lack of respect for the client's property by anyone furnishing services on behalf of the agency. This commenter suggested using the following language from §97.250 as the definition for complaint: "An allegation made by a client or the family or guardian or the client's health care provider regarding treatment or care that is (or fails to be) furnished or regarding the lack of respect for the client's property by anyone furnishing services on behalf of the agency." The commenter suggested that the language then could be deleted from §97.250.

Response: DHS understands the commenters' concerns. The HCSSA Program receives complaints relating to financial insolvency such as the inability to pay the HCSSA staff and suppliers; behavior of staff, such as being rude, abusive, neglectful and exploitive; staff competency; and criminal history checks not being performed. DHS has received an increased number of complaints of abuse, neglect, and exploitation (ANE), especially with the unlicensed personnel. DHS agrees that clarification is needed and has changed the definition to reinforce that complaints are about infractions of the standards set forth under Chapter 97.

DHS and all state agencies are subject to the Public Information Act, Government Code, Chapter 552. Information in DHS files is subject to public release unless the information falls within one of the exemptions listed in the act. Health and Safety Code, Chapter 142, does provide that certain information concerning home health agencies is confidential. Also, the Human Resources Code and federal law provides that information concerning applicants and recipients in the Medicaid program is confidential. In accordance with the Public Information Act, DHS does request an open records decision from the attorney general when necessary to exempt information from public release.

Comment: In regard to §97.2(37)(B), Definitions, Hospice services. A commenter stated, "The Medicare Conditions of Participation for hospice require an 'interdisciplinary group is responsible' and the 'hospice must designate a registered nurse to coordinate the implementation of the plan of care ..' To have the State of Texas require that the hospice services be provided by a medically (physician) directed team is contrary to the Medicare Conditions of Participation for hospice and would add a financial burden to hospice providers." The commenter further stated, "Currently the physician is required to be part of the team, but not direct it. This standard as written would require a greater investment of time by the physician and greater compensation by the agency."

Response: These rules are state licensing rules, not federal Medicare Conditions of Participation. The term "hospice services" is defined by the HCSSA licensing statute, Health and Safety Code, §142.001, and requires hospice services be provided by a medically directed interdisciplinary team. The statutory definition for "interdisciplinary team" requires that the interdisciplinary team include a physician. These are not new definitions and are current licensing requirements. No change was made.

Comment: In regard to §97.2(37)(C), Definitions, Hospice services. Two commenters requested the phrase "independent living environment" be retained in the definition, because "hospice patients can be seen in independent living environments, and that being 'homebound' is not a requirement." One commenter suggested "changing the term 'home' back to 'residence' as in previous language; there is no definition for 'home' under this section, but there is one for 'residence,' which is the standard term used throughout the regulations."

Response: DHS agrees that hospice patients can be cared for in independent living environments. The rule definition is limited by the statutory definition; therefore, the term "home" cannot be changed to "residence." However, for clarification purposes, DHS has added the following sentence to the definition: "For the purpose of this definition, the word 'home' includes a person's 'residence" as defined under this section."

Comment: In regard to §97.2(41), Definitions, Interdisciplinary team. A commenter suggested that since this term is specific only to the hospice category, and because it is already described under §97.403(e) relating to standards for hospice services, the definition should be removed from §97.2(41). The dialysis-related definition for interdisciplinary team has already been stricken from this definition and moved to the dialysis section.

Response: DHS agrees with the commenter and has deleted the definition. Subsequent definitions have been renumbered.

Comment: In regard to §97.2(43), Definitions, Long-term program. A commenter suggested that since the language "is specific to the dialysis regulations found in §97.405(n)," the verbiage in this definition should be deleted from §97.2(43) and moved to/combined with the language in §97.405(n) to complement the meaning of "client long-term program."

Response: DHS agrees and has deleted the definition for long-term program in §97.2 and moved the language to §97.405(n) as suggested. Subsequent definitions have been renumbered.

