Tag: HHS

  • As HHS head, will RFK Jr. take on big insurers?

    As HHS head, will RFK Jr. take on big insurers?

    President-elect Donald Trump has nominated Robert F. Kennedy Jr. as the next head of the US Department of Health and Human Services, reports Sheryl Gay Stolberg and Susanne Craig for The New York Times. The choice is to be expected given RFK Jr.’s strong alliance with Trump. If the Senate confirms the nomination, as expected, what will it mean for the health of our nation?

    RFK Jr. is an anti-vaxxer, critical of our public health agencies, over which he will preside. It has been reported that he might try to end legal protection for pharmaceutical companies that release vaccines, likely deterring production of new vaccines. So, our public health is likely at serious risk.

    But, Kennedy also has promised to eliminate the corporate control of our federal food and health agencies, if confirmed. And, that is desperately needed.

    Kennedy correctly describes the Food and Drug Administration (FDA) as controlled by corporations. In his words, “The F.D.A. is just a sock puppet to the industries it is supposed to regulate.” The FDA gets “user fees” from pharmaceutical and medical device companies, which represent about half its budget. Not surprisingly, it behaves in ways that would make you question its independence.

    Pharmaceutical company stocks have fallen in value since Trump announced Kennedy as his pick for HHS Secretary. Big Pharma is likely right now trying to derail Kennedy’s nomination. But, it’s hard to imagine that the Republican Congress will oppose any of Trump’s cabinet nominees.

    It’s also clear that RFK Jr. will only have as much latitude to take on the big health care corporations as Trump allows him. What Trump will allow him to do remains an open question.

    Among some of RFK’s most extreme positions is a desire to prosecute The Lancet and the New England Journal of Medicine, two of the most respected medical journals in the country, under the federal anti-corruption statute. Kennedy claims that they publish “phony science.”

    Kennedy also has called for eliminating fluoride in public water supplies, a position counter to the science. The Centers for Disease Control and Prevention (CDC) calls water fluoridation one of the greatest public health achievements. It prevents tooth decay.

    Here’s more from Just Care:

  • Health insurers increasingly deny coverage for critical care

    Health insurers increasingly deny coverage for critical care

    Elisabeth Rosenthal writes for The Washington Post on the rising rate of health insurance denials.  High denial rates are not surprising given that health insurers generate greater revenues on each claim they deny. Consequently, they often use proprietary computer algorithms to deny claims in a systematic fashion, with no regard for people’s medical needs.

    Since the Affordable Care Act, health insurers can no longer refuse to cover people with pre-existing conditions in many instances. Instead, to maximize profits, they find ways to deny care. Rosenthal highlights how one insurance company literally has as a job title “denial nurse.

    Although the US Department of Health and Human Services is charged with overseeing insurance company denials, it has not undertaken its oversight responsibilities in a meaningful way. Rather, too often, patients are faced with care denials and the obligation to pay for their care themselves or skip getting care altogether.

    The Kaiser Family Foundation (KFF) recently reported that, in 2021, one in six claims for in-network care in the state health insurance exchanges were denied, 17 percent. In one case, the insurer denied half of all claims, 49 percent! Worse still, another insurer denied four in five claims, 80 percent. And, while insurers reverse the majority of denials when people appeal, patient appeal rates are extremely low–one in 500.

    At times, denials are not only medically incomprehensible but nonsensical. For example, one patient with arrhythmia had his insurer’s approval for a heart procedure, but he was denied coverage “for injections into nerves in your spine,” which he had not received. The insurer had not paid the claim many months later, notwithstanding endless attempts to fix the error.

    In another instance, the insurer wrote a newborn to let the baby know that his neonatal care was denied because the baby could drink from a bottle and breathe on his own. Of course, the baby could not read the denial! And, an insurer denied coverage for epinephrine and steroids received in the emergency room to treat a young man with a deadly anaphylactic allergic reaction, which the insurers claimed was medically unnecessary. Though the patient’s mother has appealed, she still has not gotten the insurance to cover the services.

    Increases in insurer denial rates are likely a product of a computer system, PXDX, which I wrote about here, that allows insurers’ medical claims-review staff to deny 50 claims in ten seconds. This system saves insurers billions of dollars a year, at the expense of the health and well-being of their enrollees.

    To add insult to injury, claims can be denied because an insurer does not have a contract with a particular drug or device manufacturer. It doesn’t matter that the patient needs the treatment.

    Of course, these denials are also happening in Medicare Advantage plans. And, the Centers for Medicare and Medicaid Services (CMS) is not reporting plan denial rates to enable people to avoid plans with high denial rates. In fact, most likely, those plans are getting four and five-star ratings, because the rating system is such a farce! (You can read about why the Medicare Advantage star-ratings are a farce here.)

    The Affordable Care Act gives health insurer oversight responsibilities to HHS and requires HHS to collect and publicly report denial rates among corporate health insurers in the state health exchanges. But, HHS has not undertaken this data collection and reporting, as required. So, after more than a decade of failed government oversight, the insurers continue to deny claims with impunity.

    Here’s more from Just Care:

  • New government rules to protect patients from surprise medical bills face pushback from doctors

    New government rules to protect patients from surprise medical bills face pushback from doctors

    New rules issued by the US Department of Health and Human Services (HHS) that protect patients from surprise bills face pushback from doctors and scores of members of Congress. Secretary of HHS, Xavier Becerra, says that the goal is to keep physicians and hospitals from charging prices that are significantly higher than the average market price. Most important, patients will no longer have to deal with these unexpected bills.

    The rules are the Biden administration’s attempt to make good on Congress’s No Surprises Act. The Act is intended to protect patients with private health insurance from unexpected bills sent to them from out-of-network providers, excluding ambulance companies. Instead of burdening patients with these bills, doctors and hospitals are required to negotiate their rates with insurers. If that doesn’t work, they must go to arbitration.

    The HHS rules appropriately assume that a fair rate is around the average that health insurers are paying for similar services. Some doctors groups are suggesting that they might be driven out of business if their rates are forced down to an average rate. But, HHS feels that the primary goal needs to be protecting patients. Moreover, HHS does not believe it will hurt physicians who are charging well over the average rate to accept an average rate.

    No patient should be forced to pay two or three times more than the average cost. A recent HHS report on surprise medical bills reveals that out-of-network charges average $1,219 for anesthesiologists and $24,000 for air ambulances.

    The HHS rules are projected to bring down health insurance premiums by as much as one percent, according to the Congressional Budget Office.

    One hundred and fifty-two Republican and Democratic members of Congress are not happy with the HHS rules and would like to see them revised. They argue that the rules give too much power to the insurers but don’t seem to consider the fact that many physicians and hospitals are using their power to gouge patients and send them into medical debt.

    Here’s more from Just Care:

  • 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:

  • Beginning January 2022, HHS bans surprise bills from out-of-network providers

    Beginning January 2022, HHS bans surprise bills from out-of-network providers

    HHS has issued an interim final rule that bans surprise bills for patients who receive care from out-of-network providers at in-network hospitals. The rule applies to both emergency and non-emergency care, reports Joyce Frieden at Medpage Today.

    Many patients find, even when they are careful to see in-network doctors at in-network hospitals, that they receive care from a range of 0ut-of-network providers as well. Radiologists, anesthesiologists and emergency doctors are three types of specialists that often do not provide in-network care. With this new HHS rule, patients will only pay the in-network copay for out-of-network services in in-network hospitals.

    The HHS rule builds on Trump administration policy. It bans surprise medical bills as well as high charges from out-of-network providers for non-emergency care for which people have no advance notice. These are unexpected charges because they are either buried in the fine print from an insurer or are left out.

    People who receive out-of-network services in non-emergency situations need to have notice and give their consent. As it is, when patients are billed for out-of-network care, their out-of-pocket payments generally do not count towards their deductible or their out-of-pocket cap.

    The HHS interim final rule also forbids insurance companies from retroactively denying emergency room visits, reports Robert King for Fierce Healthcare. In essence, insurers cannot second guess individuals as to whether they experienced an emergency after they receive emergency services. Insurers must pay these claims.

    HHS plans to issue a series of other interim final rules in the next several months. It will be requiring better price transparency for consumers as well as better tools for comparing provider charges. HHS Secretary Xavier Becerra wants these rules to be crystal clear and understood by all parties so that they actually work in practice and not simply in theory. Time will tell.

  • How should Medicare innovate to improve quality and reduce spending?

    How should Medicare innovate to improve quality and reduce spending?

    Donald Berwick, MD, former head of the Centers for Medicare and Medicaid Services and Richard Gilfillan, MD, former head of the Center for Medicare and Medicaid Innovation (CMMI) write in JAMA Network about the value of CMMI, a creation of the Affordable Care Act that has just reached its tenth year of operation.

    Before CMMI, there was no governmental agency charged with looking scientifically into how best to reshape our nation’s health care financing and delivery systems. Specifically, CMMI is supposed to test new ways of delivering and paying for care that bring down spending while maintaining or improving quality or improve quality while either not increasing spending or reducing it.

    CMMI has significant resources to work with. It has $20 billion to test new models of delivering and paying for care over 20 years, or $1 billion a year. The Secretary of Health and Human Services (HHS) has authority to bring CMMI models to national scale that fit within the parameters of its work, without requiring legislation.

    Between 2010 and 2020, CMMI tested 54 models. Some of these models focused on better care for individuals and better population health, while spending less. Some tested new models of delivering primary care, including medical homes and accountable care organizations. And, some models tested new ways of paying for care, through bundled payments for a group of services over a period of time, instead of through a payment for each service delivered.

    One independent review found that fewer than ten percent of the models tested led to significant reductions in spending. CMMI reports on its website that nearly 10 percent of models tested improved quality and/or reduced costs.

    Beyond that, the tests showed where the savings could be found and where not, as well as where and how the system could be gamed. As of now, CMS has certified four models to be scaled nationally, including a national diabetes prevention program.

    Berwick and Gilfillan recommend that CMMI model tests should be aligned with an HHS and CMS strategic plan for improving health and health care value and promoting equity. They also recommend that, over time, the ACO model should apply to all clinicians and hospitals, which would be paid a capitated rate for the total cost of care. They recommend CMMI test models that focus on social determinants of health, in partnership with other executive branch departments, such as the Department of Transportation and the Department of Housing and Urban Development. They recommend that CMMI test new models of care delivery. And, they recommend increased public-private partnerships to promote better health care and the public health. The entire evaluation process should be public.

    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:

  • Biden has power to authorize free Medicare for everyone

    Biden has power to authorize free Medicare for everyone

    President-elect Biden could guarantee everyone in the US affordable healthcare if he wanted to. David Dayen writes for The American Prospect that, because of the pandemic, a Biden administration–without Congress–has the power to ensure everyone in the country free health care coverage through Medicare. Will Biden have the courage to act and save millions of lives in the process?

    Dayen reports that the Social Security Administration and the Department of Health and Human Services have the authority to give people Medicare for free during the pandemic. A provision in the Affordable Care Act allows this coverage for all people who are subject to an “environmental exposure.” Consequently, the COVID-19 pandemic could make everyone in the country eligible for Medicare, if the incoming administration chose to exercise its authority to do so. 

    Congress might not be planning to enact Medicare for All any time soon. But, in a real way, Section 1881A of the Social Security Act specifically confers the authority on the administration to put in place Medicare for all who want it. Today, more than 2,500 people of Libby, Montana have free Medicare. These people have Medicare because they were exposed to an environmental hazard that could lead to medical issues. So, the federal government is covering their medical costs.

    It’s hard to imagine that President-elect Joe Biden will use this power even in a limited way to provide Medicare to millions of Americans with COVID-19 or who have tested positive for COVID and who otherwise might not be able to afford needed care during this pandemic. But, the ACA provides his administration the authority to establish “optional pilot programs” throughout the country, because of President Trump’s public health emergency declaration. Individuals can then choose to apply for Medicare benefits. They will meet the criteria so long as they are in the middle of a “public health hazard to which an emergency declaration applies . . .” There is nothing to stop HHS from establishing such a pilot program.

    Indeed, HHS could establish the program for everyone in the country, as everyone is at risk of COVID. Cost of testing and treatment should not impede people’s access to care and would promote the public health. And, Biden has said that he supports free coronavirus treatment and a free vaccine.

    What’s more radical: Giving everyone free Medicare or letting tens of thousands of Americans die because the federal government did not do so?

    Here’s more from Just Care:

  • Biden picks California AG Xavier Becerra to head HHS

    Biden picks California AG Xavier Becerra to head HHS

    There is some good news for people with Medicare and Americans writ large! President-elect Joe Biden has named California Attorney General, Xavier Becerra, to head the US Department of Health and Human Services. Becerra is a vocal advocate of Medicare for All and a politically savvy former member of Congress.

    Joe Biden could not have picked a better candidate than Xavier Becerra to serve as Secretary of the US Department of Health and Human Services. Becerra is not a physician, but he has tremendous expertise in health care policy and the politics of health care. Before becoming Attorney General for California, Becerra served for 24 years in the US House of Representatives. And, as California Attorney General, he has led the charge to defend the legality of the Affordable Care Act.

    In the role of HHS Secretary, Becerra would help set the direction of our nation’s health care policy. Of course, Becerra would have to answer to the President. And, any major reforms would need to come from Congress.

    Becerra could and should put an end to many of the Trump administration’s health care policies, including a move afoot to privatize traditional Medicare. He could also implement rules that brought down prescription drug prices, at least for people in Medicare and Medicaid.

    David Sirota reports in the Daily Poster that Becerra supported government action to end patents on some high-priced drugs through the exercise of “march-in rights.” Under the law, when the federal government has invested in research and development for medicines that are not reasonably priced, it can march in, pay the manufacturer a royalty, and issue licenses to other manufacturers to produce the drugs at a lower cost.

    As California’s attorney general, Becerra advocated for the Trump administration to exercise march-in rights to bring down the cost of remdesivir for the treatment of COVID. The federal government paid for much of its research and development.

    President Obama refused to exercise march-in rights. And, it is not at all clear that President-elect Biden will be willing to exercise them either. But, with millions of Americans unable to pay for their medicines and drug prices through the roof, pressure is mounting on the government to step in.

    Becerra also has supported importation of prescription drugs from abroad. While that would be a band-aid measure, it is an important one that would help reset the price of prescription drugs in this country on a par with other countries. As Secretary of HHS, Becerra could make it a lot easier for states and other agencies to import drugs from abroad.

    Here’s more from Just Care:

  • Coronavirus: HHS allocates stimulus money away from many hospitals that desperately need it

    Coronavirus: HHS allocates stimulus money away from many hospitals that desperately need it

    Kaiser Health News reports that the US Department of Health and Human Services (HHS) is misdirecting the first $30 billion of stimulus funds intended for health care providers treating COVID-19 patients. It is apportioning the stimulus money based on hospitals’ revenues from traditional Medicare and away from hospitals that desperately need it. Hospitals burdened with high COVID-19 expenses which do not treat a sizable portion of people with traditional Medicare are losing out. Will the hospitals most at risk stay afloat?

    The CARES Act, which appropriated $100 billion for hospitals and doctors, gives HHS discretion as to how to allocate these money. Why HHS chose to distribute the money based on past Medicare payments is an open question but appears to be because it was easy to do. The law specifically states that the money is intended “to prevent, prepare for and respond to coronavirus.”

    Hospitals that treat a disproportionate share of uninsured patients and patients with Medicaid are not seeing the money they need. For example, Florida’s Jackson Health hospital system, one of the nation’s largest public health systems, is suffering from lack of federal funds and a huge COVID-19 caseload. It is losing $25 million a month in revenue from canceling elective procedures. It is not alone.

    Other hospitals in “hot spot” areas are also not seeing the emergency money they need. In stark contrast, hospitals in states that are not facing heavy COVID-19 caseloads are receiving more than $300,000 for each report COVID-19 case. And, many of these hospitals are generating good income because they can continue to perform elective procedures. New York is receiving just $12,000 for each COVID-19 case. New York has the highest number of recorded COVID-19 cases. New Jersey has the second-highest number.

    It appears that our nation’s multi-payer system makes it easier to channel money to traditional Medicare providers than to hospitals that don’t see as many fee-for-service Medicare patients. That said, HHS claims it will focus its next wave of payments on rural hospitals and hospitals that don’t see as many Medicare patients.

    Here’s more from Just Care: