The Biden administration is facing increasing pressure from states to allow drug imports from Canada to lower the cost of prescription drugs.
On Dec. 5, Colorado became at least the fourth state to seek federal permission to use the strategy, after Florida, New Hampshire and New Mexico.
President Joe Biden has endorsed this approach, but his administration has yet to greenlight the state plan.
“The states are doing their job and the only thing holding them back is the Biden administration,” said Jane Horvath, a health policy consultant who has worked with states on import plans.
U.S. Department of Health and Human Services Secretary Xavier Becerra addresses reporters during a press conference at HHS headquarters in Washington, DC, June 28.
Alex Wong, Getty Images
Health and Human Services Secretary Xavier Becerra told KHN on Dec. 5 that the Biden administration welcomed applications from Colorado and other states for drug import programs. However, in 2023, he did not commit to ruling on any application by the FDA.
People are also reading…
When asked what his message was for the state, he said:
US buyers pay the highest prices in the world for brand-name drugs. Medicines are generally cheap in neighboring Canada, where the government controls prices.
Under President Donald Trump, the US government has declared that it is safe to import drugs from Canada. This meets the requirements set by the Federal Drug Importation Act of 2003. The Trump administration finalized rules for states to apply in September 2020.
During his campaign at the White House, Mr Biden said he would allow consumers to import prescription drugs from other countries if the federal government certified them as safe.
After Biden takes office in 2021, he will order the FDA to work with states to import prescription drugs from Canada. In his speech last year, he quoted estimates of how much money Coloradoans could save by importing how he’s trying to bring drug prices down.
Despite the administration’s official endorsement, early applicants were frustrated by the FDA’s inaction.
In August, nearly two years after submitting its drug proposal, Florida sued the federal government, blaming the Biden administration for its slow review. The federal government denied the charges. Florida Governor Ron DeSantis, a potential 2024 Republican presidential nominee, supports the state’s efforts.
In November, about three months after Florida sued, the FDA sent Florida a 15-page letter asking it to fill dozens of gaps in its plans. The letter asked if the state wanted to withdraw its application and file another.
Florida said in a December court filing that “suddenly evoking so many supposed flaws” in its proposal was another “stall tactic” by the government.
Jake Leon, a spokesperson for the New Hampshire Department of Health and Human Services, said New Hampshire’s proposal was rejected because it did not identify a Canadian wholesaler to provide the drug. He said he was told he could reapply if he found it.
New Mexico is still in discussions with the FDA, said David Morgan, spokesperson for the state health department.
Other states have expressed interest in importing, but have yet to seek federal approval.
The pharmaceutical industry, wary of government-organized import programs that could eat away at its profits, opposes the strategy, claiming it would circumvent regulations designed to keep drugs safe in the United States. .
America’s Pharmaceutical Research and Manufacturers, a pharmaceutical industry lobbying group known as PhRMA, sued the federal government in 2020 to block drug imports. That lawsuit is pending. The Biden administration argued in court that the lawsuit was void because it was unclear when the government would approve the state’s import plan.
Many of the branded drugs sold in the United States are already manufactured overseas. In addition, millions of Americans visit online pharmacies and other countries to purchase low-priced drugs from Canada and abroad.
Colorado officials said their proposal aims to save residents and employers an average of 65 percent on the cost of dozens of drugs, including diabetes, asthma and cancer drugs.
Kim Bimestefer, executive director of the Colorado Department of Health Policy and Finance, told KHN that the state wants to disrupt the current drug pricing system, which allows manufacturers to charge as much as the market will bear. The FDA has told state officials it will take six months to consider the proposal, she said.
The Colorado proposal uses a wholesaler in Ontario, Canada, to ship drugs across the border in Buffalo, New York, to an importer headquartered in Boise, Idaho. After being tested, they are sent to Colorado pharmacies and sold to residents and employers.
Bimestefer said Colorado plans to have its safety checks on drugs brought in from Canada exceed those on drugs sold in the United States. “We are very confident in its quality and bullish on savings,” she said of the Canadian drug.
Colorado’s filing said the state’s import strategy has faced resistance not only from pharmaceutical companies, but also concerns from pharmacies and the Canadian government.
Canadian officials have opposed US import plans. This is because we fear that this effort could lead to drug shortages in Canada. But Bimestefer said Colorado will only bring the drug if both countries have sufficient supplies.
