WASHINGTON -- Lawmakers developing bills aimed at increasing transparency around drug pricing need to watch out for unintended consequences, several witnesses said Tuesday at a House Energy & Commerce Health Subcommittee hearing.
"We are concerned that this provision might have serious unintended consequences for patient care," said Madelaine Feldman, MD, president of the Coalition of State Rheumatology Organizations, who was speaking on behalf of the Alliance of Specialty Medicine. "Patients can wait weeks to over a month before getting final approval and then actually getting the prescribed medicine. It's extremely important to have on hand these samples to start the patients right away; it can make the difference between saving a joint or not."
Requiring completely public disclosure of the amount spent on samples "[could] have a chilling effect on manufacturers' willingness to provide us with these samples because of the potential of false shaming campaigns on Twitter and the like," said Feldman, a rheumatologist in New Orleans. "This can be harmful to the doctor-patient relationship and undermines patients' trust in their physician." She urged the lawmakers to instead follow a 2017 recommendation from the Medicare Payment Advisory Commission (MedPAC) that would require drugmakers to report spending on samples to oversight agencies, researchers, payers, and health plans under a confidential data use agreement.
"Samples are very important to beneficiaries, so you don't want to damage this valuable source of drugs," said Douglas Holtz-Eakin, president of the American Action Forum, a right-leaning think tank. "I think it makes sense to build on existing reporting rather than inventing new reporting; provide the information to the FDA and provide it to oversight and professional researchers, so the information about the influence of samples on competition is learned, but damaging public disclosure is avoided."
Another bill provision, in the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act, introduced by representatives Jan Schakowsky (D-Ill.) and Francis Rooney (R-Fla.), would require pharmaceutical companies to announce 30 days in advance if they are planning to raise the price of a particular drug. Rep. Nanette Barragan (D-Calif.) noted that drug companies sued over a drug transparency law enacted in California in 2017 requires drugmakers to notify insurers at least 60 days in advance if they plan to increase a drug price by more than 16% in a 2-year period.
"We're concerned about the impact that a 60-day notification could have on the market, given the opportunity it creates for bulk purchasing and stockpiling," said Lisa Joldersma, senior vice president for insurance and state issues at the Pharmaceutical Research and Manufacturers of America -- a trade group for drug manufacturers -- when asked by Barragan about the matter. Rep. Buddy Carter (R-Ga.), a pharmacist, echoed that concern when his turn came to ask questions at the hearing. "If we knew the price was going up, of course we're going to buy it at a lower price and stockpile it," he said. "There is a danger there."
These two bills were just a part of a package of bills that the subcommittee is considering. Some of the other bills include:
The Stopping the Pharmaceutical Industry from Keeping Drugs Expensive Act, requiring drugmakers to submit documentation to the federal government justifying a 10% or $10,000 increase in the wholesale average cost of any applicable drug over a 12-month period; a summary of the manufacturer's justification would then be published onto the website of the Centers for Medicare & Medicaid Services.
The Public Disclosure of Drug Discounts Act, requiring pharmacy benefit managers (PBMs) to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available.
The Prescription Pricing for the People Act, requiring the Federal Trade Commission (FTC) to conduct a study on the state of competition in the drug supply chain and to make recommendations for ways to improve transparency and competition.
Subcommittee Democrats spent much of the hearing time complaining about drug companies' lack of transparency. Rep. Pete Welch (D-Vt.) asked Joldersma whether her members would be willing to provide the subcommittee with information on how much they spend on research and development (R&D), on advertising, on stock buybacks, and on pay and compensation for top executives. "I would have to consult with my counsel," Joldersma began, but Welch interrupted her, "What's the big deal? ... Pharma is claiming it spends all this money on R&D but it won't show us the books, so at a certain point, count me as skeptical."
"The whining that's going on about having to talk about some transparency is really irritating to me," said Schakowsky. "Drug companies tell us all the time, 'It's about R&D; it costs so much. ... If you're going to use that as an excuse for raising prices, we have the absolute right to know how much is being spent."
Republicans, for their part, expressed concerns about whether the bills would impose an undue burden on the drug industry, and stifle innovation. "The more government regulation you put on an industry, the less companies will enter into it," said Rep. Markwayne Mullin (R-Okla.). "Congress should not be in the business of creating jobs; what we should be doing is creating an environment for entrepreneurs to create jobs."
"Everybody has some stake to blame on this," he said. "I don't want Congress to overreact."
WASHINGTON — House members seem to be passing healthcare legislation at a fairly good clip these days, but their counterparts in the Senate don't appear to be in any hurry to take up the bills.
As of mid-May, according to a report from David Bernstein at public radio station WGBH, the Senate has passed only 27 bills so far this session, and only 17 have become law; of those, two received roll call votes while the rest were passed on voice vote or unanimous consent. The House, meanwhile, has passed a total of 227 bills, including 10 on healthcare.
Congressional Democratic leadership has taken note. "The American people want us to protect their healthcare," said Senate Minority Leader Chuck Schumer (D-N.Y.) at a press conference held last week by House and Senate Democrats. "The new Democratic majority in the House has taken action and passed bills to ... further protect Americans with preexisting conditions and help Americans get better drug coverage. The Republican-led Senate: no movement, nothing—no debate, no legislation, no votes."
Senate Majority Leader Mitch McConnell (R-Ky.) "has turned the Senate into a legislative graveyard and buried this bipartisan legislation to improve Americans' health," Schumer continued. "We ask, what is he so afraid of? The issue is too important to too many Americans ... it's time for Leader McConnell to restore the Senate to the legislating body it once was, and there's no better place to start than healthcare."
Rep. Annie Kuster (D-N.H.), co-sponsor of a House-passed bill that would revoke Trump administration guidance encouraging states to allow the sale of less-expensive health insurance plans that don't cover preexisting conditions, said it was "time for Mitch McConnell to bring our legislation to the Senate floor and put the American people ahead of your partisan agenda."