Comment: In regard to §97.2(46), Definitions, Medication list. A commenter expressed concern regarding the proposed term "recommended dosage." The commenter stated, "The medication list should have the physician-ordered dosage for each medication on the list. Many agencies provide the patient with a copy of this list to clarify what medications the client is to take, how much, and how often. The physician orders a specific dosage for the patient, for example 10 milligrams. The recommended dosage for that medication may be a range of 10-50 milligrams. Other times the physician-ordered dosage is not in the range of 'recommended' dosage because the physician is aware of client-specific circumstances."

Response: DHS agrees that the language needs clarification. The definition (now §97.2(44) has been changed to say, "A list of a client's medications that includes the physician orders relating to dosage and the frequency and method of administration."

Comment: In regard to §97.2(70), Definitions, Residence. Two commenters suggested that the term "independent living environment" be reinstated to maintain consistency in terminology and to support situations identified in the nurse delegation rules under 22 TAC §218.8.

Response: DHS disagrees with the suggestion, because the word "residence" is defined by statute and, therefore, the term "independent living environment" cannot be added to the definition. No change was made as a result of the comment, however, as a result of deleting two of the definitions, the definition for "residence" is now at §97.2(68).

Comment: In regard to §97.2(73), Definitions, Respite services. Two commenters asked that the phrase "Respite services may be provided under home health, hospice, or personal assistance services depending on the needs of the client" not be removed. One commenter stated, "this was an issue before and was added to clarify that respite could be provided in any category of service, not just in PAS as some thought. The commenters expressed concern that the first sentence implies there are only two situations in which respite services can be provided. "Many persons have care needs who are not 'disabled' or at risk of abuse or neglect," and "limiting respite to caregivers for those with disabilities or at risk of abuse or neglect excludes those caretakers of the terminally ill or those just acutely ill who are exhausted and need some extra assistance." One commenter suggested deleting the language "with disabilities" to broaden the definition. One commenter stated, "Respite services are directly referred to under the hospice and PAS regulations, but may also be provided under licensed home health or licensed and certified home health categories."

Response: The term "respite services" is defined by statute and limits these services to primary caregivers providing care to individuals of all ages with disabilities or at risk of abuse or neglect. No change was made as a result of the comments, however, as a result of deleting two of the definitions, the definition for "respite services" is now at §97.2(71).

Comment: In regard to §97.2(76)(C), Definitions, Skilled services. A commenter suggested listing physical, occupational, and respiratory therapies separately to acknowledge the respective individual disciplines and to be in agreement with the services listed under §97.401(c) (Standards Specific to Licensed Home Health Services). A commenter requested clarification regarding the use of certified occupational therapy assistants, physical therapy assistants, and speech therapy assistants because they are used by some agencies when supervised by qualified occupational therapists (OTs), physical therapists (PTs) and speech language pathologists or speech therapists (STs). Another commenter suggested including licensed physical therapy assistants and certified occupational therapy assistants under this definition.

Response: DHS disagrees that licensed physical therapy assistants, certified occupational therapy assistants, and speech therapy assistants should be added under the definition of skilled services. The decision to use these assistants is a business decision of the physical therapists, occupational therapists, and speech therapists. Any skilled services provided by therapy assistants would be provided under the provisions of the applicable occupations act and rules adopted thereunder. No change was made as a result of the comment, however, as a result of deleting two of the definitions, the definition for "skilled services" is now at §97.2(74).

Comment: In regard to §97.2(77), Definitions, Social worker. A commenter requested clarification regarding the use of social worker assistants, as there are some social work associates with bachelor degrees that can be used as assistants in the certified category.

Response: The decision to use social worker assistants is a business decision of the social worker. Any skilled services provided by a social worker assistant would be provided under the provisions of the applicable occupations act and rules adopted thereunder. No change was made as a result of the comment, however, as a result of deleting two of the definitions, the definition for "social worker" is now at §97.2(75).

Comment: In regard to §97.11(g)(3)(K)(v), Application and Issuance of Initial License. Regarding the agency administrators' resume or curriculum vitae, a commenter suggested changing the regulatory reference from §97.244(a) to §97.244(a)(1), because referencing subsection (a) would include both paragraph (1), relating to qualifications, and paragraph (2), relating to conditions. The commenter reasoned that resumes or curriculum vitae normally include qualifications, not those other items listed under conditions.

Response: DHS understands the commenter's reasoning for the requested change, however, DHS needs to ensure that the administrator meets both the qualifications and the conditions required for the administrator. To clarify this, the language in §97.11(g)(3)(K)(v) has been changed as follows: "The resume or curriculum vitae must reflect that the administrator meets the qualifications and conditions described in §97.244(a) .."

Comment: In regard to §97.214, Telephone Number Change. A commenter suggested changing the requirement for "prior notification" to allow an agency to notify DHS "as soon as possible" of a change in telephone number. The commenter stated, "There are times when an agency obtains or is assigned a new phone number and is unaware of the new number until the effective date of the change, thereby making prior notification impossible."

Response: DHS agrees with the commenter's suggestion and has changed the language as follows: "An agency must notify the Texas Department of Human Services in writing within seven days of a change in the agency's telephone number."

Comment: In regard to §97.216, Change in Agency Certification or Accreditation Status. A commenter asked why there is a need for requiring an agency to notify DHS of change or loss of Medicare certification status. The commenter stated, "DHS is the survey authority for both state licensure and Medicare certification and should have direct involvement in, as well as knowledge of, any agency's Medicare decertification/termination or other adverse action. Unless an agency voluntarily withdraws its Medicare certification, there should not be a need for notification to DHS. Furthermore, if an agency is voluntarily withdrawing its certification, there would be no formal written notice to provide to DHS." The commenter suggested changing the language to delete this requirement and only require notification of loss of JCAHO or CHAP accreditation.

Response: As the contracted state agency to conduct Medicare certifications, DHS needs to be notified of any and all decertifications. DHS has also found that some agencies would drop certification when they were found to be out of compliance so they could not be sanctioned. DHS not only needs to know the loss of the accreditation status; DHS needs to know when the agency acquired the accreditation status that is deemed versus non-deemed. No change was made.

Comment: In regard to §97.218, Agency Organizational Changes. A commenter expressed concern with regard to the proposed change that requires home health agencies to immediately notify DHS in writing of a change in the administrator, controlling person, or chief financial officer of that agency so that DHS may conduct a criminal history check on the new individual. The commenter believes the proposed language is ambiguous in defining an agency's responsibility for notification. The commenter believes it is unclear as to whether the agency must notify DHS upon a candidate's selection to fill one of these positions, or when the candidate is actually formally approved for that position by the agency, such as by a vote of the agency's board. Moreover, it is unclear as to what the agency's or DHS's responsibilities are, if any, after the notification of the change to DHS. The commenter recommends DHS maintain the current rule that clearly outlines the agency's responsibility for notification within 15 calendar days of a change in the administrator or chief financial officer."

Response: DHS does not believe the language is ambiguous. The language clearly states that an agency must notify DHS immediately of any change in its agency administrator, controlling person, or chief financial officer. The language does not say that the agency must obtain approval from DHS before offering a candidate the position. If the criminal history check reveals something that would preclude the new administrator from qualifying, the agency clearly would have to reappoint the administrator. No change was made.

Comment: In regard to §97.219, Procedures for Adding or Deleting a Category to the License. A commenter believes that it was understandable to require 30 days advance notice of the addition of a category, however the commenter questioned the need for an agency to provide 30 days advance notice of "deletion" of a category and suggested deleting this requirement. The commenter believes that in many cases, it may not be feasible for agency to provide 30 days advance notice of deletion of category, especially if the reason is loss of all staff or director, etc. Cessation of category provision might occur in an unanticipated, abrupt manner.

Response: As previously mentioned, DHS found that some agencies would drop a category for which they were found to be out of compliance so they could not be sanctioned, then add the category back immediately after the surveyor left. If there are extreme situations that would prevent the 30-day notice, DHS will be attuned to them. No change was made.