Celgene tops the list of manufacturers being accused of 'gaming tactics' that can impede, or even halt, the development of generics.
The U.S. Food & Drug Administration released a list Thursday of drug manufacturers accused of limiting access to samples of their products to impede the development of generic alternatives to their brand-name drugs.
The summary list of allegations—which FDA notes have not been investigated or confirmed—includes situations in which companies have voluntarily limited distribution and situations in which the FDA has imposed limitations as part of the Risk Evaluation and Mitigation Strategy (REMS) program.
"In some cases, brand drug sponsors may use these limited distribution arrangements, whether or not they are REMS-related, as a basis for blocking potential generic applicants from accessing the samples they need," the FDA list explains.
When generic companies are unable to purchase samples, it can slow down their work or stop it entirely, delaying the arrival of more-affordable alternatives, the FDA says.
The list: There are 52 products included in the FDA's list of "access inquiries" from prospective generic applications regarding reference listed drugs. Many of these products have been the subject of multiple inquiries.
Top company: Celgene Corp., which is cited as the sponsor of three of the 52 products listed, came out on top in terms of the most access inquiries regarding its products. There were eight inquiries regarding Pomalyst(pomalidomide), 10 regarding Thalomid (thalomide), and 13 regarding Revlimid (lenalidomide), for a total of 31 inquiries. All three Celgene products have REMS-related restrictions.
NPR Health Investigation: Celgene's tactics pertaining to Revlimid, which treats multiple myeloma, appear to have caught the attention of Health and Human Services Secretary Alex Azar, NPR's Alison Kodjak reported Thursday in a lengthy investigation. "Celgene has kept generic competition at bay by constructing an almost impenetrable fortress of patents and grants of market exclusivity around Revlimid, and its sister drug Thalomid, while also taking steps to ensure that generic competitors can't get their hands on enough of the drugs to develop viable alternatives," Kodjak wrote.
Pro-generic administration: FDA Commissioner Scott Gottlieb—who has championed ramping up approvals for generic drugs as a key tool in tamping down pharmaceutical spending—has criticized manufacturers for getting in the way of this mission by gaming the system. "They exploit loopholes in our system, to delay generic entry," Gottlieb said in a speech earlier this month. "In these ways, they extend a drug’s monopoly beyond what Congress intended."
Coordinated effort: The release of FDA's list contributes to a weeklong coordinated effort by federal officials to tackle drug prices. President Donald Trump unveiled a general blueprint of goals and priorities last Friday. Azar gave several speeches and media interviews on the topic in recent days, and the Centers for Medicare & Medicaid Services chimed in with updated drug pricing dashboards to promote transparency.
Premier praise: Among the organizations praising FDA for its naming-and-shaming initiative was Premier. "We loudly applaud FDA’s proactive leadership to promote competitive markets by calling out manufacturers that abuse well-intentioned programs like the Risk Evaluation and Mitigation Strategy (REMS) so as to maintain market exclusivity," Blair Childs, senior vice president of public affairs, said in a statement. "This is an encouraging development, and we hope it is the start of more such actions to promote transparency."
Celgene reportedly declined NPR's multiple requests for comment.
Editor's note: This story was updated Friday, May 18, 2018, to include a statement from Premier.
The meeting Thursday follows resignations this week by the organization's medical executive committee.
A group of physician leaders at CHI St. Alexius Health in Bismarck, North Dakota, resigned from their posts on the organization's medical executive committee this week, citing conflict with their regional administrative office.
In a blunt letter to the board chairman, the group called for the ouster of four people from their divisional office nearly 200 miles away in Fargo, as the local Fox affiliate reported. The doctors threatened to step down from the committee effective May 15, which was Tuesday, if their demands were not met.
Charles Allen, DO, FACEP, FACOEP, an emergency physician who had been serving as the committee's president, confirmed to HealthLeaders Media that the committee had, in fact, resigned as threatened.
"There have been no dismissals or resignation letters from administration at this time," Allen wrote in an email Wednesday evening.
Board meeting Thursday. When asked for an update on the organization's response, a spokesperson confirmed that the board of directors for CHI St. Alexius Health will meet on Thursday in a closed session. Any key actions the board takes will be announced thereafter, the spokesperson said.
