FDA Commissioner Gottlieb Resigns

Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, has resigned after about 2 years (1). Gottlieb was a controversial appointee by the Trump administration due to his ties to the pharmaceutical industry. However, he stood out in the anti-regulatory Trump administration, where some officials such as Scott Pruitt, the former head of the Environmental Protection Agency, appeared intent on reducing the clout of the departments and agencies they headed. For nearly two years, Gottlieb has avidly promoted the FDA, inserting the agency into important health issues and sometimes taking on industries regulated by the agency.

Under Gottlieb’s leadership the FDA has made sweeping moves to lower smoking and vaping amongst minors. Gottlieb’s departure could throw into question other controversial tobacco initiatives he championed that have not yet emerged from the FDA, including proposals to ban menthol cigarettes and to reduce nicotine levels in cigarettes. In his resignation letter to Health and Human Services Secretary, Alex Azar, Gottlieb listed his accomplishments, including accelerating the approval of generic drugs and modernizing the process for handling novel gene and precision therapies to treat those with cancer.

The resignation took some senior FDA officials by surprise, and came as Gottlieb’s signature issue – youth vaping – is being reviewed by the White House Office of Management and Budget. The plan, detailed by Gottlieb last fall, would sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping, which he argues could lead to a whole new generation addicted to nicotine.

Gottlieb, who has been commuting weekly to Washington from his home in Connecticut, said he wants to spend more time with his family. The resignation was apparently not sought by the White House. A senior White House official said Gottlieb had spoken to President Trump, and that the president liked the FDA chief and did not want him to leave. While Gottlieb had some policy disagreements with the White House, he is well respected, and could even be asked to take another post, said two officials. Gottlieb declined to comment on that possibility.

Most praised Gottlieb including his predecessor, Robert Califf, and Friends of Cancer Research and Tobacco Free Kids (1). However, he was not without his critics. Pieter Cohen, an associate professor at Harvard Medical School who conducts research into the safety of dietary supplements, faulted Gottlieb for not taking significant action on major safety problems involving dietary supplements. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, criticized Gottlieb’s opioid policy. “I am concerned, because he seems to have a tendency to spend most of his time talking and very little of his time implementing policy.” The advocacy group Public Citizen said that Gottlieb’s time as the agency's head "was marked by regulatory decision making regarding medications and medical devices that tilted further in favor of industry's financial interests rather than the interests of public health (2).” The group cited the controversial approval in April of an opioid called Dsuvia, which is 10 times more powerful than fentanyl.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Laurie McGinley L, Bernstein L, Dawsey J.  FDA Commissioner Gottlieb, who raised alarms about teen vaping, resigns. Washington Post. March 5, 2019. Available at: https://www.washingtonpost.com/health/2019/03/05/fda-commissioner-gottlieb-who-raised-alarms-about-teen-vaping-resigns/?utm_term=.b50dd0bbb2ae (accessed 3-6-19).
2. Scutti S, Diamond J, Goldschmidt D. FDA Commissioner Dr. Scott Gottlieb to resign next month. CNN Politics. March 5, 2019. Available at: https://www.cnn.com/2019/03/05/politics/gottlieb-resigning-fda-health-bn/index.html (accessed 3-6-19).

Cite as: Robbins RA. FDA commissioner Gottlieb resigns. Southwest J Pulm Crit Care. 2019;18(3):65-6. doi: https://doi.org/10.13175/swjpcc012-19 PDF 

Physicians Generate an Average $2.4 Million a Year Per Hospital

Hospitals are more frequently employing physicians which has been associated with increasing costs (1). Physician generated revenue may be one explanation for the upsurge in hospital employed physicians. According to a survey from Merritt Hawkins, physicians generate an average $2,378,727 per year in net revenue on behalf of their affiliated hospitals (2). This includes both net inpatient and outpatient revenue derived from patient hospital admissions, tests, treatments, prescriptions, and procedures performed or ordered by physicians. Travis Singleton, Merritt Hawkins Executive Vice President commented, “Physicians continue to drive the financial health and viability of hospitals ...”.

It is not just physician specialists who generate high dollar volumes for hospitals, the survey indicates. Family physicians generate an average of $2.1 million in net revenue annually for their affiliated hospitals, while general internists generate an average of almost $2.7 million. The average net revenue generated by all physicians included in the survey ($2,378,727) is up 52% from 2016, the last year Merritt Hawkins conducted the survey. Average revenue generated by each of the 18 medical specialties included in the survey increased compared to 2016, in most cases significantly.

The survey also provides a cost/benefits analysis showing which physicians provide the best return on investment by comparing salaries in various medical specialties to revenue generated by physicians in those specialties. Family physicians showed the best return with an average starting salary of $241,000, according to Merritt Hawkins’ data, while generating nine times that much in hospital revenue. “Primary care physicians such as family physicians represent an excellent return on investment …” Singleton said.

While the number of hospital inpatient stays has decreased or remained flat in recent years, the cost per hospital stay has increased, said Singleton, one factor that may be driving the comparatively high revenue averages generated by physicians. In addition, the number of hospital outpatient visits has more than tripled since 1975 and the average cost of these visits has grown, a further reason for physician revenue increases, according to Singleton. An additional reason is that hospitals are reimbursed at a higher rate for the same services compared to physicians’ offices. According to Winn et al. (3), outpatient hospital costs are about double compared to independent physician offices for the same chemotherapy services (3).

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Kacik A. Rapid rise in hospital-employed physicians increases costs. Modern Healthcare. March 16, 2018. Available at: https://www.modernhealthcare.com/article/20180316/TRANSFORMATION02/180319913/rapid-rise-in-hospital-employed-physicians-increases-costs (accessed 3-1-19).
2. Merritt Hawkins. Survey: Physicians Generate an Average $2.4 Million a Year Per Hospital. February 25, 2019. Available at: https://www.merritthawkins.com/uploadedFiles/MerrittHawkins_PressRelease_2019.pdf (accessed 3-1-19).
3. Winn AN, Keating NL, Trogdon JG, Basch EM, Dusetzina SB. Spending by commercial insurers on chemotherapy based on site of care, 2004-2014. JAMA Oncol. 2018 Apr 1;4(4):580-1. [CrossRef] [PubMed] 

Cite as: Robbins RA. Physicians generate an average $2.4 million a year per hospital. Southwest J Pulm Crit Care. 2019;18(3):61-2. doi: https://doi.org/10.13175/swjpcc010-19 PDF 

Drug Prices Continue to Rise

President Trump asserted in a Tweet that drug prices declined in 2018 for the first time in nearly 50 years. However, President Trump’s assertion does not agree with my personal experience or the facts.

I take dofetilide (Tikosyn®) for atrial fibrillation. However, when I recently ordered the medication, my co-pay for 3 months increased from $95 in October, 2018 to $140, an increase approaching 50%. The amount the drug manufacturer (Pfizer) raised the price is unclear but the amount charged by the on-line pharmacy (AllianceRxWalgreens) that my insurance company (Blue Cross/Blue Shield Arizona) mandates I use, likely reflects a price increase in the drug.

Trump’s claim that drug prices decreased in 2018 is wrong. A recent analysis of brand-name drugs by the Associated Press found 96 price increases for every price cut in the first seven months of 2018 (1). At the start of last year, drug makers hiked prices on 1,800 medicines by a median of 9.1 percent, and many continued to increase prices throughout the year.

Trump met with Ian Read, CEO of Pfizer, in July, 2018 following a scolding via Twitter where Trump condemned Pfizer’s increase in drug prices. Pfizer agreed to delay the increases until early 2019 and now those price increases are apparently occurring.

Trump’s tweet comes just days after the president summoned his top domestic policy advisers, including health secretary Alex Azar, to the White House to discuss the slate of drug price hikes that came Jan. 1. Last week, Trump blasted pharmaceutical companies for those increases, writing on Twitter “drug makers are not living up to their commitments.”

Azar, who has been vocally defending his agency’s work to lower drug prices in television appearances and on Twitter this month, retweeted Trump’s claim of an historic price drop in 2018, but tacked on a comment saying, “President Trump has done more to address high drug prices than any President in history. More to come!”

Clearly, both Trump and Azar are engaging in Washington spin. Just before the November 2018 election, Trump announced a price-reduction plan that ties what Medicare pays for certain drugs to much lower prices paid in other economically advanced countries (1). Congressional Democrats have also introduced legislation to tackle the issue. However, Trump and congressional Democrats are now locked in a stalemate that shutdown the government and it seems unlikely they could come together to take actions on drug prices this year.

Richard A. Robbins, MD

Editor, SWJPCC

Reference

1. Associated Press. Trump hails drug price decline not supported by the evidence. January 11, 2019. Available at: https://www.apnews.com/bce3a214039c4271b3f3337e0e522b2a (accessed 1/14/19).

Cite as: Robbins RA. Drug prices continue to rise. Southwest J Pulm Crit Care. 2019;18(1):20-1. doi: https://doi.org/10.13175/swjpcc002-19 PDF

New Center for Physician Rights

Cases of unfair physician treatment by regulatory boards and hospitals have been well publicized. However, little action to insure oversight of physician regulatory bodies has been done. Physicians who believe they have been subjected to unfair discipline now have a place to turn for information, advice, and support. The new center called The Center for Physician Rights (CPR) was founded by Kernan Manion, MD. According to their website the Center will offer:

1. Free confidential case review;
2. Case consultation and coaching;
3. Serve as a central authoritative informational and consultative resource;
4. Pursue organizational and legislative change.

CPR will develop an informational website and produce a monthly e-newsletter / blog updating subscribers of relevant developments. They hope to serve as the definitive “go to” knowledge resource by establishing a centralized reference library with essential resources based on their extensive research and cumulatively accruing knowledge of judicial decisions, case trends and operant medical licensing boards.

Manion’s own career-ending experience with the North Carolina Medical Board (NCMB) was well publicized (1). His case dates back to September 2009, when he worked as a civilian psychiatrist under contract with the Deployment Health Center at Naval Hospital Camp Lejeune, in Jacksonville, North Carolina. After he raised concerns with the US Navy and a personnel contractor about what he believed was dangerously deficient care of active duty service members who had posttraumatic stress disorder, he was dismissed. Later an anonymous source raised concerns about his mental health, which resulted in an investigation by the North Carolina Medical Board. Although an independent, comprehensive psychological evaluation determined he had no mental disorder or other psychological impairment, an assessment by the Board concluded otherwise, and he was forced to deactivate his medical license. In 2016, he launched a lawsuit against the NCMB, which was ultimately unsuccessful on appeal because it exceeded the time limit for filing a petition. Manion blamed the NCMB for using stall tactics to delay the legal process.

Richard A. Robbins, MD

Editor, SWJPCC

Reference

1. Anderson P.  One-Man Fight: MD Takes on State Medical Board, PHP. Medscape. November 8, 2016. Available at: https://www.medscape.com/viewarticle/871569 (accessed 11/13/18).

Cite as: Robbins RA. New center for physician rights. Southwest J Pulm Crit Care. 2018;17(5):137. doi: https://doi.org/10.13175/swjpcc116-18 PDF 

CMS Decreases Clinic Visit Payments to Hospital-Employed Physicians and Expands Decreases in Drug Payments 340B Cuts

The Centers for Medicare and Medicaid Services (CMS) has reimbursed hospital-employed physicians more than self-employed physicians. However, CMS is moving forward with plans to expand its site-neutral payment policy to clinic visits, a move that could save the agency hundreds of millions of dollars (1).

Clinic visits are the most common service billed to CMS. CMS estimates that it is now paying about $75 to $85 more on average for the same service in hospital outpatient settings compared to physician offices. Beneficiaries are responsible for 20% of that increased cost. The payment change is projected to save Medicare $610 million and patients about $150 million. Higher CMS payments to hospital-employed physicians have also been have associated with higher commercial prices and spending for outpatient care which could save CMS even more money (2).

However, CMS abandoned its 2016 plan to expand a site-neutral rule. That regulation would have paid hospital off-campus facilities less than hospital-based outpatient departments if they started billing Medicare after Nov. 2, 2015. Following pushback from the American Hospital Association and others, the agency said it decided to not finalize that provision.

CMS’ 340B Drug Discount Program requires drug manufacturers to provide outpatient drugs to eligible hospital-based departments at significantly reduced prices. CMS will expand last year's cuts to 340B discounts given to outpatient facilities. Last year, the agency cut 340B drug payments by $1.6 billion, or 22.5% less than the average sales price. CMS is expanding the 340B cut to off-campus provider-based departments to prevent hospitals from moving their drug administration services for 340B-acquired drugs to an off-campus facility to receive a higher payment.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Dickson V. CMS slashes clinic visit payments, expands 340B cuts. Modern Healthcare. November 2, 2018. Available at: https://www.modernhealthcare.com/article/20181102/NEWS/181109978 (accessed 11/2/18).
2. Neprash HT, Chernew ME, Hicks AL, Gibson T, McWilliams JM. Association of financial integration between physicians and hospitals with commercial health care prices. JAMA Intern Med. 2015 Dec;175(12):1932-9. [CrossRef] [PubMed]

Cite as: Robbins RA. CMS decreases clinic visit payments to hospital-employed physicians and expands decreases in drug payments 340b cuts. Southwest J Pulm Crit Care. 2018;17(5):136. doi: https://doi.org/10.13175/swjpcc115-18 PDF