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AUTHORITY NOTE:Promulgated in accordance with R.S. 40:4.A.(1), R.S. 40:5.3, and the FDA/CFSAN & ISSC Model Ordinance VIII, 2003.

HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1309 (June 2002), amended LR 31:2896 (November 2005), LR 34:2175 (October 2008).

§333.General Provisions [formerly paragraph 9:052-3]

A. - F.5.

G.Recalls

1.Certified dealers shall adopt written procedures for conducting recalls of adulterated or misbranded shellfish products. These written procedures for conducting recalls shall be based on, and complementary to, the FDA Enforcement Policy on Recalls published in the April 1, 2003 Code of Federal Regulations, Title 21, Chapter 1, Subchapter A, Part 7-Enforcement Policy which is also contained in the 2003 NSSP Guide for the Control of Molluscan Shellfish under Section VII (Federal Regulations) thereof.
2.Certified dealers shall follow their written recall procedures to include timely notification of the Office of Public Health of a situation requiring recall, timely notification of consignee who received the affected product, and effective removal or correction of the affected product.

AUTHORITY NOTE:Promulgated in accordance with R.S. 40:4.A.(1) and R.S. 40:5.3.

HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1309 (June 2002), amended LR 28:1592 (July 2002), repromulgated LR 29:173 (February 2003), LR 34:2176 (October 2008).

Alan Levine

Secretary

0810#095

RULE

Department of Health and Hospitals

Office of the Secretary

Bureau of Health Services Financing

Inpatient Hospital Services―Non-Rural, Non-State Hospitals Reimbursement Methodology Coverage of Hemophilia Blood Products (LAC 50:V.965)

The Department of Health and Hospitals, Office of the Secretary, Bureau of Health Services Financing has adopted LAC 50:V.965 in the Medical Assistance Program as authorized by R.S. 36:254 and pursuant to Title XIX of the Social Security Act. This Rule is promulgated in accordance with the provisions of the Administrative Procedure Act, R.S. 49:950 et seq.

Title 50

PUBLIC HEALTH―MEDICAL ASSISTANCE

Part V.  Hospital Services

Subpart 1.  Inpatient Hospitals

Chapter 9.Non-Rural, Non-State Hospitals

Subchapter B.Reimbursement Methodology

§965.Hemophilia Blood Products

A.Effective for dates of service on or after May 20, 2008, the Department of Health and Hospitals shall provide

additional reimbursements to certain non-rural, non-state acute care hospitals for the extraordinary costs incurred in purchasing blood products for certain Medicaid recipients diagnosed with, and receiving inpatient treatment for hemophilia.

B.Hospital Qualifications. To qualify for the additional reimbursement, the hospital must:

1.be classified as a major teaching hospital and contractually affiliated with a university located in Louisiana that is recognized by the Centers for Disease Control and Prevention and the Health Resource and Services Administration, Maternal and Child Health Bureau as maintaining a comprehensive hemophilia care center;
2.have provided clotting factors to a Medicaid recipient who has been diagnosed with hemophilia and has been hospitalized at the qualifying hospital for a period exceeding six days; and
3.have actual cost exceeding $50,000 for acquiring the blood products used in the provision of clotting factors during the hospitalization;
a.actual cost is the hospital's cost of acquiring blood products for the approved inpatient hospital dates of service as contained on the hospital’s original invoices, less all discount and rebate programs applicable to the invoiced products.

C.Reimbursement. Hospitals who meet the afore-mentioned qualifications may receive reimbursement for their actual costs that exceed $50,000 if the hospital submits a request for reimbursement to the Medicaid Program within 180 days of the patient’s discharge from the hospital.

1.The request for reimbursement shall be submitted in a format specified by the department.

AUTHORITY NOTE:Promulgated in accordance with R.S. 36:254 and Title XIX of the Social Security Act.

HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Office of the Secretary, Bureau of Health Services Financing, LR 34:2176 (October 2008).

Implementation of the provisions of this Rule may be contingent upon the approval of the U.S. Department of Health and Human Services, Center for Medicaid Services (CMS) if it is determined that submission to CMS for review and approval is required.

Alan Levine

Secretary

0810#099

RULE

Department of Health and Hospitals Office of the Secretary

Bureau of Health Services Financing

Minimum Licensing Standards for Adult Day Health Care (LAC 48:I.Chapter 42)

The Department of Health and Hospitals, Office of the Secretary, Bureau of Health Services Financing has adopted LAC 48:I.Chapter 42 in the Medical Assistance Program as authorized by R.S. 36:254 and R.S. 40:2120.41-46, and pursuant to Title XIX of the Social Security Act. This Rule is promulgated in accordance with the provisions of the

Louisiana Register   Vol. 34, No. 10   October 20, 2008

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