Seeking a resolution. Earlier in the week, the spokesperson reiterated an earlier statement acknowledging that Catholic Health Initiatives and CHI St. Alexius Health are aware of the committee members' concerns and hoping to find a resolution.
Dispute is long-running. The committee's letter noted that frustrations with the CHI Fargo Division administrative staff had previously led to a vote of no confidence, a letter of disapproval sent to the national office, and an offer in February for the members to resign from the committee. The division's Fargo-based executive officer, Jeffery S. Drop, has responded with promises but insufficient action, the letter states.
Docs want four heads. The letter specifically calls for the dismissal or resignation of Drop; Benjamin Chaska, MD, the division's chief medical officer; and Francine Kyaw, the division director for physician and advanced practice clinician employment services. It also calls for the organization to end its relationship with Matt Grimshaw, a regional president.
Don't forget geography. The doctors also requested that the division office be relocated from Fargo to Bismarck. "We understand that these changes will not resolve the myriad of problems that face our facilities," the doctors wrote. "But a new leadership team based in the heart of the communities we serve will act as a good-faith effort to rebuild our foundation. We need administrators and physicians working side by side, as a team."
One doctor whose name is listed on the letter, neuroscience chair Stephen Markewich, does not appear to have signed it. He did not respond to a request for comment.
Competitors looked for ways to improve security and better support sensitive health data on a type of server designed for interoperability.
A healthcare technology company based in Boston won a competition to root out security flaws in a type of open-source server designed for health data, the Office of the National Coordinator for Health Information Technology (ONC) announced Thursday morning.
The firm, 1upHealth, which touts Boston Children's Hospital as an investor, successfully identified ways to improve Fast Healthcare Interoperability Resources (FHIR®) servers. For this, the company was named the winner of ONC's Secure API Server Showdown.
During the first stage of the challenge, the firm Asymmetrik built a secure FHIR server to Health Level 7 (HL7®) specificiations. During the second stage, competitors looked for ways to improve security and better support sensitive health data.
The result: The final product of this challenge is "a unique open source FHIR implementation" available to developers using common tools JavaScript, Node.js, and MongoDB, according to the ONC announcement.
Requirements met: The implementation developed through this challenge meets the security technical requirements of the Argonaut Data Query Implementation Guide (Version 1.0.0).
Familiar name: The winner of this challenge, 1upHealth, was also among two firms that won ONC's Health Data Provenance Challenge in March.
Federal officials have expressed opposition to the idea, which still has a long way to go before it can be implemented.
Vermont Gov. Phil Scott reportedly signed a bill into law Wednesday making his state the first in the nation to legalize the wholesale importation of prescription drugs from Canada, despite opposition from federal officials.
Scott, a Republican, took his time studying the measure after state lawmakers sent it his way last week. He signed the bill Wednesday morning, setting the stage for possible conflict with Trump administration officials, as Politico reported, citing a spokesperson for the governor.
Vermont's move comes less than a week after President Donald Trump and Health and Human Services Secretary Alex Azar unveiled a plan to reduce spending on prescription drugs. Importing drugs from Canada is nowhere in the federal plan.
Just a stunt? Azar went so far as to call drug importation "a gimmick" on Monday, saying Canada's drug market is too small to fix drug pricing in the U.S. and that importing drugs introduces safety concerns.
Industry opposition: The lobbying group Pharmaceutical Researchers and Manufacturers of America (PhRMA), which expressed "serious concerns" about Trump's drug pricing proposals, echoed Azar's safety concerns on importation. "Lawmakers cannot guarantee the authenticity and safety of prescription medicines when they bypass the FDA-approval process, and the Canadian government does not inspect or take responsibility for the legitimacy of prescription medicines shipped to the U.S.," the organization said in a statement, as The Hill reported.
A measured measure: Rather than immediately opening Vermont's 90-mile Canadian border to a flood of prescription drugs, the bill simply requires the state to put together a design plan by the end of the year and submit a formal request by July 2019 to HHS, which would need to certify the state's program.
Model legislation: Vermont's bill acknowledges that it was modeled on language proposed by the National Academy for State Health Policy, which says at least eight other states are considering similar proposals.
Importation previously permitted: Vermont was previously among several states that allowed individuals to import drugs by having prescriptions refilled by foregin pharmacies as part of the "ISaveRx" program started by Illinois. After running into trouble with regulators, the program ended in 2009, as the Associated Press reported.
Federal officials continued their messaging on price transparency with the unveiling of updated Medicare and Medicaid drug pricing dashboards.
Editor's note: This story was updated Friday, May 18, 2018, to include additional information about Vermont's past participation in the "ISaveRx" program and to clarify that the state's new, first-of-its-kind law seeks to permit wholesale imports.
A watchdog agency cites egregious cases as the federal government promotes interoperability of health data.
The fees patients pay for copies of their own medical records vary drastically, sometimes running afoul of the restrictions written into federal law, according to a Government Accountability Office report released this week.
The watchdog agency's report provided a list of egregious cases, including one in which a patient was charged $148 for a digital copy of her medical record. Two others were charged more than $500 apiece for a single request, the report said, citing an unnamed patient advocacy organization.
Some providers may be unaware of their duties under the Health Insurance Portability and Accountability Act (HIPAA), which requires providers and insurers to give people access to their medical records upon request, the GAO report states.
"This right of access allows patients to obtain their medical records in a timely manner while being charged a reasonable, cost-based fee," the report states.
What's reasonable?Interpretive guidance released in 2016 by the Health and Human Services Office for Civil Rights says the fee a provider charges to give patients a copy of their records may account for only four categories of expenses: (1) labor to copy the records, (2) supplies, such as paper or electronic media, (3) postage, and (4) the preparation of a summary of the personal health information included.
What's prohibited? The HHS OCR guidance says providers are not allowed to charge fees that account for expenses to verify, document, search for, or retrieve the information, maintain systems, pay for infrastructure, or other expenses not expressly permitted by HIPAA. (Even so, the GAO report mentions at least one example in which a hospital's retrieval-of-information vendor charged a patient a retrieval fee, despite HIPAA's prohibition.)
Beware state laws. Some states have laws on the books that seem to allow providers to pass additional expenses along to patients. But HIPAA preempts these more-permissive state-law provisions, the HHS OCR guidance and GAO report note. (State laws that establish greater access rights are not preempted by HIPAA.)
Three permissible calculations. Although the HHS OCR guidance does not prescribe a fee schedule, it does outline three permissible ways to calculate fees: (1) actual costs, counting labor, material, and postage; (2) average costs, based on a schedule developed by the provider; or (3) a flat fee capped at $6.50 for all electronic copies of information stored electronically.
Interoperability rules. This GAO report comes as the Centers for Medicare & Medicaid Services pushes a planned overhaul of the "meaningful use" electronic health record incentive program, which CMS rebranded last month "promoting interoperability." The Office of the National Coordinator for Health IT, meanwhile, plans to introduce a proposed interoperability rule this fall. Both could significantly impact this medical records request process.
The GAO was directed to produce this report by June 13, pursuant to the 21st Century Cures Act.
The updated tools draw attention to year-over-year changes in drug prices.
A redesigned set of online dashboardsreleased Tuesday by the Centers for Medicare & Medicaid Services includes data on year-over-year drug pricing changes and shines a spotlight on the manufacturers that have raised their prices.
Although the agency has had drug pricing dashboards for a while, the updated versions are designed to make it clearer how prices have changed over time, CMS Administrator Seema Verma said during an interview with The Washington Postbroadcast live online.
"So you'll be able to see whether there's been a double-digit increase or a triple-digit increase or, in some cases, a quadruple-digit increase," Verma said Tuesday. "All of that information is available as of today."
"We want to make sure patients have that information," she added. "Our goal is to focus on patients, but I think it could be used by a variety of different individuals."
Medicare's rising drug costs: In 2012, Medicare spent $109 billion, or 17% of its total budget, on prescription drugs; in 2016, that figure rose to $174 billion, or 23% of the program's total budget, according to the CMS announcement.
Data through 2016: The most recent data made available in these dashboards comes from 2016. More information on each data set is available in an online fact sheet.
These updated tools aim to bring "transparency and accountability to what has been a largely hidden process," Verma said in a statement announcing the change.
The rollout follows a speech last Friday by President Donald Trump, when the administration released a blueprint outlining a general plan to lower prescription drug costs—a plan which Health and Human Services Secretary Alex Azar continued to explain this week.
Three-quarters of survey respondents said they expect the online retailer's potentially earthshattering foray into healthcare to work out.
Most healthcare leaders have a positive view of Amazon's aspirations to transform healthcare, according to a survey conducted by Reaction Data, a firm based about 30 miles south of Salt Lake City, in American Fork, Utah.
The survey's results suggest a majority of those in the industry generally support what Amazon has set out to do and expect the initiative to succeed. This is unsurprising, given the company's track record, the researchers wrote.
"To say Amazon has disrupted the retail market would be an understatement. They have mastered the process of online shopping and next day delivery," the survey report states. "Based on the response we have received from those in the healthcare space, their play will be received with open arms."
Respondents include C-suite: Of the 152 people who responded to the survey, 44 were chief executive officers, according to Reaction Data.
Majority supportive: Asked whether they support Amazon's plan, 62% of respondents said yes. Only 12% said they do not support the plan, with one detractor questioning how Amazon's entry would affect group purchasing contracts.
Most expect success: Three-quarters of respondents said they expect Amazon to succeed, according to Reaction Data.
Consumer healthcare: The survey comes after CNBC reported in February that Amazon had quietly launched a line of over-the-counter health products and reported this month that the company has a team dedicated to leveraging the Alexa technology for health and wellness applications.
Prescription drugs: Amazon has explored the possibility of handling prescription drugs, but the company shelved a plan in April to sell drugs to hospitals, as CNBC reported.
Regardless of which entry-points Amazon chooses, observers are putting odds on the company's ability to figure out and finalize a plan that works, as Rob Haslehurst, managing director for Boston-based L.E.K. Consulting, said in March.
"They have repeatedly shown that they have the capabilities, the patience, and the deep pockets to disrupt industry after industry," Haslehurst said. "Healthcare is no exception."
The president and CEO spoke about pharmaceutical pricing, value-based care, and technology.
The efforts to reduce drug prices announced in recent days by the Trump administration are a promising development for the future of American healthcare, the top executive for Pittsburgh-based Highmark Health said Tuesday.
"It's a step in the right direction," President and CEO David L. Holmberg said during an interview with The Washington Postbroadcast live online.
"The challenge we all have is we're on the verge of miracle drugs," Holmberg added, "and the problem we all have is those miracle drugs are going to have a miracle price."
Spending: Holmberg said about 22% of healthcare spending goes to pharmaceuticals. "That's not necessarily sustainable," he said. This figure makes prescription drugs the largest category, barely edging out physician services, according to the America's Health Insurance Plans Center for Policy and Research.
Value: When discussing drug pricing reforms, it's important to take a step back and look at the bigger picture in the context of value-based care delivery, Holmberg said. "We really have to think about the whole healthcare system differently," he added. That's why Highmark Health signed an outcomes-based contract for Symbicort. The rebate will be tied to the drug's efficacy.
Technology: When it comes to leveraging technology in healthcare, leaders need to ensure that each application solves a defined problem, Holmberg said. Technology for technology's sake will just get in the way. "There's a reason why healthcare has been such a tough nut to crack," he said.
Data: One of the key areas in which technology can solve problems for healthcare is in data integration and analytics, Holmberg said. As both a health system and an insurer, Highmark Health has access to a significant amount of clinical and claims data.
"The real superpower that we're focused on—particularly with our partnership with Carnegie Mellon and Johns Hopkins and Penn State—is, 'What do you do with that information? And how do you turn it into predictive data?'" Holmberg said. "So our goal is for our folks to be able to reach out to somebody and say, 'You're on the verge of having diabetes,' not see them after they have an emergency room visit and they have a crisis."
The purported specialist in rheumatology was indicted in a $240 million healthcare fraud.
A twin-engine jet, blue Maserati coupe, and several high-end homes are among the belongings prosecutors aim to force a Texas doctor to forfeit for allegedly perpetrating a $240 million healthcare fraud.
Jorge Zamora-Quezada, 61, appeared in court Monday to face a seven-count indictment. He's accused of making dubious diagnoses and administering unneeded chemotherapy as part of a conspiracy to rake in millions of dollars in reimbursements to support a lifestyle the Department of Justice described as "lavish and opulent."
The indictmentincludes little information about the victims in this case, but Acting Assistant Attorney General John P. Cronan said in a statement that Zamora-Quezada's alleged conduct "jeopardized the health and wellbeing of innocent children, elderly, and disabled victims."
Christopher Combs, the FBI's special agent in charge, said recovering Zamora-Quezada's ill-gotten gains is of secondary importance.
"This investigation highlights an even greater concern presented by healthcare fraud than the significant financial losses—the physical and emotional harm suffered by the patients and their families," Combs said in the statement.
The plot: Prosecutors allege that Zamora-Quezada—the only defendant in this case—conspired with others to falsely diagnose vulnerable patients in San Antonio, the Rio Grande Valley, and elsewhere. They then allegedly administered unneeded drugs and repetitive tests to increase revenue.
The proceeds: The co-conspirators allegedly bought private jets, luxury cars, designer clothing, and high-end real estate in the U.S. and Mexico. They are accused of laundering their money through real estate deals, including for a condo in Aspen, Colorado; a condo in Punta Mita, Mexico; two penthouses in Puerto Vallarta, Mexico; and a number of commercial and residential properties in Texas.
The cover-up: The DOJ alleges that Zamora-Quezada and his alleged partners in crime created fake patient records and concealed medical information from Medicare authorities "by stashing them in an unsecured and dilapidated barn located in the Rio Grande Valley" to obstruct investigations into their conduct.
The timeline: The fraud began approximately in 2000 and continued through the filing of the sealed indictment, court records state.
Zamora-Quezada, who owned medical practices in Brownsville, Edinburg, and San Antonio, was a licensed physician who purported to specialize in rheumatology, according to the indictment.
A detention hearing is scheduled for 2 p.m. Tuesday in the U.S. District Court for the Southern District of Texas.
The former pharma exec said the U.S. should steer clear of an 'open borders' policy for unsafe foreign drugs.
The prospect of reducing prescription drug prices by importing cheaper supply from Canada is "just a gimmick," Health and Human Services Secretary Alex Azar said Monday morning.
The comment came during a speech at the Hubert H. Humphrey building in Washington, D.C., following up on President Donald Trump's speech Friday outlining the administration's general plan to promote affordability.
The relative size of Canada's drug market is the main reason why drug importation isn't part of the U.S. plan, Azar said.
"They're a lovely neighbor to the north, but they're a small one," he added.
Analysis by the Congressional Budget Office determined that permitting drug importation would have "no meaningful effect" on U.S. prescription drug prices, Azar said. In 2004, after evaluating the proposals under consideration at the time, CBO concluded that importing Canadian drugs "would produce a negligible reduction in drug spending."
When the CBO analyzed a bill introduced last year by U.S. Sen. Bernie Sanders, I-Vt., to authorize the importation of certain prescription drugs from Canada (and later from countries in the Organizations for Economic Co-operation and Development), the CBO preliminarily estimated it would save taxpayers $6.8 billion over 10 years.
Azar's speech comes less than a week after state lawmakers in Vermont voted to legalize the importation of Canadian drugs. Gov. Philip Scott, a Republican, reportedly said he would study the bill before deciding whether to sign it into law. The measure could set the stage for a legal conflict between the state and federal government.
Citing four prior Food and Drug Administration commissioners, Azar said there's no way to guarantee that drugs purportedly coming to the U.S. from Canada or Europe originated where their distributors claim, raising safety concerns. The last thing we need, Azar said, is "open borders" for unsafe drugs.
Azar's speech reiterated the administration's four reform strategies on drug prices: improving competition, reducing out-of-pocket costs for patients, enhancing negotiations for government payers, and fashioning incentives to lower list prices.
