PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of Subpart 43-2 of Title 10 NYCRR.
Statutory authority:
Public Health Law, sections 2776(1)(e), 201(1)(h), (p) and 206(3)
Subject:
HIV Uninsured Care Programs.
Purpose:
Receive and expend funds to provide medications, medical treatment and other supportive services to persons with HIV disease.
Text of proposed rule:
Subpart 43-2 is amended to read:
SUBPART 43-2
[AIDS DRUG ASSISTANCE PROGRAM] HIV UNINSURED CARE PROGRAMS
Section 43-2.1 is amended to read:
Section 43-2.1 Scope. These regulations govern the application and eligibility determination process for the [AIDS Drug Assistance Program] HIV Uninsured Care Programs and establish the rights and responsibilities of applicants, participants, [medical] providers, and [the contractor] contractors in that process.
Section 43-2.2(e) and (f) are amended to read:
(e) Period of coverage. Coverage for assistance for each individual program component is effective [on the first date a drug is dispensed to an individual who is determined to be eligible for participation in the program] as specified in the individual's notification of eligibility. Coverage will terminate under the following circumstances:
(1) the applicant indicates in writing that he/she no longer needs or desires assistance;
(2) the department determines that a change in the participant's circumstances or residence has affected his/her eligibility;
(3) the participant has died or cannot be located; and
(4) funding for the [AIDS Drug Assistance Program] HIV Uninsured Care Programs is exhausted.
(f) Program means the HIV Uninsured Care Programs, including the following service components:
(1) AIDS Drug Assistance Program, which provides coverage of medications;
(2) ADAP Plus, which provides coverage for ambulatory care services;
(3) ADAP Plus Insurance Continuation, which pays for insurance premiums for eligible individuals who have cost effective insurance policies; and
(4) the HIV Home Care Program, which provides coverage for home care services.
Section 43-2.2(i) is amended to read as follows:
(i) [Contractor means any corporation which has entered into a contract with the department to assist in carrying out the provisions of the program] Available household income means the applicant's household income after deducting the amount paid by the applicant under the Federal Insurance Contributions Act for Social Security and Medicare and the cost of health care coverage paid by the applicant.
A new Section 43-2.2(j) is added to read:
(j) Provider means a medical provider, including a pharmacy, hospital, clinic, physician, laboratory or home health care agency.
Section 43-2.3 is amended to read:
Section 43-2.3 Confidentiality. All information which may identify an applicant which is received by the program will be confidential and can only be used when necessary for supervision, monitoring or administration of the program. Information received by any contractor, his agents, employees, or by any other person or agency concerning applicants or participants in the program is confidential and may not be disclosed without the written approval of the [AIDS Drug Assistance] HIV Uninsured Care Program Director, who shall approve disclosure only in conformance with Article 27-F of the Public Health Law and the federal standards with respect to the privacy and security of individually identifiable health information contained in Part 164 of Title 45 of the Code of Federal Regulations.
Section 43-2.4(a) is amended to read:
43-2.4 Use of the application form. (a) The State-approved application form must be completed:
(1) for each applicant upon initial application and recertification, if required; and
(2) documentation may be required when there is a change in status affecting eligibility.
Section 43-2.5(b)(1) is amended to read:
(b) Financial eligibility will be based upon the [total gross income] available household income [to the applicant's household].
(1) In order to be eligible, an applicant's available household income must be equal to or less than [the income guideline for the applicant's family size as specified below:] 435% of the amount under the annual United States Department of Health and Human Services poverty guidelines for the applicant's family size. Federal poverty guidelines are published annually by the Department of Health and Human Services in the Federal Register.
[Schedule--Statewide Standard of Need (Annual)
Number of persons in household
ONE
TWO
THREE+
44,000
59,200
74,400]
Section 43-2.5(c) is amended to read:
(c) Liquid resources shall be reviewed to determine their availability in determining eligibility for the program. In order to be eligible, an applicant's liquid resources must be less than $25,000.
[(1)] Liquid resources are cash or those assets which can be readily converted to cash such as bank accounts, lump sum payments, i.e., stocks, bonds and mutual fund shares. [Resources in an Individual Retirement Account (IRA) or other tax deferred compensation plan will be calculated at the rate of 50% for purposes of determining liquid assets.]
Section 43-2.5(d) is amended to read:
(d) Full and proper use shall be made of existing public and private medical and health services and facilities for obtaining therapeutic drugs, medical services, and related supplies and equipment for the treatment of HIV or AIDS.
Section 43-2.5(e) is amended to read:
(e) An applicant or recipient of assistance may be required as a condition of eligibility or continued eligibility to assign any rights he/she may have for [drug] coverage benefits under any health insurance policy or group health plan to the department.
