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HR 3 - Lower Drug Costs Now Act of 2019 - National Key Vote

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Title: Lower Drug Costs Now Act of 2019

Vote Smart's Synopsis:

Vote to pass a bill that authorizes the Department of Health and Human Services to negotiate the prices of prescription drugs.

Highlights:

 

  • Requires the Secretary of the Department of Health and Human Services (HHS) to establish a Fair Negotiation Program, under which the Secretary will (Sec. 1191):

    • Publish a list of selected drugs; 

    • Enter into agreements with selected drug manufacturers; 

    • Negotiate and, if applicable, renegotiate maximum fair prices for selected drugs; and 

    • Carry out administrative duties. 

  • Defines “maximum fair price” as the price published in the Federal Register for a specific drug in a specific year, as required in section 1195 (Sec. 1191).

  • Requires the HHS Secretary to select and publish in the Federal Register a list of the following as “selected drugs” (Sec. 1192):

    • At least 25 negotiation-eligible drugs during 2023; 

    • At least 50 negotiation-eligible drugs during 2024 or a subsequent year;

    • All negotiation-eligible drugs; and 

    • All new-entrant negotiation-eligible drugs with respect to each year. 

  • Amends the Social Security Act to state that the out-of-pocket threshold for Medicare enrollees is $2,000 for the year 2022 (Sec. 301).

  • Requires the HHS Secretary to report to each Medicare part B single-source drug manufacturer that has prices increasing faster than inflation and therefore requires providing a rebate to consumers, the following, no later than 6 months after the end of each quarter beginning on or after July 1, 2021 (Sec 201):

    • Information on the total number of units of the billing and payment code of each drug; 

    • Information on the amount of excess average sales price increase; and

    • The rebate amount for each part B rebatable drug. 

  • Requires a qualifying drug manufacturer to submit a report to the HHS Secretary for a qualifying drug when (Sec. 401):

    • There is an increase in the price of the qualifying drug that results in an increase in the wholesale acquisition cost of the drug that is equal to:

      • 10 percent or more within a 12-month period beginning on or after January 1, 2019; or

      • 25 percent or more within a 36-month period beginning on or after January 1, 2019;

    • The estimated price of the qualifying drug or spending per individual or per user of such drug for the applicable year is at least $26,000 beginning on or after January 1, 2021; or

    • There was an increase in the price of the qualifying drug that resulted in an increase in the wholesale acquisition cost of that drug that is equal to:

      • 10 percent or more within a 12-month period that begins and ends during the 5-year period preceding January 1, 2021; or

      • 25 percent or more within a 36-month period that begins and ends during the 5-year period preceding January 1, 2021.

  • Classifies insulin as a qualifying single-source drug (Sec. 1192).

  • Requires the HHS Secretary to include the average international market (AIM) price in their projection of drug savings, which should be projected across different dosage forms and strengths of the drugs, taking into consideration both the volume of drugs, the extent such data is available, and the amount by which the net price for the drugs exceeds the AIM price for the drugs (Sec. 1192). 

  • Defines “average international market price” or “AIM price” as the average price for a unit of the drug as computed in all of the following countries (Sec. 1191):

    • Australia;

    • Canada;

    • France;

    • Germany;

    • Japan; and

    • The United Kingdom.

  • Requires a group health plan or a health insurance issuer offering group or individual health insurance coverage to publicly disclose any election by the plan or issuer to not participate in the Fair Price Negotiation Program for a selected drug for which coverage is provided under such plan or coverage before the beginning of the year that such an election was made (Sec. 2729A).

  • Establishes the Opioid Epidemic Response Fund and authorizes the HHS Secretary to use any of those funds available to carry out programs and activities to address the opioid and substance use disorder epidemic (Sec. 721).

  • Appropriates $1.98 billion to the Opioid Epidemic Response Fund for each fiscal year from 2021 through 2025 (Sec. 721).

  • Requires that the total amount in the Opioid Epidemic Response Fund for each fiscal year from 2021 through 2025, to be allocated as follows (Sec. 721):

    • $1.5 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA); 

    • $120 million for the Centers for Disease Control and Prevention (CDC); 

    • $10 million for the Food and Drug Administration (FDA);

    • $240 million for the National Institutes of Health (NIH); 

    • $90 million for the Health Resources and Services Administration; and

    • $20 million for the Administration for Children and Families.  

  • Authorizes the following appropriations to the Community Health Centers Fund (Sec. 808):

    • $1 billion for each of the fiscal years from 2021 through 2025 to be transferred to the HHS Secretary to provide additional enhanced funding for the community health center program under the Public Health Service Act; and 

    • $5 billion for the period of fiscal years 2021 through 2025 to be transferred to the HHS Secretary for capital projects of the community health center program.

  • Requires the HHS Secretary to specify the following dental and oral health care for 2025 and each subsequent year, including (Sec. 601):

    • Basic treatments, which may include basic tooth restorations, basic periodontic services, tooth extractions, and oral disease management services; and

    • Major treatments, which may include major tooth restorations, major periodontic services, bridges, crowns, and root canals. 

  • Requires that any selected drug manufacturer that has entered into an agreement under this act that does not provide access to a maximum fair price for a drug in such year to be subject to a civil monetary penalty equal to 10 times the amount of the difference between the price for such drug and the maximum fair price (Sec. 1198).

  • Specifies that the above highlight applies to the following (Sec. 1198):

    • A fair-price-eligible individual for whom a drug is furnished or dispensed during such year; or 

    • A hospital, physician, or another service provider who furnished or administered such drug.

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