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REGS : 10.14.02 Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment

 

 Content Editor

 
PROPOSAL
Maryland Register
Issue Date:  January 10, 2014
Volume 41 • Issue 1 • Pages 28—32
 
Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 14 CANCER CONTROL
10.14.02 Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment
Authority: Health-General Article, §§2-102, 2-104, and 2-105, Annotated Code of Maryland
Notice of Proposed Action
[14-014-P]
The Secretary of Health and Mental Hygiene proposes to amend Regulations .02—.04, .07—.14, and .22 under COMAR 10.14.02 Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment.
Statement of Purpose
The purpose of this action is to revise and update language to align the Breast and Cervical Cancer Diagnosis and Treatment Program (Program) with health reform changes, effective January 1, 2014 and add language limiting pharmacy rebate repayment to a certain time period. The proposed amendments will:
(1) Allow reimbursement for co-pays and co-insurance for insured individuals;
(2) Modify references to reimbursing MHIP costs for only as long as MHIP is available;
(3) Eliminate references to enrolling new individuals in the Maryland Health Insurance Plan (MHIP); and
(4) Prohibit a drug manufacturer or its designee from disputing or requesting repayment of any rebate paid under COMAR 10.14.02.08H more than 3 years after the date the rebate was paid to the Department.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. As a result of the implementation of health care reform on January 1, 2014, the proposed action will result in a reduction of program expenditures from fee-for-service medical reimbursements and an increase of expenditures from the payment of insurance deductibles and patient contribution amounts (co-pays and co-insurance) for program participants. The proposal will also modify current regulatory language that permits the Program to reimburse for Maryland Health Insurance Plan (MHIP) costs so that this reimbursement can only be made for as long as MHIP is available. As MHIP is phased out, the Program will no longer pay for MHIP premiums, co-pays, and co-insurance. Current program participants that are enrolled in MHIP through the Program will shift from MHIP coverage to expanded Medicaid coverage, insurance coverage through the Maryland Health Benefit Exchange (MHBE), or will fall out of coverage altogether. Additionally, this proposed action will prohibit a drug manufacturer or its designee from disputing or requesting repayment of any rebate paid (under COMAR 10.14.02.08H) more than three years after the date the rebate was paid to the Department. This modification along with the shift of program participants to health insurance coverage reimbursements and from MHIP to other health insurance coverage will result in an economic impact to the Program; however, the Department is unable to determine the economic impact of this proposed action due to many unknown variables.
 
 
Revenue (R+/R-)
 
II. Types of Economic Impact.
Expenditure
(E+/E-)
Magnitude
 

 
 
 
 
 
A. On issuing agency:
(E-)
Indeterminate
B. On other State agencies:
NONE
 
C. On local governments:
NONE
 
 
 
Benefit (+)
Cost (-)
Magnitude
 

 
 
 
 
 
D. On regulated industries or trade groups:
NONE
 
E. On other industries or trade groups:
NONE
 
F. Direct and indirect effects on public:
NONE
 
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
A. The Program is unable to determine the full economic impact of the proposed action.
The proposed action will allow reimbursement for deductible and patient contribution amounts (co-pays and co-insurance) for individuals that meet the Program’s eligibility standards. Traditionally, the Program has reimbursed medical providers on a fee-for-service basis for medical procedures and services related to the diagnosis and/or treatment of breast and cervical cancer. In recent years, the Program has enrolled a subset of its participants (approximately 100) in MHIP. For this subset of participants, the Program reimbursed MHIP premiums, deductibles, and patient contribution amounts instead of following the fee-for-service reimbursement model. However, for the majority of Program participants these costs have not previously been incurred. The exact costs to reimburse medical providers for program participant deductibles and patient contribution amounts are not able to be accurately estimated at this time. This is because individuals enrolling in health insurance coverage via the MHBE will be able to choose different plan options that will have differing deductible, co-pay, and co-insurance amounts. The Department is unable to know which plans participants may choose to enroll in, and since the patient contribution amounts that the Program will be expected to reimburse will vary so greatly, an accurate figure for these costs is not able to be determined. The Program assumes that the average patient contribution amount per program participant per year will be approximately $5,000. However, the Program is uncertain as to how many existing program participants who are currently have medical services reimbursed as fee-for-service will be enrolled in new health coverage between January 1 and March 31, 2014 (the end of open enrollment through the MHBE). Additionally, a proportion of these program participants may be eligible for expanded Medicaid, but the Program is uncertain as to how many people will access either expanded Medicaid or other health insurance coverage. The Program assumes that there will also be program participants that will continue to have no coverage and will need to have medical services reimbursed under the existing fee-for-service structure.
The proposed action also modifies references to reimbursing MHIP costs for as long as MHIP is available (estimated to end in sometime in CY2014). Any reduction of expenditures or savings achieved from no longer reimbursing expenses related to MHIP will be redirected to pay for the deductibles and patient contribution amounts for participants enrolled in other health insurance. Additionally, this action will result in no new MHIP enrollees through the Program and therefore no additional premiums, co-pays, and co-insurance for MHIP will be reimbursed for new program participants.
The additional proposed action will prohibit a drug manufacturer or its designee from disputing or requesting repayment of any rebate paid more than three years after the date the rebate was paid to the Department. This provision puts the Program in alignment with existing Medicaid regulations (COMAR 10.09.03.05-1. The Department is unable to assess the potential economic impact because it is unknown whether this may result in a negative revenue impact due to the limitation of the time period for disputes and repayment requests.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele A. Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499; TTY:800-735-2258, or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through February 10, 2014. A public hearing has not been scheduled.
 
