Determining if Drug Price Increases are Justified

Drug prices continue to increase but the reasons for the increases are often nebulous. The Institute for Clinical and Economic Review (ICER) evaluated the pricing in partnerships with SSR Health Inc, a research firm, calculated the increases excluding discounts and after-market rebates (1). It was the first such annual report by the Boston-based research group, which assesses the cost-effectiveness of drugs.

A list of 78 drugs with price hikes at more than twice the rate of medical inflation was developed. From this list 9 drugs were selected for detailed review because they had the largest increase in drug spending due to a net price change. ICER reviewed these 9 drugs to determine if the price increases were supported by new clinical evidence based on new indications or data suggesting superiority over other drugs. Of these 9 drugs, ICER concluded 7 did not have justification for the price increases.

Advair, Glaxo’s beta agonist/steroid combination was the only bronchodilator on the list but was not selected for detailed review. Rituxan, a drug which can be used to treat granulomatosis with polyangiitis (GPA, formerly known as Wegener's Granulomatosis) and microscopic polyangiitis (MPA) was one of the drugs selected for review and ICER concluded the price increase was not justified.

ICER acknowledged it was difficult to determine the actual increase in spending on the drugs, but said it was confident that the seven drugs cost increase were more than other drugs (2). "If manufacturers weren't raising prices if they haven't shown a new important benefit, I think that would help," ICER Chief Medical Officer David Rind said. He added that he hoped pricing drugs based on new benefits could help slow cost hikes.

Not surprisingly pharmaceutical companies with drugs on the list were critical of the report. Gilead, Lilly, Pfizer and Roche were all critical of the report or defended their drug pricing policies (2). Both California and Vermont now have laws tracking substantial drug price increases, requiring drug manufacturers to submit information that might justify increases above a certain threshold (1). ICER hopes their report is a first step in providing the public and policymakers with information they can use to advance the public debate on drug price increases.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Institute for Clinical and Economic Review. Unsupported price increase report: 2019 assessment. October 8, 2019. Available at: https://bit.ly/31XIdyk (accessed 10/11/19).
2. Humer C. Humira, Rituxan top list of U.S. drugs with biggest price increases: report. Reuters Health News. October 9, 2019. Available at: https://www.reuters.com/article/us-usa-healthcare-drugpricing/humira-rituxan-top-list-of-u-s-drugs-with-biggest-price-increases-report-idUSKBN1WN1BE (accessed 10/11/19).

Cite as: Robbins RA. Determining if drug price incrases are justified. Southwest J Pulm Crit Care. 2019;19(4):123-4. doi: https://doi.org/10.13175/swjpcc064-19 PDF 

Court Overturns CMS' Site-Neutral Payment Policy

On Tuesday of this week (9/17/19) a federal district court judge ruled in favor of an American Hospital Association (AHA) and Association of American Medical Colleges (AAMC) complaint that the Centers for Medicare & Medicaid Services (CMS) had overstepped its bounds by implementing site-neutral payments in January. US District Judge Rosemary M. Collyer said in her decision, "The Court finds that CMS exceeded its statutory authority when it cut the payment rate for clinic services at off-campus provider-based clinics" (1).

Under its site-neutral policy, CMS had begun paying the outpatient provider-based departments of hospitals the same for visits that it paid to independent physician practices. Previously, the hospital providers had been paid significantly more for these services than to community practices and the change in CMS policy was expected to level the playing field between independent offices and hospital-employed practices. In addition, it lowered the incentive of healthcare systems to acquire more physicians and their practices, according to some health policy experts.

The difference in costs is substantial with hospitals charging 2-6 times more than an independent physician office (2). The site-neutral payments were expected to cost hospitals $760 million in 2020, according to the suit.

The Medicare Payment Advisory Commission had advised Congress that hospitals were buying physician offices and converting them to off-campus provider-based departments partly because payments were higher than independent physician offices. In the Bipartisan Budget Act of 2015, Congress allowed hospitals to bill CMS at the higher outpatient department rate if they existed prior to Nov. 2, 2015. The law permitted CMS to change the payment system for newly established hospital-based outpatient departments. However, one expert told Medscape Medical News last year that this provision of the budget act hadn't had much impact, because many hospitals just added newly recruited physicians to the PBDs that had been grandfathered in (1).

Asked to comment on the court ruling, a CMS spokesperson told Medscape Medical News, "We are aware of the decision and are determining next steps" (1).  The AHA and the AAMC were jubilant. In a joint statement, they said, "We are pleased with the District Court's decision that the Department of Health and Human Services exceeded its statutory authority when it reduced payments for hospital outpatient services provided in grandfathered, off-campus, provider-based departments. The ruling, which will allow hospitals to maintain access to important services for patients and communities, affirmed that the cuts directly undercut the clear intent of Congress to protect hospital outpatient departments because of the many real and crucial differences between them and other sites of care."

John Cullen, MD, president of the American Academy of Family Physicians, said in a statement that the AAFP is disappointed with the court ruling. "The decision preserves a system that both costs patients more in out-of-pocket expenses and limits their choice of physicians by paying hospital outpatient departments more for the same services provided by community-based physicians." he said. He added, these payment disparities across sites of service "force many community clinics to close their doors or sell their practices to hospitals. The small private practices, which provide high-quality care at a lower cost, are most at risk as a result of this decision." Robert Doherty, senior vice president, governmental affairs and public policy, for the American College of Physicians, tweeted, "This is very bad news for all the patients harmed by hospitals adding 'facility fees' for visits to doctors in practices they acquired."

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Terry K. Court overturns CMS' site-neutral payment policy; doc groups upset. Medscape Medical News. September 19, 2019. Available at: https://www.medscape.com/viewarticle/918744?nlid=131645_5401&src=wnl_dne_190920_mscpedit&uac=9273DT&impID=2101100&faf=1#vp_2 (accessed 9/19/19).
2. Carey MJ. Facility fees: the farce everyone pays for. Medical Economics. August 16, 2018. Available at: https://www.medicaleconomics.com/blog/facility-fees-farce-everyone-pays (accessed 9/19/19).

Cite as: Robbins RA. Court overturns CMS' site-neutral payment policy. Southwest J Pulm Crit Care. 2019;19(3):101-2. doi: https://doi.org/10.13175/swjpcc060-19 PDF 

Pulmonary Disease Linked to Vaping

As of August 21, 153 cases of severe respiratory disease associated with vaping had been reported to the CDC mostly in adolescents and teens (1). Cases have been reported in 16 states including California and New Mexico. No specific cause has been identified although the available evidence does not suggest and infectious source. Many of the cases appear similar with tetrahydrocannabinol (THC) containing products often mixed with the vaping solution (2). Patients’ respiratory symptoms at presentation included cough, shortness of breath and fatigue that worsened over several days or weeks before hospital admission. Some patients also reported fever, chest pain, weight loss, nausea or diarrhea.  Chest radiographs have been reported to show bilateral opacities and CT chest scans have demonstrated diffuse ground-opacities, often with sub-pleural sparing. In some cases, patients experienced respiratory failure requiring mechanical ventilation but subsequently improved with treatment with corticosteroids.

The Arizona Department of Health issued a warning to the public yesterday. If a case is suspected, the Arizona Poison and Drug Information System should be contacted at 800-222-1222.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. CDC. CDC, FDA, states continue to investigate severe pulmonary disease among people who use e-cigarettes. August 21, 2019. Available at: https://www.cdc.gov/media/releases/2019/s0821-cdc-fda-states-e-cigarettes.html (accessed 8/22/19).
2. CDC. CDC urges clinicians to report possible cases of unexplained vaping-associated pulmonary illness to their state/local health department. August 14, 2019. Available at: https://emergency.cdc.gov/newsletters/coca/081619.htm (accessed 8/22/19).

Cite as: Robbins RA. Pulmonary disease linked to vaping. Southwest J Pulm Crit Care. 2019;19(2):84. doi: https://doi.org/10.13175/swjpcc057-19 PDF 

CEO Compensation-One Reason Healthcare Costs So Much

The Southwestern states were well represented in the category of highest executive pay at non-profit healthcare organizations (1). Leading the way was Bernard Tyson, Chief Executive Officer (CEO) of Kaiser in California, who earned over $16 million in salary. Lloyd Dean, CEO of Dignity Health in San Francisco, and Peter Fine, CEO of Banner in Phoenix, also made the top ten at over $9 million and $8 million respectively. The top 10 are listed in Table 1 and the salaries of the top 50 were all over $4 million.

Table 1. Top 10 Healthcare Executives Salary (2017) (1).

However, the salary only tells part of the part of the story. Note that on the far right of Table 1 under the category of other compensation, are some exceedingly high percentages. Adding in other compensation generates the executive total compensation (Table 2).

Table 2. Top 10 Total Executive Compensation (2017) (1).

Please note that these are all not-for-profit corporations. Economists talk about the pay ratio between CEOs and employees. Comparing Peter Fine's $25+ million salary with the average primary care physician salary of $155,212, a group not generally considered to be undercompensated, which means Mr. Fine earns more in 2 days than a physician earns in a year (2). Fine earns about $164 for every $1 earned by a physician

The people responsible for Mr. Fine’s compensation at Banner and other healthcare organizations are the board of directors. At Banner this consists of 13 members and 2 physicians. The physicians are Ronald J. Creasman MD, a retired Gilbert, AZ pulmonologist, and John Koster MD, the retired CEO of Providence Health & Services in Renton, WA. The others are mostly current or retired corporate executives and many sit on multiple corporate boards.

Steffie Woolhandler, MD, cofounder of nonprofit Physicians for a National Health Program, describes CEO compensation as a misallocation of funds collected for medical services. Overly generous compensation for executives of healthcare organizations diverts resources that would be better spent on patients, Woolhandler told Medscape Medical News in an interview (3). "This is money that is being taken out of the healthcare system and handed over to CEOs. This is money that is not being spent on medications. It is not being spent on doctor visits," Woolhandler said. "It is not being spent on hospitalizations. It's just going in the pockets of these CEOs."

Modern Healthcare reported that the combined compensation for the 25 top paid executives of nonprofit health systems rose to $197.9 million in 2017 from $148.6 million in 2016 (1). That's a pay increase of 33% for top executives of nonprofits. In contrast, the average increase was just over 5% for physicians in 2016 and 2017 (3). The largest increase seen in 2017 for any specialty was 24% among plastic surgeons. On the other end of the spectrum, pediatricians reported an average salary decrease of 1% in 2017 (3). Annual gross income for registered nurses was essentially flat, with respondents reporting an average income of $81,000 in 2017 and $80,000 in 2016, according to the Medscape's 2018 RN/LPN Compensation Report (3).

Overly generous executive compensation can erode the public's trust in healthcare organizations, especially given the growing backlash against aggressive bill-collection tactics, said Martin Makary MD MPH of Johns Hopkins, an expert in healthcare finance (3). Makary questioned the argument that substantial pay packages and increases are needed to attract and keep the best executive talent. Hospitals would do well to consider higher pay for the people who care directly for patients, he said. "What about the talent on the frontline, nurses and doctors? What about the clinicians and the staff at the hospital? Don't we want the best bedside nurses?" Makary said. The compensation packages for executives leading large healthcare nonprofit organizations reflect the market power these systems possess, J. Michael McWilliams, MD, PhD, a professor of healthcare policy at Harvard Medical School, told Medscape Medical News in an email exchange (3).

The increase in healthcare costs has largely been fueled by administrative overhead which now consumes about 40% of the healthcare dollar (5). The excessive compensation packages for healthcare CEOs and the salaries of their underlings likely contribute to this rising administrative cost. These excessive costs also make accusations against physicians, nurses and other healthcare workers that their salaries are largely responsible for the increase in healthcare costs ring pretty hollow. In order to control costs, understanding where the money is spent is essential.

In 2016 the Arizona Hospital Executive Compensation Act limiting CEO compensation to $450,000/year was proposed (6). Although the act was later dropped from the ballot, a survey of Southwest Journal of Pulmonary and Critical Care readers showed that 83% supported the measure and 35% though limiting CEO pay would improve patient care. It seems astonishing that so called not-for-profit organizations pay CEOs this amount of compensation. All of the money earned by or donated to a not-for-profit organization should be used in pursuing the organization's objectives and keeping it running. CEO compensation in the millions does not seem to fit these goals.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Kacik A. Highest-paid not-for-profit health system executives earn 33% raise in 2017. Modern Healthcare. June, 2019. Available at: https://www.modernhealthcare.com/executive-compensation/highest-paid-not-profit-health-system-executives-earn-33-raise-2017 (accessed 8/17/19).
2. Banner Health. Banner Health - physicians & surgeons salaries in the United States. Available at: https://www.indeed.com/cmp/Banner-Health/salaries?job_category=meddr (accessed 8/17/19).
3. Young KD. Docs get tiny raises while nonprofit healthcare CEOs get > $10M. Medscape. August 2, 2019. Available at: https://www.medscape.com/viewarticle/916423?src=WNL_trdalrt_190815_MSCPEDIT&uac=9273DT&impID=2060646&faf=1#vp_2 (accessed 8/17/19).
4. Robbins RA, Natt B. Medical image of the week: medical administrative growth. Southwest J Pulm Crit Care. 2018;17(1):35. [CrossRef]
5. Robbins RA. Survey shows support for the hospital executive compensation act. Southwest J Pulm Crit Care. 2016;13:90. [CrossRef]

Cite as: Robbins RA. CEO compensation-one reason healthcare costs so much. Southwest J Pulm Crit Care. 2019;19(2):76-8. doi: https://doi.org/10.13175/swjpcc055-19 PDF 

Doctor or Money Shortage in California?

An LA Times article titled “California doesn’t have enough doctors. To recruit them, the state is paying off medical school debt” describes a program where the State of California will pay off student debts using Proposition 56 tobacco tax revenue (1). California’s program is aimed at increasing the number of doctors who see Medi-Cal patients which has not kept pace with the rapid expansion of the state’s healthcare program for the poor, which now covers 1 in 3 residents in the state. The trends of decreasing doctors who accept Medi-Cal along with the increasing number of Medi-Cal patients led healthcare, education and business leaders to form the California Future Health Workforce Commission (CFHWC) in 2017 to study the state’s impending healthcare crisis (2). The CFHWC task force ultimately proposed a $3-billion plan over the next 10 years including $120 million for loan forgiveness incentives that’s meant to ensure physicians and dentists take on Medi-Cal patients. Another component of the program would allow nurse practitioners to practice independently from physicians.

The program is telling of both education and reimbursement in California. The CFHWC task force states that California is experiencing a shortage of doctors (3). This is not true. It is true that the graduation of doctors has not kept pace with the expanding California population. The national average of medical school students per 100,000 people is 30.3; California has 18.4 students per 100,000 (1,3). That’s the third-lowest rate among the 45 states that have at least one medical school. California has made relatively few investments in increasing enrollment at medical schools in the state. The only new public medical school to open in California in the last four decades is at UC Riverside and class size has only slightly expanded in the other schools (1,3). At the same time, more than one-third of the state’s doctors and nurse practitioners are reaching retirement age (1).

