JustCare

Tag: Executive Order

  • Biden steps in on drug prices

    Biden steps in on drug prices

    David Dayen reports in the American Prospect on new developments at the White House regarding legislation that would lower prescription drug prices. President Joe Biden’s executive order on economic competition takes (baby) steps towards the federal government removing patents on excessively priced brand-name drugs so that other companies could manufacture them at lower cost. This threat to pharmaceutical company patents, in turn, could move Congress to take bold action on drug prices.

    The potential for executive action on drug prices derives from legislation that gives the government “march-in rights,” to seize drug patents when drugs are developed with government funding and the drugs are not publicly available on “reasonable terms.” There has been a long debate over the meaning of “reasonable terms,” with the sponsors of the Bayh-Dole Act of 1980 and others claiming that it somehow excludes excessive pricing. But, Kamala Harris in her campaign platform supported its use for this purpose.

    Before Trump left office, his administration tried to kill any further discussion on the use of march-in rights to address high-priced drugs through NIST, the National Institute of Standards and Technology. Now, President Biden is asking NIST not to finalize Trump’s proposed new rule.

    Right now, there is a request pending for the government to march-in and break the patent on the prostate cancer drug, Xtandi. Its price in the US is $150,000 for a year’s treatment and, with insurance, copays can easily be $10,000. Other wealthy countries sell it for as low as $30,000.

    To date, the Department of Defense has not acted on the march-in request for Xtandi. President Biden’s intervention on the NIST rule might change that. Let us see.

    In addition to requesting that NIST not finalize the Trump rule on march-in rights, President Biden’s executive order seeks:

    1. The FTC to end pay-for-delay, which permits pharmaceutical companies holding patents on brand-name drugs to pay generic manufacturers to delay bringing competitor generic drugs to market.
    2. Opens the door to drug imports from Canada. This sounds good, but, people can import drugs from Canada today without worry about FDA action. Americans should be able to import drugs from any country, not just Canada.
    3. Directs Secretary Xavier Becerra at the Department of Health and Human Services to recommend how the US should proceed on drug prices. Becerra could support march-in rights as well as compulsory licensing. He could also propose that drugs for people with Medicare cost no more than they do in any other wealthy nation.

    One thing’s clear: If Democrats want to keep control of the House in 2022, it would help a lot if they passed legislation to lower drug prices. The overwhelming majority of Americans support this report. If drug prices remain high, the odds of their winning will likely come way down.

    Here’s more from Just Care:

  • Several states plan to import drugs from Canada

    Several states plan to import drugs from Canada

    With drug prices in the US now substantially more than twice as much as in other countries, Donald Trump issued an executive order in his final days as president allowing states to import many drugs from Canada under certain conditions. Now, Phil Galewitz reports for Kaiser Health News that several states are planning to seek approval from the US Department of Health and Human Services (HHS) to get drugs at lower cost from our northern neighbor. Will the Biden administration provide approval?

    A new RAND report finds that in the 17 years between 2000 and 2017, drug prices in the US rose 76 percent. They are likely to continue to increase. Today, we pay on average more than two and a half times what other wealthy countries pay for brand-name and generic prescription drugs.

    Interestingly, we pay about 3.44 times more than other countries for brand-name drugs, but 84 percent of what other countries pay for generic drugs. We pay on average about 1.7 times what Mexicans pay for their brand-name drugs and 7.7 times what Turks pay for their brand-name drugs.

    During his presidential campaign, President Joe Biden supported the policy of drug importation from Canada as one way to help Americans afford their medications. Of course, Pharma opposes importation, claiming patient safety issues. But, its arguments around safety hold little weight. People have been importing drugs safely from Canada for years. Moreover, forcing people to go without needed medicines because they are unaffordable creates grave patient safety issues.

    Pharma has sued to stop the Trump policy from taking effect. The federal government must respond shortly. We will have a good sense of whether President Biden still supports importation from Canada, based on the federal government’s response to the lawsuit.

    Florida, Colorado, Vermont, New Hampshire and Maine have decided to take importation into their own hands. Some are contracting with private businesses to deliver them drugs from abroad. Florida’s plan is to get lower-cost drugs for state programs, such as Medicaid. It thinks it could save as much as $150 million in year one.

    Colorado is looking to contract with a private company to obtain drugs from Canada for its residents that would be available at their local pharmacies. And, health insurers in Colorado would be able to make the drugs available on their formularies. Colorado policy experts believe that importing drugs from Canada would more than cut the price of many drugs in half for Colorado residents.

    For its part, the Canadian government seems willing to cooperate with the states. However, it will only cooperate when it has a healthy supply of a drug. While that could be an issue with generic drugs, it does not appear to be an issue with brand-name drugs. Trump’s executive order does not allow importation of insulin or injectables.

    The Secretary of HHS must approve a state’s importation policy and find it safe. President Biden’s HHS nominee, Xavier Becerra supported a law allowing importation from Canada as a member of the House of Representatives back in 2003. That was a while ago; it’s not clear how HHS will respond in 2021.

    Again, safety should not be an issue. Many drugs sold in the US are safely imported from abroad already.