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(61) (text unchanged)
(62) “Program” means the Breast and Cervical Cancer Diagnosis and Treatment Program within the Department established to:
(a) (text unchanged)
(b) Pay for MHIP coverage, if available, for eligible patients in lieu of providing direct reimbursement to participating medical care providers.
(63)—(73) (text unchanged)
.03 Patient Eligibility.
A.—B. (text unchanged)
C. Health insurance statuses which may render an applicant eligible include the following:
(1)—(2) (text unchanged)
(3) The applicant has health insurance other than Medical Assistance or Medicare which:
(a) (text unchanged)
(b) Requires that a deductible be paid by the applicant for the covered medical procedure or service; [or]
(c) Reimburses at a rate lower than the Medical Assistance approved rate in the State; or
(d) Has a patient contribution amount for the reimbursed medical procedure or service that the applicant is required to pay;
(4) The applicant is enrolled in one of the following Medical Assistance programs:
(a)—(c) (text unchanged)
(d) Qualified Medicare Beneficiary (QMB) [; or].
[(5) The applicant meets all other eligibility criteria under this regulation and is also eligible for MHIP.]
D.—F. (text unchanged)
G. An eligible patient is responsible for the following:
(1) (text unchanged)
(2) Selecting and using only a participating medical care provider; and
(3) Signing the release of patient information form for the Program developed and approved by the Department [; and
(4) If covered by health insurance other than Medicare or MHIP, paying the patient contribution amount].
.04 Physician Services.
A. To be considered a participating physician in the Program, the provider shall:
(1)—(3) (text unchanged)
(4) Agree to accept, for each covered medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter:
(a) (text unchanged)
(b) The reimbursement rate approved by the insurer plus the payment of the outstanding deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a reimbursed procedure or service;
(c) The reimbursement rate approved by Medicare plus the payment of the outstanding deductible and the patient contribution amount by the Department for an eligible patient who is covered by Medicare [only]; or
(d) (text unchanged)
(5) (text unchanged)
[(6) Agree not to bill an eligible patient, who has health insurance other than Medicare, for an additional charge for the reimbursed medical procedure performed or service provided other than the patient contribution amount, excluding the deductible; ]
[(7)] (6) Agree not to bill an eligible patient, who is uninsured or is covered by Medicare or [MHIP] other insurance, for an additional charge for the reimbursed medical procedure performed or service provided;
[(8)] (7)[(12)] (11) (text unchanged)
B.—D. (text unchanged)
E. The participating physician is responsible for the following:
(1)—(4) (text unchanged)
(5) Submitting a bill for the reimbursed medical procedure performed or service provided on the designated Departmental form within 12 months of the date of service as follows:
(a) (text unchanged)
(b) If an eligible patient is covered by Medicare or [MHIP] or other insurance, the participating physician shall bill:
(i) Medicare or [MHIP] the other insurance for the procedure or service in accordance with Medicare or [MHIP] the other insurance billing specifications; and
(ii) The Department for the outstanding deductible and patient contribution amount [; or
(c) If an eligible patient has health insurance other than Medicare or MHIP and the insurance provides coverage for the medical procedure or service, the participating physician shall bill the:
(i) Eligible patient’s insurer for the procedure or service,
(ii) Department for any outstanding deductible and, if the insurer pays less than the current Medical Assistance approved rate for the service, the difference between the insurance reimbursement rate and the Medical Assistance approved rate in the State, and
(iii) Patient for any patient contribution amount;].
(6)—(9) (text unchanged)
F.—G. (text unchanged)
.07 Physical Therapy Services.
A.—E. (text unchanged)
F. Reimbursement Principles.
(1) The Department shall reimburse the participating physical therapist:
(a) For a covered service performed in the provider’s office for an eligible patient who:
(i) Is uninsured or has insurance that does not provide coverage for the reimbursed procedure or service, the current Medical Assistance approved rate in the State[,]; or
