Notwithstanding any other provision of this Act, the Secretary of Health and Human Services shall not promulgate any regulation that-
(1) creates any unreasonable barriers to the ability of individuals to obtain appropriate medical care;
(2) impedes timely access to health care services;
(3) interferes with communications regarding a full range of treatment options between the patient and the provider;
(4) restricts the ability of health care providers to provide full disclosure of all relevant information to patients making health care decisions;
(5) violates the principles of informed consent and the ethical standards of health care professionals; or
(6) limits the availability of health care treatment for the full duration of a patient’s medical needs.
The passage of health care reform requires the creation of numerous regulations from various Health and Human Service (HHS) agencies such as the Food and Drug Administration and the Centers for Medicare and Medicaid. Regulations will provide substantive detail that will spell out what is included in the new health law (see short note below from Columbia University on The Regulatory Process).Â The HHS Secretary shall not put into effect any regulation that thwarts access to therapies and appropriate medical care.Â
What does this mean for the bleeding disorders community?
Regulations created by HHS should not put into effect any regulation that will impede access to care and therapies.Â This provision (notwithstanding any other provision of the new health law) is a step towards protecting access to products and appropriate medical care for people with bleeding disorders.
Note:Â Short explanation of the regulatory process – “When Congress passes a law, often it cannot describe every detail of the implementation of that law. Instead, it authorizes various executive departments and agencies to write the rules and regulations which implement the intent of the law. Congress will describe the broad area of regulatory mandate, but the executive agency is responsible for filling in the specifics and administering the regulations, via the Federal Register, the Code of Federal Regulations (CFR), and other administrative decisions.”