Advocates urge clinicians to consult with elective surgery patients about local anesthetics shortages, the potential health risks, and alternative forms of pain management.
A global shortage of local anesthetics threatens patient care and could worsen the opioid crisis as patients and their caregivers use other methods of pain relief, the American Society of Regional Anesthesia and Pain Medicine says.
Because of that, ASRA is urging hospitals, physicians and other clinicians who provide elective surgery to consult with their patients ahead of the procedure to warn of potential local anesthesia shortages and their potential health risks, and to discuss alternative strategies for pain management.
"This conversation needs to be taken to the public," says Edward R. Mariano, MD, a professor of Anesthesiology, Perioperative and Pain Medicine Stanford University School of Medicine.
"If I were helping a family member make a decision about when and how to have a knee replacement surgery scheduled, I would want to know whether the hospital where my mom or dad was having knee replacement actually has suitable stock of local anesthetics so my family member is going to get good care," Mariano says.
Even minor surgical procedures can lead to long-term opioid use. Regional anesthesia, especially with continuous peripheral nerve block techniques, has been shown repeatedly to reduce patients’ need for opioid analgesia, Mariano says.
Now, this care is threatened with ongoing global shortage of local anesthetic drugs, including bupivacaine, lidocaine, ropivacaine. Targeted injections of these numbing drugs at the surgery site can eliminate the need for injectable opioids such as fentanyl, hydromorphone, morphine, which also are in short supply.
Mariano says elective surgery patients oten know the date of their procedure months in advance, which provides an excellent window of opportunity for clinicians to consult with them about pain management.
"From the patient point of view, when you show up for your surgery you don't necessarily know when you go in whether that hospital is suffering from a local anesthetic shortage," he says. "It is not a reason that most hospitals would consider for delaying or even cancelling elective procedures. But, we know from our data that certain types of anesthetics and pain control modalities have a direct positive effect on decreasing opioid use."
Mariano says patients must be fully informed about any potential health risks before elective surgery.
"For knee replacement patients, for example, there is an association between having a spinal or an epidural anesthetic and having a lower risk of 30-day mortality. That's huge," he says.
"We know this effect is greater if you happen to be a patient with obstructive sleep apnea. There was a recent article that brought up general anesthesia and memory loss," he says. "So, if you have a reason to avoid general anesthesia and you have a surgery that doesn't require general anesthesia, then as a patient you have a right to request a spinal anesthetic, and you have the right to schedule when you know that that is going to be the anesthetic available to you."
ASRA will take up the issue during a session on April 21, held in conjunction with the 2018 World Congress on Regional Anesthesia and Pain Medicine. Mariano is asking clinicians and healthcare administrators who are dealing with local anesthetics shortages to help find solutions.
"I'd be interested if they have found alternative vendors or, if they've come up with strategies to avoid effects on clinical care, I'd like to hear about it," he said. "If their hospital has started introducing these drug shortage conversations in their process of surgical informed consent I'm interested in hearing about that."
(Providers interested in sharing their solutions can reach Dr. Mariano at emariano@stanford.edu)
Healthcare mergers and acquisitions saw a banner year in 2017, despite economic and political uncertainty. Analysts believe that lower corporate taxes will continue to lure foreign investors into the $3.3 trillion U.S. healthcare sector.
Healthcare merger and acquisition values surged globally in 2017, rising 27% to $332 billion while the deal count increased 16%. That robust activity should continue in 2018, according to a report from Bain & Company.
"The industry is at a major inflection point, and as a result, we're seeing category leaders consolidate and the silos between sectors starting to blur," said Dale Stafford, partner and leader of Bain’s Americas M&A practice.
"While total corporate deal value in healthcare hasn't quite equaled its 2015 peak, average annual activity over the past four years has been strong, nearly twice the level of the previous four years. This activity is profoundly reshaping the industry," Stafford said.
The investment in the healthcare sector in the United States and globally continued in 2017 despite unease about the state of the global economy, and political turbulence in the U.S. around efforts to roll back the Affordable Care Act.