(ii) Has [insurance other than] Medicare or [MHIP] other insurance that provides reimbursement for a covered procedure or service, the outstanding deductible and the patient contribution amount required by the insurer; and
[(iii) Is covered by Medicare, pursuant to COMAR 10.09.17.06F and G;
(iv) Is covered by MHIP, pursuant to Regulation .22 of this chapter; or
(v) Has insurance that provides reimbursement for the covered procedure or service that is less than the current Medical Assistance rate, the difference between the reimbursement rate approved by the insurer and the Medical Assistance approved rate in the State plus the payment of the outstanding deductible; and]
(b) (text unchanged)
(2) (text unchanged)
G.—H. (text unchanged)
.08 Pharmacy Services.
A.—B. (text unchanged)
C. Nonreimbursed pharmacy services include but are not limited to:
(1)—(3) (text unchanged)
(4) A drug not directly related to the diagnosis and treatment of breast or cervical cancer or a complication of treatment for breast or cervical cancer.
D. (text unchanged)
E. The Department shall reimburse the participating pharmacy:
(1) Pursuant to COMAR 10.09.03.07A—G and H(1)—(3), and (5)—(6); and
(2) For the deductible or patient contribution amount, or both.
F.—H. (text unchanged)
I. Limitations.
(1)—(2) (text unchanged)
(3) No manufacturer or its designee may dispute or request repayment of any rebate paid under §H of this regulation more than 3 years after the date the rebate was paid.
J. (text unchanged)
.09 Hospital Services.
A.—D. (text unchanged)
E. The participating hospital is responsible for:
(1) Submitting a bill for the reimbursed services provided on the designated Departmental form as follows:
(a) If an eligible patient is uninsured, or is insured[,] but the insurance does not provide coverage for the reimbursed service, the participating hospital shall send the Department the bill for the service, with a denial from the patient’s insurance carrier, within 12 months of the date of discharge or outpatient service; or
(b) If an eligible patient is covered by Medicare or [MHIP] other insurance, the participating hospital shall bill:
(i) Medicare or [MHIP] the other insurance for the procedure or service; and
(ii) The Department for the outstanding deductible and patient contribution amount;[or
(c) If an eligible patient has insurance other than Medicare or MHIP and the insurance provides coverage for the reimbursed service, the participating hospital shall bill the:
(i) Eligible patient’s insurer for the service;
(ii) Department for the outstanding deductible; and
(iii) Eligible patient for the patient contribution amount;]
(2)—(3) (text unchanged)
F. (text unchanged)
G. Reimbursement Rates.
(1) A participating hospital located in Maryland shall be reimbursed by the Department:
(a) (text unchanged)
(b) Pursuant to COMAR 10.09.06.10K and L for an eligible patient who is covered by Medicare; or
[(c) Pursuant to Regulation .22 of this chapter for an eligible patient who is covered by MHIP; or]
[(d)] (c) For an eligible patient who has insurance other than Medicare [or MHIP] that provides coverage for the reimbursed service, the outstanding deductible and patient contribution amount required by the insurer.
(2) A participating hospital located in a state bordering Maryland shall be reimbursed by the Department:
(a) (text unchanged)
(b) Pursuant to COMAR 10.09.06.10K and L for an eligible patient who is covered by Medicare; or
[(c) Pursuant to Regulation .22 of this chapter for an eligible patient who is covered by MHIP; or]
[(d)] (c) For an eligible patient who has insurance other than Medicare [or MHIP] that provides coverage for the reimbursed services, the outstanding deductible and patient contribution amount required by the insurer.
(3) A participating hospital located in the District of Columbia shall be reimbursed by the Department:
(a) (text unchanged)
(b) Pursuant to COMAR 10.09.06.10K and L for an eligible patient who is covered by Medicare; or
[(c) Pursuant to Regulation .22 of this chapter, for an eligible patient who is covered by MHIP; or]
[(d)] (c) For an eligible patient who has insurance other than Medicare [or MHIP] that provides coverage for the reimbursed services, the outstanding deductible and patient contribution required by the insurer.
H. (text unchanged)
.10 Disposable Medical Supplies and Durable Medical Equipment.
A.—D. (text unchanged)
E. Reimbursement Procedures. The participating medical supply company:
(1) Shall submit the request for payment for the reimbursed service on the form designated by the Department within 12 months of the date of service as follows:
