“A statement late Friday said the confirmed cases are in Mbandaka city, where a single case was confirmed earlier in the week.
There are now 17 confirmed Ebola cases in this outbreak, including one death, plus 21 probable cases and five suspected ones.
Three new cases of the often lethal Ebola virus have been confirmed in a city of more than 1 million people, Congo’s health minister announced, as the spread of the hemorrhagic fever in an urban area raised alarm.
The statement late Friday said the confirmed cases are in Mbandaka city, where a single case was confirmed earlier in the week.
There are now 17 confirmed Ebola cases in this outbreak, including one death, plus 21 probable cases and five suspected ones. It was not immediately clear what link the new cases might have to others…
Health officials are trying to track down more than 500 people who have been in contact with those feared infected, a task that became more urgent with the spread to Mbandaka, which lies on the Congo River, a busy traffic corridor, and is an hour’s flight from the capital.” (A)
“The next global plague is coming…
The big picture: The total number of outbreaks every 10 years “has more than tripled since the 1980s,” Yong says. Bill Gates told Yong that if there was a severe flu pandemic, more than 33 million people could be killed across the world in 250 days.
“Boy, do we not have our act together.” — Bill Gates…
Preparing and confronting a pandemic relies on multiple moving parts, from the doctors to the nurses, appropriate hospital isolation for infected patients, vaccine delivery, Congress appropriation, and more. The director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, told Yong: “It’s like a chain—one weak link and the whole thing falls apart. You need no weak links.”” (B)
Although Chattanooga’s health care systems have never treated anyone for Ebola virus, Africa’s latest outbreak is a reminder that in today’s world, emerging infectious diseases are only a plane ride away.
In the event that a rare, deadly pathogen should strike the region, there’s a network of behind-the-scenes health care professionals — hospital workers, emergency medical services providers, health department staff — trained and prepared to handle the situation. They also know that there’s risk involved…
Following the 2014 Ebola outbreak in West Africa, the United States government sought to beef up the nation’s ability to respond and treat patients infected with Ebola and other emerging infectious diseases in the event they traveled into the country.
Every hospital in Tennessee became a “front-line” facility, and six hospitals around the state — one of which is Erlanger’s main campus — were chosen as assessment facilities, meaning the hospital would provide the first 96 hours of supportive care to patients with suspicious symptoms and diagnose the illness through screening and lab tests. If test results are positive, EMS would transport the patient to a treatment facility in Atlanta.”
Dr. Jay Sizemore, an infectious diseases specialist and medical consultant for the team, said the first step is to know current pathogen activity around the world and where and when the patient traveled. (C)
(A) Congo says 3 new Ebola cases confirmed in large city, https://www.cnbc.com/2018/05/19/congo-says-3-new-ebola-cases-confirmed-in-large-city.html
(B) What we’re reading: U.S. is unprepared for a global plague, by Haley Britzky, https://www.axios.com/america-unprepared-global-plague-pandemic-cfd85278-eea5-49e2-a6f1-58e76ee34171.html
(C) Should Ebola or another infectious disease strike Chattanooga, a team of health care professionals is ready, http://www.timesfreepress.com/news/local/story/2018/jun/17/should-ebolor-another-infectious-disease-stri/473216/
“On average, in one corner of the world or another, a new infectious disease has emerged every year for the past 30 years: mers, Nipah, Hendra, and many more.
…Despite advances in antibiotics and vaccines, and the successful eradication of smallpox, Homo sapiens is still locked in the same epic battle with viruses and other pathogens that we’ve been fighting since the beginning of our history. When cities first arose, diseases laid them low, a process repeated over and over for millennia. When Europeans colonized the Americas, smallpox followed. When soldiers fought in the first global war, influenza hitched a ride, and found new opportunities in the unprecedented scale of the conflict. Down through the centuries, diseases have always excelled at exploiting flux…
Perhaps most important, the U.S. is prone to the same forgetfulness and shortsightedness that befall all nations, rich and poor—and the myopia has worsened considerably in recent years. Public-health programs are low on money; hospitals are stretched perilously thin; crucial funding is being slashed. And while we tend to think of science when we think of pandemic response, the worse the situation, the more the defense depends on political leadership.
