II 

117TH CONGRESS 

1ST SESSION S. 754 

To provide health insurance benefits for outpatient and inpatient items and 

services related to the diagnosis and treatment of a congenital anomaly 

or birth defect. 

IN THE SENATE OF THE UNITED STATES 

MARCH 16, 2021 

Ms. BALDWIN (for herself, Ms. ERNST, Mr. BROWN, Ms. MURKOWSKI, Ms. 

KLOBUCHAR, Mr. MARSHALL, Mrs. SHAHEEN, Mr. WICKER, Mr. WHITEHOUSE, Mr. TILLIS, Ms. STABENOW, Mr. CRAMER, Mr. VAN HOLLEN, 

Mr. BOOZMAN, Mr. PETERS, Ms. COLLINS, Mr. MARKEY, Mrs. CAPITO, 

Mr. BOOKER, Mr. GRAHAM, Ms. SMITH, Mr. GRASSLEY, Ms. SINEMA, 

Mr. MORAN, Mr. MURPHY, Mr. DAINES, Mr. BLUMENTHAL, Mr. BRAUN, 

and Mr. REED) introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide health insurance benefits for outpatient and inpatient items and services related to the diagnosis and 

treatment of a congenital anomaly or birth defect. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Lasting 

5 Smiles Act’’. 


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1 SEC. 2. COVERAGE OF CONGENITAL ANOMALY OR BIRTH 

2 DEFECT. 

3 (a) PUBLIC HEALTH SERVICE ACT AMENDMENTS.— 

4 Part D of title XXVII of the Public Health Service Act 

5 (42 U.S.C. 300gg–111 et seq.) is amended by adding at 

6 the end the following new section: 

7 ‘‘SEC. 2799A–11. STANDARDS RELATING TO BENEFITS FOR 

8 CONGENITAL ANOMALY OR BIRTH DEFECT. 

9 ‘‘(a) REQUIREMENTS FOR CARE AND RECONSTRUC10 TIVE TREATMENT.— 

11 ‘‘(1) IN GENERAL.—A group health plan, and a 

12 health insurance issuer offering group or individual 

13 health insurance coverage, shall provide coverage for 

14 outpatient and inpatient items and services related 

15 to the diagnosis and treatment of a congenital 

16 anomaly or birth defect. 

17 ‘‘(2) REQUIREMENTS.— 

18 ‘‘(A) IN GENERAL.—Coverage provided 

19 under paragraph (1) shall include any medically 

20 necessary item or service to functionally im21 prove, repair, or restore any body part to 

22 achieve normal body functioning or appearance, 

23 as determined by the treating physician (as de24 fined in section 1861(r) of the Social Security 

25 Act), due to congenital anomaly or birth defect. 


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1 ‘‘(B) FINANCIAL REQUIREMENTS AND

2 TREATMENT REQUIREMENTS.—Any coverage 

3 provided under paragraph (1) under a group 

4 health plan or individual or group health insur5 ance coverage offered by a health insurance 

6 issuer may be subject to coverage limits (such 

7 as medical necessity, pre-authorization, or pre8 certification) and cost-sharing requirements 

9 (such as coinsurance, copayments, and 

10 deductibles), as required by the plan or issuer, 

11 that are no more restrictive than the predomi12 nant coverage limits and cost-sharing require13 ments, respectively, applied to substantially all 

14 medical and surgical benefits covered by the 

15 plan (or coverage). 

16 ‘‘(3) TREATMENT DEFINED.—In this section: 

17 ‘‘(A) IN GENERAL.—Except as provided in 

18 subparagraph (B), the term ‘treatment’ in19 cludes, with respect to a group health plan or 

20 group or individual health insurance coverage 

21 offered by a health insurance issuer, inpatient 

22 and outpatient items and services performed to 

23 improve, repair, or restore bodily function (or 

24 performed to approximate a normal appear25 ance), due to a congenital anomaly or birth deVerDate Sep 11 2014 18:14 Apr 09, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S754.IS S754

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1 fect, and includes treatment to any and all 

2 missing or abnormal body parts (including 

3 teeth, the oral cavity, and their associated 

4 structures) that would otherwise be provided 

5 under the plan or coverage for any other injury 

6 or sickness, including— 

7 ‘‘(i) any items or services, including 

8 inpatient and outpatient care, reconstruc9 tive services and procedures, and complica10 tions thereof; 

11 ‘‘(ii) adjunctive dental, orthodontic, or 

12 prosthodontic support from birth until the 

13 medical or surgical treatment of the defect 

14 or anomaly has been completed, including 

15 ongoing or subsequent treatment required 

16 to maintain function or approximate a nor17 mal appearance; 

18 ‘‘(iii) procedures that materially im19 prove, repair, or restore bodily function; 

20 and 

21 ‘‘(iv) procedures for secondary condi22 tions and follow-up treatment associated 

23 with the underlying congenital anomaly or 

24 birth defect. 


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1 ‘‘(B) EXCEPTION.—The term ‘treatment’ 

2 shall not include cosmetic surgery performed to 

3 reshape normal structures of the body to im4 prove appearance or self-esteem. 

5 ‘‘(b) NOTICE.—A group health plan under this part 

6 shall comply with the notice requirement under section 

7 714(c) of the Employee Retirement Income Security Act 

8 of 1974 with respect to the requirements of this section 

9 as if such section applied to such plan.’’. 

10 (b) ERISA AMENDMENTS.— 

11 (1) IN GENERAL.—Subpart B of part 7 of sub12 title B of title I of the Employee Retirement Income 

13 Security Act of 1974 is amended by adding at the 

14 end the following: 

15 ‘‘SEC. 726. STANDARDS RELATING TO BENEFITS FOR CON16 GENITAL ANOMALY OR BIRTH DEFECT. 

17 ‘‘(a) REQUIREMENTS FOR CARE AND RECONSTRUC18 TIVE TREATMENT.— 

19 ‘‘(1) IN GENERAL.—A group health plan, and a 

20 health insurance issuer offering group health insur21 ance coverage, shall provide coverage for outpatient 

22 and inpatient items and services related to the diag23 nosis and treatment of a congenital anomaly or birth 

24 defect. 

25 ‘‘(2) REQUIREMENTS.— 


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•S 754 IS

1 ‘‘(A) IN GENERAL.—Coverage provided 

2 under paragraph (1) shall include any medically 

3 necessary item or service to functionally im4 prove, repair, or restore any body part to 

5 achieve normal body functioning or appearance, 

6 as determined by the treating physician (as de7 fined in section 1861(r) of the Social Security 

8 Act), due to congenital anomaly or birth defect. 

9 ‘‘(B) FINANCIAL REQUIREMENTS AND

10 TREATMENT REQUIREMENTS.—Any coverage 

11 provided under paragraph (1) under a group 

12 health plan or group health insurance coverage 

13 offered by a health insurance issuer may be 

14 subject to coverage limits (such as medical ne15 cessity, pre-authorization, or pre-certification) 

16 and cost-sharing requirements (such as coinsur17 ance, copayments, and deductibles), as required 

18 by the plan or issuer, that are no more restric19 tive than the predominant coverage limits and 

20 cost-sharing requirements, respectively, applied 

21 to substantially all medical and surgical benefits 

22 covered by the plan (or coverage). 

23 ‘‘(3) TREATMENT DEFINED.—In this section: 

24 ‘‘(A) IN GENERAL.—Except as provided in 

25 subparagraph (B), the term ‘treatment’ inVerDate Sep 11 2014 18:14 Apr 09, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S754.IS S754

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1 cludes, with respect to a group health plan or 

2 group health insurance coverage offered by a 

3 health insurance issuer, inpatient and out4 patient items and services performed to im5 prove, repair, or restore bodily function (or per6 formed to approximate a normal appearance), 

7 due to a congenital anomaly or birth defect, and 

8 includes treatment to any and all missing or ab9 normal body parts (including teeth, the oral 

10 cavity, and their associated structures) that 

11 would otherwise be provided under the plan or 

12 coverage for any other injury or sickness, in13 cluding— 

14 ‘‘(i) any items or services, including 

15 inpatient and outpatient care, reconstruc16 tive services and procedures, and complica17 tions thereof; 

18 ‘‘(ii) adjunctive dental, orthodontic, or 

19 prosthodontic support from birth until the 

20 medical or surgical treatment of the defect 

21 or anomaly has been completed, including 

22 ongoing or subsequent treatment required 

23 to maintain function or approximate a nor24 mal appearance; 


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1 ‘‘(iii) procedures that materially im2 prove, repair, or restore bodily function; 

3 and 

4 ‘‘(iv) procedures for secondary condi5 tions and follow-up treatment associated 

6 with the underlying congenital anomaly or 

7 birth defect. 

8 ‘‘(B) EXCEPTION.—The term ‘treatment’ 

9 shall not include cosmetic surgery performed to 

10 reshape normal structures of the body to im11 prove appearance or self-esteem. 

12 ‘‘(b) NOTICE.—A group health plan under this part 

13 shall comply with the notice requirement under section 

14 714(c) with respect to the requirements of this section as 

15 if such section applied to such plan.’’. 

16 (2) TECHNICAL AMENDMENTS.— 

17 (A) Section 732(a) of such Act (29 U.S.C. 

18 1191a(a)) is amended by striking ‘‘section 711’’ 

19 and inserting ‘‘sections 711 and 726’’. 

20 (B) The table of contents in section 1 of 

21 such Act is amended by inserting after the item 

22 relating to section 725 the following new item: 

‘‘Sec. 726. Standards relating to benefits for congenital anomaly or birth defect.’’ 

23 (c) INTERNAL REVENUE CODE AMENDMENTS.— 


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1 (1) IN GENERAL.—Subchapter B of chapter 

2 100 of the Internal Revenue Code of 1986 is amend3 ed by adding at the end the following: 

4 ‘‘SEC. 9826. STANDARDS RELATING TO BENEFITS FOR CON5 GENITAL ANOMALY OR BIRTH DEFECT. 

6 ‘‘(a) REQUIREMENTS FOR CARE AND RECONSTRUC7 TIVE TREATMENT.— 

8 ‘‘(1) IN GENERAL.—A group health plan shall 

9 provide coverage for outpatient and inpatient items 

10 and services related to the diagnosis and treatment 

11 of a congenital anomaly or birth defect. 

12 ‘‘(2) REQUIREMENTS.— 

13 ‘‘(A) IN GENERAL.—Coverage provided 

14 under paragraph (1) shall include any medically 

15 necessary item or service to functionally im16 prove, repair, or restore any body part to 

17 achieve normal body functioning or appearance, 

18 as determined by the treating physician (as de19 fined in section 1861(r) of the Social Security 

20 Act), due to congenital anomaly or birth defect. 

21 ‘‘(B) FINANCIAL REQUIREMENTS AND

22 TREATMENT REQUIREMENTS.—Any coverage 

23 provided under paragraph (1) under a group 

24 health plan may be subject to coverage limits 

25 (such as medical necessity, pre-authorization, or 


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1 pre-certification) and cost-sharing requirements 

2 (such as coinsurance, copayments, and 

3 deductibles), as required by the plan, that are 

4 no more restrictive than the predominant cov5 erage limits and cost-sharing requirements, re6 spectively, applied to substantially all medical 

7 and surgical benefits covered by the plan. 

