Tag: HHS

Office of Inspector General finds that Medicare Part D plans inappropriately deny drug coverage
A new report from the HHS Office of the Inspector General (OIG) finds that Medicare Part D drug plans are inappropriately denying drug coverage to their members. Consequently, thousands of people with Medicare are forced to pay for drugs that should be covered or to forego filling their prescriptions.

The OIG report explains that, much like Medicare Advantage plans, Part D plans are coming between patients and their doctors, second-guessing whether their members need the drugs their doctors have prescribed. It also shows that Part D insurers are putting their profits ahead of the health care needs of their members. The question is whether the federal government has a way to hold these private insurers accountable for their misdeeds and ensure that they cover the prescription drugs their members need.

According to the OIG, in 2017, Medicare Part D insurers denied millions of claims for prescription drugs presented at people’s pharmacies. However, on appeal, they overturned many of the claims they had previously denied. The reversals indicate that the original denials were inappropriate.

In some cases, the drugs people had been prescribed were not on the Part D insurer’s approved drug list or they required a preapproval. Whatever the case, older adults and people with disabilities were forced to pay out of pocket for their drugs, to forego filling their prescriptions, or to take further steps to get their drugs approved. And, in many cases, they could not navigate the process to get their drugs approved.

The small fraction of people who appealed their coverage denials, won a partial or total reversal nearly three out of four times (73 percent). But, the overwhelming majority of people whose claims were denied did not appeal. The goal should be for the Medicare Part D plans to have systems in place that eliminate the wrongful denials in the first place.

In short, Medicare Part D plans sometimes engage in inappropriate denials or delays of medications for people with Medicare. The OIG recommends that CMS take action: 1) so that communication improves between Part D plans and prescribers to minimize avoidable rejections at the pharmacy and denials of coverage; and, 2) to reduce inappropriate pharmacy rejections and inappropriate coverage denials. It further recommends that CMS notify people with Medicare about inappropriate denials and other performance problems by Part D plans.

CMS agreed with all four recommendations. But, CMS has been misleading people with Medicare about Medicare Advantage over the last few years. Time will tell if CMS acts on these recommendations.

If you believe Congress should rein in drug prices, please sign this petition..

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October 2, 2019
Sanders drug bill makes it easier for patients to afford their medicines
At my pediatric clinic, I often hear how my patients and their families struggle at pharmacies, forced to choose between paying for their prescriptions or their groceries.

They are not alone: More than one in five patients cannot afford the medications prescribed by their health-care providers. This is even worse for Black and Latino families and seniors on fixed incomes, who often have even fewer dollars to stretch for prescriptions.

Late last month, Sen. Bernie Sanders (I-VT) and Rep. Ro Khanna (D-CA) announced legislation called the Prescription Drug Price Relief Act, which intends to stop price gouging by allowing the federal government to approve cheaper versions of generic medications, thus stripping pharmaceutical corporations that refuse to lower prices of their monopolies.

To show you how this policy would work, let’s use Advair as an example. As a pediatrician, I frequently prescribe this inhaler for my asthmatic patients. Under the Prescription Drug Price Relief Act, the Secretary of the Department of Health and Human Services (HHS) would establish a process to first compare the United States’ excessively priced brand-name drugs with the prices of those same drugs in five wealthy countries: France, Germany, the United Kingdom, Japan, and Canada. In 2015, the median cost—or middle price—for a month’s supply of Advair in these five countries was $46.99. In the good ol’ US of A, which lacks the regulations that other countries use to keep drug prices down, it cost $154.80, and that’s after discounts. This domestic price-gouging by the GlaxoSmithKline corporation is literally making it harder for my young patients to breathe.

Based on this price information, the Prescription Drug Price Relief Act would dictate to GlaxoSmithKline that the maximum price they could charge would be $46.99, the median in the other wealthy countries. If GSK refused to lower the price, then the U.S. government would issue competitive licenses to any company that wanted to produce a generic version of Advair and sell it at or below $46.99.

