Sen. Grassley Pushes to Hold Biden Administration Accountable on Measures to Improve Prescription Drug Price Transparency

WASHINGTON, Aug. 11 -- Sen. Charles E. Grassley, R-Iowa, issued the following news release and Aug. 9, 2022, letter:

Sen. Chuck Grassley (R-Iowa) is pushing the Biden administration to provide a concrete plan for implementing two critical measures that would improve prescription drug price transparency and hold health insurance companies accountable. Specifically, Grassley requests an update from the Centers for Medicare & Medicaid Services (CMS) on the status of the Medicare Part D real-time benefit tool (RTBT), and he also requests an update from the Department of Health and Human Services (HHS) and the Department of Labor (DOL) on their plans to implement prescription drug price transparency rules for health insurance companies.

"Transparency will bring more accountability to the health care industry and lower costs for consumers," Grassley said. "I'm calling on CMS to properly implement a real-time benefit tool that empowers seniors to know more about the true cost of their medications. I'm also calling on federal agencies to implement price transparency rules for prescription drug data without any further delay. It's past time for our health care industry to operate in the sunlight."

"I appreciate Senator Grassley's work to put a much needed spotlight on health care transparency, including pharmaceutical price transparency. Federal agencies must live up to their promises. It's critical that consumers, employers and taxpayers are provided this information in a timely manner to make informed decisions about their health care. Too often consumers don't know the real cost of a service or prescription drug, and they are left footing the bill. Transparency will bring more accountability and lower costs," said Paul M. Pietzsch, president of the Health Policy Corporation of Iowa, an independent, nonprofit organization working to develop and support initiatives which relate to cost containment, quality and access of health services in Iowa.

For years, Grassley has led the effort to pass bipartisan prescription drug pricing reform that saves money for taxpayers and consumers, caps annual out-of-pocket expenses and prevents prices from rising faster than inflation - all without raising taxes or causing prices to climb even higher. Grassley is the author of the Prescription Drug Pricing Reduction Act (PDPRA), which includes 25 bipartisan provisions to establish accountability and transparency in the pharmaceutical industry.

Recently, Grassley filed PDPRA as an amendment with 10 Republican cosponsors to the Democrats' reckless tax and spending bill - meaning comprehensive drug pricing reform could have garnered the 60 votes needed to overcome a filibuster and could have passed with bipartisan support. However, these provisions were left out of the bill, with Democrats instead choosing to take an entirely partisan approach.

In the past year, Grassley has passed five of his bipartisan drug-pricing bills out of committee that seek to lower prices, increase competition and hold Big Pharma and middlemen accountable. Unfortunately, Majority Leader Schumer won't bring them up for a vote - even though they would easily pass the Senate.

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August 8, 2022

To: The Honorable Xavier Becerra, Secretary, U.S. Department of Health & Human Services, 200 Independence Ave S.W., Washington, D.C. 20201

The Honorable Marty Walsh, Secretary, U.S. Department of Labor, 200 Constitution Ave N.W., C-2318, Washington, D.C. 20210

Dear Secretary Becerra and Secretary Walsh,

I firmly believe transparency brings accountability and fosters competition. I appreciate your Departments' commitment to implementing health care price transparency rules on hospitals and health insurance companies. I have heard people argue that price information is too administratively difficult to provide, too complicated for consumers to understand, or incomplete, therefore the information should be hidden far away from sunshine. They must not believe in accountability. It's long past time for Americans to have access to prices in our health care system. Final regulations have gone into effect over the past two years, yet prescription drug pricing and cost information have gotten a pass. I request an update from your Departments on the specific efforts you will be taking to publish prescription drug pricing and cost information.

I co-authored the Physician Payment Sunshine Act that became law in 2010,/1 which required public disclosure of payments between drug companies and doctors in a Centers for Medicare & Medicaid Services (CMS) Open Payments Database./2 In 2018, I helped expand the Sunshine Act to include other health care professionals (i.e., physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, or certified nurse-midwife)./3 To date, over 78 million records have been published totaling a value of over $63 billion./4 Information that can withstand public scrutiny and the broad light of day has the added benefit of helping to deter wrongdoing, improving accountability, and promoting competition.

