California Declaration of Compliance
Halt Medical, Inc. is committed to ensuring compliance with its company policies and with applicable laws and regulations following the highest standards of corporate conduct. Halt Medical’s compliance program is in accordance with California Health and Safety Code, §119402, the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers” developed by the United States Department of Health and Human Services Office of Inspector General (OIG). This program incorporates policies that comply with the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Healthcare Professionals”. The OIG Guidance acknowledges that the implementation of a compliance program cannot ensure that improper employee conduct will never occur. Nonetheless, Halt Medical expects and requires its employees to abide by Halt Medical’s policies and internal requirements described in the program.
Halt Medical declares, to the best of its knowledge and based on its good faith understanding of the statutory requirements that Halt Medical is in compliance with Comprehensive Compliance Program and Chapter 8, Part 15, Division 104 of the California Health and Safety Code.
Halt Medical has set the annual aggregate limit on covered promotional expenditures at $5,000-$10,000 per covered medical or healthcare professional for annual periods. This limit may be revised by Halt Medical from time to time to match the region or area. The foregoing limit does not represent any usual, customary, average, or typical amount for medical or health care professionals.
Halt Medical exempts certain expenditures from this limit based upon a good faith understanding of California Health & Safety Code §§ 119400-119402 and the PhRMA Code. Such exemptions include:
- Device samples given to physicians and healthcare professionals intended for free distribution to patients;
- Financial support for continuing medical education forums;
- Financial support for health educational scholarships;
- Payments made for legitimate professional services provided by a healthcare or medical professional that are provided at the fair market value for the services rendered; and
- Documents, informational or educational brochures, and other items that inform medical or healthcare professional about Halt Medical products, provide scientific and educational data, support medical research and education, or enhance a patient’s understanding or management of a disease state or disorder.
This program became effective as of July 1, 2014. Halt Medical will assess it’s the program at least annually. A copy of our compliance program may be obtained by calling (925) 634-7943.