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WASHINGTON, DC – Senator James Lankford (R-OK) today questioned Secretary of the Department of Health and Human Services (HHS) Alex M. Azar II on a series of issues including his work to reduce the cost of prescription drug pricing by addressing the issues with tiering, access to rural hospitals and his bill with Senator Dick Durbin (D-IL) to update Medicare’s Critical Access Hospital (CAH) designation; his bill to protect healthcare providers from discrimination if they decline to participate in abortions; and HHS’s standards on nicotine in vape pens.
Background on Prescription Drug Pricing
Since joining the Senate Finance Committee in 2019, Lankford has participated in several hearings on prescription drug pricing and has provided real solutions to combat the rising costs of prescription drugs. He introduced the Prescription Pricing for the People Act of 2019 with Senators Chuck Grassley (R-IA), Chairman of the Finance Committee and Senator Maria Cantwell (D-WA). The bill would require the Federal Trade Commission (FTC) to study the role and recent merger activity of PBMs, as well as possible anticompetitive behavior. Additional legislation Lankford has introduced to address prescription drug prices includes Transparency for Pharmacists, Right Price for Medicare Acts, and the Phair Relief Act. Lankford released an episode on his podcast, The Breakdown with James Lankford, to layout the issue with rising costs, Medicare Part D, pharmacy benefit managers (PBMs), generic tiering, and surprise billing.
Background on Conscience Protection Act
Lankford introduced the Conscience Protection Act to protect healthcare providers, including healthcare professionals, entities, and health insurance plans from government discrimination if they decline to participate in abortions. The Conscience Protection Act also provides a private right of action for victims of discrimination, to ensure that an individual’s rights are protected.
Currently, if a healthcare provider, including insurance plans, refuses to provide abortions, the only recourse is to file a complaint with the Office of Civil Rights (OCR). On August 28, 2019, OCR issued a notice of violation to the University of Vermont Medical Center (UVMMC) because it conscience rights protected in the Church Amendment by forcing a nurse to assist in an elective abortion. HHS found there were other nurses in the room capable and without objection ready to participate in this abortion, but UVMMC still required this nurse to participate. In the Notice of Violation, OCR asked that UVMMC notify OCR within 30 days whether UVMMC intends to work collaboratively with OCR to change its policies so it no longer requires health care personnel to participate in abortion against their religious or moral objections and to take immediate steps to remedy the effect of its past discriminatory conduct. Otherwise, OCR indicated it would forward the Notice to the Health Resources and Services Administration (HRSA), for consideration and potential revocation of funds.
Background on Rural Hospital Relief Act
The Rural Hospital Relief Act would support rural hospitals by providing flexibility around the 35-mile distance requirement and enabling states to certify a hospital as a “necessary provider” in order to obtain CAH designation. This authority ended in 2006, but today’s bill would re-open this financial lifeline for certain rural hospitals that serve a low-income community, are located in a health professional shortage area, and have operated with negative margins for multiple years.
The Rural Hospital Relief Act is supported by the Oklahoma Hospital Association (OHA), Illinois Critical Access Hospital Network (ICAHN), Illinois Health and Hospital Association (IHA), and National Rural Health Association (NRHA).
On prescription drug pricing:
Lankford: You’ve also put out some proposals on Part D generic tiering to allow basically a secondary preferred specialty secondary tiering for drugs to try to get better benefits out there. If there is any recommendation I can continue to make on that is that we continue to be able to lean on that and to be able to target generics and biosimilars to be able to make sure it’s not just a benefit across the board but its really a benefit to those that are the consumers… Where does that rule stand at this point and what are your thoughts on that?
Azar: So, we have proposed that as part of the Part D regulation… to allow the drug plans to have the second tier for specialty drugs. Those are the more expensive drugs. The specialty tier maybe around $660 a month that triggers that. Right now, the regulations somewhat disable the insurance companies from negotiating bigger discounts from pharma because it just has the one-tier. This proposal would allow there to be a more favorable tier. So not more restrictive for patient access but a more favorable one to entice drug companies to give even more discounts in order to secure access to that tier. That would lower cost-sharing for the patient.
Lankford: It’s one of the things that several of us on this committee are working through right now to be able to provide multiple tiers and some other options for that and block some of the companies that are preventing drugs from going on to the generic tier and pushing it on to the higher price tier. That’s something we’re trying to be able to work out legislatively.
On rural hospital access:
Lankford: Several of us have mentioned something about rural hospital relief. My state has seen several—seven—rural hospitals that have closed as of late. This is a big issue. Senator Durbin and I are actually working on some legislation dealing with critical access hospitals (CAH) and getting greater flexibility there. I know you are also, in the regulation, trying to deal with that as well. To allow them to be out-patient emergency hospitals access to critical access. Where does that stand at this point?
Azar: So I’m actually very happy that is in the President’s Budget this year, to have Congress authorize us to allow that kind of flexibility so that a critical access hospital could have emergency function outpatient, but not be subject to all the requirements of in-patient. In addition, the budget proposes that we have enhanced payments for those critical access hospitals that would elect for an emergency, so they could reimburse at the regular emergency rate as well as the supplemental amount of payment for them.
Senator Lankford: We look forward to getting a chance to be able to walk through that because that will be important for all of us in rural states. Senator Durbin and I will continue along with our legislation trying to be able to solve this legislatively long term.
On nicotine standards for vaping devices:
Lankford: There’s not a standard level of nicotine. Several vaping devices choose to have very, very high levels of nicotine that they know is the most addictive portion of this. This is an area that we’ve raised to the FDA and you before. Is there a way to get a standard level for nicotine so these devices don’t intentionally load them up with high levels of nicotine to increase addiction? Where does that stand?
Azar: There’s not a regulation under the PMTA, the authorization process for e-cigarettes that we have for novel tobacco products, a regulation setting a nicotine level. In the course now, the May 2020 deadline that the court has set for these e-cigarettes to come in and apply for approval for authorization. Under the PMTA, looking at appropriate nicotine levels will be one of the factors that we can examine at FDA in determining if an e-cigarette’s entry into the marketplace is supportive of the furtherance of the public’s health. So that will be one of the criteria that we can look at.
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