PROTECT for Rare Act

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 3551 Introduced in Senate (IS)] <DOC> 119th CONGRESS 1st Session S. 3551 To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to provide for coverage of certain drugs used in the treatment or management of a rare disease or condition, and for other purposes. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES December 17, 2025 Mr. Tillis (for himself and Mr. Heinrich) introduced the following bill; which was read twice and referred to the Committee on Finance _______________________________________________________________________ A BILL To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to provide for coverage of certain drugs used in the treatment or management of a rare disease or condition, 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 ``Providing Realistic Opportunity To Equal and Comparable Treatment for Rare Act'' or the ``PROTECT for Rare Act''. SEC. 2. COVERAGE OF CERTAIN DRUGS USED IN TREATMENT OR MANAGEMENT OF A RARE DISEASE OR CONDITION. (a) Medicare.-- (1) Definition.-- (A) In general.--Section 1861(t)(2) of the Social Security Act (42 U.S.C. 1395x(t)(2)) is amended-- (i) in subparagraph (A), by inserting after ``regimen'' the following: ``, or used in the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States,''; and (ii) in subparagraph (B)(ii)-- (I) in subclause (I), by striking ``, or'' at the end and inserting a semicolon; (II) in subclause (II), by striking the period at the end and inserting ``; or''; and (III) by adding at the end the following new subclause: ``(III) in the case of a drug that is used in the