(a) If an eligible patient is uninsured, or is insured [,] but the insurance does not provide coverage for the reimbursed service, the participating medical supply company shall send the Department the bill for the service, with a denial from the patient’s insurance carrier; or
(b) If an eligible patient is covered by Medicare or [MHIP] other insurance, the participating medical supply company shall bill:
(i) Medicare or [MHIP] the other insurance for the service; and
(ii) The Department for the outstanding deductible and patient contribution amount;[or
(c) If an eligible patient has insurance other than Medicare or MHIP and the insurance provides coverage for the reimbursed service, the participating medical supply company shall bill the:
(i) Eligible patient’s insurer for the service,
(ii) Department for the outstanding deductible and, if the insurer pays less than the current Medical Assistance approved rate for the service, the difference between the insurance reimbursement rate and the Medical Assistance approved rate in the State, and
(iii) Eligible patient for the patient contribution amount;]
(2)—(3) (text unchanged)
F. Reimbursement Procedures.
(1) The Department shall reimburse the participating medical supply company:
(a) (text unchanged)
(b) Pursuant to COMAR 10.09.12.07R and S for an eligible patient who is covered by Medicare; or
[(c) Pursuant to Regulation .22 of this chapter for an eligible patient who is covered by MHIP; or]
[(d)] (c) The outstanding deductible and patient contribution amount required by the insurer for an eligible patient who has insurance, other than Medicare or [MHIP] other insurance, that provides coverage for the reimbursed service.
(2) (text unchanged)
G. (text unchanged)
.11 Home Health Services.
A.—D. (text unchanged)
E. The participating home health services provider is responsible for:
(1) Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service, as follows:
(a) If an eligible patient is uninsured or is insured, but the insurance does not provide coverage for a reimbursed service, the participating home health services provider shall send the Department the bill for the service; or
(b) If an eligible patient is covered by Medicare or [MHIP] other insurance, the participating home health services provider shall bill:
(i) Medicare or [MHIP] the other insurance for the procedure or service; and
(ii) The Department for the outstanding deductible and patient contribution amount [; or
(c) If an eligible patient has insurance other than Medicare or MHIP and the insurance provides coverage for a reimbursed service, the participating home health services provider shall bill the:
(i) Eligible patient’s insurer for the service;
(ii) Department for the outstanding deductible and, if the insurer pays less than the current Medical Assistance approved rate for the service, the difference between the insurance reimbursement rate and the Medical Assistance approved rate in the State; and
(iii) Eligible patient for the patient contribution amount]; and
(2) (text unchanged)
F. Reimbursement Rates. A non-hospital-based participating home health services provider located in Maryland, or a participating home health services provider located in a jurisdiction bordering Maryland shall be reimbursed by the Department:
(1) Pursuant to COMAR 10.09.04.07E for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursement service; and
(2) For the outstanding deductible and patient contribution amount, if applicable, for an eligible patient who is covered by Medicare or [MHIP] other insurance [; and].
[(3) The outstanding deductible required by the insurer for an eligible patient who has insurance other than Medicare or MHIP that provides coverage for the reimbursed service.]
G. (text unchanged)
.12 Medical Laboratory Services.
A.—C. (text unchanged)
D. Reimbursement Procedures. The participating medical laboratory is responsible for:
(1) Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service as follows:
(a) If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating medical laboratory shall send the bill to the Department; or
(b) If an eligible patient is covered by Medicare or [MHIP] other insurance, the participating medical laboratory shall bill:
(i) Medicare or [MHIP] the other insurance for the service, and
(ii) The Department for the outstanding deductible and patient contribution amount [; or
(c) If an eligible patient has insurance, other than Medicare or MHIP, and the insurance provides coverage for the reimbursed service, the participating medical laboratory shall bill the:
(i) Eligible patient’s insurer for the service,
(ii) Department for the outstanding deductible and, if the insurer pays less than the current Medical Assistance approved rate for the service, the difference between the insurance reimbursement rate and the Medical Assistance approved rate in the State, and
(iii) Eligible patient for the patient contribution amount]; and
(2) (text unchanged)
E. Payment Procedures.
(1) The Department shall pay the participating medical laboratory for a reimbursed service:
(a) Pursuant to COMAR 10.09.09.07E for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed service; or
(b) Pursuant to COMAR 10.09.09.07F and G for an eligible patient who is covered by Medicare[;
(c) Pursuant to Regulation .22 of this chapter for an eligible patient who is covered by MHIP; or
(d) For an eligible patient who has insurance, other than Medicare or MHIP, that provides coverage for the reimbursed service, the outstanding deductible required by the insurer plus, if the insurer pays less than the current Medical Assistance approved rate for the service, the difference between the insurer’s reimbursement rate and the Medical Assistance approved rate in the State].
(2) (text unchanged)
F. (text unchanged)
.13 Freestanding Ambulatory Surgical Center Services.
A.—C. (text unchanged)
D. A participating freestanding ambulatory surgical center shall:
(1) (text unchanged)
(2) Submit a bill for the reimbursed service provided for an eligible patient on the form designated by the Department within 12 months of the date of service as follows:
(a) If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating freestanding ambulatory surgical center shall send the bill to the Department; or
(b) If an eligible patient is covered by Medicare or [MHIP] other insurance, the participating freestanding ambulatory surgical center shall bill:
(i) Medicare or [MHIP] the other insurance the composite rate for the service or procedure performed; and
(ii) The Department for the outstanding deductible and patient contribution amount [;or.
(c) If an eligible patient has insurance, other than Medicare or MHIP, that provides coverage for the reimbursed service, the participating freestanding ambulatory surgical center shall bill the:
(i) Eligible patient’s insurer for the service or procedure performed,
(ii) Department for the outstanding deductible, and
(iii) Eligible patient for the patient contribution amount].
E. The Department shall pay the participating freestanding ambulatory surgical center for a reimbursed service:
(1) (text unchanged)
(2) Pursuant to COMAR 10.09.42.06F—L for an eligible patient who is covered by Medicare; or
[(3) Pursuant to Regulation .22 of this chapter for an eligible patient who is covered by MHIP; or]
[(4)] (3) The outstanding deductible and patient contribution amount required by the insurer for an eligible patient who has insurance, other than Medicare [or MHIP], that provides coverage for the reimbursed service.
F. (text unchanged)
.14 Occupational Therapy Services.
A.—D. (text unchanged)
E. Reimbursement Principles.
(1) The Department shall reimburse the participating occupational therapist:
(a) For a covered service performed in the provider’s office for an eligible patient who:
(i) (text unchanged)
(ii) Has insurance other than Medicare [or MHIP] that provides reimbursement for a covered procedure or service, the outstanding deductible required by the insurer; or
(iii) Is covered by Medicare or [MHIP] other insurance, the outstanding deductible and patient contribution amount;[or
(iv) Has insurance that provides reimbursement for the covered procedure or service that is less than the Medical Assistance rate, the difference between the reimbursement rate approved by the insurer and the Medical Assistance approved rate in the State plus the payment of the outstanding deductible;] and
(b) (text unchanged)
(2) (text unchanged)
F.—G. (text unchanged)
.22 Maryland Health Insurance Plan Coverage.
A. In lieu of providing direct reimbursement to participating medical care providers, the Program may pay MHIP, if available, to provide health coverage for individuals enrolled in the Program who are also eligible for MHIP.
B. The Program may pay MHIP, if available, for health coverage for eligible patients, including:
(1)—(3) (text unchanged)
C. The Program may not pay any amount to MHIP, if available, for an eligible patient’s spouse, children, or other family members enrolled in MHIP.
D.—E. (text unchanged)
JOSHUA M. SHARFSTEIN, M.D.
Secretary of Health and Mental Hygiene