DW blog: The First 100 Days

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Trump pick for FDA confirmed

May 10, 2017
Scott Gottlieb, MD, has been confirmed by the U.S. Senate to serve as the commissioner of the U.S. Food and Drug Administration. The Senate voted 57-42 in favor of confirmation. Dr. Gottlieb, an internist, served as deputy commissioner of the FDA under President George W. Bush.


Pick for FDA moves forward

April 27, 2017

The Senate HELP Committee has voted 14-9 to advance Scott Gottlieb, MD ― President Trump’s nomination for commissioner of the U.S. Food and Drug Administration (FDA).

Dr. Gottlieb, an internist, served as deputy commissioner of the FDA under President George W. Bush. The full Senate will now vote on Dr. Gottlieb’s nomination. However, a date has not been set for the vote yet.


Pick for FDA faces Senate committee

April 6, 2017
Scott Gottlieb, MD ― President Trump’s pick for commissioner of the U.S. Food and Drug Administration (FDA) ― faced the Senate Health, Education, Labor, and Pensions Committee at a confirmation hearing this week and discussed his thoughts about the drug-approval process. Specifically, Dr. Gottlieb indicated that the current process slows down the rate of drug approvals and can be improved without sacrificing safety. Dr. Gottlieb also stated that his first priority as commissioner of the FDA would be to address the U.S. opioid epidemic.

During the hearing, Dr. Gottlieb also answered questions about his financial and advisory ties ― which were listed in Dr. Gottlieb’s conflict of interest notice ― with about 30 medical companies. Dr. Gottlieb indicated that he would work “…with the ethics officials at HHS and FDA to have continued discussions on what additional steps I should take to make sure I’m fully complying with the law if I’m confirmed into this role.”

Dr. Gottlieb, an internist, served as deputy commissioner of the FDA under President George W. Bush. The Committee is expected to vote on Dr. Gottlieb’s appointment after congressional recess.


President Trump picks HHS deputy secretary

March 15, 2017
President Trump has announced his intent to nominate Eric D. Hargan, JD, to serve as deputy secretary of the U.S. Department of Health and Human Services (HHS). Hargan is a shareholder of Greenberg Traurig, LLP, in its Health and FDA Business practice. He previously served as deputy general counsel, principal associate deputy secretary, and acting deputy secretary of HHS under the George W. Bush Administration. Hargan’s nomination will require a Senate confirmation.


White House picks lead for FDA

March 10, 2017
President Trump has nominated Scott Gottlieb, MD, to lead the U.S. Food and Drug Administration (FDA).  In the past, Dr. Gottlieb has stated that administrative red tape is preventing competition in the drug manufacturing industry, and if confirmed, he would likely have an integral role in President Trump’s efforts to speed up the drug-approval process.

Dr. Gottlieb has a medical degree from Mount Sinai School of Medicine and did his residency in internal medicine at the Mount Sinai Medical Center. Dr. Gottlieb previously served as a deputy commissioner of the FDA under President George W. Bush.


Senate confirms Tom Price for HHS Secretary

Feb. 10, 2017
The U.S. Senate has voted (52-47) to confirm Dr. Tom Price as Secretary of the U.S. Department of Health and Human Services (HHS) under President Donald Trump. Dr. Price, an orthopedic surgeon, previously served as congressman for Georgia’s 6th district and as House Budget Committee chair and would be the first physician to serve as secretary of HHS in nearly 25 years. Dr. Price has worked on issues affecting dermatology, such as Medicare payment reform, shortening EHR reporting periods, and ensuring that the MACRA transition included opportunities for physicians to avoid penalties. Dr. Price has also demonstrated a commitment to decreasing over-burdensome regulations associated with EHR, MACRA, and quality reporting.

In other confirmation news, the Senate Finance Committee will hold a confirmation hearing for Seema Verma, President Trump's pick for CMS administrator, next week.


President Trump, pharmaceutical companies talk drug prices

Feb. 8, 2017
President Donald Trump recently met with pharmaceutical manufacturing companies such as Merck & Co. and Johnson & Johnson to discuss what can be done about the rising cost of drugs. President Trump has recently expressed an interest in allowing the government to negotiate drug prices for programs like Medicare and Medicaid. Additionally, President Trump has indicated that he would support re-importation of drugs. In the meeting, President Trump and the pharmaceutical representatives discussed easing the regulatory burdens on manufacturers and streamlining the drug approval process.


Dr. Price discusses ACA, regulatory burdens, transparency, and drug prices in nomination hearing

Jan. 24, 2017
Rep. Tom Price, MD (R-Ga.) ― President Trump’s pick for secretary of the Department of Health and Human Services (HHS) ― sat before the Senate Finance Committee, which will determine if his nomination proceeds to a confirmation vote, and answered questions about several health care issues.