McConnell's office didn't respond to a request for comment on the issue, but several analysts said this level of inaction wasn't of much concern. "Many of the bills coming out of the House are setting a marker for the election or trying to embarrass the opposition and are not intended to be enacted," said Gail Wilensky, PhD, senior fellow at Project HOPE, in Bethesda, Maryland, in an email.
Joe Antos, PhD, scholar in healthcare and retirement policy at the American Enterprise Institute, a right-leaning think tank here, agreed. "Let's not forget that the House is run by the Democrats, so they aren't sending bills to the Senate in the spirit of bipartisanship. They want to be able to claim that Republicans and McConnell in particular stopped really great policies—denoted by nice titles for legislation regardless of the actual content," he said in an email. In addition, "McConnell doesn't want to send anything to Trump that he won't sign. So there's no point in going through the committee process for most bills."
Elizabeth Carpenter, leader of the policy practice at Avalere, a healthcare consulting firm here, said in a phone interview that the congressional session "is unfolding as people would expect ... globally, major activity on Capitol Hill over the past several years has really happened [during] spending discussions or budget debates, and I think we're going to see the same thing this year."
There are some bright spots in the picture, the experts said. "The primary healthcare bill that has the best likelihood of enactment by both houses is legislation to limit 'surprise billing,'" Wilensky said, referring to the phenomenon in which patients go to an in-network hospital for a procedure but end up being treated by providers who are out of network, leading to unexpectedly large bills. "Even here, the challenge will be whether and how to pay physicians that are not part of the hospital's network, especially those that the patient doesn't actively choose."
Rodney Whitlock, PhD, of McDermott+Consulting, told MedPage Today in an email that McConnell likes to let his committee chairs—like Lindsey Graham (R-S.C.), of the Senate Judiciary Committee; Lamar Alexander (R-Tenn.), of the Senate Health, Education, Labor, & Pensions Committee; and Chuck Grassley (R-Iowa), of the Senate Finance Committee—take the lead.
"They are working on drug pricing, surprise billing, cost containment, and other health pieces. The Senate will work its will," said Whitlock.
Surprise billing and drug pricing may have a chance, "but would [House Speaker Nancy] Pelosi (D-Calif.) want to give Trump a platform to claim credit?" said Antos. "Maybe this year, but time is already growing short."
And, "since Trump is said to start his campaign in a few weeks, that seems like the end of serious legislation for the foreseeable future," he added. "Legislation giving more money for an anti-addiction campaign might also have a chance, but only if there isn't something else added that would drive away Republican votes."
Indeed, the election will be figuring into everyone's next moves, Carpenter said. "The closer we get to 2020, the more every decision made in D.C. will be based on how it impacts the election. Democrats, between now and the end of the year, face a choice on whether to work with the president or Republicans on anything healthcare-related that the president can then sign and claim credit for."
One area the Senate is not likely to do anything with is the Affordable Care Act (ACA), said Sabrina Corlette, JD, research professor at Georgetown University's Center for Health Insurance Reforms here. In addition to the House bill on "junk" insurance plans, the House passed a bill last week that would grant funds to states newly interested in setting up their own ACA insurance exchanges and would restore funding for ACA outreach that has been cut by the Trump administration.
"I don't see any urgency in Senate to take up those bills," Corlette said in a phone call. "Some of that is political—there is still a section of the Republican party that's like, 'Let's repeal the ACA root and branch,' and nothing will move them from that position. But there is also just a lack of urgency because the [ACA] markets, although a year or two ago there was serious concern insurers would drop out and prices would skyrocket—that concern has lessened somewhat. Insurers are staying in, even expanding their footprint, and prices are likely to stay fairly level in 2020 as they did this year, so we're not seeing external pressure in the Senate to take those bills up."
Among over 3,000 GI physicians, 99% received at least one payment.
The article was first published on Sunday, May 19, 2019 in MedPage Today.
By Randy Dotinga, Contributing Writer, MedPage Today
SAN DIEGO -- There was a significant link between the prescribing of biologic medications and the receipt of payments from marketing pharma companies, researchers reported here.
Every $1,000 in industry payments was associated with a $2,441 increase in prescription claims (95% CI $2,133-$2,748) for inflammatory bowel disease (IBD) drugs via Medicare (P<0.001, R2=6.49%), reported Rishad Khan, MD, of the University of Toronto, and colleagues.
The researchers accounted for patient volume, and the associated prescription cost was still significantly related to the value of industry payments, with every $1,000 in industry payments associated with a $3,846 increase in prescription claims (P<0.001, R2=7.64%, 95% CI $3,285 to $4,407), they reported at the annual Digestive Disease Week.
"I don't think it's necessarily nefarious," Khan stated. "But there's a clear association between physicians having financial relationships with industry, and those same physicians having higher prescription volumes and cost."
The researchers also found that among 3,475 gastroenterologists, 99% received at least one payment from a pharmaceutical company producing the biologic medications they prescribed, with a mean payment value of $130.
"Mainly it's meals, which get recorded as a payment," Khan said. "It might be worth $30 to $50."
The current findings line up with previous research linking physician marketing payments by pharma to higher prescription claims. A 2018 study tracked nearly 370,000 U.S. physicians, and found that the 7% who received millions of dollars worth of industry payments from opioid manufacturers in 2014 were 9% more likely to prescribe the drugs in 2015.
Khan and colleagues examined national databases for the years 2013-2015, and identified 3,441 gastroenterologists who prescribed the following IBD medications: adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), and vedolizumab (Entyvio).
They looked at pharma payments to physicians for education; food, travel, and lodging; and consulting and speaking fees, honoraria, and gifts ("other").
A total of 3,024 gastroenterologists reported average food, travel, and lodging payments of $35.
Industry payments for education were $108 on average for 1,342 gastroenterologists. The spending on the "other" category averaged $2,303 among 748 gastroenterologists.
Khan highlighted study limitations. It's not clear how the increase in prescriptions affects the health of patients, he said, and "we don't know which came first -- the increased prescriptions or the spending." Also, "gastroenterologists who are already prescribing a lot of drugs may be targeted by their colleagues for their expertise," he added.
"The main take-away [from the study] is that there's an association between getting money from a pharmaceutical company and increased prescribing of their drug," he concluded.
Report cites distinct examples of 'censorship'; However, some removed material was overtly political.
This article was first published on Wednesday, May 15, 2019 in MedPage Today.
By Shannon Firth, Washington Correspondent, MedPage Today
WASHINGTON -- Over a 2-year period, the Department of Health and Human Services has been removing or downplaying information about the rights, benefits, and services granted by the Affordable Care Act, according to a new trend report from the Web Integrity Project, an arm of the Sunlight Foundation.
The WIP tracks and monitors changes to government websites in an effort to hold agencies and federal officials accountable.
Under the Trump administration, HHS removed at least 85 fact sheets, press releases, and other informational documents from its websites, in what the WIP report suggested is an effort to diminish the presence of Affordable Care Act-related content.
Rachel Bergman, director and co-founder of WIP, asserted in a blog post that the term ACA has been "surgically removed" from many webpages, and statistics and data on the ACA's positive impacts have also been eliminated, along with links to Healthcare.gov -- the primary platform many Americans use to enroll in ACA coverage.
One portion of the agency's website, created by the Obama administration to showcase "the real-world effects" of the Affordable Care Act was "largely scrubbed of content," just after President Trump took office, noted another blog post about the removals authored by Jon Campbell, the Sunlight Foundation's senior investigator.
These pages not only explained new benefits of the ACA program but also detailed the law's impacts on coverage for underserved populations.
According to Campbell, the removal of this content reflects a widespread pattern at the agency of eliminating or "de-emphasizing the ACA," in particular, any strengths and benefits of the program.
Other removals identified in the WIP report include:
The Healthcare.gov website from the header of CMS.gov and from the footer of the Administration for Children and Families website.
References to the ACA on HHS.gov's "Who is eligible for Medicaid?" webpage.
ACA references on some CDC.gov, CMS.gov, Medicaid.gov, and Office of Minority Health webpages.
Fact sheet on declines in uninsured rates in New York
Also removed was information on slowed premium growth for beneficiaries in employer-sponsored insurance plans in Massachusetts, noted Campbell.
Some changes seemed to specifically target underserved populations, such as the removal of a document titled "Best Practices for Outreach to Latino Communities" and the removal of ACA-related questions on the website MentalHealth.gov.
"Some of the material that was removed was overtly promotional and even political," Campbell acknowledged. For example, fact sheets titled "The ACA is Working for Middle-Class Families" and "The Affordable Care Act is Working for Older Americans" indicated that they explained "what's at stake if Congressional Republicans succeed in repealing the Affordable Care Act."
Whether a "fact sheet" is the correct place for such an obvious partisan angle is up for discussion, he wrote.
Therecent legal brief, by the Department of Justice agreeing with a group of Republican attorneys general that the entire Affordable Care Act should be overturned, shows how the Trump Administration's position has changed over time, but it is unlikely to have a big effect on the overall outcome of the case, according to one expert.
"I doubt that it will affect the legal arguments," Bob Laszewski, president of Health Policy and Strategy Associates, a healthcare consulting firm in Alexandria, Virginia, said in an email to MedPage Today. "Both sides are well represented in terms of the legal arguments and I doubt the Justice Department will bring any new breakthrough arguments to the table. The real significance is political."
The Justice Department filed its brief on May 1 in the case of Texas v. Azar. That case was filed in February 2018 by the state of Texas along with 19 other states, all led at the time by Republican governors. It argued that because the tax reform bill passed by Congress -- the Tax Cuts and Jobs Act of 2017 -- gets rid of the ACA's "individual mandate" penalty for not having health insurance, the requirement for individuals to have health insurance is void, and because of that, the rest of the law -- which they say hinges on the mandate -- should be invalidated. Judge Reed O'Connor of the U.S. District Court for the Northern District of Texas ruled in the plaintiffs' favor last December, but the decision has been stayed pending an appeal.
An Evolving Position
The Trump administration's position in the case has evolved. At first, the department declined to defend certain provisions of the law -- namely, its community rating and guaranteed issue provisions, as well as the mandate itself. Then-Attorney General Jeff Sessions explained in a letter written in June 2018 to then-House Speaker Paul Ryan (R-Wisc.) that community rating, which restricts the variance in the premiums that could be charged, and guaranteed issue, which requires insurers to cover everyone, both hinge on the mandate, because without the mandate, "individuals could wait until they become sick to purchase insurance, thus driving up premiums for everyone else."
But Sessions added, "Outside of these two provisions of the ACA, the department will continue to argue that [the individual mandate] is severable from the remaining provisions of the ACA" and therefore the rest of the law is valid.
In late March, however, the Justice Department changed its tune, filing a letter stating that it had determined that Judge O'Connor's decision overturning the entire law "should be affirmed." The May 1st brief explains some of the reasoning behind that decision.
"Once the individual mandate and the guaranteed-issue and community-rating provisions are invalidated, the remaining provisions of the ACA should not be allowed to remain in effect -- again, even if the government might support some individual provisions as a policy matter," wrote Assistant Attorney General Joseph Hunt and Special Counsel August Flentje, of the department's civil division.
"As the Supreme Court recently recognized when addressing a set of provisions that 'were obviously meant to work together,' once the core provisions are struck down, the others should also be invalidated if Congress would not 'have wanted [them] to stand alone,'" they continued. "Elimination of the guaranteed-issue and community-rating provisions would fundamentally alter the ACA's other insurance reforms, which were premised on the availability of uniform plans to all potential purchasers of insurance in the individual and small-group markets."
Possible Political Consequences
That stance could put Republicans in a difficult position, said Laszewski. "By arguing that the ACA should be overturned all at once without having an alternative ready, Republicans really put themselves on the defensive against Democratic arguments that Trump and the Republicans want to blow the Affordable Care Act up without an alternative. Democrats can point to pre-existing condition reforms and the Medicaid expansion being suddenly gone without the Republicans even having a plan to replace them."
