MEDICARE COVERAGE POLICY DECISIONS

The Centers for Medicare & Medicaid Services (CMS) is a Federal agency within the U.S. Department of Health and Human Services. Programs for which CMS is responsible include Medicare, Medicaid, State Children's Health Insurance Program (SCHIP), HIPAA, and CLIA. To learn more about CMS, visit About CMS.

CMS, who administers Medicare, the nation's largest health insurance program, which covers over 39 million Americans, and provides health insurance to people age 65 and over, those who have permanent kidney failure, and certain people with disabilities, recently made some important positive coverage decisions that relate to ACP programs. Please view them below by clinking on the links.

December 7, 2000 Ruling:

Decision Memorandum on Pelvic Floor Electrical Stimulation for Treatment of Urinary Incontinence <<Program Memorandum AB-00-120>>
EFFECTIVE DATE: April 1, 2001
IMPLEMENTATION DATE: April 1, 2001

Section 60-24, Non- Implantable Pelvic Floor Electrical Stimulator, permits coverage for non- implantable pelvic floor electrical stimulators for the treatment of stress and/or urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training. A failed trial of PME training is defined as no clinically significant improvement in urinary continence after completing 4 weeks of an ordered plan of pelvic muscle exercises designed to increase periurethral muscle strength.

NOVEMBER 8, 2002 Ruling:

Decision Memorandum on Electrical Stimulation for Treatment of Wounds <<Program Memorandum AB-02-161>>
EFFECTIVE DATE: April 1, 2003
IMPLEMENTATION DATE: April 1, 2003

SUBJECT: Coverage and Billing Requirements for Electrical Stimulation for the Treatment of Wounds

For services performed on or after April 1, 2003. Medicare will cover electrical stimulation for the treatment of wounds only for chronic Stage III or Stage IV pressure ulcers, arterial ulcers, diabetic ulcers and venous stasis ulcers. All other uses of electrical stimulation for the treatment of wounds are not covered by Medicare. Electrical stimulation will not be covered as an initial treatment modality.

The use of electrical stimulation will only be covered after appropriate standard wound care has been tried for at least 30 days and there are no measurable signs of healing. If electrical stimulation is being used, wounds must be evaluated periodically by the treating physician, but no less than every 30 days by a physician. Continued treatment with electrical stimulation is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment. Additionally, electrical stimulation must be discontinued when the wound demonstrates a 100% epithelialzed wound bed.

March 19, 2004 Ruling:

National Coverage Decision (NCD) on Electromagnetic Therapy for Treatment of Wounds <<Publication 100-03>>
EFFECTIVE DATE: July 1, 2004
IMPLEMENTATION DATE: July 6, 2004

SUMMARY OF CHANGES: A reconsideration review of electromagnetic therapy for the treatment of wounds was conducted and results were found to be similar to those for electrical stimulation for the treatment of wounds. Therefore, effective July 1, 2004, CMS will cover electromagnetic therapy for the treatment of wounds for the same settings and conditions electrical stimulation for the treatment of wounds is currently covered. This means that Medicare will allow either one covered ES therapy or one covered electromagnetic therapy for the treatment of wounds

FDA Registration

ACP is subject to United States Government medical device laws administered by the Food and Drug Administration (FDA). ACP is classified as an importer, re-packager, specification developer and distributor for FDA reporting
purposes. ACP complies with FDA Good Manufacturing Practice (GMP)
regulations.

Currently marketed devices are all registered and approved under FDA 510K
requirements and qualifications. Subcontractors utilized meet ISO9000
regulations. All ACP devices are ISO9000 compliant and are CE marked, which
permits international export.

ACP's FDA Registration information is below:

Establishment Registration Database

Establishment:

ACCELERATED CARE PLUS CORP.
9855 Double R Blvd.
Reno, NV 89521
Registration Number: 1911273
Operations: Initial Distributor, Repackager/Relabeller, Specification
Developer
Status: Active
Date of Registration Status: 2005

Owner/Operator:

ACCELERATED CARE PLUS CORP.
9855 Double R Blvd.
Reno, NV 89521
Owner/Operator Number:
1911273

Official Correspondent:

Mr. Zlatko Larry Hodin
ACCELERATED CARE PLUS CORP.
9855 Double R Blvd.
Reno, NV 89521
Phone: 775-685-4000

To view ACP's FDA Registration, click here and perform a search.