The Trump administration has run up against a legal wall in its first big effort to lower drug prices. But there’s a good chance Congress will help it climb over.
Late last night, a federal judge blocked the administration’s new requirement for drugmakers to display the price of medications in television ads, saying the Department of Health and Human Services overstepped its authority with the regulation and would need approval from Congress. The decision came just a few hours before the rule would have gone into effect, my colleague Yasmeen Abutaleb reports.
The ruling is a slap in the face to President Trump and HHS Secretary Alex Azar, who have touted the effort as an important step in their broad initiative to ensure more price transparency for patients and ultimately force companies to reduce drug prices. The administration's rule prompted a lawsuit from three major pharmaceutical companies – Merck, Eli Lilly and Amgen — who argued it abridged their First Amendment rights to free speech.
HHS spokeswoman Caitlin Oakley said the administration is “disappointed in the court’s decision and will be working with the Department of Justice on next steps related to the litigation.”
“Although we are not surprised by the objections to transparency from certain special interests, putting drug prices in ads is a useful way to put patients in control and lower costs,” Oakley said in a statement.
New York Times's Katie Rogers:
On this decision, White House comes out swinging: "It is outrageous that an Obama-appointed judge sided with big pharma to keep high drug prices secret from the American people, leaving patients and families as the real victims.” https://t.co/NBo3helZ4d w/ @katie_thomas— Katie Rogers (@katierogers) July 9, 2019
Judge Amit Mehta, of the U.S. District Court for the District of Columbia, didn’t weigh in on the drug companies' First Amendment contention – and he acknowledged the policy “very well could be an effective tool in halting the rising cost of prescription drugs.” But he wrote that it’s the job of Congress, not the administration, to require such disclosures.
“To be sure, the costs imposed by the…rule amount to a rounding error for the pharmaceutical industry,” Mehta wrote. “But that argument misses the point. It is the agency’s incursion into a brand-new regulatory environment, and the rationale for it, that make the rule so consequential.”
Inside Health Policy reporter Rachel Cohrs:
Here's the @PhRMA statement on a federal judge throwing out the Trump administration's rule requiring drug makers to disclose list prices in television ads. The group highlight websites with list price information companies voluntarily created as an alternative to the HHS rule. pic.twitter.com/iU27BOBvXs— Rachel Cohrs (@rachelcohrs) July 9, 2019
Permission from Congress – even one so sharply divided down partisan lines – might not be terribly hard for the administration to obtain. The leader of the most powerful Senate committee with jurisdiction over the issue, Finance Chairman Chuck Grassley (R-Iowa), has teamed up with the chamber’s No. 2 Democrat, Sen. Dick Durbin (D-Ill.), on legislation to codify the regulation.
The two introduced their bill in May, saying it would ensure long-term implementation and clarity of the requirement HHS first proposed last fall and had just finalized at the time. “Knowing what something costs before buying it is just common sense,” Grassley then said in a statement.
Such bipartisan support is not enjoyed by several of the administration’s other proposals to lower drug prices, including a potential index being reviewed by the White House Office of Management and Budget linking the prices of certain Medicare drugs to lower prices in other countries (something Grassley has panned).
So there’s a good chance Congress could give the Trump administration a boost with this particular regulation, which would have required pharmaceutical companies to list the prices of any medications costing at least $35 for a month’s supply or a usual course of therapy.
The rule was also applauded by patient right's groups, although some analysts (and, of course the drugmakers themselves) argue that merely knowing the list price of drugs doesn’t help patients much because it doesn’t reflect discounts negotiated with insurers.
“Drug list prices have been shrouded in secrecy for too long,” AARP Vice President Nancy LeaMond said in a statement last night. “Today’s ruling is a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”
AHH: New Hampshire announced it will hold off on enforcing its new Medicaid work requirements after about 17,000 out of 25,000 recipients failed to comply with the rules in the first month.
The new rules require that beneficiaries spend at least 100 hours a month working or completing another type of qualifying activity. The state was set to send letters to thousands of people who failed to comply with a notice of dropped coverage, but will now delay the penalties through September, New Hampshire Public Radio’s Todd Bookman reports.
Gov. Chris Sununu (R) announced that state employees will also make an effort to reach more Medicaid recipients and inform them of the requirements. “Making sure we get this right is just absolutely paramount,” he said. “So the idea of giving ourselves another 120 days to move forward on this and get the implementation where we need it to be, it’s not just fair to the system, but it’s fair to those individuals.”
The governor said he signed a Democratic-supported bill into law to roll back some parts of the state’s work rules.