Robert Field, PhD, MPH, JD, professor of health management and policy at Drexel University in Philadelphia, was not impressed by the brief. "It contorts logic beyond recognition," Field said in an email. "The administration is arguing that the mandate is unconstitutional because it has been repealed. Logic like that belongs in Alice in Wonderland."
"The brief argues that the entire ACA must be struck down because the rest of the law is inseparably intertwined with the now defunct mandate," Field said. "But the rest of the law includes dozens of provisions that bear no conceivable relationship to the mandate. How is a mandate to purchase insurance central to calorie counts on chain restaurant menus, breast feeding areas in workplaces, or generic versions of biotechnology drugs? The brief doesn't even try to provide an answer."
The case itself is a “wild card” in terms of its effect on the ACA, Jonathan Weiner, DrPH, professor of health policy and management at Johns Hopkins University, in Baltimore, said in an email. “The original ruling underscores how easy it seems to be to find a high court judge who will agree with one side or the other no matter the validity of the case. Many legal scholars view the non-severability argument as ludicrous; and I can tell you from a health policy perspective it certainly is.”
Marie Fishpaw, director of domestic studies at the Heritage Foundation, a right-leaning think tank in Washington, sees the case as an opportunity of sorts. "This court case is a good reminder that Congress still needs to return to healthcare reform in order to deal with the root causes behind American's frustration with healthcare -- high costs, fewer choices, and the ability of the sick to get care when they need it," she said in an email.
Looking Ahead
Right now, people on both sides of the aisle seem intent on replacing the law, Jonathan Oberlander, PhD, professor of social medicine at the University of North Carolina at Chapel Hill, noted in a Perspective piece in the New England Journal of Medicine(subscription required)."In key respects, Obamacare is stronger politically now than it ever has been," he wrote. "It is ironic, then, that the 2020 presidential election could see both parties nominate candidates who want to supplant the ACA."
"Trump's reelection campaign will probably embrace conservative plans to repeal the law and shift more responsibility to the states. And multiple Democratic presidential candidates have embraced Medicare for All (though some Democrats support the incremental goal of expanding Medicare eligibility to more people, which would leave the ACA largely intact)."
The next step in the case will be oral arguments before a federal appeals court. "Whichever way it rules, the losing side will likely appeal to the Supreme Court," Field predicted. "If the appeal is by the administration and those challenging the law, the Supreme Court will likely decline to hear the case. The last thing it wants is an ACA redux. If those defending the law bring the appeal, the Supreme Court is likely to hear the case and uphold the law. It is unlikely that the justices would want blame for the collapse of American healthcare and the political firestorm that would ensue."
WASHINGTON -- Ensuring that drug companies don't have an economic incentive to push their products on patients is one of the big lessons to be learned from the tobacco industry in the wake of the opioid crisis, an expert said here Monday during an opioid litigation event.
"We know that under pressure of profits or the pressure of greed, some people became billionaires selling tobacco and some people became billionaires over-prescribing opioids. How do you change the mindset that says, 'That's a risk worth taking?' That's a place where the political calculus gets the hardest," Matthew Myers, president of the Washington-based Campaign for Tobacco-Free Kids, said during the Bipartisan Policy Center–sponsored event. "But we have to recognize that there is that pressure, and [even] under the best case, there will be people in those corporations who say, 'It's worth it for me.'"
In the first 25 years of the tobacco settlement, companies paid somewhere from $175 billion to $225 billion, he continued, yet it had no impact on shareholders whatsoever. "Profits went up, not down, and therefore, did you really change the incentives of those companies?" Myers said. "Not a single executive was held responsible, so does it change the mentality of an executive as you move forward?"
One of the places where the the tobacco and opioid situation diverge is that the people who caused the opioid crisis are still alive, he said. "In some cases, they're still in the companies making money off of it," Myers said. "In tobacco, by the time these cases came around, the people who made the initial decisions by and large were gone."
While legal tactics can include the creation of guardrails and injunctive relief, Myers said the "most challenging debate that we never have" is figuring out how to change the mindset of companies so they say, "That's not a risk worth taking in the future."
The Bankruptcy Issue
Several lawsuits against opioid manufacturers are currently in process, including one in Oklahoma. That case is scheduled to go to trial on May 28, said Oklahoma Attorney General Mike Hunter. Defendants in that lawsuit include Johnson & Johnson, Allergan, and Teva Pharmaceuticals, but not Purdue Pharma -- maker of oxycodone (OxyContin) -- which settled out of court with the state for $270 million.
Hunter explained how that settlement came about. "As we spent a lot of time with Purdue Pharma, it became clear we had a tough decision to make. Purdue Pharma being a privately held company, bankruptcy was a much simpler, much more elementary proposition for them than for publicly traded companies, and their admonition to us was, 'We are not going to go to trial in Oklahoma.' If I was their lawyer I would have given them the same advice," given all the legal exposure the company would have and their desire to limit their liability, said Hunter.
"There began to be sort of an opportunity; we didn't want to force Purdue Pharma into bankruptcy; that would have stayed our lawsuit and the consequence would have been zero [dollars] for the state," he said. Hunter and his colleagues knew that Purdue didn't want to settle with the state -- since that would have created a precedent for other state lawsuits -- so they came up with an alternative. "What if we were to craft a settlement that would allow you to invest in Oklahoma and a national asset?"
The $270 million settlement included roughly 22% in legal fees but also $200 million toward an endowment to the Center for Wellness and Recovery Program at Oklahoma State University's (OSU) Health Science Center in Tulsa, Hunter explained, which deals with both the opioid epidemic and addiction overall.
"Where we ended up is something we really feel good about," he said.
Hunter said his office chose to stay with an in-state lawsuit, rather than joining in an ongoing multi-state federal lawsuit in Ohio, because "of the very favorable law we have in Oklahoma with regard to abating a public nuisance ... It's a very expansive power that gives [us] the ability as attorney general to go to court, to identify what the nuisance is, and to work with the judge to determine a series of approaches that abates the nuisance."
Big Suit in Ohio
The multi-district federal litigation taking place in Ohio involves nearly 1,600 actions by 200 municipal governments who are suing drugmakers Purdue Pharma and Mallinckrodt, CVS Rx Services, and drug distributor Cardinal Health.
Judge Dan Polster of the U.S. District Court for the Northern District of Ohio in Cleveland, who is presiding over the case, "has been upfront about his view that litigation for years is not the way to resolve this crisis; he has made many comments to the effect that he's [instead] seeking a very aggressive settlement," said Abbe Gluck, JD, faculty director of the Solomon Center for Health Law and Policy at Yale University in New Haven, Connecticut.
"But he's not the only game in town; there are about 400 other cases filed by cities and states, and pending [state] attorney general investigations beyond the state of Oklahoma. Judge Polster doesn't have control over those cases, although he has invited them into his courtroom to negotiate a global settlement," said Gluck.
Oklahoma's case is interesting as it puts pressure for a quick settlement of the federal case (perhaps before May 28), said Gluck, who noted that the monetary "pie" these companies have is limited.
"[Judge Polster] wants to get his hands around that pie, and get as many different parties into that settlement as possible," she added.
What to Do With the Money?
If a settlement is decided on in either of these cases, how should that money be spent? A group of addiction-related organizations, including the Center on Addiction and the Partnership for Drug-Free Kids, has put together a list of recommendations in that area, said Marcia Lee Taylor, MPP, the Center for Addiction's executive vice president for external and government relations. They include:
Enhancing public and professional education to create a demand for evidence-based solutions to the epidemic. Examples of investment areas include a public education campaign for families to understand the risk factors for kids, creating a consumer guide for opioid treatment, and informing the public about the Parity Act of 2008, which requires insurers to offer mental health and substance abuse benefits that are equivalent to those offered for physical health. "It's important to make sure that gets out there so people can challenge their insurance companies if they're denied coverage they're likely entitled to," she said.
Increasing activity around prevention and early intervention. Priorities here include consideration of taxation and marketing restrictions for legal opioid products, furthering screening interventions, and referral to treatment -- including educating and incentivizing healthcare professionals -- and taking prevention programs really seriously. "Prevention is too often an afterthought in schools," Taylor said. "Oftentimes, it is a day or two in health class and not using evidence-based approaches."
Expanding access to evidence-based treatment and integrating treatment into the mainstream healthcare system. "Instead of just pouring dollars into a system that isn't providing quality care, [we need to] make sure we're transforming the system," said Taylor. Examples of solutions in this area include increasing treatment capacity by making sure every healthcare professional has a working knowledge of addiction, and making sure all prescribers have the training required to prescribe medication-assisted treatment, as well as using licensing requirements and payment models to drive quality in care.
"With these recommendations, we really can transform the system and make sure going forward we're better equipped as a country to better handle addiction," she concluded.
WASHINGTON -- President Trump announced an initiative Thursday aimed at ending the problem of surprise medical billing, in which patients undergoing procedures at in-network hospitals receive unexpectedly high bills because one or more of their clinicians was out of network.
Trump called surprise billing "one of the biggest concerns Americans have about healthcare" and added, "The Republican Party is very much becoming the party of healthcare. We're determined to end surprise medical billing for American patients and that's happening right now." He thanked the mostly Republican group of lawmakers who came to the White House to discuss the initiative, including senators Lamar Alexander (R-Tenn.), Maggie Hassan (D-N.H.), Bill Cassidy, MD (R-La.), and John Barrasso (R-Wyo.) and representatives Kevin Brady (R-Texas), Devin Nunes (R-Calif.), and Greg Walden (R- Ore.).
Trump announced guidelines that the White House wants Congress to use in developing surprise billing legislation. They include:
In emergency care situations, patients should never have to bear the burden of out-of-network costs they didn't agree to pay. "So-called 'balance billing' should be prohibited for emergency care. Pretty simple," he said.
When patients receive scheduled non-emergency care, they should be given a clear and honest bill up front. "This means they must be given prices for all services and out-of-pocket payments for which they will be responsible," Trump said. "This will not just protect Americans from surprise charges, it will [also] empower them to choose the best option at the lowest possible price."
Patients should not receive surprise bills from out-of-network providers that they did not choose themselves. "Very unfair," Trump said.
Legislation should protect patients without increasing federal healthcare expenditures. "Additionally, any legislation should lead to greater competition, more choice, and more healthcare freedom. We want patients to be in charge and in total control," the president said.
All types of health insurance -- large groups, small groups, and patients on the individual market should be included in the legislation. "No one in America should be bankrupted unexpectedly by healthcare costs that are absolutely out of control," said Trump
He said that "we're going to be announcing something over the next 2 weeks that's going to bring transparency to all of it. I think in a way it's going to be as important as a healthcare bill; it's going to be something really special."
Also at the announcement was Martin Makary, MD, MPH, a surgical oncologist at Johns Hopkins University in Baltimore. "When someone buys a car, they don't pay for the steering wheel separately from the spark plugs," he said. "Yet, in healthcare, surprise bills and overpriced bills are commonplace and are crushing everyday folks ... People are getting hammered right now."
Trump also introduced two families who had experienced high medical bills. Drew Calver, of Austin, Texas, said that after a heart attack 2 years ago, "although I had insurance, I was still billed $110,000 ... I feel like I was exploited at the most vulnerable time in my life just having suffered a heart attack, so I hope Congress hears this call to take action, close loopholes, end surprise billing, and work toward transparency."
Paul Davis, MD, of Findlay, Ohio, said that his daughter was billed nearly $18,000 for a urine drug screening test. "She had successful back surgery in Houston and at a post-op visit, because she was given a prescription for narcotic pain relief -- which she used as directed -- the doctor said, 'Oh, by the way, I'd like to get a urine specimen.' Fine; she did it. A year later, a bill showed up for $17,850."
He noted that her insurance company's Explanation of Benefits said that the insurer would have paid $100.92 for the test had it been done by an in-network provider. "This type of billing is all too common ... The problem of improper billing affects most [of] those who can afford it least. We must put aside any differences we have to work together to solve this problem."
"Today I'm asking Democrats and Republicans to work together; Democrats and Republicans can do this and I really think it's something [that is] going to be acted on quickly," Trump said.
Healthcare groups responded positively to the announcement, with one caveat. "The AHA commends the Administration and Congress for their work to find solutions to this problem," Rick Pollack, president and CEO of the American Hospital Association (AHA), said in a statement. "The AHA has urged Congress to enact legislation that would protect patients from surprise bills. We can achieve this by simply banning balance billing. ... Untested proposals such as bundling payments would create significant disruption to provider networks and contracting without benefiting patients."
"ACEP appreciates the White House weighing in on this important issue and welcomes congressional action to address surprise medical bills," said Vidor Friedman, MD, president of the American College of Emergency Physicians (ACEP), in a statement. "Emergency physicians strongly support taking patients out of the middle of billing disputes between insurers and out-of-network medical providers."
"ACEP is concerned about the administration's call for a single hospital bill," he continued. "Such a 'bundled payment' approach may seem simple in theory for voluntary medical procedures. But if applied to the unpredictable nature of emergency care, this untested idea opens the door to massive and costly disruption of the health care system that would shift greater costs to patients while failing to address the actual root cause of surprise bills -- inadequate networks provided by insurers."
The president also mentioned another one of his administration's healthcare initiatives. "We may allow states to buy drugs in other countries ... because the drug companies have treated us very, very unfairly and the rules and restrictions within our country have been absolutely atrocious," he said. "So we'll allow [states], with certain permission, to go to other countries if they can buy them for 40%, 50%, or 60% less. It's pretty pathetic, but that's the way it works."
WASHINGTON -- Extending the 5% payment bonus for participating in one of Medicare's new advanced alternative payment models (APMs) would help encourage their adoption, witnesses told the Senate Finance Committee Wednesday, although they had different ideas on how long it should be extended.
"We urge Congress to extend the APM incentive for an additional 6 years," said Barbara McAneny, MD, president of the American Medical Association.
"We recommend the bonuses be extended for an additional 3-5 years," said John Cullen, MD, president of the American Academy of Family Physicians.
"A good first step would be to make MACRA's advanced APM bonus permanent," said Matthew Fiedler, PhD, fellow at the USC-Brookings Schaeffer Initiative for Health Policy.
Witnesses had plenty of other suggestions for lawmakers on ways to improve the Medicare Access and CHIP Reauthorization Act of 2015, which overhauled the way physicians were paid under the Medicare program.
Under MACRA, physicians have two choices: one is to participate in MACRA's Merit-Based Incentive Payment System program, in which they must report a certain amount of quality data from 2017 in order to avoid a cut in their Medicare reimbursement. Their other options is to participate in an advanced APM, such as an accountable care organization.
"The AMA is recommending that Congress replace the scheduled physician payment freeze beginning in 2020 with positive annual updates for physicians," said McAneny. "The recent Medicare Trustees report found scheduled physician payments are not expected to keep pace with physician practice costs."
"As a result, trustees say, access for Medicare patients will be a significant issue in the future. Positive payment updates are needed to provide physicians a margin to maintain their practice as well as transition to more efficient models of care delivery," she said.
"The AMA also urges Congress to continue to make technical changes to MACRA to simplify the program and make it more clinically significant," McAneny said. "The AMA continues to hear from physicians that the measures they're required to report are taking time away from patient care."
McAneny also urged the senators to modernize the Stark self-referral and federal anti-kickback laws, which she said were preventing physician practices from working together to offer services to patients.
For example, the laws prevent physicians from getting together to offer patients transportation to appointments, help with food insecurity, or other assistance with social determinants of health.
The AAFP's Cullen focused on administrative burdens.
"The AAFP is concerned that the complexity and cost of administrative functions are creating practice environments that are more focused on administrative tasks than patient care," he said. "We are concerned that MIPS has created a burdensome and extremely complex program that has increased practice costs and is contributing to physician burnout."
"Many of my colleagues are frustrated and angry ... the AAFP believes more must be done to [improve] patient care within MIPS by reducing administrative burdens."
Fiedler had a more radical solution.
"MIPS's approach of adjusting payments based on clinician or practice performance is ill-suited to create strong, coherent incentives to improve the quality and efficiency of patient care," he said. "The fact that clinicians can choose quality measures they report under MIPS also prevents MIPS from facilitating meaningful quality comparisons across providers."
MIPS is also creating significant administrative costs, he added, noting that Medicare estimated that providers will spend $482 million reporting to MIPS in 2019.
"We agree with MedPAC [Medicare Payment Advisory Commission] and a number of other experts that the best path forward is to eliminate MIPS," he said. "Even a reformed MIPS would likely struggle to create effective incentives to improve care."
Scott Hines, MD, director of the American Medical Group Association, suggested that lawmakers "need to synchronize rules across federal ACO programs ... Currently, the rules change across the degree of risk you're taking."
The senators seemed to hear what the witnesses were telling them.
"MACRA is not without its challenges but it's certainly an improvement over the SGR [sustainable growth rate formula for physician reimbursement]," said Sen. Pat Roberts (R-Kan.). However, he added, "I have several concerns about how the law affects small and rural practices ... We have set up to pay them based on requirements that are often simply too burdensome for these practices ... Much more work needs to be done to make meaningful improvements for these providers and their patients."
Sen. Mark Warner (D-Va.) urged a bigger focus on improving interoperability of electronic health records. "We should have seen this train coming," he said. "We so overpromised [EHRs] ... On a broader [scale], we are going to move toward a more data-centric system" which needs to include data security and standards.
Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, praised the work of the Physician-Focused Payment Model Technical Advisory Committee, which is helping to develop new APMs.
"PTAC is going through the work in conceptual modeling and that's fantastic," he said. "But then it fails when it gets to the Innovation Center [at the Centers for Medicare & Medicaid Services] ... It goes inside the government and gets lost."
"The legendary New York Times health reporter Robert Pear passed away yesterday, and he was a gold standard of healthcare reporting," said Wyden, whose voice broke during his statement.
"He was described as 'the most important reporter in Washington, D.C. that nobody had ever heard of,'" Wyden said. "For all of us on this committee, this is a really sad moment because a really good guy who cared passionately about people, and passionately about improving healthcare, and always [was] trying to appeal to the better angels, passed away yesterday way too young; he was 69."
MS patients with private insurance paid 20 times more in 2016 vs 2004.
This article was first published on Thursday, May 2, 2019 in MedPage Today.
By Judy George, Senior Staff Writer
Out-of-pocket costs for prescription drugs to treat neurological disorders rose dramatically from 2004 to 2016, with multiple sclerosis medications showing the fastest increase, according to an analysis of private health insurance claims.
The average out-of-pocket costs for people taking MS drugs soared 20-fold over the study's 12-year period, reported Brian Callaghan, MD, MS, of the University of Michigan in Ann Arbor, and colleagues.
Expenditures for dementia, epilepsy, peripheral neuropathy, and Parkinson's disease drugs also increased considerably, particularly for patients with high-deductible health plans, they wrote in Neurology.
"Out-of-pocket costs have risen to the point where they can no longer be ignored by neurologists," Callaghan said.
"Neurologists can choose medications that are likely to have smaller out-of-pocket costs, such as those that are generic," he told MedPage Today. "Unfortunately, they rarely get precise out-of-pocket cost information at the point of care, which limits their ability to give patient-specific advice."
Rising MS drug costs have been a particular concern in recent years, especially as the number of new MS drugs has exploded. In 2015, the National Multiple Sclerosis Society (NMSS) surveyed nearly 9,000 people with MS and found that 40% said they faced challenges related to the cost of MS treatment, insurance, or care. And a recent study led by Guoqiao Wang, PhD, of Washington University in St. Louis, reported that 6% of MS patients did not use disease-modifying treatments (DMTs) because of insurance or financial reasons. Of those who used DMTs, nearly 25% relied on support from free or discounted drug programs.
"The financial burden of DMTs also reduced the ability of persons with MS to adhere to therapy as manifested by skipping doses," Wang, who was not involved with the current research, told MedPage Today. "As the costs for DMTs continue to rise, it's likely that more MS patients will not be able to take the drugs, or have to rely on partial support, or become non-adherent. That will eventually reduce the benefit from these therapies."
Medications prescribed by neurologists represent a big chunk of national drug costs: they accounted for $5 billion in Medicare Part D payments in 2013, trailing only internal medicine and family practice among specialties. As new drugs like biologics for migraines become available, neurology drug costs may rise and especially affect patients with high-deductible health plans, Callaghan and colleagues noted.
In this study, they evaluated claims of more than 912,000 people insured by United Healthcare who had one of five neurological conditions -- multiple sclerosis, dementia, epilepsy, peripheral neuropathy, or Parkinson's disease -- from 2004 to 2016.
For each condition, they looked at the top five most commonly prescribed medications by neurologists, plus all FDA-approved MS medications, as well as lacosamide (Vimpat) for epilepsy, and venlafaxine (Effexor brand and generic) for peripheral neuropathy. The primary outcome was the mean out-of-pocket cost for a 30-day supply of medication, including co-pays and deductibles.
The fastest rise in monthly out-of-pocket costs occurred with MS drugs, which climbed from $15/month in 2004 to $309/month in 2016. Cumulative 2-year out-of-pocket costs for MS patients were an average of $2,238, which varied considerably from patient to patient: 5% of MS patients paid an average of $90, while another 5% paid $9,855 or more.
Expenditures also varied widely from condition to condition. Cumulative 2-year out-of-pocket costs for epilepsy patients were an average of $230, for example, about one-tenth that of MS drugs.
Out-of-pocket costs for brand name medications for other neurological conditions also rose considerably. Patients in high-deductible health plans incurred about twice the monthly out-of-pocket expense compared with patients not on those plans: $661 versus $246 for MS drugs, and $40 versus $18 for epilepsy, in 2016.
While these expenses are steep, MS drug costs can hit patients with government insurance even harder, noted Dennis Bourdette, MD, of Oregon Health and Science University in Portland, who was not involved with the research. For example, Medicare beneficiaries without low-income subsidies are expected to have annual out-of-pocket costs of $6,894 for MS treatments this year.
"MS patients with private insurance are shielded from the rising cost of drugs because the pharmaceutical companies provide financial assistance to cover co-pays and other out of pocket expenses," Bourdette told MedPage Today. "However, patients are indirectly affected by the high costs because private insurance companies lower their costs by restricting coverage to a limited number of drugs based on the negotiated rebates they receive. Rising costs of drugs affect MS patients on Medicare Part D directly as their out-of-pocket expenses rise; by federal law, pharmaceutical companies are forbidden to provide financial assistance for patients on Medicare."
To address high neurology drug costs and drug-pricing policies, the American Academy of Neurology, which funded the study by Callaghan and colleagues, recently created a Neurology Drug Pricing Task Force. The NMSS also has proposed recommendations about MS drug access.
"Medications should be affordable and the process for getting them simple and transparent," NMSS executive vice president of advocacy Bari Talente, JD, told MedPage Today. "We advocate across the board -- at the federal and state level, and across the supply chain -- to support those goals."
This study has several limitations, Callaghan and co-authors noted: it looked at drug costs for only five neurologic conditions and did not evaluate all drugs used to treat them. It did not include information from outside financial support programs like other insurers, pharmaceutical companies, or philanthropic donations. It also did not include people who did not fill an initial prescription because of cost.
