[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4400 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4400

   To amend the Public Health Service Act to provide for an internet 
  website to provide educational materials for health care providers, 
 patients, and caregivers, regarding the meaning of the terms, and the 
  standards for review and licensing of, biological products, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 19, 2019

Mr. Bucshon (for himself and Mr. Engel) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
   To amend the Public Health Service Act to provide for an internet 
  website to provide educational materials for health care providers, 
 patients, and caregivers, regarding the meaning of the terms, and the 
  standards for review and licensing of, biological products, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Advancing Education on Biosimilars 
Act of 2019''.

SEC. 2. EDUCATION ON BIOLOGICAL PRODUCTS.

    (a) Website; Continuing Education.--Subpart 1 of part F of title 
III of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended 
by adding at the end the following:

``SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS.

    ``(a) Internet Website.--
            ``(1) In general.--The Secretary shall maintain and operate 
        an internet website to provide educational materials for health 
        care providers, patients, and caregivers, regarding the meaning 
        of the terms, and the standards for review and licensing of, 
        biological products, including biosimilar biological products 
        and interchangeable biosimilar biological products.
            ``(2) Content.--Educational materials provided under 
        paragraph (1) may include--
                    ``(A) explanations of key statutory and regulatory 
                terms, including `biosimilar' and `interchangeable', 
                and clarification regarding the use of interchangeable 
                biosimilar biological products;
                    ``(B) information related to development programs 
                for biological products, including biosimilar 
                biological products and interchangeable biosimilar 
                biological products and relevant clinical 
                considerations for prescribers, which may include, as 
                appropriate and applicable, information related to the 
                comparability of such biological products;
                    ``(C) an explanation of the process for reporting 
                adverse events for biological products, including 
                biosimilar biological products and interchangeable 
                biosimilar biological products; and
                    ``(D) an explanation of the relationship between 
                biosimilar biological products and interchangeable 
                biosimilar biological products licensed under section 
                351(k) and reference products (as defined in section 
                351(i)), including the standards for review and 
                licensing of each such type of biological product.
            ``(3) Format.--The educational materials provided under 
        paragraph (1) may be--
                    ``(A) in formats such as webinars, continuing 
                medical education modules, videos, fact sheets, 
                infographics, stakeholder toolkits, or other formats as 
                appropriate and applicable; and
                    ``(B) tailored for the unique needs of health care 
                providers, patients, caregivers, and other audiences, 
                as the Secretary determines appropriate.
            ``(4) Other information.--In addition to the information 
        described in paragraph (2), the Secretary shall continue to 
        publish the following information:
                    ``(A) The action package of each biological product 
                licensed under subsection (a) or (k).
                    ``(B) The summary review of each biological product 
                licensed under subsection (a) or (k).
            ``(5) Confidential and trade secret information.--This 
        subsection does not authorize the disclosure of any trade 
        secret, confidential commercial or financial information, or 
        other matter described in section 552(b) of title 5.
    ``(b) Continuing Education.--The Secretary shall advance education 
and awareness among health care providers regarding biological 
products, including biosimilar biological products and interchangeable 
biosimilar biological products, as appropriate, including by developing 
or improving continuing education programs that advance the education 
of such providers on the prescribing of, and relevant clinical 
considerations with respect to, biological products, including 
biosimilar biological products and interchangeable biosimilar 
biological products.''.
    (b) Application Under the Medicare Merit-Based Incentive Payment 
System.--Section 1848(q)(5)(C) of the Social Security Act (42 U.S.C. 
1395w-4(q)(5)(C)) is amended by adding at the end the following new 
clause:
                            ``(iv) Clinical medical education program 
                        on biosimilar biological products.--Completion 
                        of a clinical medical education program 
                        developed or improved under section 352A(b) of 
                        the Public Health Service Act by a MIPS 
                        eligible professional during a performance 
                        period shall earn such eligible professional 
                        one-half of the highest potential score for the 
                        performance category described in paragraph 
                        (2)(A)(iii) for such performance period. A MIPS 
                        eligible professional may only count the 
                        completion of such a program for purposes of 
                        such category one time during the eligible 
                        professional's lifetime.''.
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