Obey the Law, Obey CoPs Standard 484.100

The Conditions of Participation (CoPs) cover many different areas that effect home health agencies (HHAs) including compliance with the law.  Standard 484.100 addresses compliance with federal, state and local laws and regulations regarding the health and safety of patients.  In addition, it covers state or local law licensing of HHAs that must be followed in order to operate.  In our continuing series on CoPs, we will cover how compliance with the law is covered in standard 484.100.

Disclosure of Ownership and Management Information

Besides complying with the requirements of part 420 subpart C of this standard’s chapter, the HHA must also disclose the information listed below, commonly called an 855.  It must be provided to the state survey agency at the time of the HHA’s initial request for certification, for every survey, and when there is any change in ownership or management.

  • The names and addresses of all persons with an ownership or controlling interest in the HHA. This is further defined in §420.201, §420.202, and §420.206 of the chapter relating to standard 484.100.

 

  • The name and address of each person who is an officer, a director, an agent, or a managing employee of the HHA as defined in §420.201, §420.202, and §420.206 of this chapter.

 

  • The name and business address of the corporation, association, or other company that is responsible for the management of the HHA, and the names and addresses of the chief executive officer and the chairperson of the board of directors of that corporation, association, or other company responsible for the management of the HHA.

 

Licensing

Also, licensing is a critical element of standard 484.100.  According to it, the home health agency (including branches) and all persons furnishing services to patients must be licensed, certified or registered, as applicable, in accordance with the state licensing authority as meeting those requirements.

Laboratory Services

Laboratory services is another area that must be in compliance with the law.  Below are the areas specifically called out relating to our CLIA (Clinical Laboratory Improvement Amendment of 1988) laws:

  • If the HHA refers specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter.

 

  • If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter.

New in the regulations is that the HHA may not substitute its equipment for a patient’s equipment when assisting with self-administered tests.

Below is the very important response to comments in the Final Rule:

HHAs may not substitute HHA-owned self-administered testing equipment for patient-owned self-administered testing equipment.

‘‘Agencies may also use their own self-administered testing equipment for a short, defined period of time when the patient has not yet obtained his or her own testing equipment, such as in the days immediately following physician orders to obtain the testing equipment when a patient may not have the time and resources immediately available to complete the process.

We would expect the HHA to use available resources to assist the patient in obtaining his or her own testing equipment as quickly as possible.

…Enabling patients to use their own equipment will improve the quality of care management they experience and will avoid the potential for a patient to not have access to any testing equipment in emergency situations when HHA staff may not be immediately available to provide it.

In cases specifically related to the use of self-administered testing equipment for purposes of blood glucose monitoring, if, despite all HHA efforts to help patients identify and access existing resources that mitigate or alleviate any potential barriers to obtaining this essential equipment, a patient refuses to obtain his or her own testing equipment, and if the patient is receiving the Medicare home health benefit, then the refusal to obtain self-administered testing could be grounds for patient discharge.

Daily, and multiple daily visits for purposes of blood glucose monitoring over a long period of time would not meet the criteria for coverage of Medicare home health services which prohibits payment for services that are more than part-time or intermittent.

Therefore, an HHA would be permitted to discharge the patient because the payment source will no longer pay”.

Further Info on the CLIA Waiver

The CLIA also has been effected by CoPs.  Below is the Final Rule Response:

“If the HHA is only assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the FDA (regardless of appliance ownership status), testing self-administration assistance is not required to be in compliance with the applicable requirements of part 493 of this chapter (CLIA).

However, if the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, then the testing must be in compliance with all applicable requirements of part 493 of this chapter.”

Ensuring Compliance

When CMS, the State or accrediting body come knocking on your agency’s door be sure you are ready.  It is critical that you and your staff are in compliance per standard 484.100.  Our team at 5 Star Consultants can provide you with a high level or in-depth overview of the revised CoPs.  For further information about these training options and the many others we offer, please contact us at [email protected] or 866-428-4040.

Source:  CMS.gov website

Southern Web SupportObey the Law, Obey CoPs Standard 484.100
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