Competitive licensing, sometimes called compulsory licensing, has been used around the world for decades and are approved under U.S. trade law in order to maintain access to needed medications when high prices are restricting that access. What this means is that the legislation would put patents, not patients, at risk. If a drug company tried to restrict access, another company could produce a generic version.

Importantly, the international reference price is not the only way a price could be termed excessive. The Prescription Drug Price Relief Act would allow any person in this country to lodge a complaint with an office within HHS that a drug price is excessive. Then by using multiple criteria—including but not restricted to the international reference price—HHS would deem if the drug is excessively priced.

The government would also maintain a publicly available database listing brand-name drugs, their prices in the United States, and how those prices compare to other countries. Every big pharmaceutical corporation would be required to report to the HHS about domestic and international pricing for the brand-name drugs they manufacture. Failure to report would result in financial penalties to Big Pharma, and the money would go to competitive research grant programs at the National Institutes of Health, who already do nearly all the research on new drugs and devices.

Many public health experts and consumer advocates anticipate that under the Prescription Drug Price Relief Act, a big pharmaceutical corporation like GlaxoSmithKline would opt to drop the price of drugs like Advair instead of losing their patents and sales to a generic drug company.

Getting prescriptions filled should not be another challenge for my patients and their families who are already struggling with asthma, diabetes, depression, cancer, and many other illnesses. The Prescription Drug Price Relief Act would provide some overdue peace of mind because it puts patients before profits. Even if this legislation doesn’t pass in 2019, it sets a bold marker on what transformative legislation needs to look like. Policies rooted in health justice should lower everyone’s drug prices and never put people’s access to medicine at risk. Instead, smart policies put a drug corporation’s patent at risk.

It is up to us, the ordinary people struggling in an unjust health system, to put pressure on all of our elected officials to pass policies like the Prescription Drug Price Relief Act. Illness and disease do not care if you are a Republican or Democrat. All of us have a human right to health care and accessible prescriptions regardless of what we look like, where we live, or how we vote. Together, we can push legislators to put patients before politics and profits.

This article was originally published by Rewire.News.

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December 10, 2018
Pharma is undermining the discovery of new drugs
Mariana Mazzucato’s op-ed in the Washington Post offers yet another reason why the federal government should be regulating drug prices. Pharma is not investing a meaningful amount of its enormous profits on drug innovations. In fact, Pharma is undermining the discovery of new drugs that we desperately need.

According to Mazzucato, the data show that nearly 80 percent of the new drugs that the FDA approves are variations on drugs that have already been on the market. And, even when the drugs are truly new, pharmaceutical corporations are not making new drug discoveries to help people with diseases where they cannot profit handsomely. Just one in 25 approved drugs around the world between 2001 and 2011 were aimed to help people with rare diseases.

Currently, it is legal for a drug company to run out a drug’s patent over 20 years, take that drug off the market to prevent generic competition, and reformulate its drug so that it is administered differently or at different frequencies. It can then get a new patent for its reformulated drug and extend its ability to control the price of the drug. Wherever, possible, that is what drug companies do.

How can we address this problem? The government should take a mission-oriented approach for the research and development of new drugs, much as it does for the development of breakthrough technologies for national security through DARPA, the US Defense Advanced Research Projects Agency. It should use taxpayer money for the public good, to benefit taxpayers–to drive important new drug discoveries that are needed and to ensure that the new drugs are priced fairly. That’s how the Internet was created, along with the microchip and other major technological advances.

We need the US government driving critical medical breakthroughs. The US Department of Health and Human Services (HHS) should be promoting health care innovation, targeting the kinds of discoveries we most need. A well-functioning HHS would have more leverage over how its corporate health industry partners acted for the public good. HHS would ensure more transparency among pharmaceutical companies, so that the public better understood their costs, investments, and profits. Finally, HHS would demand fair drug prices.

Today, pharmaceutical companies have far less financial incentive to develop drugs that cure diseases than to develop drugs that people must take for the rest of their lives to control their diseases. It is usually more profitable to keep someone on a drug for decades than to provide the person with a drug that ends their disease once and for all. Goldman Sachs analysts and others should not be asking, “Is curing patients a sustainable business model?”