8 ‘‘(3) TREATMENT DEFINED.—In this section: 

9 ‘‘(A) IN GENERAL.—Except as provided in 

10 subparagraph (B), the term ‘treatment’ in11 cludes, with respect to a group health plan, in12 patient and outpatient items and services per13 formed to improve, repair, or restore bodily 

14 function (or performed to approximate a normal 

15 appearance), due to a congenital anomaly or 

16 birth defect, and includes treatment to any and 

17 all missing or abnormal body parts (including 

18 teeth, the oral cavity, and their associated 

19 structures) that would otherwise be provided 

20 under the plan for any other injury or sickness, 

21 including— 

22 ‘‘(i) any items or services, including 

23 inpatient and outpatient care, reconstruc24 tive services and procedures, and complica25 tions thereof; 


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1 ‘‘(ii) adjunctive dental, orthodontic, or 

2 prosthodontic support from birth until the 

3 medical or surgical treatment of the defect 

4 or anomaly has been completed, including 

5 ongoing or subsequent treatment required 

6 to maintain function or approximate a nor7 mal appearance; 

8 ‘‘(iii) procedures that materially im9 prove, repair, or restore bodily function; 

10 and 

11 ‘‘(iv) procedures for secondary condi12 tions and follow-up treatment associated 

13 with the underlying congenital anomaly or 

14 birth defect. 

15 ‘‘(B) EXCEPTION.—The term ‘treatment’ 

16 shall not include cosmetic surgery performed to 

17 reshape normal structures of the body to im18 prove appearance or self-esteem. 

19 ‘‘(b) NOTICE.—A group health plan under this part 

20 shall comply with the notice requirement under section 

21 714(c) of the Employee Retirement Income Security Act 

22 of 1974 with respect to the requirements of this section 

23 as if such section applied to such plan.’’. 


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1 (2) CLERICAL AMENDMENT.—The table of sec2 tions for such subchapter is amended by adding at 

3 the end the following new item: 

‘‘Sec. 9826. Standards relating to benefits for congenital anomaly or birth defect.’’. 

4 (d) RULE OF CONSTRUCTION.—A group health plan 

5 or health insurance issuer shall provide the benefits de6 scribed in section 2799A–11 of the Public Health Service 

7 Act (as added by subsection (a)), section 726 of the Em8 ployee Retirement Income Security Act of 1974 (as added 

9 by subsection (b)), and section 9826 of the Internal Rev10 enue Code of 1986 (as added by subsection (c)) under the 

11 terms of such plan or health insurance coverage offered 

12 by such issuer. 

13 (e) CLARIFYING AMENDMENT REGARDING APPLICA14 TION TO GRANDFATHERED PLANS.—Section 

15 1251(a)(4)(A) of the Patient Protection and Affordable 

16 Care Act (42 U.S.C. 18011(a)(4)(A)), is amended by add17 ing at the end the following: 

18 ‘‘(v) Section 2799A–11 (relating to 

19 standards relating to benefits for con20 genital anomaly or birth defect), as added 

21 by section 2(a) of the Ensuring Lasting 

22 Smiles Act.’’. 

23 (f) EFFECTIVE DATE.—The amendments made by 

24 this section shall apply with respect to group health plans 


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1 for plan years beginning on or after January 1, 2022, and 

2 with respect to health insurance coverage offered, sold, 

3 issued, renewed, in effect, or operated in the individual 

4 market on or after such date. 

5 (g) COORDINATED REGULATIONS.—Section 104(1) 

6 of the Health Insurance Portability and Accountability 

7 Act of 1996 is amended by striking ‘‘this subtitle (and 

8 the amendments made by this subtitle and section 401)’’ 

9 and inserting ‘‘the provisions of part 7 of subtitle B of 

10 title I of the Employee Retirement Income Security Act 

11 of 1974, the provisions of parts A, C, and D of title XXVII 

12 of the Public Health Service Act, and chapter 100 of the 

13 Internal Revenue Code of 1986’’. 

Æ 


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