Still, Bain said investors are lured into the $3.3 trillion U.S. healthcare sector by fundamental drivers that include an aging population, a rising prevalence of chronic disease, the robust development of new drugs and medical devices, and the fragmented and inefficient care delivery system that is ripe for disruption.
Looking Ahead in 2018
Bain says it expects the continued high level of healthcare M&As to continue in 2018, despite valuations at or near record high levels.
"Already, we've seen aggressive moves by corporates across healthcare, retail and technology this year, fusing sectors and leading others to make offensive and defensive moves," Bain says.
Forces that will affect the M&A market this year include:
Evolving laws and regulations. U.S. tax reform will mean lower corporate rates, potentially making healthcare assets attractive to foreign investors eager to expand in the world's largest economy.
Innovation. In the pharma sector, the development of next-generation platforms such as biosimilars and gene therapy will accelerate. They have the potential to disrupt the industry, creating buying opportunities while putting stress on traditional companies.
Changing nature of total shareholder return. Rising stock markets have been very generous to the shareholders of public healthcare companies, but that’s not something they can count on going forward. Forty-five percent of TSR growth at publicly traded global healthcare companies over the past five years came from an expansion of price-to-earnings multiples—that is more than growth from either revenue or earnings.
Bain says companies will face renewed pressure to build total shareholder return through revenue growth, margin expansion or financial leverage.
"If they cannot drive revenue growth internally, they’ll likely look for it in acquisitions, adding further fuel to healthcare M&A," Bain says.
The vaguely outlined collaborative between Amazon, Berkshire Hathaway, and J.P. Chase Morgan poses no short-term threats to established health insurance companies, Moody's says.
"Both of these mergers are designed to better control rising medical costs, which is one of the most vexing problems facing health insurers," Moody's says this week in its Healthcare Quarterly.
Prescription drug prices are a big driver of rising medical costs, and the Health Care Cost Institute reports that prescription drugs increased from 17% to 19% of the total healthcare spend between 2012 and 2016.
"The annual medical cost trend for insurers, which consists of the level of utilization, medical inflation, the impact of technology advances and the sources of medical care (i.e. low-cost clinics versus high-cost hospitals), has been moderating in recent years. But it still came in at approximately 6% in 2017, well above inflation," Moody's says.
According to Moody's:
The CVS/Aetna merger has the potential to lower medical costs as Aetna will be better able to engage with its members as they purchase drugs at CVS retail pharmacies or through its prescription drug programs. The combination will foster increased use of lower-cost care as Aetna members access routine care at CVS stores and Minute Clinics.
Cigna will incrementally benefit from its purchase of Express Scripts by combining its own integrated solutions with Express Scripts' ability to manage pharmacy costs. While Express Scripts does not have a retail presence, Cigna will benefit from a more diversified revenue stream.
The impact of these mergers on the health insurance sector is limited. When finalized, the three largest PBMs will each be part of a vertically integrated entity that includes a large health insurer. That trend started in 2015 when UnitedHealth Group bought Catamaran, now known as OptumRx.
As a result of these deals, most other health insurers will have to contract with a PBM that is owned by a competing health insurer. Competition among the PBMs for market share will remain intense. Their offerings to third parties will have to be competitive with their internal offerings or they'll risk losing customers. Because of that these vertically integrated offerings could benefit the broader industry over time.
The mergers are a credit negative for branded drug makers. For example, Aetna could encourage policyholders to buy generics at CVS pharmacies or through its prescription drug programs. The mergers will have little impact on generic drug makers, since both CVS and Express Scripts are already part of large generic drug purchasing alliances.
Amazon, Berkshire Hathaway, J.P. Morgan Chase
In a separate analysis, Moody's says the announcement in January that Amazon, Berkshire Hathaway Inc., and J.P Morgan Chase would combine to form some sort of health insurance venture likely would have little short-term credit impact on the commercial healthcare sector.
"The new venture is likely to have little, if any, credit impact on the health insurance sector over the next three years," Moody's says. "The three companies combined have less than one million employees, which is a fraction of the membership of the large, publicly traded health insurers."
The three companies provided scant details on what their combined initiative would involve, but Moody's says it likely would be designed to leverage the companies' bargaining powers with payers and providers.