Section 43-2.5(f) is amended to read as follows:
(f) [The department may employ a contractor to determine eligibility consistent with the requirements and responsibilities of Subpart 43-2 of this Part. Eligibility determinations are subject to department review and adjustment.]
In order to be eligible for ADAP Plus Insurance Continuation, an applicant must have:
(1) a health insurance policy that is determined to be cost effective by the department, based on the cost of premiums, limitations of coverage (i.e., deductible, caps, co-payments) and estimates of the monetary value of projected utilization and reimbursement under the insurance policy, and
(2) a premium cost that is more than 4% of the applicant’s available household income, if the applicant’s available household income is greater than 200% of the amount under the annual United States Department of Health and Human Services poverty guidelines for the applicant's family size, and
(3) an employer contribution of 50% or more of the total cost of the health insurance premium, if the applicant is employed full time and eligible for employer sponsored health insurance.
Section 43-2.9 is amended to read:
[Issuance of Program eligibility cards. (a) The department or authorized parties shall issue a program eligibility card to each person determined eligible for benefits.
(b) The card shall include the following information:
(1) participant's full name;
(2) participant's identification number;
(3) participant's effective date of coverage;
(4) category of drugs for which the participant is eligible; and
(5) the effective date of coverage for each category.]
RESERVED
Section 43-2.10 is amended to read:
43-2.10 Investigation. The department official shall review and verify information received on applications, as required. Documents, personal observation, personal and collateral interviews and contacts, reports, correspondence and conferences are means of verification of information supplied. When information is sought from collateral sources, other than public records or sources designated by the applicant on the application form [because the applicant or participant cannot provide verification], the department will inform the applicant/participant or his/her representative of what information is desired, why it is needed and how it will be used.
Section 43-2.14 is amended to read:
43-2.14 Enrollment of providers. The department will contract with or enter into provider agreements with [pharmacies and health care] providers, including providers of related laboratory and ancillary services, which demonstrate that they are qualified to provide [prescriptions drugs] program services.
Section 43-2.15(a) and (b) are amended to read:
Audit and [claim] review. (a) Providers shall be subject to audit and reviews for quality assurance and proper utilization by the commissioner, his agents or designees. With respect to such audits and reviews, the provider may be required:
(1) to reimburse the department for overpayments discovered by audits; and
(2) to pay restitution for any direct or indirect monetary damage to the program resulting from their improperly or inappropriately furnishing covered drugs, services, supplies or equipment.
(b) The commissioner, his agents or designees may conduct audits and [claim] reviews, and investigate potential fraud or abuse in a provider's conduct.
Section 43-2.15(d) is amended to read:
(d) When audit findings indicate that a provider has provided covered drugs, services, supplies or equipment in a manner which may be inconsistent with regulations governing the program, or with established standards for quality, or in an otherwise unauthorized manner, the commissioner may summarily suspend a provider's participation in the program and/or payment of all claims submitted and of all future claims may be delayed or suspended. When claims are delayed or suspended, a notice of the withholding payment or recoupment shall be sent to the provider by the department. This notice shall inform the provider that within 30 days he/she may request in writing an administrative review of the audit determination before a designee of the commissioner. The review must occur and a decision rendered within a reasonable time after a request for review. If the designee of the commissioner decides withholding or recoupment is warranted, or if no request for review is made by the provider with the 30 days provided, the department shall continue to recoup or withhold funds pursuant to the audit determination.
Section 43-2.16(e) is amended to read:
(e) All claims made under the program shall be subject to audit by the commissioner, his agents or designees, for a period of [three] six years from the date of their filing, or as required by state law, regulation or funding source. [t]This limitation shall not apply to situations in which fraud may be involved or where the provider or an agent thereof prevents or obstructs the performance of an audit pursuant to this Part.
Section 43-2.17 is amended to read:
43-2.17 Recoupment of overpayments. Overpayments determined to have been made pursuant to this section and section 43-2.16 of this Subpart shall be recovered by billing the provider for reimbursement, withholding the provider's current or withholding future payments on claims submitted or a percentage of payments otherwise payable on such claims, or such other remedies as may be available through a court of law.
A new section 43-2.18 is added to read:
Section 43-2.18 Claims submission. (a) Providers shall submit claims for drugs or services within ninety days of the date of service in the manner and form proscribed by the program in order to receive reimbursement.
(b) The department will not be obligated to pay claims submitted more than ninety days after the date of service. Claims submitted later than 90 days with written justification may be considered for payment if funds are available.
Text of proposed rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
Statutory Authority:
Statutory authority for the AIDS Drug Assistance Program exists under Public Health Law (PHL) Section 2776(1) (e) which authorizes the New York State Department of Health AIDS Institute to promote the availability of supportive services for affected persons. Therapeutic drugs, ambulatory care services, home care services and insurance premium payment assistance are provided through the HIV Uninsured Care Programs. PHL Section 201(1) (p) permits the Department to receive and expend funds available for public health. The Department promotes therapeutic services for communicable diseases affecting public health under the authority of Section 201(1) (h). Section 206(3) permits the Commissioner to enter into contracts to carry out the general intent and purposes of the Public Health Law. HIV Uninsured Care Programs use federal funds allocated under the Ryan White HIV/AIDS Treatment Modernization Act.
Legislative Objectives:
The statutes enable the Commissioner to receive and expend funds for the public health, including funds necessary to provide medications, medical treatment and other supportive services to persons with HIV disease.
Needs and Benefits:
The purpose of the regulation is to promulgate procedures for the HIV Uninsured Care Programs, which include ambulatory and home care services, payment for certain medications and premium payments to assure insurance continuation for eligible participants. The HIV Uninsured Care Programs are funded by federal grants and administered by the New York State Department of Health.
Through the HIV Uninsured Care Programs, the Department of Health offers selected drugs, ambulatory care, home care services and insurance continuation payments at no charge to medically and financially eligible individuals who are residents of New York State. The State determines eligibility for the HIV Uninsured Care Programs and notifies applicants of their eligibility for the program.
The regulations cover a broad scope of services. The definition of "Provider" will allow participation in the program by hospitals, clinics, physicians, laboratories and home health care agencies. The scope of services covered by the program has expanded and now includes ambulatory care, home care and insurance premium payments. Oversight authority permits review of quality of care and utilization to assure compliance with department standards and protocols. Due to the requirements of federal grants which restrict the period of time funds are available, the department will not be obligated to pay claims submitted by providers more than ninety days from the date of service.
Costs:
The proposed amendments will have no impact on the administrative costs of the program to the State. Any additional administrative costs associated with the broader scope of the program are funded through federal grants. Offsets in costs to the state will be achieved by preventing costly hospital inpatient stays and the increased costs associated with opportunistic infections due to debilitated immune system response.
Cost Effectiveness:
A wide range of studies have examined the cost effectiveness of various medical components of HIV care, as well as the delivery of HIV care through AIDS Drug Assistance Programs.
Cost-effectiveness analyses have been successfully used to evaluate most new developments in HIV clinical therapeutics, including HIV screening, opportunistic infection prophylaxis, antiretroviral therapy, and the use of diagnostic tests.
Additional studies have documented significant reductions or offsets in health care costs resulting from use of highly active antiretroviral therapy (HAART).
The cost-effectiveness of NY ADAP was analyzed in a pharmo-economic model in 1996 and the results illustrate that the cost of the program is offset by an equal reduction in medical system cost.
Cost-effectiveness analyses have demonstrated that even the most comprehensive ADAPs are a comparatively attractive use of HIV care resources and a good value, and that the cost-effectiveness of combination antiretroviral therapy compares favorably with other HIV patient care interventions and other accepted medical investments in terms of quality-adjusted life-year saved.
Costs to Local Governments:
There is no cost to local governments associated with this proposed rule change.
Costs to Private Regulated Parties:
No additional costs will be incurred by Private Regulated Parties. A single application may be utilized for all components of the programs. The application includes the same data elements previously required for the AIDS Drug Assistance Program (ADAP). Physicians have been and will continue to be required to submit information to verify patient's medical eligibility. Physicians enrolled as providers must submit claim forms comprised of data elements from the standard Medicaid claim format.
Costs to the Department of Health:
No new costs will be incurred by the Department, local governments or small businesses by these proposed regulatory revisions. The additional cost of providing medical benefits to individuals who continue eligibility for the programs due to annual cost of living increments in Federal Poverty Level (FPL) will be paid for using Federal funds allocated to the Programs through the Ryan White HIV/AIDS Treatment Modernization Act. For individuals who have partial insurance (underinsured) the Programs will mitigate potential cost increases by coordinating medical benefit coverage with other insurance plans. To further reduce future program cost and enhance access to comprehensive health care, individuals will be assisted in securing more comprehensive health insurance coverage through the ADAP Plus Insurance Continuation component of the program.
Local Government Mandates:
There is no impact on local government mandates associated with this proposed rule change.
Paperwork:
No new paperwork for referring physicians or pharmacies is necessitated by these changes. Physicians continue to provide information to the State to assess the medical eligibility of the applicant, and pharmacies must continue to submit claims in the manner specified by the Department of Health.
Health care providers must submit claim forms in the manner specified by the Department. The claim forms are comprised of data elements consistent with those maintained by the providers for claiming reimbursement from Medicaid. Home care providers must also submit care plans for pre-approval of services for individuals, in a format analogous to that used for Medicaid.
Duplications:
These regulations do not duplicate any existing state or federal requirements.
Alternatives:
ADAP engaged a focus group of community leaders and people living with HIV who would be most impacted by the regulation changes. The overwhelming consensus of the group was to proceed with the proposed changes. Some group members believed the change in income criteria may not be high enough. Because the programs are grant funded there is no guarantee of continued funding. In order to balance need against available resources the proposed changes would enable individuals to access care while at the same time assuring sufficient resources to continue comprehensive HIV care for uninsured and underinsured New York State residents.
There are no reasonable alternatives to enacting these regulation changes to eligibility and reimbursement procedures.
Federal Standards:
These regulations do not exceed any minimum standard of the federal government.
Compliance Schedule:
Providers will be expected to comply with these requirements as soon as they become effective, upon publication of a notice of adoption in the State Register.
Regulatory Flexibility Analysis
Effect on Small Business:
Approximately 3,270 pharmacies, 160 Article 28 health facilities, 330 physicians, 200 home care agencies and 61 laboratories are enrolled in this program. Although it has not been determined precisely how many employ 100 or fewer employees, the Department estimates that most of the enrolled pharmacies, physicians and home care agencies, as well as a significant number of enrolled laboratories can be classified as small businesses.
Compliance Requirements:
All enrolled parties would be required to submit documentation and conform to the procedures set forth in these regulations.
Professional Services:
Providers will not be required to adopt a new record keeping procedures to comply with these regulations. However, service information must be submitted to the Department in the prescribed claim format in order to document delivery of service for reimbursement by the program.
Compliance Costs:
No capital costs are required to comply with these regulations. Health Care providers must maintain records of service delivery. Reimbursement to providers will be made using standard Medicaid formats. The cost to each health care provider to submit the information requested on the claim form is dependent on the number of program participants being served and the frequency of services. We estimate that costs to providers to submit claims to the program will entail an average of approximately 15 minutes per month for each consequently reimbursed participant served during the month.
Economic and Technological Feasibility:
To the extent possible all efforts will be made to assure that payments and the claim submission processes are consistent with current industry technology.
Minimizing Adverse Impact:
These proposed amendments to existing regulations pertain to an optional program for Pharmacies, Article 28 facilities, physicians, home care agencies and laboratories. They do not produce an adverse impact on such providers, but rather ensure payment for services rendered to low income underinsured participants.
Opportunity for Small Business Input:
Copies of these proposed regulations will be transmitted to the Greater New York Hospital Association, the Health Care Association of New York, the Community Health Care Association of New York, New York County Medical Society, New York State Home Care Association and several high volume enrolled providers.
Rural Area Flexibility Analysis
Rural Areas Applicability:
The HIV Uninsured Care Programs are available statewide, and the program seeks to enroll adequate numbers of eligible providers from all areas, especially rural areas to ensure convenient access to covered services.
Compliance Requirements:
All enrolled parties would be required to submit documentation and conform to the procedures set forth in these regulations.
Professional Services:
Providers will not be required to adopt new record keeping procedures to comply with these regulations. However, service information must be submitted to the Department in the proscribed claim format in order to document delivery of service for reimbursement by the program. The claim format is consistent with that utilized by the providers for claims submitted to Medicaid.
Capital Costs and Annual Costs of Compliance:
No capital costs are required to comply with these restrictions. Health care providers must maintain records of service delivery. Reimbursement to providers will be made using standard Medicaid formats. The cost to each health care provider to submit the information requested on the claim form to the program is dependent on the number of program participants being served and the frequency of services. We estimate that costs to providers to submit claims to the program will entail an average of approximately 15 minutes per month for each participant served during a month for which reimbursement is being sought. These costs are consequently reimbursed as part of the applicable rate schedule for the provider.
Minimizing Adverse Impact:
These proposed amendments to existing regulations pertain to an optional program for pharmacies, Article 28 facilities, physicians, home care agencies, and laboratories. They do no produce an adverse impact on such providers, but rather ensure payment for services rendered to low income participants.
Opportunity for Small Business Input:
Copies of these proposed regulations have been transmitted to the Health Care Association of New York, the Community Health Care Association of New York, New York State Home Care Association and several enrolled providers serving rural areas.
Job Impact Statement
Nature of Impact:
By providing access to quality health care the HIV Uninsured Care Programs hope to improve health outcomes subsequently resulting in increased employability and access to private rather than publicly funded health care. It is assumed that the impact of the proposed rule changes will be positive.
Categories and Numbers Affected:
The programs serve over 22,000 low income HIV infected New York State residents each year. It is impossible to determine the number or categories of employment opportunities impacted.
