[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3528 Reported in House (RH)]

<DOC>





                                                 Union Calendar No. 582
115th CONGRESS
  2d Session
                                H. R. 3528

                      [Report No. 115-748, Part I]

     To amend title XVIII of the Social Security Act to require e-
   prescribing for coverage under part D of the Medicare program of 
           prescription drugs that are controlled substances.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 28, 2017

Ms. Clark of Massachusetts (for herself and Mr. Mullin) 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

                             June 12, 2018

Additional sponsors: Mr. Higgins of New York, Ms. Esty of Connecticut, 
   Mr. Himes, Mr. Kennedy, Mr. Kelly of Pennsylvania, Mr. Tonko, Mr. 
 Panetta, Mr. Donovan, Mr. King of New York, Mr. Budd, Mr. Katko, Mr. 
 Long, Mr. Thompson of Pennsylvania, Ms. Stefanik, Mr. Collins of New 
York, Mr. MacArthur, Ms. Shea-Porter, Ms. Slaughter, Mrs. Walorski, Mr. 
       Norcross, Mr. Moulton, Mr. Jenkins of West Virginia, Mr. 
 Krishnamoorthi, Mr. Flores, Mr. Ryan of Ohio, Ms. Jenkins of Kansas, 
Mr. Payne, Ms. Hanabusa, Mr. Knight, Mr. Schneider, Mr. Schweikert, Ms. 
Titus, Mr. Faso, Ms. Kuster of New Hampshire, Ms. DeGette, Mr. Yarmuth, 
    Mr. Pocan, Ms. Wasserman Schultz, Ms. Bonamici, Mr. Cohen, Mr. 
 O'Halleran, Mr. Renacci, Mr. Hastings, Mrs. Blackburn, Mr. Poliquin, 
Mrs. Handel, Mr. Walden, Mr. Fitzpatrick, Mr. Cramer, and Mr. Brooks of 
                                Alabama


                             June 12, 2018

  Reported from the Committee on Energy and Commerce with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

                             June 12, 2018

The Committee on Ways and Means discharged; committed to the Committee 
 of the Whole House on the State of the Union and ordered to be printed
 [For text of introduced bill, see copy of bill as introduced on July 
                               28, 2017]

_______________________________________________________________________

                                 A BILL


 
     To amend title XVIII of the Social Security Act to require e-
   prescribing for coverage under part D of the Medicare program of 
           prescription drugs that are controlled substances.


 


    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 ``Every Prescription Conveyed Securely 
Act''.

SEC. 2. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED PART D 
              CONTROLLED SUBSTANCES.