Affordable Care Act
Sen. Ron Wyden (D-Ore.), ranking member of the Senate Finance Committee, referenced President Trump’s executive order that directs the secretary of HHS to work toward the swift repeal of the ACA. Sen. Wyden asked Dr. Price if he could assure that no one citizen will be worse off if the ACA is repealed? Dr. Price committed to working with Congress to ensure access to high-quality care. Piggybacking off of Sen. Wyden’s question, Sen. Sherrod Brown (D-Ohio) asked if Dr. Price would enforce the ACA’s ban on discriminating against patients with pre-existing conditions or patients with illnesses that are expensive to treat. Dr. Price responded, “Nobody ought to lose their insurance because they get a bad diagnosis.”

Sen. Pat Roberts (R-Kan.) asked what tools Dr. Price will utilize to provide stability and improve the individual insurance markets to make them more appealing so that insurance carriers will want to come back? Dr. Price stated, “This law isn’t working. It’s not working for patients. One of the goals I have is to lower the temperature in this debate.” He indicated that government should assure carriers that the replacement plan will be more attractive to insurers.

When asked by Sen. Richard Burr (R-N.C.) what his overall goals are for an ACA replacement plan, Dr. Price reiterated his desire to provide accessible and affordable coverage for high quality care while offering patients choices.

CMMI
Sen. Orrin Hatch (R-Utah), chair of the Senate Finance Committee, asked Dr. Price about his thoughts on the Center for Medicare and Medicaid Innovation (CMMI) ― the agency under CMS that develops and tests value-based payment models. “Innovation is so incredibly important to health care and the vibrant quality of health care that we need to be able to provide to our citizens,” Dr. Price said. “One of the roles that we as policymakers have is to incentivize innovation. The Center for Medicare and Medicaid Innovation is a vehicle that might do just that. I think, however, that CMMI has gotten off track a bit. I think that what it has done is defined areas where it has mandatorily dictated to physicians and other providers in this country in certain areas how they must practice. I’m a strong supporter of innovation but I hope that we can move CMMI in a direction that actually makes sense for patients.”

Regulatory burdens
Sen. Roberts referenced various regulations, such as meaningful use, that have caused undue burdens on providers and asked Dr. Price how he will work to alleviate the burden. In response, Dr. Price agreed stating that, “The regulatory scheme that we’ve put in place is choking the individuals that are actually trying to provide care. So much so that you have physicians and other providers who are leaving the practice. The meaningful use project makes it that much more difficult. We’ve turned physicians into data entry clerks.” Dr. Price went on to say that recognizing the problem is the first step and then government must take a second look at the consequences of what it has done.

Transparency: Quality and cost
Sen. Pat Toomey (R-Pa.) asked Dr. Price about his opinions on transparency in health care, to which Dr. Price stated firmly that quality and cost information regarding care should be available to patients. “Outcomes are important and we need to be measuring what makes sense from a quality standpoint and allow patients and others to see what those outcomes are,” Dr. Price said. “But it’s transparency in pricing as well. If you’re an individual and want to know what something costs, it’s virtually impossible to find out what that is. If we want to make the system patient-friendly, not insurance-friendly or government-friendly, then we would make that a priority.”

Drug pricing
With regard to access to medications, Sen. Wyden asked Dr. Price if he would be willing to follow President Trump’s recommendation and allow federal health care plans the authority to negotiate drug prices. In response, Dr. Price said, “Right now the PBMs [pharmacy benefits managers] are doing that negotiation. It’s important to have the conversation and look at whether or not there’s a better way to do that. If there is, then I’m certainly open to it.”

In addition to a litany of questions on various health care related issues, several members of the committee reiterated concerns about the ethics of Dr. Price’s investments in various health-related companies while supporting bills that could have benefited these companies. The Senate Finance Committee will vote on Dr. Price’s nomination within the next several weeks.


Dr. Price faces Senate HELP committee in nomination hearing

Jan. 18, 2017
The Senate Health, Education, Labor and Pensions (HELP) Committee held a nomination hearing for Rep. Tom Price, MD (R-Ga.) ― President-elect Donald Trump’s pick for secretary of the Department of Health and Human Services. The American Academy of Dermatology Association attended the hearing. Among several health care related issues that were addressed during the hearing, most notably Dr. Price was asked about his thoughts on a replacement for the Affordable Care Act (ACA), access to drugs, and regulatory burdens on physicians. Additionally, Dr. Price addressed concerns about his financial ties to a medical device company.