We need to put patients ahead of profits. It is a matter of our health security and, as such, a matter of national security.

Here’s more from Just Care:
October 29, 2018
Congressman Doggett takes lead on Medicare drug price negotiation bill
Congressman Lloyd Doggett of Texas, along with 59 other House Democrats, just introduced a bill that would require Medicare drug price negotiation. Doggett’s bill provides the Secretary of HHS with the countervailing power needed to keep Pharma from gouging people with Medicare. And, if Pharma refuses to sell a prescription drug at a fair price, the bill protects patient access to the drugs, by requiring compulsory licensing.

Doggett’s bill represents the first big Congressional initiative to rein in drug prices. It strikes the “noninterference clause” from the law that enacted Medicare Part D prescription drug coverage. This clause prevents HHS from negotiating Part D drug prices at the moment. Rather, Doggett’s bill requires the Secretary of HHS to negotiate drug prices. And, it ensures that Pharma cannot keep drugs off the market if it does not like the price HHS is willing to pay.

According to Steve Knievel of Public Citizen, “What makes this bill unique relative to other Medicare Part D price negotiation bills is that it includes a novel fallback mechanism to allow for competition when negotiations with a drug manufacturer fail to arrive at an appropriate price. It puts the drug company’s patent monopoly at risk.”

In brief, if Pharma and HHS cannot agree on an appropriate price for a drug, the Secretary of HHS would be obligated to issue a “competitive license” to a generic drugmaker, resulting in generic competition of the drug. HHS would license the use of the patent, clinical trial data and any other rights needed by a generic drugmaker to make the drug. Whether a drug price is appropriate would be based, among other things, on comparative effectiveness research, the cost of covering the drug, the burden on patients who need the drug.

The prescription drug’s patent holder would receive a royalty, which would be calculated based on a variety of factors, including the cost of research and development of the drug and the drug’s benefits.

Public Citizen believes that this bill gives the Secretary of HHS the needed leverage to negotiate a reasonable drug price, eviscerating a drugmaker’s patent monopoly, where appropriate, and protecting patients. And, recognizing that it may take a little time for the generic drugmaker to produce the drug, during that period, the Secretary is authorized to set the price of the drug at the international reference price, its average price in other wealthy countries.

If the pharmaceutical company will not sell the drug to people with Medicare at the average price it sells it to the Germans, the Japanese and other wealthy countries, the generic drugmaker would have a license to sell the drug to all federal programs, not only Medicare Part D.

This bill is a huge step forward, though it only covers the 18 percent of people in the US with Medicare. Ideally, it would offer prescription drug price protection to everyone in the US. It could do so easily if it also gave everyone in the US Medicare exclusively for the purpose of benefiting from HHS’ negotiated prices. Without that benefit, it goes without saying that Pharma will attempt to use its monopoly pricing power to raise prescription drug prices for everyone who does not have Medicare. And, that will penalize people not yet on Medicare as well as the businesses that provide them health insurance.

To ensure access to critical medications for everyone, prescription drug innovation should not be linked to drug prices. Jamie Love at Knowledge Ecology International (KEI), an international expert on drug pricing, explains that “The Democrats also need to understand and endorse the progressive delinking of R&D incentives from drug prices, so that access and innovation are not at odds with each other.”

If you want Congress to rein in drug prices, please sign this petition.

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July 25, 2018
Trump’s pick to head HHS drove up insulin prices at Eli Lilly
Caitlyn McClure of the Other 98 reports that Alex Azar, President Trump’s pick to head the US Department of Health and Human Services (HHS), is a Pharma executive who drove up insulin prices at Eli Lilly. If confirmed, Azar can be counted on to help Pharma and disregard the public interest in having HHS ensure Americans good affordable health care.

Over the last 50 years, Eli Lilly has paid billions of dollar in settlements for illegal marketing of drugs, bribery, and the sale of unsafe products. Ten years ago, the FDA charged Lilly with misleading marketing of dog medicines.