“New Hampshire’s work requirement remains at the center of a federal lawsuit brought by four residents who allege the new rules could force them to lose their coverage,” Todd reports. “Last month, the N.H. Attorney General’s office filed a brief in the case defending the work requirement, writing that ‘the only persons likely to experience gaps in coverage are persons who choose not to comply with the requirements.’ ”
OOF: A new report from HHS’s inspector general detailed dozens of examples of hospice providers who put patients at risk when they were in terrible pain or had other problems. It also chided Medicare for failing to provide adequate oversight and enforcement for those providers.
In one such circumstance, a patient who was living at home under hospice care had a “maggot infestation” where a feeding tube entered his abdomen. The patient was under the care of Vitas Healthcare, the nation’s largest hospice chain, as our Post colleague Christopher Rowland reports. The chain isn’t named in the watchdog report but The Post “identified the 2016 Missouri case by reviewing state inspection records and matching them to the specific circumstances described by the inspector general.”
“Other dire cases listed by the inspector general included a patient whose pressure ulcers developed gangrene, resulting in an amputation; a patient whose injuries from an apparent sexual assault were missed and discovered only at a hospital; and another who did not receive appropriate medication and died in pain,” he writes. “Despite the seriousness of the harm, the hospices in each of the dozen cases did not face serious consequences — largely because Medicare has few disciplinary tools at its disposal, the inspector general said.”
The report also found Medicare does not give consumers many options to vet hospice providers or a process to report complaints.
OUCH: A new study of more than 200 babies found that a third of toddlers exposed to the Zika virus in the womb experienced developmental and other problems. That was true even if the toddlers were born without microcephaly, the abnormally small head that has become one of the physical traits associated with the disease.
The researchers found a very small number of the toddlers in the study who were born with microcephaly saw their symptoms improve, our Post colleague Lindsey Bever reports. “The researchers found that eight of those children had microcephaly — four developed it at birth and remained affected by it, two were born without it but fit the diagnostic criteria within the first year, and two were born with it but grew out of it, according to the study,” Lindsey writes.
There was also a higher rate of autism found among the children who were exposed to Zika.
The new research highlights the subtlety and complexity of the defects associated with Zika, infectious disease expert Albert Ko, who was not part of the study, told Lindsey. “Because a large number of children without microcephaly are nevertheless still suffering neurosensory and developmental problems, children who were exposed to the virus before birth should be monitored throughout their formative years for potential problems in school and in life,” she adds.
Joe Biden on Obamacare: “I'm opposed to any Republican who wants to dismantle it or any Democrat who wants to dismantle it. … Starting over would be, I think, a sin” pic.twitter.com/NjiIasRqh1— CNN Politics (@CNNPolitics) July 9, 2019
— Former vice president Joe Biden panned some of his rivals for the Democratic presidential nomination who support a Medicare-for-all health-care system, saying that “starting over would be, I think, a sin.”
Biden said the existing ACA should be able to provide a Medicare option for people to buy into, rather than create an overhauled health-care system that could not exist alongside the ACA.
"That's why I'm opposed to any Republican who wants to dismantle it or any Democrat who wants to dismantle it," he said. "The idea that you're going to come along and take the most significant thing that happened — that any president has tried to do and that got done -— and dismantle it makes no sense to me."
“Biden has argued for a ‘public option’ that would allow people to opt into government coverage without eliminating employer-based insurance,” CNN’s Eric Bradner writes. “It's the same approach Obama initially sought in 2009, but could not get Congress to include in the Affordable Care Act.”
He acknowledged the previous administration couldn’t get it done, but “now things are changing,” he said about a public option.
— The latest update from the Centers for Disease Control and Prevention suggests the nation’s measles outbreak may be slowing down, with 14 new measles cases reported in the week between June 27 and July 3. The number of measles cases has now reached 1,109 in 28 states this year.
“While it's a smaller number of new cases than was typical in the spring, this year's outbreak hit the greatest number of measles cases reported in the United States since 1992 and since the measles virus was eliminated from the country in the year 2000,” CNN’s Jacqueline Howard reports.
Peter Hotez, co-director of the Texas Children's Hospital Center for Vaccine Development, cited a summer break for school-aged kids and the season aspect of the virus as factors that could be contributing to the slow down of new cases. “We know it peaks in the spring and then declines in the summer. So there is a seasonality to the virus, just like there's a seasonality to influenza,” Hotez told Jacqueline. “A couple of questions that I'm looking at is: One, what happens when kids come back to school in the fall? Because although measles cases have declined, they haven't disappeared … I am concerned that we're going to see the uptick again as we move into the fall months — and then the other question: What happens in 2020?”
— And here are a few more good reads:
- The House Veterans Affairs Subcommittee on Health holds an oversight hearing on the “Cost of Caring” on Wednesday.
- The House Oversight and Reform Committee holds a hearing on “Hearing: The Trump Administration's Attack on the ACA: Reversal in Court Case Threatens Health Care for Millions of Americans” on Wednesday.
- The House Oversight and Reform Committee hold a hearing on childhood trauma on Thursday.
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