More than 60% of California’s students who attended medical school in 2017 left the state for their residency, according to the commission’s report. Most doctors settle near their residencies and California must expand the number of residency positions offered according to the CFHWC task force (1,3). They added that the state has historically underfunded those programs (1,3).

Despite these deficiencies, California does not have a shortage of doctors compared to other states (Table 1).

Table 1. Number of physicians per 100,000 population (Phys/10⁵ Pop) by state (2016 data, 4).

In 2016 California ranked nineteenth of the fifty states in numbers of physicians per 100,000 population (4). In addition, it ranked 22^nd in active primary care physicians (4).

What the CFHWC task force really means (and says intermittently) is that the number of doctors willing to accept Medi-Cal payment is low. The reason for this is pretty simple, Medi-Cal reimbursement is abysmally small. For a routine office call (CPT code 99213) Medi-Cal reimburses $24.00 (5). This office code is for about 15 minutes of patient contact and must include: 1. an expanded problem focused history, 2. an expanded problem focused examination, and 3. medical decision making of low complexity. This might be difficult to accomplish in 15 minutes. Documentation and billing would require at least 5 minutes more if the physician is a lightning fast typist. In contrast, Medicare pays $77.72 and Arizona Health Care Cost Containment System (AHCCCS) Administration (Arizona’s Medicaid) pays $51.42. Income generated from a busy practice seeing only Medi-Cal patients at $24.00 per office visit would mean $72/hour, about $500/day (7 hours/day), $2500 per week ($500/day X 5 days a week) or about $120,000/year (48 weeks). Although office overhead (payroll, rent, vendors, information technology, insurance, office equipment, etc.) varies widely, in 2002 the average general internist’s office overhead was about $250,000 (6). Expenses have not likely decreased in the last 16 years meaning that under the very best of circumstances, a physician seeing only Medi-Cal patients would lose $130,000/year serving California’s poor.

Medi-Cal has seemed to attempt to place the financial burden of caring for the poor on physicians and nurse practitioners rather than solving the problem of low reimbursement. Recent residency graduates who agree to have their debt relieved by California in exchange for seeing Medi-Cal patients may find their debt increasing under California’s proposal. Cuts could be made in other areas (hospital costs, drugs, etc.) but ultimately it seems that adequate reimbursement will be necessary to solve the impending “healthcare crisis”.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Gutierrez M. California doesn’t have enough doctors. To recruit them, the state is paying off medical school debt. LA Times. July 16, 2019. Available at: https://www.latimes.com/politics/la-pol-ca-california-doctor-shortage-medical-debt-20190716-story.html (accessed 7/19/19).
2. Gutierrez M. $3 billion is needed to address California’s doctor shortage, task force says. LA Times. February 5, 2019. Available at: https://www.latimes.com/politics/la-pol-ca-california-future-health-workforce-commission-doctor-shortage-20190205-story.html (accessed 7/19/19).
3. Mijic V. Meeting the demand for health: fact sheet on California’s looming workforce crisis. California Future Health Workforce Commission. February 4, 2019. Available at: https://futurehealthworkforce.org/2019/02/04/ca-looming-workforce-crisis/ (accessed 7/19/19).
4. American Association of Medical Colleges. 2017 State Physician Workforce Data Report. Available at: https://store.aamc.org/downloadable/download/sample/sample_id/30/ (accessed 7/19/19).
5. Department of Healthcare Services Medi-Cal. Medi-Cal rates as of 07/15/2019 (codes 94799 thru 99600). Available at: https://files.medi-cal.ca.gov/pubsdoco/rates/rates_information.asp?num=22&first=94799&last=99600 (accessed 7/19/19).
6. Weiss GG. Expense survey: what it costs to practice today. Med Econ. 2002 Dec 9;79(23):36-8, 41. [PubMed]

Cite as: Robbins RA. Doctor of money shortage in California? Southwest J Pulm Crit Care. 2019;19(1):15-7. doi: https://doi.org/10.13175/swjpcc050-19 PDF