ACA replacement
When asked by Committee Chair Sen. Lamar Alexander (R-Tenn.) about Dr. Price’s goal for an ACA replacement plan, Dr. Price stated that health care needs to be affordable, accessible, high quality, and responsive to patients, offer incentives for innovation, and ensure choices are made by and preserved for patients. When asked about the timing of repeal and replace, he stated, “I think that one of the important things that we need to convey to the American people is that nobody is interested in pulling the rug out from anybody.” Dr. Price also expressed an interest in implementing high-risk pools and expanding the use of health savings accounts in a replacement plan to cover general health services.

Medicare drug price negotiations
Sen. Bernie Sanders (I-Vt.) asked Dr. Price if he would join him and Democrats in efforts to allow Medicare to negotiate drug prices and allows drugs to be imported from Canada. Without confirming his position on government price negotiations or importation, Dr. Price stated that the cost of drugs is a high priority for all Americans and he committed to working with Congress in addressing the drug pricing issue.

Regulatory burdens
Sen. Bill Cassidy (R-La.) asked Dr. Price for his thoughts on what the government can do to address the regulatory burden that physicians are experiencing with electronic health record (EHR) requirements, such as Meaningful Use. Dr. Price said that EHRs are important from an innovative standpoint because they allow patients access to their medical history. However, he said that the federal government’s role is to ensure interoperability between EHR systems. Additionally, he indicated that the government should work more closely with providers in determining the metrics that should be measured through these systems to improve quality. “If we truly worked with the providers and asked them what we should measure, I suspect that there are some very specific things we could use.”

Government authority in health care
Sen. Pat Roberts (R-Kan.) expressed his concerns about the increased authority of the Independent Payment Advisory Board (IPAB), the Centers for Medicare and Medicaid Innovation (CMMI), the U.S. Preventative Services Task Force (USPSTF), and the Patient-Centered Outcomes Research Institute (PCORI). Dr. Price stated his concerns about CMMI, indicating that the patient should be at the center of care and that health care treatments should not be dictated by government.

Questions on ethics
Committee Ranking Member Sen. Patty Murray (D-Wash.) and Sen. Elizabeth Warren (D-Mass.) questioned the ethics of Dr. Price’s ties to a medical device company. Recently, information has been released about Dr. Price’s personal investments and potential ties to his legislative actions. According to House records, in 2016 Dr. Price bought between $1,001 to $15,000 worth of shares in Zimmer Biomet ― a knee and hip implant manufacturer. Shortly after the purchase, Dr. Price introduced the HIP Act that would have delayed a CMS regulation that would hurt Zimmer Biomet financially. Zimmer Biomet's PAC also donated to Dr. Price's reelection campaign.

When questioned at the hearing, Dr. Price indicated that the trade in Zimmer Biomet shares in his broker-direct account was handled by a broker and also denied knowledge of nonpublic information when trading certain stocks. Sen. Orrin Hatch (R-Utah) asked, “Can you confirm that you have always followed the law relating to trading in stocks while serving as a member of Congress?” Dr. Price responded, “Everything that we have done has been above board, transparent, ethical, and legal. The Office of Government Ethics has looked at our holdings and given advice on what needs to be done in terms of divesting from certain stock holdings to make certain that there are no conflicts of interest. We have read those, agreed to those, and signed those. That document is online for everybody to see.” View Dr. Price’s public financial disclosure report and his ethics agreement.

The HELP Committee hearing is considered a courtesy hearing. A formal hearing before the Senate Finance Committee ― the committee that will vote on Dr. Price’s nomination ― is scheduled for Jan. 24.


President-elect Trump addresses ACA, drug prices in first press conference

Jan. 11, 2017

In his first press conference as President-elect, Donald Trump has restated his position that the Affordable Care Act (ACA) should be repealed and replaced as soon as possible. He stated, “We're going to be submitting, as soon as our secretary [Dr. Tom Price] is approved, almost simultaneously ― shortly thereafter ― a plan. It will be repeal and replace. It will be, essentially simultaneously.”

Additionally, President-elect Trump reiterated his position that Medicare should be allowed to negotiate drug prices. “We’re the largest buyer of drugs in the world, and yet we don't bid properly…were going to start bidding and were going to save billions of dollars over a period of time,” the President-elect said.

Click here to read a transcript of the press conference.


Tentative hearing scheduled for Dr. Price nomination

Jan. 3, 2017
The Senate Health, Education, Labor and Pensions Committee has set a tentative date for a hearing for Rep. Tom Price, MD (R-Ga.) ― President-elect Donald Trump’s pick for Secretary of the U.S. Department of Health and Human Services ― on Jan. 18. However, the hearing date will not be officially announced until one week before it is definitively scheduled to occur. This is would be a courtesy hearing, as it is the Senate Finance Committee that will ultimately vote on the nomination.

The American Academy of Dermatology Association (AADA) has had a long-standing relationship with Dr. Price, who was a featured speaker at the AADA's 2012 Legislative Conference. The AADA has worked with him on issues such as Medicare payment reform, shortening EHR reporting periods, and ensuring that the MACRA transition included opportunities for physicians to avoid penalties.

Similarly, Seema Verma, President-elect Trump’s choice for CMS administrator, can anticipate a confirmation hearing in the near future. Although a date for her hearing has not been publicly floated, the Senate Finance Committee indicates that it has received three years of tax returns and completed questionnaires from both Dr. Price and Verma.


Cures, drug pricing, and the next Administration

Dec. 14, 2016
Yesterday afternoon at the White House, joined by Vice President Joe Biden and key lawmakers from both parties, President Obama signed into law the 21st Century Cures Act, which makes new advancements in medical research and seeks to accelerate the approval of new drugs and treatments for patients. “It is wonderful to see how well Democrats and Republicans in the closing days of this Congress came together around a common cause,” said the President at the official signing ceremony. “I think it indicates the power of this issue and how deeply it touches every family across America.”

Among the federal agencies tasked with implementing the 21st Century Cures Act is the National Institutes of Health (NIH), which will see an increase in funding. Francis Collins, MD, PhD, a physician-geneticist, currently heads up the medical research agency. While President-elect Trump has yet to announce his picks of whom he wants to lead the Food and Drug Administration and the NIH, several key Republicans have expressed their support for keeping Collins on board.

The 21st Century Cures Act was applauded by many as it made its way through Congress and to the President’s desk for signature. However, additional actions are expected in the coming months in order to help address escalating drug prices. Barbara Greenan, senior director of Advocacy and Policy at the AADA, said the AADA “…looks forward to working with the new Administration and Congress on addressing this highly impactful issue in the context of other health system reforms.”


Tackling drug prices

Dec. 7, 2016

Congress has passed the 21st Century Cures Act, legislation that will provide funding for the U.S. Food and Drug Administration (FDA) to accelerate the drug and medical device approval process. The legislation will also provide funding for basic, translational, and clinical research. The legislation is deemed by many as a means to quell the rising cost of drugs by encouraging more drugs to enter the market more quickly. However, additional efforts to address this issue are likely when the new Administration and Congress take over, and according to Barbara Greenan, senior director of Advocacy and Policy at the AADA, they will be multifaceted. “Certainly, expediting the backlog of generic drug approvals at the FDA is one way to drive down drug prices. However, this issue is complex and the new Congress and Administration will have to work with all stakeholders to find solutions that ensure patients have access to effective treatments.”

Specifically, several members of Congress are looking to alleviate the drug pricing issue by granting Medicare the authority to negotiate drug prices with manufacturers. “This is a concept that Democrats have largely supported and that President-elect Trump supported while on the campaign trail, but congressional Republicans generally oppose it,” said Christine O’Connor, AADA associate director of congressional policy.

Another option that has been kicked around is removing restrictions on drug importation. For example, in the 114th Congress, Sens. John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) introduced the Safe and Affordable Drugs from Canada Act. “President-elect Trump has indicated that he would support re-importation of drugs,” O’Connor said, “and there is some bipartisan support in Congress to do this. However, the pharmaceutical industry opposes re-importation.” Similarly, Congress may also turn the focus on the manufacturers and require more transparency into drug-pricing methods. “For example, in the 114th Congress, Sens. John McCain (R-Ariz.) and Tammy Baldwin (D-Wis.) introduced the FAIR Drug Pricing Act that would require drug manufacturers to explain price increases of more than 10 percent.” While these pieces of legislation will die at the close of the 114th Congress, similar legislation may be introduced next year in the new 115th Congress.

Of course, even if legislation passes muster in both chambers on the Hill and in the White House, the new Administration will likely be tasked with implementing these new laws. “There will be a heavy lift on the regulatory side to implement and operationalize drug pricing legislation,” Greenan said. “However, rising cost of drugs cannot be ignored and the AADA looks forward to working with the new Administration and Congress on addressing this highly impactful issue in the context of other health system reforms.”


Congress appoints new E&C chair

Dec. 1, 2016
While President-elect Donald Trump’s transition team is vetting members of the new Administration’s cabinet, on Capitol Hill, Rep. Greg Walden (R-Ore.) has been selected as the chair of the U.S. House Energy and Commerce Committee which has jurisdiction over issues concerning health care, and is the primary committee for addressing the Affordable Care Act, the Medicare Access and Chip Reauthorization Act (MACRA), compounding, drug pricing, and the 21st Century Cures bill that, if passed, would provide medical research funding. Rep. Walden will replace Rep. Fred Upton (R-Mich.), who has served in the role since 2010. Rep. Walden is the outgoing National Republican Congressional Committee chairman. According to his congressional website, he is in favor of repealing and replacing the Affordable Care Act and he also supported the 21st Century Cures Act.