    Importation is not a solution to out-of-control drug prices in the US. It will only help a small portion of the population. But, making it legal to import drugs should help reset the market price for drugs in this country. It should make it harder for Pharma to challenge regulation of drug prices to levels at which people can legally import them.

    Here’s more from Just Care:

  • President Trump’s prescription drug executive orders won’t bring down prices

    President Trump’s prescription drug executive orders won’t bring down prices

    For a long time now, President Trump has said that Americans should not be paying more for drugs than people in other wealthy countries, who generally pay prices that are half what we pay. Yet, Trump has done nothing to bring down prescription drug prices. On Friday, he signed three executive orders that are restatements of old intentions to address drug prices but won’t in fact do anything about drug prices.

    To be clear, no executive order on its own can bring down prescription drug prices. Trump’s executive orders are no more than pronouncements. Still, the pharmaceutical industry strongly opposes them. And, Trump is expected to kowtow to Pharma because he is depending on the pharmaceutical industry to get a COVID-19 vaccine manufactured and distributed quickly.

    The executive orders are Trump’s attempt to show Americans that he is doing something about prescription drug prices. He is in fact doing precious little. He held off releasing one prescription drug executive order that focused on bringing down the cost of some costly drugs for people with Medicare because he first wanted to meet with Pharma executives to hear whether they had an alternative proposal more to their liking. If implemented, the order would keep Medicare from paying more for drugs that doctors administer–such as chemotherapy and rheumatology treatments–than what other wealthy nations pay.

    To repeat, if signed, this executive order would only help people with Medicare. And, experts say that it would take many years to implement. Among other things, the federal government would most likely have to defend it from legal attacks by the pharmaceutical industry.

    Of the executive orders Trump signed, one allows insulin and some other drugs to be imported from Canada. That order is already in an FDA draft rule that came out in December. The order simply reiterates what’s in play.

    Another executive order would allow people to get low-cost insulin and EpiPens from Federally Qualified Health Centers (FQHC). FQHC’s are government-funded clinics that offer low-cost care throughout the country.

    And, a third executive order would preclude pharmacy benefit managers (PBMs) from keeping rebates from pharmaceutical companies for themselves. PBMs would need to give the discounts to people with Medicare if the secretary of HHS agrees that doing so would not lead to higher federal costs or higher premiums. But, the Congressional Budget Office has already declared that passing rebates onto consumers would increase federal costs and drive up premiums in Medicare Part D prescription drug plans.

    Alex Azar, the Secretary for Health and Human Services (HHS), has not said whether or how the administration plans to move forward to implement President Trump’s executive orders. The administration must comply with a formal rule-making process even to experiment with an executive order. Expansive programs generally require Congress to enact a law.

    For its part, Pharma has refused to meet with the President because industry executives so object to his executive orders. Pharma says that pegging drug prices to prices in other countries is “a radical and dangerous policy.”

    Earlier this year, the US House of Representatives passed HR3, which caps drug prices in the US for as many as 250 drugs at the average of what other wealthy countries pay. It covers drugs people buy at the pharmacy as well as drugs that doctors must administer. The Republican-led Senate has not taken up this bill.

    Here’s more from Just Care:

  • President Trump blows up ACA adding $200 billion to deficit

    President Trump blows up ACA adding $200 billion to deficit

    President Trump has been saying for a long time that the ACA was going to implode. He was counting on Republicans in Congress to make sure that happened. Without their assistance, he just issued an Executive Order that blows up the ACA and  adds nearly $200 billion to the deficit.

    On October 12, 2017, Trump signed an Executive Order that ends subsidies to help people with modest incomes enrolled in state health insurance exchanges pay their deductibles and copays. These “cost-sharing reductions” cost the federal government about $7 billion a year and save the seven million people who benefit from this help about $1,000 each in out-of-pocket costs. Vox’s Sarah Kliff reports that this provision in Trump’s Executive Order means:

    • Insurers could increase premiums by 20 percent in 2018 in order to cover their increased costs. Premiums could increase by 25 percent by 2020.
    • The federal deficit will increase because the government will have to spend $194 billion more to subsidize the increased premiums of 10 million people in the health care exchanges, according to the Congressional Budget Office.
    • One million more people will be uninsured in 2018.
    • Some health insurers will lose a lot of money on 2018 premiums set before the Executive Order was signed.
    • More health insurers may decide to leave the health insurance exchanges.

    Congress could fix this problem by passing a law that specifically approves these cost-sharing reduction payments. Some believe that this is possible as part of a bi-partisan fix to avoid driving up the deficit.

    In addition, the Trump Executive Order allows insurers to sell skimpy policies that do not cover the essential benefits mandated in the ACA. Some healthy people might leave the state exchanges and buy these skimpy policies because they cost less. But, these people will put their own health at risk if they get sick, because they are likely not to have the coverage they need. And, they will drive up premiums for people in the state exchanges.

    Attorneys general from 18 states and the District of Columbia, including New York and California, filed a lawsuit on October 13 challenging Trump’s Executive Order, the Hill reports.

    Here’s more from Just Care: