Ten well-known drug companies in Canada have started to voluntarily disclose how much money they pay to physicians, hospitals, and health care groups, with the information posted on their websites. The ten companies participating in the voluntary disclosure are: GlaxoSmithKline, Amgen, Bristol-Myers Squibb, Gilead, Eli Lilly, Merck, Novartis, Purdue, Roche, and AbbVie Corp.
There are three different categories that the voluntary disclosure covers: fees for health care professional services/transfer of value to Canadian health care professionals; funding to health care organizations; and sponsorship of Canadian health care professionals travel.
The fees for service category covers any direct or indirect payments made to a Canadian health care provider, defined as: a payment to the HCP as an individual; a payment to the HCP’s incorporated name or business name for services rendered by that HCP; a payment indirectly to the HCP through a third-party intermediary; or a payment made to a health care organization for services rendered by an HCP associated with or employed by the health care organization.
The funding to health care organizations covers any direct or indirect funding to a health care organization for supporting efforts related, but not limited, to charitable, educational, and scientific activities. The provision specifically excludes any funding resulting a purchase/exchange of goods or services, such as commercial booths or business to business/partnership agreements; all funding related to clinical trials; and payments made to a Canadian health care organization for services rendered by a HCP and which have already been disclosed under the first category.
Sponsorship of travel is defined as a direct or indirect provision of financial assistance to a Canadian health care provider for the purpose of attending an international congress for expenses related to travel, accommodation, meals, and congress registration fees.
GlaxoSmithKline (GSK Canada) spearheaded the voluntarily disclosure, revealing it paid a little over $2 million to health care providers and organizations in 2016. Approximately $1.19 million of that went to fund health care organizations, while it paid roughly $943,000 in fees for health care professional services. GSK Canada paid $0 in “Sponsorship of HCP Travel.”
Merck Canada made roughly $9 million in payments, with over $7 million going toward health care professional services and $2 million to patient groups and health organizations.
Roche Canada made $8 million in payments to doctors and health organization groups. That amount was broken down into the three categories, with roughly $6.14 million in fees to healthcare providers (including payments for services, such as the provision of unfunded medical services, and speaking and/or consulting engagements); $2.17 million for funding to health care organizations (including grants and donations that support efforts such as philanthropic, educational, and/or scientific activities); and $267k in sponsorship of health care provider travel (funding to support provider travel to attend international congresses and/or global standalone meetings hosted by Roche).
The ten companies made $48 million in payments throughout 2016, though not all companies were able to include figures for the entire year. The ten companies announced – through an industry group Innovative Medicines Canada – that they would all begin to release the numbers, as they are all committed to “enhancing trust by disclosing the payment voluntarily.”
More countries are passing Sunshine-style transparency reporting programs with each passing year. These Canadian companies have decided to take the initiative to disclose these payments without any legal requirement, more likely than not, in an attempt to pre-empt any legislative efforts to mandate it.
Over three years ago, the Toronto Star filed a freedom of information (FIPPA) request with the Health Ministry in Ontario, Canada, seeking physician-identified data on the top 100 billers. Last year, the information and privacy commissioner ordered the disclosure of the top billers’ identities, along with amounts each receives in payments from the taxpayer-funded insurance plan.
The Health Ministry allowed partial access to the Star, including payments and most medical specialties, withholding physician names. The Ministry withheld the names as it determined releasing the names would be an “unjustified invasion of privacy.”
However, two groups of doctors, along with the Ontario Medical Association, fought the disclosure all the way to Ontario’s Divisional Court. The three-judge panel dismissed an application to quash the aforementioned order from the Information and Privacy Commissioner. The panel ruled that the order was a reasonable one, and that the ministry shall release the names of the highest-paid physicians public.
The groups opposing the release of information argued that an adjudicator with the Information and Privacy Commissioner erred in departing from previous commission orders that found such information was personal. That adjudicator, John Higgins, concluded that physicians receive OHIP payments in relation to their business or profession. Further, he noted that the money does not reflect the actual income of the physicians, because doctors pay overhead expenses out of the payments received.
The lawyers argued that,
The adjudicator’s determination that the information being sought was not ‘personal information’ is wrong as a matter of both fact and law and is clearly unreasonable. While he recognized the existence of those prior determinations … he chose to ignore or distinguish them on specious grounds while ignoring the overwhelming weight of authority they supply.
They also argued that publishing the names of the top billers “accomplishes nothing other than naming and shaming.” The lawyer for the groups argued in front of the judges – “who really cares what the names are? The question is whether or not the ministry is properly administering a multibillion fund and whether the question of the proper operation of that fund…can be accomplished without disclosing names.”
The Court rejected the argument made by the doctors that the Star had failed to establish a proper rationale for the disclosure. It found that the argument ignores the well-established rationale that underlies access to information legislation. The decision states, “[t]he rationale is that the public is entitled to information in the possession of their governments so that the public may, among other things, hold their governments accountable.”
Justice Ian Nordheimer stated that the Star did not even need a reason to obtain access to the information. The FIPPA requires that the information be provided unless a privacy exemption is demonstrated. However, once it is determined that the information is not personal information, there is no statutory basis to refuse to provide it. The decision further notes, “The proper question to be asked in this context … is not ‘why do you need it?’ but rather ‘why should you not have it.”
This ruling will affect other Information and Privacy Commissioner cases, including an appeal made by the Star, seeking the release of physician-identified billings for all Ontario doctors. The Commissioner previously put this appeal on hold, pending the outcome of this case.
Part 2: The Tension Increases - Online Auctions Violate the AKS
We have noted in previous articles that there is an increasing tension between efforts to reduce healthcare costs and assuring those efforts are not improper inducements under the Anti-Kickback Statute’s (“AKS”). In a recent opinion by the Federal District Court in Connecticut, that tension ratcheted up several notches with the Court’s novel application of the AKS to certain e-commerce arrangements.
The decision in Medpricer.com, Inc. v. Becton, Dickinson & Co was originally decided in March 2017 and reaffirmed in April. Judge Michael Shea’s decision resolved a contract dispute between MedPricer, a company that provides an online portal for the auctioning of medical supplies and equipment, and Becton, Dickinson & Company (“BD”), a medical products provider.
The National Academies of Sciences, Engineering, and Medicine recently released a report, requested by the United States Food and Drug Administration, that highlights what can be done to stop the opioid use disorder and other opioid-related harms without closing access to opioids for patients who need them.
The committee that conducted the study and wrote the report recommended actions the FDA, other federal agencies, state and local governments, and health-related organizations should take – which include promoting more cautious prescribing of opioids, expanding access to treatment for opioid use disorder, preventing more overdose deaths, weighing societal impacts in opioid-related regulatory decisions, and investing in research to better understand the nature of pain and develop non-addictive alternatives.
In more recent years, national initiatives to reduce opioid prescribing have modestly decreased the number of prescription opioids dispensed. Unfortunately, many people who otherwise would have been using prescription opioids have transitioned to heroin use. According to the report, the declining price of heroin, together with regulatory efforts designed to reduce harms associated with the use of prescription opioids – including the availability of abuse-deterrent formulations – may be contributing to increased heroin use.
One approach to addressing the opioid epidemic is to have a fundamental shift in the nation’s approach to prescribing practices and improve awareness of the risks and benefits of opioids. Therefore, the committee recommended education for both health professionals and the public. Such education should involve mandating pain-related education for all health professionals who provide care to people with pain, requiring and providing basic training in the treatment of opioid use disorder for health care providers, and training prescribers and pharmacists to recognize and counsel patients who are at risk for opioid use disorder or overdose. In addition, the lack of attention paid to educating the public about the risks and benefits of prescription opioids needs to be addressed. The report called for an evaluation of the impact and cost of an education program that raises awareness among patients with pain and the public.
The committee stressed that restrictions on lawful access to prescription opioids could have other unintended effects, and any policy designed to curtail legal access to them will inevitably drive some people toward the illegal market. Therefore, a strategy for reducing lawful access to opioids should be coupled with an investment in treatment for the millions who have opioid use disorder.
The committee recommended that states – with assistance from relevant federal agencies, particularly the Substance Abuse and Mental Health Services Administration – provide universal access to evidence-based treatment for opioid use disorder in a variety of settings, including hospitals, criminal justice settings, and substance-use treatment programs. The U.S. Department of Health and Human Services (HHS) and state health financing agencies should also remove impediments to full coverage of medications approved by the FDA for treatment of opioid use disorder.
Several other strategies that the committee recommended include:
- the FDA should complete a review of the safety and effectiveness of all approved opioids;
- states should convene a public-private partnership to implement drug take-back programs that allow drugs to be returned to any pharmacy on any day, rather than relying on occasional take-back events;
- public and private payers, including insurance companies, should develop reimbursement models that support evidence-based and cost-effective comprehensive pain management, including both drug and non-drug treatments for pain;
- HHS, in concert with state organizations, should conduct or sponsor research on how data from prescription drug monitoring programs can be better leveraged to track opioid prescribing and dispensing information; and
- the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, the U.S. Department of Veterans Affairs, and industry should invest in research that examines the nature of pain and opioid use disorder, as well as develop new non-addictive treatments for pain.
Earlier this month, the American Academy of Family Physicians (AAFP) announced a collaboration with the American Board of Family Medicine (ABFM) to create a more seamless credit-reporting experience for family physicians. The new process will allow AAFP members to use the AAFP as a one-stop shop for all of their Continuing Medical Education (CME) credit reporting needs.
It is hoped that this new process will make it easier for providers to claim their credit for performance improvement CME activities with both the AAFP and the ABFM.
The AAFP – as one of the nation’s three CME accrediting bodies – will work with CME provider organizations that wish to have their CME activities (including performance improvement activities) certified for AAFP Prescribed and/or Elective credit. CME providers can seek approval for those activities through the AAFP Credit System.
The AAFP and ABFM are currently working together to allow CME providers to apply for AAFP Performance Improvement CME Credit and ABFM Certification Activity credit for their performance improvement activities through the AAFP Credit System using a single application process. Starting in October, CME providers who apply for dual credit using the new unified process will no longer have to pay an additional fee for ABFM Certification Activity credit approval.
In addition to meeting AAFP performance improvement activity requirements, to be eligible to receive Certification Activity credit from the ABFM, each performance improvement activity must comply with the ABFM's Industry Support Policy and meet the ABFM Requirements for Performance Improvement activities, and the provider must agree to periodic audits by the ABFM.
From the physician-learner's perspective, the unified process means that ABFM diplomates will have more performance improvement activities to choose from. In addition, when the physician reports CME credit for a dually approved performance improvement activity to the AAFP, the ABFM will automatically be notified that the performance improvement certification activity has been completed.
The AAFP was created as a national professional association to protect the rights of general practitioners, and is the oldest national CME accreditor. Each year, the AAFP produces over 100 CME activities, including the Family Medicine Experience, live events, as well as journal and online CME sessions that are designed for family physicians with input from members. AAFP also reviews more than 3,000 activities from about 1,300 different organizations for accreditation annually to ensure they meet the needs of family physicians.