"Whether or not the announcement is a harbinger of more heated competition from non-traditional participants in health insurance, outside of these three companies, remains the larger question," Moody's says.
"Our view is that the industry leaders are not sitting still and are taking steps to enhance capabilities. While improvements by new competitors are always possible, we do not see any immediate threat to the large incumbents."
Federal prosecutors allege that Allergan knowingly sold LAP-BANDs with defective or flawed access ports and lied to the FDA about the cause of the leaks.
Drug and medical device maker Allergan Inc. will pay $3.5 million to resolve whistleblower allegations that it knowingly sold defective LAP-BAND surgical gastric bands to healthcare providers, the Department of Justice said.
"Patients have every right to expect that medical devices used during surgery are free of defects," Robert K. Hur, U.S. Attorney for Maryland, said in a media release.
"Patients also have the right to expect that procedures involving medical devices have been subject to the rigorous review and approval process of the Food and Drug Administration," Hur said. "When marketing and selling medical devices that may have defects or may be used in unapproved procedures, patients can be put at risk."
An Allergan spokesperson on Wednesday declined to comment on the settlement.
The LAP-BAND is an inflatable silicone band that is placed around a patient’s stomach during surgery. Adding or removing saline through a subcutaneous access port adjusts the LAP-BAND, which constricts or expands the size of the stomach pouch.
Federal prosecutors allege that between 2008 and 2010 Allergan knowingly sold LAP-BANDs with defective access ports. To conceal the defect and to induce healthcare professionals to continue using the LAP-BAND, Allergan misrepresented facts concerning the cause of access port leaks to the public and the FDA.
Allergan allegedly failed to collect data and complaint files, nor did it provide remuneration to clinicians who reported access port leaks, DOJ said.
In addition, prosecutors allege that between 2008 and 2012, Allergan knowingly advertised, marketed, and distributed LAP-BAND for use in two procedures that were not approved by the FDA.
Allergan allegedly induced clinicians to use LAP-BAND for these unapproved procedures through proctoring, workshops, advisory boards, and training events in which these two uses were discussed and/or demonstrated.
The two whistleblowers who brought the suit will split $594,064, the federal government will collect $3.3 million, and state Medicaid programs will receive $200,000.
The settlement was filed with the U.S. District Court in Maryland.
Insurers, unions, consumer groups urge CMS to re-issue a rule on steering in the individual market and prohibit third-party premium assistance payments made by a financially-interested party.
An unlikely ad hoc group of insurers, businesses, unions, and consumer groups want the federal government to crack down on what they say is the inappropriate steering of Medicaid and Medicare-eligible patients with end stage renal disease into higher-paying commercial coverage.
The group said dialysis providers are "gaming" a provision in the Affordable Care Act that allows them to provide premium assistance for patients enrolled in Exchange plans through a "financially interested third party – the American Kidney Fund."
In exchange for the premium assistance, the dialysis providers collect higher reimbursements from commercial plans, even though the patients are Medicare- or Medicaid-eligible.
"What may appear to be innocent assistance to a patient, may in fact be an effort to change that individual’s coverage and caregiving in a way that benefits the third party or others, and not the patient," the ad hoc group said in a joint letter to Health and Human Services Secretary Alex Azar.
American Kidney Fund President and CEO LaVarne A. Burton said the letter to Azar is the latest shot in a long-term, coordinated "discrimination strategy against ESRD patients."
"It’s appalling," Burton said. "The real steering playbook is outlined in today’s letter spearheaded by insurers, employers and labor unions: let’s get these people off employer-provided insurance and let’s push them onto the government rolls whether that works for them or not."
The letter to Azar was signed by groups including America’s Health Insurance Plans, Blue Cross Blue Shield Association, Families USA, National Partnership for Women & Families, National Association of Wholesalers-Distributors, and Service Employees International Union.
The group has called on the Centers for Medicare & Medicaid Services to re-issue its rule on steering in the individual market and prohibit third-party payments made directly or indirectly by a financially-interested party. They also want policymakers to protect the employer market from inappropriate steering.
"This gaming of the Affordable Care Act’s guaranteed issue rules generates significant profit for dialysis providers engaged in these schemes. J.P. Morgan estimated that the return on 'charitable' donations by dialysis providers to the American Kidney Fund likely exceeds 500%," the letter said.
In 2016, J.P. Morgan reported that 6,400 Qualified Health Plans purchased through the AKF drove an estimated $1.7 billion in adverse selection. This steering into the employer market generates $450 million a year in operating income for one dialysis provider that the letter did not identify.
"When third parties with conflicts of interest and who gain financially intervene in the provision of health insurance benefits in a manner that changes the financial balance inherent in the relationship between payers and plan beneficiaries, to the detriment of the healthcare system, the results can be adverse for the individual being assisted, for other plan beneficiaries, and for the sustainability of commercial health plans as a whole," the letter said.
On Tuesday afternoon, AKF sent a rebuttal letter to Azar that accused the health plans, business groups, unions and consumer groups of "misleading statements, omissions, half-truths and outright falsehoods."
"The letter has one true purpose: to limit the health coverage options of people with kidney failure by forcing them off private insurance and onto government health programs," the AKF letter said.
AKF Responds
Here is Burton's entire statement:
"For years, if not decades, some very profitable business groups and health insurance providers have tried and pursued a discrimination strategy against ESRD patients. It’s appalling.
The real steering playbook is outlined in today’s letter spearheaded by insurers, employers and labor unions: let’s get these people off employer-provided insurance and let’s push them onto the government rolls whether that works for them or not.
Unfortunately, many times, only when people have a personal experience (family or friend) with ESRD do they realize the difficult health care decisions patients have to make. To the powerful groups that spearheaded this letter, ESRD patients are a cost that they want shifted elsewhere. To us, they are men, women, husbands, wives, mothers and fathers who deserve the dignity to have the health care that best suits their personal and family situation, even if they need charitable help to pay for it.
Our goal is to make health coverage possible for those who can least afford it when they get kidney disease. With very few exceptions, these are patients with little to no meaningful assets. Certainly not enough to afford health care without tremendous out-of-pocket costs. We help patients with any type of insurance plan they’ve chosen, public or private. It’s ironic that the same insurers who say all ESRD patients belong on Medicare are, at the same time, denying charitable premium assistance that allows Medicare patients to afford the Medigap plans that protect them from personal financial ruin.
These groups don’t understand what these patients experience. They just look at cost and say it should be someone else’s problem to bear.
Healthcare coverage cannot just be for healthy people. This letter should send a chill down the spine of every person with a chronic disease. Which disease will be rejected by insurers and employers for health coverage next--cancer, diabetes, obesity or asthma? Because they won’t just stop with kidney failure.
This outright discrimination against ESRD patients, who are disproportionately members of minority groups, has to stop. It’s a life and death situation, and like previous Administrations, Congresses and courts, we believe Secretary Azar will reject this cynical effort to deny health coverage to people who need it most."
Barriers that ACOs may face in shifting visits to PCPs 'could include low numbers of PCPs contracted in the ACO, and existing referral patterns and patient relationships with specialists.'
Primary care physicians are supposed to play a key role providing cost-effective care under the Medicare accountable care organization model.
However, anew studyfrom the University of Pittsburgh Graduate School of Public Health shows that a large proportion of Medicare ACO patients with chronic conditions skipped primary care management and evaluation consults and visited more expensive specialists instead.
"Many ACOs may underutilize PCPs, and thus could actively shift care to less expensive primary care for potential savings to payers," the study said.
The researchers analyzed data on 3.7 million visits to 219 ACOs by 1.1 million Medicare patients in 2013, one year after ACOs began under the Affordable Care Act. The patients had at least one of eight chronic conditions that can be managed by primary care, including: asthma, chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, high cholesterol, high blood pressure, and osteoarthritis.
Study lead author Evan S. Cole, a researcher with the Graduate School of Public Health at the University of Pittsburgh, stressed that the study provides an "early look" at ACOs and that more recent data could show that care patterns have shifted toward primary care as ACOs mature and gain experience.
"Our study provided a snapshot of the distribution of visits for chronic conditions between primary care providers and specialists by ACO-attributed Medicare beneficiaries in 2013, and thus we cannot draw conclusions on whether that distribution shifted in any way in the following years," Cole said.
"I believe that is an important question to explore in future research and hope our study informs that research. I am personally not aware of other analyses that would indicate a shift towards or away from primary care for the management of chronic conditions within ACOs since 2013," he said.
The study found that:
On average, 61% of chronic condition evaluation and management visits were to PCPs. However, that figure varied across ACOs from 34% to 81%.
There was substantial variation by condition. PCPs accounted for most visits for hyperlipidemia, hypertension, and diabetes, but only 17.5% of visits for depression.
Demographics and health factors of the ACOs’ patient populations were associated with the proportion of PCP visits.
ACOs with a larger supply of specialists had lower proportions of visits for chronic conditions delivered by PCPs.
On average, about half of providers contracted to provide care for ACOs were PCPs in 2013, but that figure varied from 13% to 100%.
The share of visits for chronic conditions made to PCPs were higher at ACOs that had contracted with a higher proportion of PCPs.
Overall, patterns of chronic condition visits were similar for ACO-attributed patients compared to similar non-ACO Medicare beneficiaries.
The researchers stressed that the study provides an "early look" ACOs, and that more-recent data could show that care patterns have shifted toward primary care as ACOs mature and gain experience.
Medicare paid a total of $17.6 million in telehealth payments in 2015, compared with $61,302 in 2001, but a review found significant shortcomings in the documentation for the consultations.
More than half of the $13.8 million in Medicare telehealth payments examined by federal auditors fell short of reporting requirements.
Medicare telehealth payments include a fee paid to the clinician performing the service at a distant site, and an originating-site fee paid to the hospital or clinic where the patient receives the service.
However, the Department of Health and Human Services' Office of the Inspector General focused its audit on the more than 191,000 Medicare distant-site telehealth claims totaling $13.8 million and filed between 2014 and 1015 that did not have those required corresponding originating-site claims.
The auditors then reviewed a sampling of 100 of those incomplete telehealth claims and found that 31 did not meet reporting requirements.
Specifically:
24 claims were unallowable because the beneficiaries received services at non-rural originating sites;
7 claims were billed by ineligible institutional providers;
3 claims were for services provided to beneficiaries at unauthorized originating sites;
2 claims were for services provided by an unallowable means of communication;
1 claim was for a non-covered service;
1 claim was for services provided by a physician located outside the United States.
"We estimated that Medicare could have saved approximately $3.7 million during our audit period if practitioners had provided telehealth services in accordance with Medicare requirements," the auditors said.
OIG blamed CMS for the deficiencies, and said the agency failed to ensure that:
There was oversight to disallow payments for errors where telehealth claim edits could not be implemented;
All contractor claim edits were in place;
Clinicians were aware of Medicare telehealth requirements.
OIG recommended that CMS:
Conduct periodic post-payment reviews to disallow payments for errors for which telehealth claim edits cannot be implemented;
Work with Medicare contractors to implement all telehealth claim edits listed in the Medicare Claims Processing Manual;
Offer training sessions to clinicians on Medicare telehealth requirements.
New survey shows that while there is widespread agreement that risk-based population health models are here to stay, a growing number of healthcare providers are reluctant to take on the risk.
Many healthcare providers are reluctant to embrace risk-based population health models and are falling further behind the pace setters in this space, a new survey shows.
In their third annual survey, consultants Numerof & Associates queried more than 400 healthcare executives about their status risk-based population health models and found that:
Progress has fallen short of expectations. In the 2015 survey, 59% of respondents said they would be at least "very prepared" to take on risk in 2017. This year, 21% felt they had achieved that mark.
Risk-based contracts for organizations are mostly experimental. For 70% of respondents, lower than 20% reported revenue involvement.
Financial loss is a deterrent for taking on risk. 25% of respondents noted financial loss as a roadblock to adapting a more risk-based model.
Executives agree that population health is the future of healthcare. Respondents, on average, expect 15% revenue growth stemming from at-risk agreements over the next 2 years.
Cost and quality management is lacking. 58% of respondents rated their organization as average, or worse than average, when asked about their management in cost variation.
Numerof & Associates President Rita Numerof said virtually all healthcare providers believe that healthcare delivery is headed towards a risk-based, population health model, but that "a few leading organizations have separated themselves from the rest of the pack."
"The shift in the business model has proven difficult for many to achieve due to institutional hurdles and concerns over financial losses," Numerof said.
Numerof managing partner Michael Abrams said that at some point providers have to take the leap or risk falling even further behind.
"Hospitals that hedge their bets by experimenting at the margins with at-risk payment models underestimate the importance of moving up the experience curve," Abrams said. "Accountability for cost and quality is inevitable, and the sooner a commitment is made, the sooner the necessary competencies will be developed."
Survey collaborator David B. Nash, MD, dean of the Jefferson College of Population Health, said risk-bearing population health models have created "an apparent paradox in our country today."
"We want to improve health, but the numbers say that we are far short of previously stated goals," Nash said. "One is therefore forced to ask the question--what is the real mission of our industry at this key juncture?"
The retail pharmacy giant has the potential to be a game-changer in the highly concentrated, $34 billion kidney dialysis industry, using its ubiquitous retail presence to push consumers into home dialysis.
CVS Health's announcement that it will enter the kidney home dialysis market presents the company with as many challenges as opportunities, says industry analyst Jack Curran.
"The dialysis market right now is very concentrated," says Curran, a senior analyst with IBISWorld.
"If any company is going to be able to move into this industry and succeed it is going to have to be a large company with a lot of resources, like CVS," he said. "Right now, with their very heavy M&A activity, in trying to grow their healthcare offerings, CVS is probably going to be very well positioned to succeed."
The biggest challenge for CVS in the kidney dialysis market is its lack in-center dialysis. Fresenius Medical Care and DaVitacontrol about 95% of the in-center market, and Curran estimates that 8% or less of all dialyses occur in the home.
Nearly 700,000 people have end-stage renal disease, and nearly 500,000 of these patients are on active dialysis and more than 120,000 new ESRD cases are diagnosed each year.
Medicare spends nearly $34 billion each year on dialysis patient care.
Bruce Culleton, MD, CMO at CVS Specialty, says the high costs of dialysis are not reflected in the outcomes, noting that mortality rates for Medicare patients treated with in-center hemodialysis are up to 10 times higher than among the general Medicare population.
"While in-center dialysis clinics are currently the most common choice for hemodialysis treatment, published clinical research has shown improved cardiac health, metabolic control, and survival for patients who are treated with longer, more frequent dialysis treatments. This treatment paradigm is best delivered in the convenience of a patient's home," Culleton said.
"CVS Health is uniquely positioned to build a solution that will enable us to identify and intervene earlier with patients to optimize the management of chronic kidney disease, while at the same time making home dialysis therapies a real option for more patients," he said.
Curran says that CVS will be challenged to convince dialysis patients to stay at home.
"It comes down to consumer preference," he says. "People feel more comfortable going into a center where they know they have someone skilled who can handle it. To do home dialysis you have to go through about one month of training. So, it’s a big time investment to do home dialysis."
However, a big player such as CVS with its massive retail presence could change consumer views about home dialysis.
"When you have patients going into CVS clinics and learning about their home dialysis options, if CVS is telling them one of their options is home dialysis, they are likely going to look into it," he said.
In addition, CVS could be poised to take control of the home dialysis market because Fresenius and DaVita are in-clinic centric "so they’re not going to push for home dialysis, even close to as much as a company like CVS would do when they are only offering it," Curran says.
Curran says it will be telling to see who CVS choses to partner with when it comes into the home dialysis market.
"They haven't said what company they’re going to be working with, or who will manufacture their home dialysis device," he says. "The dialysis home equipment industry is also very concentrated. It may depend on the resources of that company and how well-positioned they are to produce a product that is going to be able to compete with Fresenius and Baxter’s devices."
Curran says there are rumors that CVS could work with Baxter, the nation's largest home dialysis equipment manufacturer. "I haven’t seen anything confirmed," he said, "but if that is the case, it's going to be a huge opportunity that could set them apart."
For Curran, who CVS partners with will speak volumes.
"If it's a bigger manufacturer, that is a sign that they are going to do well," he says. "If it's a smaller company that hasn't worked with dialysis equipment that is going to be a challenge. Because of the high concentration in the dialysis equipment manufacturing industry, it's going to be a lot more competitive to get products out."
Even though the dialysis market is highly concentrated, Curran says CVS could still shake things up for established players such as DaVita and Fresenius.
"If CVS's entering this market increases demand for in-home dialysis, then these companies may emphasis their in-home dialysis services," he says. "And meanwhile, they may also push the fact that they have in-center dialysis, as a way of saying that we are able to offer more than CVS, or that they can provide different options."
Compared to physicians who receive no money, those who were paid for meals and lodging from drug makers had higher odds of prescribing that company's cancer drugs.
Physicians who accepted money from drug companies for meals, talks, and travel were more likely to prescribe those companies’ drugs for two cancer types, a new study in JAMA Internal Medicineshows.
"The main takeaway is that oncologists who received money from a pharmaceutical company were more likely to choose that company's drug the following year," said study lead author Aaron Mitchell, MD, a fellow in the UNC School of Medicine Division of Hematology & Oncology.
Researchers analyzed prescriptions for Medicare patients with two cancers where there are multiple treatment options: metastatic renal cell cancer, and chronic myeloid leukemia.
"We wanted to look at cancer types for which there were several similar medications to choose from," Mitchell said. "Further, we wanted to look at cancer types where the different treatments would all be considered as 'standard of care' based on FDA approval and NCCN recommendation. RCC and CML and the associated drug sets best met these criteria.
They used publicly available data from 2013 to 2014 that was reported through Open Payments, a provision of the federal Patient Protection and Affordable Care Act that required drug makers to disclose gifts or transfers in value greater than $10 to physicians and teaching hospitals.
Compared to physicians who received no money, those who were paid for meals and lodging from a drug maker had higher odds of prescribing that company's drug for metastatic renal cell carcinoma and for chronic myeloid leukemia.
For metastatic renal cell cancer, physicians who received any payment in 2013 had twice the odds of prescribing that company's drug, and for chronic myeloid leukemia physicians who received any general payment had 29% higher odds of prescribing that company's drug.
A review of specific drugs found a significant decrease in the use of the leukemia treatment imatinib when physicians received payments. Novartis makes both imatinib and another treatment, nilotinib.
Since imatinib was about to lose its patent protection, the authors said the finding suggests that payments were done in the hope of "switching" physicians from the older drug imatinib to the newer drug nilotinib.
Mitchell said the "proof-of-principle" study was designed to see if there was a link between industry payments and the cancer drug prescriptions, but he cautioned that it does not show a cause-and-effect relationship, and that the payments are not improper.
"Industry payments to physicians are entirely above-board and legal," he said. "Whether they are unethical is an area of ongoing debate in the medical community, which different physicians would disagree about."
"None of these drugs would be considered more effective than the other as based on FDA approval and recommendation by the NCCN," he said. "Furthermore, if a medication's use were due to it being more effective, then we would expect to see higher use of that drug among all physicians, with no difference between those who did and did not receive money from the drug's manufacturer."
Mitchell said he can't say if the influence of the drug industry affects a broad array of drugs beyond the ones examined in the study, but "we think this is a worthwhile question."
"In terms of other areas of medical practice besides oncology, other researchers have suggested that this may be quite ubiquitous," he said. "Similar associations have been found for blood pressure drugs, cholesterol drugs, anti-depressants, and others."
Mitchell said it is the responsibility of each physician to decide whether they want to enter a financial relationship with the drug industry, and that of the patient to decide whether this information will influence their choice of physician.
"As this potential problem gets increasingly recognized, I would look toward physician professional societies and patient advocacy groups to raise awareness and call for more transparent and restrained behavior on the part of physicians," Mitchell said.
"Many academic institutions and medical centers have instituted conflict-of-interest policies in order to manage any real or perceived bias from physician-industry relationships, though this is by no means universal."