The study was funded by the American Academy of Neurology Health Services Research Subcommittee.
Researchers reported relationships with Impeto Medical Inc., Advance Medical, Bracket Global, NeuroOne, and AstraZeneca.
Care intensity greater at teaching hospitals, but sicker patients are the reason
This article was first published on Thursday, May 2, 2019 in MedPage Today.
By Diana Swift, Contributing Writer
Differences in metrics of cost-effective hospital care for inflammatory bowel disease (IBD) are driven more by disease severity than hospital teaching status, according to a University of Pennsylvania study published online in Inflammatory Bowel Diseases.
The findings suggest that insurers should not exclude teaching hospitals from their network of coverage in favor of community hospitals on grounds of cost-effectiveness.
After a multivariable analysis for confounders of disease complexity, the only metric for which teaching hospitals were at any disadvantage was 30-day readmission rates for ulcerative colitis (UC), which was 1.9 percentage points higher in major teaching hospitals versus non-teaching hospitals (95% CI 0.33-3.61) after multivariable adjustment.
"This finding demonstrates that despite the time and resources needed to train new physicians, conduct pioneering research, and trial newer and potentially costly therapies, outcomes at academic centers do not suffer when compared with their community counterparts," wrote Gary R. Lichtenstein, MD, of the Perelman Center for Advanced Medicine in Philadelphia, and colleagues.
In unadjusted analysis, however, mean length of stay, mean direct costs, and 30-day readmission rates were numerically greater among teaching institutions for both UC and Crohn's disease (CD). The unadjusted mortality rate was also greater in major teaching hospitals for UC but not CD.
Incidence and prevalence of IBD are on the rise in the U.S., currently affecting more than 3 million adults.
Improving the cost effectiveness of care is a major consideration. Although teaching hospitals have overall higher costs and more often utilize medical trainees to provide care than their community counterparts, little is known about the way teaching status actually impacts hospitalization outcomes, the authors noted, stating that theirs is the first study to do so.
Although hospitalization is thought to account for more than 30% of the as much as $31.6 billion in annual costs of IBD, previous studies have not examined the impact of teaching status and the use of trainees for providing care, the researchers noted.
Medically complex patients are often referred to teaching hospitals with high-volume academic physicians, and these centers have overall higher costs and receive funding from the federal government for training and research.
"They are considered less likely to provide cost-effective care, so some insurers may narrow their treatment networks to exclude teaching hospitals in order to control costs and premiums, as has been done in cancer treatment," co-author Rahul S. Dalal, MD, of the Hospital of the University of Pennsylvania, told MedPage Today. "But we found that the higher costs were attributable to the severity of the patient populations at referral centers."
Study details
Using the Vizient clinical database, the investigators identified patients hospitalized for CD or UC from October 1, 2014 to March 31, 2018. With hospitals divided into major and minor teaching hospitals and non-teaching hospitals according to the 2016 annual survey of the American Hospital Association, they evaluated the association between teaching status and mean length of stay, mean direct cost of patient care, 30-day readmission rate, and in-hospital mortality rate. Adjustments were made for a range of patient characteristics and covariates of disease complexity that might affect resource utilization. Other variables included mean number of comorbidities per hospitalized patient, proportion of cases transferred from outside hospitals, and the proportions requiring intensive care, total colectomy or bowel resection, lower endoscopy, parenteral nutrition, or blood transfusion.
For the final analysis, the database yielded 29,863 discharges from 291 hospitals for UC and 62,698 discharges from 314 hospitals for CD. Hospitals not included by the American Hospital Association's annual survey or those with fewer than five IBD discharges or missing data were not factored into the aggregate data.
Major teaching centers had a significantly higher case mix index, reflecting resource use intensity, and their IBD patients were significantly more likely to have the following characteristics:
Younger age (18 to 30)
Black or Hispanic ethnicity
Primarily Medicaid coverage
Transfer originally from an outside hospital
Complications such as colectomy or bowel resection, lower endoscopy
Extreme severity of illness on admission
Parenteral nutrition
"I think this is an important study that provides more granular adjustment for disease severity," commented Ashwin N. Ananthakrishnan, MD, MPH, of Massachusetts General Hospital in Boston, who was not involved in this research. He added that when many studies in the literature compare big categories, such as teaching versus non-teaching hospitals or small versus large hospitals, the sites with more referral cases or more complex cases usually appear to have worse outcomes.
"But this study confirms, as suspected, that this is a false association once disease severity is factored in," he said. "So as we think about paying for IBD care in the future – perhaps through bundled payments for diseases – this study highlights the importance of adjusting for severity of disease in such decision making."
The authors cited the need for studies to better characterize the factors that drive increased resource utilization in order to provide high-value inpatient IBD care at all medical centers. Access to patient-level data might shed light on these factors.
Among study limitations, the authors noted its reliance on aggregate data at the hospital level with no patient-level data. In addition, since Vizient has not been validated for the study of IBD, the analysis relied on ICD coding for diagnoses and procedures and therefore may have omitted hospitalizations coded primarily as abdominal pain or diarrhea that did not include IBD as a primary or secondary discharge diagnosis. Conversely, some hospitalizations may have been included because of miscoding of the discharge diagnosis that ultimately may have proved to be a condition other than IBD.
Furthermore, the study was unable to isolate the impact of resident teaching on outcomes for hospitalized IBD patients. Finally, it was unable to measure inpatient biologic therapy, which likely would have been utilized to a greater extent in teaching hospitals and would have increased the direct costs and hospital stays at these centers.
Lichtenstein reported ties to Salix, Shire, Axcan, Ferring, Abbott, UCB, Bristol-Meyers Squibb, Elan, and Prometheus. Co-author Lewis disclosed ties with Pfizer, Gilead, UCB, Janssen, Ortho biotech, Celgene, AbbVie, Samsung Bioepis, Bridge Biotherapeutics, Merck, Takeda, and Nestle Health Sciences. Ananthakrishnan reported no conflicts of interest.