Today, Eli Lilly is embroiled in allegations around insulin price fixing. At least five states are investigating Lilly for raising insulin prices to the same level as its competitors. In addition, a federal class-action RICO (Racketeer Influenced and Corrupt Organizations Act) suit has been brought against Lilly.

Azar was president of Lilly USA in 2012. During his ten-year tenure at Lilly, Lilly tripled its price for insulin and hiked up prices on other drugs to increase its revenue. It created no new drugs. James Elliott of The Nation reports that Lilly’s Humalog, an insulin medicine, costs more today than it did in 1996 when it came to market. In the last 10 years, while Azar was at Eli Lilly, its list price went from $74 to $269.

McClure points out that Trump’s selection of Azar as HHS head is at odds with Trump’s alleged goal of keeping Pharma from “getting away with murder.”

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November 22, 2017
Republican Medicaid reform proposals devastating
As a pediatrician, I prioritize the importance of Medicaid in child health. But as an American I am proud of how Medicaid also cares for 27 million adults with struggling incomes, 6 million older adults, 10 million Americans with disabilities, in addition to 33 million children. With nearly 1 in 3 Americans covered by Medicaid and Medicare, we all know and love people who rely on these programs for their health care. But, the Republican Medicaid reform proposals, which thankfully appear to be dead for now, would be devastating to the program.

Health care providers are hardly thrilled about lower reimbursement from Medicaid, but American taxpayers should recognize that Medicaid is doing a better job than the private insurance industry at providing cost-effective health care. Prior to states opting for Medicaid expansion under the Affordable Care Act, Medicaid spending growth per enrollee was 3.1 percent, compared to the private insurance industry’s 4.6 percent. In 2013, as states began expanding their Medicaid programs, the Congressional Budget Office revised estimates of projected federal Medicaid spending, and determined the federal government would be spending $385 billion less on Medicaid between 2011 and 2020. Talk about getting bang for your taxpayer buck.

Despite this track record of high performance and low costs, Congressional Republicans would like nothing more than to destroy and overhaul Medicaid through proposals like block grants and per capita caps. The majority of the American people did not vote for Trump, and they gave zero mandate to his regime or members of Congress to wreck health care.

However, Trump’s Secretary of Health and Human Services (HHS) Tom Price, Speaker of the House Paul Ryan, and their allies in Congress have plotted against patients before on caps and block grants for Medicaid, which starts by slashing over $1 trillion dollars over 10 years from the program, reducing it by a third of its current size. Then, the federal government would set arbitrary, fixed limits on how much it will contribute to each state’s Medicaid program. There will be no flexibility for any state in the event of economic downfall, epidemics, natural disasters, or other unforeseen challenges. The dominos fall from there, hurting the health care of millions of patients and families.

Because per capita caps and block grants drastically reduce a state’s financial resources for Medicaid patients, Americans can expect to see 14 million patients kicked out of the program with nowhere else to go for coverage. For those patients who manage to qualify for capped or block-granted Medicaid, the severe budget restrictions will limit already limited benefits. That means my patients with disabilities will have fewer visits with physical therapists. The rising cost of long-term care services will be passed to older Americans because capped or block-granted Medicaid cannot cover as much.

Currently, patients and families covered by Medicaid are not facing exorbitant out-of-pocket costs for health care and prescriptions. That peace of mind will end with caps and block grants, as more states demand “more skin in the game” from patients who are already struggling with poor economic and health conditions. In the game of caps and block grants, average Americans are the losers.

Your local hospitals and clinics depend on Medicaid funds in order to serve your community, and that funding needs to be flexible when new health challenges come up from natural disasters, opioid addiction, or diseases like Zika. The per capita caps and block grants envisioned by Ryan and Price are so restrictive that state governments will not receive additional federal Medicaid funds when those unexpected public health challenges arise. Natural disasters and the opioid epidemic are already burdensome for local economies. Capped or block-granted Medicaid will worsen the impact for everyone.

Doctors, patients, and families need to send a clear message to the Trump regime, our Congress, Secretary Tom Price, and Speaker Paul Ryan: We are standing up for our fellow Americans on Medicaid. We absolutely reject block grants and per capita caps. Medicaid is proving its fiscal responsibility by providing health care on a lean budget to over 70 million Americans. People we love are on Medicaid and they are happy with their care. Where we can make upgrades that improve the health of our fellow Americans, we should. However, the majority of Americans did not vote for their health care to be wrecked by per capita caps or block grants for Medicaid. This cannot happen on our watch.
Here’s more from Just Care:
July 19, 2017
Trump HHS pick is fierce opponent of Medicare and ACA
President-elect Trump‘s choice of Tom Price to head the Department of Health and Human Services (HHS) sends a strong signal that the Trump Administration will be allied with Speaker Paul Ryan in repealing the Affordable Care Act. Price also is a fierce opponent of Medicare. He supports gutting both Medicare and Medicaid and rationing health care based on people’s ability to pay for it.

As a Congressman and Chair of the House Budget Committee, Price has made his views on health care known. He authored a bill that turns over much control over health insurance to the industry, with the Orwellian name, Empowering Patients First Act. He supports health insurance regulations that allow insurers to charge older people significantly more than they may today and to sell policies that offer less than adequate coverage. And, he is opposed to subsidies to help people with low incomes afford their health care.

If Price has his druthers, Congress would privatize Medicare and Medicaid, turning them over entirely to private insurance companies. Like Ryan, he wants to eliminate their guaranteed benefits and leave older adults, people with disabilities and people with low-incomes at the mercy of insurers, with inadequate coverage, in the health care marketplace.

Just recently, Price’s Budget Committee released a plan that would have Congress automatically cut Medicare, Medicaid and Social Security substantially to pay for tax cuts mainly for the wealthiest Americans, which president-elect Trump and Congressional Republicans support. The Center for American Progress reports that under his plan, over ten years, Social Security would be cut $1.7 trillion, Medicare would be cut $1.1 trillion, and Medicaid would be cut by nearly $700,000 billion.

And, even without Congressional action affecting our health care system, as head of HHS, Price will have tremendous power to drive changes in Medicare, Medicaid and health insurance in America. As head of HHS, Price will determine how laws are interpreted. He can choose for HHS to limit its oversight of health insurers or to stop spending money on enforcement or to revise provider payment policies.

There’s no candy-coating what will happen if Ryan and Price get their way in Congress. Here’s what we should expect:
- The ACA will be repealed, Medicare will no longer guarantee basic health care coverage, and Medicaid will likely be turned over to the states in the form of federal block grants.
- Hospitals and doctors will ratchet up their charges.
- Drug companies will increase drug prices.
- Insurance companies will compete for business by keeping their premiums as low as possible for the young and healthy and denying coverage or charging high deductibles and out-of-pocket costs when people need care; people with costly conditions will be forced to pay exorbitant premiums as well as high deductibles and copays for coverage or forego care.
- Insurers will restrict their coverage as much as possible and give people only a limited choice of doctors and hospitals. There may not be a guaranteed package of Medicare benefits.
- Government will provide little oversight of the health care industry and/or will not hold insurers accountable for failing to deliver good quality care.
The American Medical Association, AMA, and American Hospital Association, AHA, are both supporting Tom Price. They likely see deregulation of the health care industry as a way for doctors and hospitals to charge higher rates and operate with less accountability. However, deregulation of the health insurance industry will ultimately bite doctors and hospitals in the back.

If Price’s views prevail and Congress kills Medicare and Medicaid, insurers are more than likely to use their leverage to form narrow networks, keeping their enrollees from using costly specialists and specialty hospitals. Alternatively, insurers will raise out-of-pocket costs for specialty care so high that patients won’t be able to afford them, and doctors and hospitals will be left holding the bag.

If you oppose deregulation of our health insurance system and an end to Medicare’s guaranteed benefits, please sign this petition and visit your Senators to make your views known.

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December 15, 2016