Title of Regulation: 12VAC30-60. Standards Established and Methods Used to Assure High Quality Care (amending 12VAC30-60-70).

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC 1396 et seq.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: October 4, 2017.

Effective Date: October 19, 2017.

Agency Contact: Emily McClellan, Regulatory Supervisor, Department of Medical Assistance Services, Policy Division, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-4300, FAX (804) 786-1680, or email emily.mcclellan@dmas.virginia.gov.

Basis: Section 32.1-325 of the Code of Virginia grants the Board of Medical Assistance Services the authority to administer and amend the Plan for Medical Assistance. Section 32.1-324 of the Code of Virginia authorizes the Director of the Department of Medical Assistance Services (DMAS) to administer and amend the Plan for Medical Assistance according to the board's requirements. The Medicaid authority as established by § 1902(a) of the Social Security Act (42 USC § 1396a) provides governing authority for payments for services.

This change serves to bring accreditation requirements for home health accrediting organizations (HHAs) in line with the exemptions from state licensure requirements set forth in § 32.1-162.8 of the Code of Virginia.

Purpose: The purpose of this action is to bring the accreditation requirements for HHAs in line with (i) the state licensure requirements outlined in § 32.1-162.8 of the Code of Virginia and (ii) the list of accreditation organizations for Medicare HHAs approved by the Centers for Medicare and Medicaid Services. Consistency among approved accreditation organizations will clarify and streamline requirements for providers and DMAS.

This regulation is essential to protect the health, safety, or welfare of citizens in that it provides consistency between the regulations and the Code of Virginia with regard to the licensure requirements for HHAs. This consistency will help ensure that HHAs are appropriately licensed to provide services to Medicaid members.

Rationale for Using Fast-Track Rulemaking Process: This regulatory change is expected to be noncontroversial in that it is not a change in process, but simply updates the regulations so that they are in accordance Code of Virginia provisions that have been in effect since July 1, 2010. Conversations with the Virginia Association for Home Care and Hospice, which is the HHA provider association, have yielded support for this regulatory change.

The three main reasons to make this regulatory change are:

1. Accreditation organizations (e.g. JCAHO and CHAP) may change from time to time. New accreditation organizations may arise and others may no longer offer accreditation for certain providers, programs, or facilities. The revised language for 12VAC30-60-70 allows for that flexibility.

2. Since many HHAs provide services under Medicare and Medicaid, aligning the Virginia Medicaid accreditation requirements to the Medicare requirements will streamline HHA requirements and ensure consistency. The revised language for 12VAC30-60-70 ensures consistency.

3. Lastly, the Virginia Department of Health (VDH) oversees licensing, and exemptions from licensing, for HHAs. Virginia Medicaid can simplify its HHA requirements by mirroring the VDH language for accreditation requirements in order to qualify for an exemption from licensing as found in § 32.1-162.8 of the Code of Virginia.

Section 32.1-162.8 of the Code of Virginia exempts from licensure "any home care organization located in the Commonwealth that after initial licensure" is "certified by the Department of Health under provisions of Title XVIII or Title XIX of the Social Security Act; or accredited by any organization recognized by the Centers for Medicare and Medicaid Services for the purposes of Medicare certification; or licensed for hospice services under Article 7 (§ 32.1-162.1 et seq.)." The revised language for 12VAC30-60-70 provides for simplicity.

Conversations with the Virginia Association for Home Care and Hospice, the HHA provider association, have yielded support for this regulatory change, which simply brings Virginia Medicaid in line with VDH and Medicare requirements and allowances.

JCAHO and CHAP, which are currently approved accreditation organizations under 12VAC30-60-70 B, are also approved accreditation organizations by Medicare and would not be negatively impacted by this regulatory change.

Substance: Virginia regulations identify the requirements that HHAs must meet to participate as a provider of home health services in Virginia Medicaid and establish several licensure exemptions for HHAs after initial licensure. The current list of exemptions in Virginia regulations includes accreditation by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) or the Community Health Accreditation Program (CHAP). This language was promulgated in 2005 and incorporated into the Virginia Administrative Code, but different language was enacted by the legislature and incorporated into the Code of Virginia in 2010. The Code of Virginia uses broader language that establishes an exemption for HHAs accredited by any organization recognized by the Centers for Medicare and Medicaid Services for purposes of Medicare certification. The discrepancy between the Virginia Administrative Code and Code of Virginia language has not yet been rectified, and this regulatory change will bring the Virginia Administrative Code into alignment with § 32.1-162.8 of the Code of Virginia.

Issues: The primary advantage to the agency and to the public, including Medicaid providers and Medicaid members, is the alignment of statutory requirements with Virginia regulations so that the licensure requirements for HHAs are clear. There are no disadvantages to the agency or the public.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Department of Medical Assistance Services proposes to update this regulation to comply with Virginia Code Section 32.1-162.8 relating to exemptions from Home Health Agency (HHA) licensing.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. This regulation establishes several licensure exemptions for HHAs after initial licensure. The current list of exemptions in the regulation includes accreditation by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and the Community Health Accreditation Program (CHAP). This language was written into the regulation in 2005, but different language was entered into § 32.1-162.8 of the Code of Virginia in 2010. The statute exempts "any organization recognized by the Centers for Medicare and Medicaid Services for the purposes of Medicare certification."

The proposed language replaces the specific exemptions for JCAHO and CHAP, both of which are recognized by the Centers for Medicare and Medicaid Services (CMS) for the purposes of Medicare certification, with the exact language in the statute. The Accreditation Commission for Health Care, Inc. (ACHC) is also currently recognized by CMS and is exempt under the statute, but is not specifically mentioned in the regulation.

The proposed amendment will align the language with the statute. Since all three organizations are currently exempt under the statute and will continue to be exempt, no significant economic effect is expected other than improving the consistency between the regulation and the statute.

Businesses and Entities Affected. The proposed amendment applies to HHAs recognized by CMS and therefore exempt from HHA licensure requirements. There are currently three organizations recognized by CMS.

Localities Particularly Affected. The proposed change does not affect any locality more than others.

Projected Impact on Employment. No impact on employment is expected.

Effects on the Use and Value of Private Property. No impact on the use and value of private property is expected.

Real Estate Development Costs. No impact on real estate development costs is expected.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. All three HHAs are believed to be small businesses. The proposed amendment does not impose costs on them but may benefit them by improving the consistency between the regulation and the statute.

Alternative Method that Minimizes Adverse Impact. No adverse impact on small businesses is expected.

Adverse Impacts:

Businesses. The proposed amendments do not have an adverse impact on non-small businesses.

Localities. The proposed amendments will not adversely affect localities.

Other Entities. The proposed amendments will not adversely affect other entities.

Agency's Response to Economic Impact Analysis: The agency has reviewed the economic impact analysis prepared by the Department of Planning and Budget. The agency concurs with this analysis.

Summary:

The amendment conforms regulatory language to § 32.1-162.8 of the Code of Virginia by establishing an exemption for home health agencies accredited by any organization recognized by the Centers for Medicare and Medicaid Services for purposes of Medicare certification.

12VAC30-60-70. Utilization control: home health services.

A. Home health services that meet the standards prescribed for participation under Title XVIII, will be supplied.

B. Home health services shall be provided by a home health agency that is (i) licensed by the Virginia Department of Health (VDH), (ii) certified by the Virginia Department of Health under provisions of Title XVIII (Medicare) or Title XIX (Medicaid) of the Social Security Act, or (iii) accredited either by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or by the Community Health Accreditation Program (CHAP) established by the National League of Nursing by any organization recognized by the Centers for Medicare and Medicaid Services (CMS) for purposes of Medicare certification. Services shall be provided on a part-time or intermittent basis to a recipient in any setting in which normal life activities take place. Home health services shall not be furnished to individuals residing in a hospital, nursing facility, intermediate care facility for individuals with intellectual disabilities, or any setting in which payment is or could be made under Medicaid for inpatient services that include room and board. Home health services must be ordered or prescribed by a physician and be part of a written plan of care that the physician shall review at least every 60 days.

C. Covered services. Any one of the following services may be offered as the sole home health service and shall not be contingent upon the provision of another service.

1. Nursing services;

2. Home health aide services;

3. Physical therapy services;

4. Occupational therapy services; or

5. Speech-language pathology services.

D. General conditions. The following general conditions apply to skilled nursing, home health aide, physical therapy, occupational therapy, and speech-language pathology services provided by home health agencies.

1. The patient must be under the care of a physician who is legally authorized to practice and who is acting within the scope of his license. The physician may be the patient's private physician or a physician on the staff of the home health agency or a physician working under an arrangement with the institution which is the patient's residence or, if the agency is hospital-based, a physician on the hospital or agency staff.

2. No payment shall be made for home health services unless a face-to-face encounter has been performed by an approved practitioner, as outlined in this subsection, with the Medicaid individual within the 90 days before the start of the services or within the 30 days after the start of the services. The face-to-face encounter shall be related to the primary reason the Medicaid individual requires home health services.

a. The face-to-face encounter shall be conducted by one of the following approved practitioners:

(1) A physician licensed to practice medicine;

(2) A nurse practitioner or clinical nurse specialist within the scope of his practice under state law and working in collaboration with the physician who orders the Medicaid individual's services;

(3) A certified nurse midwife within the scope of his practice under state law;

(4) A physician assistant within the scope of his practice under state law and working under the supervision of the physician who orders the Medicaid individual's services; or

(5) For Medicaid individuals admitted to home health immediately after an acute or post-acute stay, the attending acute or post-acute physician.

b. The practitioner performing the face-to-face encounter shall document the clinical findings of the encounter in the Medicaid individual's record and communicate the clinical findings of the encounter to the ordering physician.

c. Face-to-face encounters may occur through telehealth, which shall not include by phone or email.

3. When a patient is admitted to home health services a start-of-care comprehensive assessment must be completed no later than five calendar days after the start of care date.

4. Services shall be furnished under a written plan of care and must be established and periodically reviewed by a physician. The requested services or items must be necessary to carry out the plan of care and must be related to the patient's condition. The initial plan of care (certification) must be reviewed by the attending physician, or physician designee. The physician must sign the initial certification before the home health agency may bill DMAS.

5. A physician shall review and recertify the plan of care every 60 days. A physician recertification shall be performed within the last five days of each current 60-day certification period, (i.e., between and including days 56-60). The physician recertification statement must indicate the continuing need for services and should estimate how long home health services will be needed. The physician must sign the recertification before the home health agency may bill DMAS.

6. The physician-orders for therapy services shall include the specific procedures and modalities to be used, identify the specific discipline to carry out the plan of care, and indicate the frequency and duration for services.

7. A written physician's statement located in the medical record must certify that:

a. The patient needs licensed nursing care, home health aide services, physical or occupational therapy, or speech-language pathology services;

b. A plan for furnishing such services to the individual has been established and is periodically reviewed by a physician; and

c. These services were furnished while the individual was under the care of a physician.

8. The plan of care shall contain at least the following information:

a. Diagnosis and prognosis;

b. Functional limitations;

c. Orders for nursing or other therapeutic services;

d. Orders for home health aide services, when applicable;

e. Orders for medications and treatments, when applicable;

f. Orders for special dietary or nutritional needs, when applicable; and

g. Orders for medical tests, when applicable, including laboratory tests and x-rays.

E. Utilization review shall be performed by DMAS to determine if services are appropriately provided and to ensure that the services provided to Medicaid recipients are medically necessary and appropriate. Such post payment review audits may be unannounced. Services not specifically documented in patients' medical records as having been rendered shall be deemed not to have been rendered and no reimbursement shall be provided.

F. All services furnished by a home health agency, whether provided directly by the agency or under arrangements with others, must be performed by appropriately qualified personnel. The following criteria shall apply to the provision of home health services:

1. Nursing services. Nursing services must be provided by a registered nurse or by a licensed practical nurse under the supervision of a graduate of an approved school of professional nursing and who is licensed as a registered nurse.

2. Home health aide services. Home health aides must meet the qualifications specified for home health aides by 42 CFR 484.36. Home health aide services may include assisting with personal hygiene, meal preparation and feeding, walking, and taking and recording blood pressure, pulse, and respiration. Home health aide services must be provided under the general supervision of a registered nurse. A recipient may not receive duplicative home health aide and personal care aide services.

3. Rehabilitation services. Services shall be specific and provide effective treatment for patients' conditions in accordance with accepted standards of medical practice. The amount, frequency, and duration of the services shall be reasonable. Rehabilitative services shall be provided with the expectation, based on the assessment made by physicians of patients' rehabilitation potential, that the condition of patients will improve significantly in a reasonable and generally predictable period of time, or shall be necessary to the establishment of a safe and effective maintenance program required in connection with the specific diagnosis.

a. Physical therapy services shall be directly and specifically related to an active written plan of care approved by a physician after any needed consultation with a physical therapist licensed by the Board of Physical Therapy. The services shall be of a level of complexity and sophistication, or the condition of the patient shall be of a nature that the services can only be performed by a physical therapist licensed by the Board of Physical Therapy, or a physical therapy assistant who is licensed by the Board of Physical Therapy and is under the direct supervision of a physical therapist licensed by the Board of Physical Therapy. When physical therapy services are provided by a qualified physical therapy assistant, such services shall be provided under the supervision of a qualified physical therapist who makes an onsite supervisory visit at least once every 30 days. This supervisory visit shall not be reimbursable.

b. Occupational therapy services shall be directly and specifically related to an active written plan of care approved by a physician after any needed consultation with an occupational therapist registered and licensed by the National Board for Certification in Occupational Therapy and licensed by the Virginia Board of Medicine. The services shall be of a level of complexity and sophistication, or the condition of the patient shall be of a nature that the services can only be performed by an occupational therapist registered and licensed by the National Board for Certification in Occupational Therapy and licensed by the Virginia Board of Medicine, or an occupational therapy assistant who is certified by the National Board for Certification in Occupational Therapy under the direct supervision of an occupational therapist as defined in this subdivision. When occupational therapy services are provided by a qualified occupational therapy assistant, such services shall be provided under the supervision of a qualified occupational therapist, as defined in this subdivision, who makes an onsite supervisory visit at least once every 30 days. This supervisory visit shall not be reimbursable.

c. Speech-language pathology services shall be directly and specifically related to an active written plan of care approved by a physician after any needed consultation with a speech-language pathologist licensed by the Virginia Department of Health Professions, Virginia Board of Audiology and Speech-Language Pathology. The services shall be of a level of complexity and sophistication, or the condition of the patient shall be of a nature that the services can only be performed by a speech-language pathologist licensed by the Virginia Board of Audiology and Speech-Language Pathology.

4. A visit shall be defined as the duration of time that a nurse, home health aide, or rehabilitation therapist is with a client to provide services prescribed by a physician and that are covered home health services. Visits shall not be defined in measurements or increments of time.