I have continued to establish greater transparency in our health care industry to ensure it's held accountable on behalf of taxpayers and patients. Most recently, I have cosponsored the Health Care PRICE Transparency Act that would codify federal regulations establishing price transparency for hospitals and health insurance companies./5 Furthermore, I have taken on Big Pharma to require price disclosures on advertisements for prescription drugs./6 As you know, hospitals began reporting the cost of items and services in January 2021/7 and health insurance companies began reporting prices of covered items and services in July 2022./8 In August 2021, your Departments delayed prescription drug price disclosure because, "regulators were considering whether that part of the rule remains appropriate, after passage of a subsequent law and 'stakeholder concerns."/9 The Department of Health and Human Services (HHS) and the Department of Labor (DOL) guidance/10 stated, due to duplicative guidance, that the "Departments will defer enforcement of the requirement in the TiC Final Rules that plans and issuers must publish machine-readable file related to prescription drugs while it considers, through notice-and-comment rulemaking, whether the prescription drug machine-readable file requirement remains appropriate."/11

While the pharmaceutical industry initially got a pass, I was pleased to read in an interim final rule issued later in 2021/12 that your Departments will require health plans to submit prescription drug data to your Departments and you plan to produce a report on prescription drug spending beginning in June 2023./13 This is encouraging news, but I remain concerned the information publicly released may not provide the complete picture to patients and policymakers. Furthermore, I remain concerned about the lack of additional timely guidance. As your interim final rule indicates,/14 regulated entities will use every excuse not to provide this information timely or completely. Your Departments' timely efforts are critical to compliance.

With less than six months from the compliance date for regulated entities to report prescription drug pricing information (December 27, 2022), I respectfully ask you to address the following questions in writing:

1. Throughout the interim final rule,/15 your Departments indicated you will seek further comments. Based on comment received, have the Departments released updated comprehensive guidance?

2. By December 27, 2022, the regulated entities are required to submit data complying with the statute through a section 204 data submission for the 2020 and 2021 reference years. Have the Departments released the 204 data submission guidance that is referenced throughout the interim final rule?

3. Throughout the interim final rule, the Departments indicate a federal data collection system will be built by federal agencies and specifications for regulated entities will need to be released. Is the federal data collection system operational as of August 8, 2022? Have regulated entities received the data collection system specifications and guidance?

4. Given the poor compliance of hospitals with existing price transparency rules,/16 I remain concerned the Departments non-enforcement of the existing rules set the precedence for poor compliance. What steps are the Departments taking to ensure complete, accurate, and reliable data that will inform 2023 reporting outlined by the Departments? Will you be issuing a compliance audit?

5. As the interim final rule and statute indicate, the Departments are required to publish biannual section 204 public reports. I will note the statute requires "no confidential or trade secret information submitted to the Secretary under subsection (a) shall be included in the report under subsection (b)."/17 Will the Departments be publicly releasing any raw data submitted by regulated entities?

I urge the Departments not to further delay prescription drug data transparency requirements for health plans. Any further delay will cheat Americans out of critical information and give our prescription drug industry a pass. If your Departments cannot move forward in a timely manner to require this transparency, I request in writing specific reasons why and what Congress can do to empower you to do so.

It's long past due that our health care industry operates in sunlight. I agree with what former Obama and Trump administration officials recently wrote about health care price transparency rules, "the status quo is unacceptable" and "a more transparent marketplace...will give everyone the information they need and deserve to make better decisions about their care."/18 I stand ready to ensure your efforts and future congressional action bring this necessary prescription drug price data to light.

Sincerely,

Charles E. Grassley

United States Senator

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View footnotes here: https://www.grassley.senate.gov/imo/media/doc/grassley_to_hhs_and_labor_dptpricetransparencyofprescriptiondrugs.pdf

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August 8, 2022

To: The Honorable Chiquita Brooks-LaSure, Administrator, Centers for Medicare & Medicaid Services, U.S. Department of Health & Human Services, 200 Independence Avenue S.W., Washington, D.C. 20201

Dear Administrator Brooks-LaSure,

I firmly believe prescription drug prices and costs need more daylight./1 Patients should have access to prescription drug costs, formulary alternatives, and utilization management requirements in real-time. Recent research indicates that "there is a clear role for informatics tools" to provide data on patient prescription drug costs./2 I helped pass a provision in the Consolidated Appropriations Act of 2021 that requires Medicare Part D plans to increase the use of electronic real-time benefit tools (RTBT) to put some sunshine on patient prescription costs./3 This was a bipartisan provision originally contained in the bipartisan Prescription Drug Pricing Reduction Act./4

Beginning in January 2021, the prescriber RTBT requirement went into effect giving Part D prescribers information in real-time about lower-cost alternative drugs available and utilization requirements under the beneficiary's Part D plan. Furthermore, beginning January 2023, Part D plans will be required to implement a beneficiary RTBT allowing patients to "view the information included in the prescriber RTBT system, which will include accurate, timely, and clinically appropriate patient-specific real-time formulary and benefit information (including cost, formulary alternatives and utilization management requirements).".5 The implementation of this transparency will benefit patients.

With the implementation of the RTBT beneficiary component less than six months away, I request an update on your agency's implementation efforts with Part D plans and documentation on how Part D plans are educating beneficiaries on this new tool. I respectfully ask you to address the following questions in writing:

1. How is the current RTBT being used by prescribers under Medicare Part D for calendar (CY) 2022? If you have utilization data, can you provide an analysis of the data or an audit?

2. Are all Medicare Part D plans for CY 2022 currently compliant with the RTBT requirements including electronic health record integration?

3. For CY 2023, what action is CMS taking to ensure improved compliance? Furthermore, how is the agency conducting oversight of provider accessibility and usability of the tool? What education has CMS conducted in CY 2022 to improve use by providers?

4. Is CMS able to determine trend data or examples where the RTBT determined a lower cost, therapeutic equivalent alternative? If so, how will this information be publicized? Can you provide specific examples and trend data?

5. Is the RTBT falling short of its intention? If so, what statutory, regulatory, or guidance efforts will CMS be taking or recommending to improve the RTBT?

6. Are Medicare Part D plans prepared and compliant to offer the RTBT on January 1, 2023? Has the agency conducted surveys among beneficiaries to determine awareness or does the agency plan to conduct surveys?

7. What steps have the agency and Medicare Part D plans taken to inform beneficiaries of the RTBT availability on January 1, 2023? What actions will the agency be taking or requiring of the Medicare Part D plans between now and January 1, 2023? After January 1, 2023?

8. Are there statutory or regulatory barriers preventing the effectiveness of RTBT for beneficiaries?

The Medicare real-time benefit tool empowers prescribers and patients with critical information about prescription drug costs, formulary alternatives, and utilization management requirements in real-time. It's long past due that our health care industry operates in sunlight. I stand ready to help make sure your efforts and future congressional action ensures the Medicare real-time benefit tool's success. Transparency will bring more accountability to the health care industry. I look forward to your timely answers.

Sincerely,

Charles E. Grassley

United States Senator

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Footnotes:

1/ Office of Senator Chuck Grassley, "Q&A: Drug Advertising Needs More Daylight," July 26, 2021, https://www.grassley.senate.gov/news/news-releases/qanda-drug-advertising-needs-more-daylight.

2/ Kiessling KA, Iott BE, Pater JA, Toscos TR, Wagner SR, Gottlieb LM, Veinot TC. Health informatics interventions to minimize out-of-pocket medication costs for patients: what providers want. JAMIA Open. 2022 Feb 24;5(1):ooac007. doi: 10.1093/jamiaopen/ooac007. PMID: 35274083; PMCID: PMC8903137.

3/ Public Law (P.L.) 116-260, Division CC, Title I, Sec. 119, "Increasing the use of real-time benefit tools to lower beneficiary costs."

4/ U.S. Senate. Committee on Finance. Prescription Drug Pricing Reduction Act of 2019. (S. Rpt. 116-120). Washington: Government Printing Office, 2019. https://www.finance.senate.gov/imo/media/doc/CRPT- 116srpt120.pdf.

5/ Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly, 86 FR 5864-6135 (to be codified at C.F.R. Parts 405, 417, 422, 423, 455, 460).

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Original text here: https://www.grassley.senate.gov/news/news-releases/grassley-pushes-to-hold-biden-administration-accountable-on-measures-to-improve-prescription-drug-price-transparency