What a Sudden Medical Cost Ban Means for You
What a Sudden Medical Cost Ban Means for You
Nearly 2 in 3 US adults worry about additional medical costs that they are unaware of, as high medical costs are expected for many patients in the US healthcare system. That’s no surprise. One in three Americans reports being “very concerned” about the burden of these staggering medical costs. His 2020 Harris Poll survey, commissioned by the American Heart Association, found that nearly half of respondents were unable to seek medical care due to the economic impact of health care.
This worry is not unfounded. His 2020 analysis by the Kaiser Family Foundation found that 30% of adults with health insurance had an unexpected medical bill within the past two years. This means that the patient was billed for all or part of the treatment they believed was covered by their insurance. If the provider is outside the patient’s insurance network, emergency scenarios such as calling an ambulance or landing her in the ER can result in unexpected medical costs. These unexpected costs vary, but the average ranges from $750 for him to $2,600 for him.
The No Surprises Act was signed into law on December 27, 2020 as part of the Consolidated Appropriations Act of 2021 to address the unexpected burden of medical expenses. of the network, except for ground ambulance services. It also prohibits surprise charges for more routine services from out-of-network providers at in-network facilities.
Sidecar Health has compiled a list of facts about unexpected medical claims and what the No Surprises Act, which took effect January 1, will do to combat unexpected medical claims. Information comes primarily from the Centers for Medicare and Medicaid Services, the main regulatory agencies behind the No Surprise Act.
insta_photos // Shutterstock
What are unexpected medical expenses?
Patients may incur unexpected medical costs in a variety of ways, including receiving care from out-of-network hospitals, doctors, or other providers they did not choose. Another case is when a healthcare provider bills a patient for the difference between the total cost of the service and what the patient’s insurance paid.
Many alarming medical costs arise from emergency visits. Even if a patient diligently chooses to go to an in-network hospital in an emergency, the patient may be seen by a doctor outside that hospital’s network, incurring unexpected costs. According to the US Department of Health and Human Services, about one-sixth of emergency room visits and hospitalizations result in an unexpected medical expense.
jolls // shutterstock
What types of medical services will be affected?
The No Surprises Act prohibits surprise charges for most emergency services and ambulance transport, even those received from out-of-network providers. This means that when a patient sees an out-of-network emergency provider, they cannot claim further out-of-network cost shares, such as co-payments and deductibles. Cost sharing should be based on the insurance plan’s in-network rate. This protection applies to most off-network emergencies and some non-emergency services.
In addition, patients cannot be billed for out-of-network ancillary services. For example, pre-surgery visits to non-network anesthesiologists at in-network hospitals will not result in unexpected charges.
Spiroview Inc // Shutterstock
How will this affect existing state laws regarding surprise bills?
As federal law, the No Surprises Act serves as the baseline consumer protection in all states. Many states have their own surprise claim laws that provide at least the same level of protection as no-surprise laws. In most cases, state law applies, but where no state law exists, the no-surprise law applies.
Shida Production // Shutterstock
Are ambulances exempt from the ban?
Patients cannot choose an ambulance service to respond to emergency calls. About 50% of emergency ground ambulances incur out-of-network charges, but these services are not covered by the No Surprise Act protection. Approximately 3 million privately insured patients require an ambulance each year, and many may face unexpected bills later. Unexpected charges related to this service will continue to be governed by state law. Currently, 10 states have rules regarding surprise billing outside the ambulance network. The average cost of ground ambulance services is $450.
Air ambulance transport services are significantly more expensive, with an average charge of over $21,700. However, emergency air transportation is protected under the No Surprise Act, which requires insurance companies to cover air transportation providers as out-of-network services, and patients only pay out-of-network standard copayments or deductibles. have to pay.
Alexander Oganezov // Shutterstock
No health insurance?You will get a “Honest Quote”
“Honest” cost estimates are provided to those who do not have insurance or to those who have insurance but choose to pay out-of-pocket medical costs. These estimates are not intended to be exact, but should reasonably detail a list of anticipated charges and services associated with patient care. If the bill ends up being at least $400 more than the good faith estimate, the patient has 120 days from the billing date to file an appeal. Patients can utilize the federally regulated dispute process to determine the amount they must pay in the event of an incorrect quote.
This story was originally published in Sidecar Health and was produced and distributed in partnership with Stacker Studio.
Sashirin Pamai // Shutterstock
.