    (a) In General.--Section 1860D-4(e) of the Social Security Act (42 
U.S.C. 1395w-104(e)) is amended by adding at the end the following:
            ``(7) Requirement of e-prescribing for controlled 
        substances.--
                    ``(A) In general.--Subject to subparagraph (B), a 
                prescription for a covered part D drug under a 
                prescription drug plan (or under an MA-PD plan) for a 
                schedule II, III, IV, or V controlled substance shall 
                be transmitted by a health care practitioner 
                electronically in accordance with an electronic 
                prescription drug program that meets the requirements 
                of paragraph (2).
                    ``(B) Exception for certain circumstances.--The 
                Secretary shall, pursuant to rulemaking, specify 
                circumstances with respect to which the Secretary may 
                waive the requirement under subparagraph (A), with 
                respect to a covered part D drug, including in the case 
                of--
                            ``(i) a prescription issued when the 
                        practitioner and dispenser are the same entity;
                            ``(ii) a prescription issued that cannot be 
                        transmitted electronically under the most 
                        recently implemented version of the National 
                        Council for Prescription Drug Programs SCRIPT 
                        Standard;
                            ``(iii) a prescription issued by a 
                        practitioner who has received a waiver or a 
                        renewal thereof for a specified period 
                        determined by the Secretary, not to exceed one 
                        year, from the requirement to use electronic 
                        prescribing, pursuant to a process established 
                        by regulation by the Secretary, due to 
                        demonstrated economic hardship, technological 
                        limitations that are not reasonably within the 
                        control of the practitioner, or other 
                        exceptional circumstance demonstrated by the 
                        practitioner;
                            ``(iv) a prescription issued by a 
                        practitioner under circumstances in which, 
                        notwithstanding the practitioner's ability to 
                        submit a prescription electronically as 
                        required by this subsection, such practitioner 
                        reasonably determines that it would be 
                        impractical for the individual involved to 
                        obtain substances prescribed by electronic 
                        prescription in a timely manner, and such delay 
                        would adversely impact the individual's medical 
                        condition involved;
                            ``(v) a prescription issued by a 
                        practitioner allowing for the dispensing of a 
                        non-patient specific prescription pursuant to a 
                        standing order, approved protocol for drug 
                        therapy, collaborative drug management, or 
                        comprehensive medication management, in 
                        response to a public health emergency, or other 
                        circumstances where the practitioner may issue 
                        a non-patient specific prescription;
                            ``(vi) a prescription issued by a 
                        practitioner prescribing a drug under a 
                        research protocol;
                            ``(vii) a prescription issued by a 
                        practitioner for a drug for which the Food and 
                        Drug Administration requires a prescription to 
                        contain elements that are not able to be 
                        included in electronic prescribing, such as a 
                        drug with risk evaluation and mitigation 
                        strategies that include elements to assure safe 
                        use; and
                            ``(viii) a prescription issued by a 
                        practitioner for an individual who--
                                    ``(I) receives hospice care under 
                                this title; or
                                    ``(II) is a resident of a skilled 
                                nursing facility (as defined in section 
                                1819(a)), or a medical institution or 
                                nursing facility for which payment is 
                                made for an institutionalized 
                                individual under section 1902(q)(1)(B), 
                                for which frequently abused drugs are 
                                dispensed for residents through a 
                                contract with a single pharmacy, as 
                                determined by the Secretary in 
                                accordance with this paragraph.
                    ``(C) Dispensing.--Nothing in this paragraph shall 
                be construed as requiring a sponsor of a prescription 
                drug plan under this part, MA organization offering an 
                MA-PD plan under part C, or a pharmacist to verify that 
                a practitioner, with respect to a prescription for a 
                covered part D drug, has a waiver (or is otherwise 
                exempt) under subparagraph (B) from the requirement 
                under subparagraph (A). Nothing in this paragraph shall 
                be construed as affecting the ability of the plan to 
                cover or the pharmacists' ability to continue to 
                dispense covered part D drugs from otherwise valid 
                written, oral or fax prescriptions that are consistent 
                with laws and regulations. Nothing in this paragraph 
                shall be construed as affecting the ability of the 
                beneficiary involved to designate a particular pharmacy 
                to dispense a prescribed drug to the extent consistent 
                with the requirements under subsection (b)(1) and under 
                this paragraph.
                    ``(D) Enforcement.--The Secretary shall, pursuant 
                to rulemaking, have authority to enforce and specify 
                appropriate penalties for non-compliance with the 
                requirement under subparagraph (A).''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to coverage of drugs prescribed on or after January 1, 2021.
                                                 Union Calendar No. 582

115th CONGRESS

  2d Session

                               H. R. 3528

                      [Report No. 115-748, Part I]

_______________________________________________________________________

                                 A BILL

     To amend title XVIII of the Social Security Act to require e-
   prescribing for coverage under part D of the Medicare program of 
           prescription drugs that are controlled substances.

_______________________________________________________________________

                             June 12, 2018

  Reported from the Committee on Energy and Commerce with an amendment

                             June 12, 2018

The Committee on Ways and Means discharged; committed to the Committee 
 of the Whole House on the State of the Union and ordered to be printed