(a) This part shall not be construed to prohibit or restrict - (1) An insurer, hospital or medical service company, health maintenance organization, or any agent, or entity that administers benefit plans, or similar organizations from underwriting risks, classifying risks, or administering such risks that are based on or not inconsistent with State law; or (2) A person or organization covered by this part from establishing, sponsoring, observing or administering the terms of a bona fide benefit plan that are based on underwriting risks, classifying risks, or administering such risks that are based on or not inconsistent with State law; or (3) A person or organization covered by this part from establishing, sponsoring, observing or administering the terms of a bona fide benefit plan that is not subject to State laws that regulate insurance.
This is a very important designation because serious (or life-threatening) conditions are eligible for several drug review programs intended to speed drugs to market.
In my next post, I will attempt to explain what these programs are and how they might help those of us waiting for treatment.
(2) Nothing in this paragraph (c) shall be construed to encourage, prohibit, restrict, or authorize the conducting of testing for the illegal use of drugs.
(a) A public accommodation shall maintain in operable working condition those features of facilities and equipment that are required to be readily accessible to and usable by persons with disabilities by the Act or this part.
(a) When a place of public accommodation is located in a private residence, the portion of the residence used exclusively as a residence is not covered by this part, but that portion used exclusively in the operation of the place of public accommodation or that portion used both for the place of public accommodation and for residential purposes is covered by this part.
(b) The portion of the residence covered under paragraph (a) of this section extends to those elements used to enter the place of public accommodation, including the homeowner's front sidewalk, if any, the door or entryway, and hallways; and those portions of the residence, interior or exterior, available to or used by customers or clients, including restrooms.
During the stakeholder teleconference with FDA on September 13, 2012, Dr.
Sandra Kweder said that FDA considers ME/CFS to be a serious or life-threatening condition.
Subparts C and D of this part provide guidance on the application of the statute to specific situations.
The specific provisions, including the limitations on those provisions, control over the general provisions in circumstances where both specific and general provisions apply.
It is unclear to me whether FDA believes CFS is life-threatening.