When Ebola flared in 2014, the science-minded President Barack Obama calmly and quickly took the reins. The White House is now home to a president who is neither calm nor science-minded. We should not underestimate what that may mean if risk becomes reality.” (A)
“Disease tends to spread more easily and more rapidly among denser populations. And as populations grow, they can put a greater strain on already stretched resources, from sanitation to medical resources such as vaccines. Over the last few years, we have seen demand for emergency stockpiles of vaccines for diseases like cholera and yellow fever increase dramatically. While we can currently meet this demand, the growing number of mega-cities with populations of 10 million or more, and the increasing risk of urban epidemics that come with them, could deplete these stockpiles very quickly…
While stockpiles are essential, they remain only part of the solution. As cities continue to grow, our best defense will be anticipating outbreaks before they occur. For some diseases, that means making childhood immunization and pre-emptive vaccination campaigns a priority. In other cases, it may mean greater investment in sanitation infrastructure, which can help prevent not just cholera but other water-borne diseases, like the diarrhea-causing rotavirus. And many poor countries are in desperate need of basic diagnostics and surveillance capabilities, enabling them to detect an outbreak as early as possible gives them an opportunity to quickly respond.
All too often with infectious diseases, it is only when people start to die that necessary action is taken. To avoid this, the answer is simple: All countries must step up their long-term efforts to prevent and, wherever possible, eliminate infectious disease. If we keep waiting until outbreaks occur, we may soon find that our ability to respond, contain, and end them is gravely inadequate.” (B)
“Even for outbreaks with excellent vaccines, supplies cannot always be ready fast enough. Once supplies are ready to bring to market, they still need to be fitted into the supply chain, stored properly, and transported to the appropriate individuals — wherever they are.
The logistical issues can be enormous. We are seeing those issues with the experimental Ebola vaccines in the Democratic Republic of the Congo now as aid workers use small boats or motorbikes carrying portable freezers of vaccine to reach remote villages. Vaccines must be administered properly. That means recruiting and training medical professionals and educating the public so that people seek out and receive a vaccine. It also means tracking doses and side effects.
This is why preparedness is vital. Vaccines have a very specific function for containing disease. But even if we develop a vaccine for every possibility, they still have limitations. Local communities must therefore be prepared to prevent and contain outbreaks and limit the impact of those outbreaks on health care and public services.
Preparation means having comprehensive, resilient primary health care services and systems in place with working components: strong leadership, engaged communities, laboratories and hospitals, pharmaceutical systems, supply chains, and disease surveillance systems.”
“Disease outbreaks start and end at the community level, so focusing efforts there is critical. At the global health nonprofit where I work, Management Sciences for Health, we help local authorities develop preparedness plans so that leaders know how to react, communicate risks and lead residents in adopting preventive behaviors.” (C)
“In early May, a strange disease began to affect people in the southern Indian state of Kerala, killing 17 people. The cause was an almost unknown virus called Nipah virus. Even though the virus has been contained, for the moment, WHO is concerned about the Nipah virus which might indeed become the Disease X.
Many of the disease experts consider Nipah to be the most frightening and worrying ’emerging’ virus of the last decades, at least. It is no coincidence that WHO has it as one of the eight priority viruses for which a vaccine should be developed.
According to The New York Times, Nipah infection causes flu symptoms, such as fever, body aches, and vomiting, which often progress to acute respiratory syndrome and encephalitis, or brain inflammation.
Some survivors show persistent neurological effects, including personality changes.
WHO is concerned that Nipah virus might become the Disease X. (D)
“American researchers have developed a platform capable of delivering single-dose vaccines that fully protect against infectious diseases such as Zika, Ebola and Lassa fever…
The vaccines are suitable for repeated use, stable at refrigerator temperatures or lyophilized for non-cold chain needle-free application, and amenable to rapid and affordable scale-up for use in both epidemic response and routine vaccination, according to Basu.
In proof-of-concept studies, the researchers tested three independent vaccines against three different families of viruses. Each vaccine demonstrated full protection after a single dose, using various lethal challenge models. (E)
“The head of the World Health Organization (WHO) on Tuesday cautioned against declaring victory too early in Congo’s Ebola epidemic, despite encouraging signs that it may be brought under control.
“The outbreak is stabilizing, but still the outbreak is not over,” WHO chief Tedros Adhanom Ghebreyesus told journalists on a visit to Democratic Republic of Congo’s capital Kinshasa. “We are still at war, and we need to continue to strengthen our surveillance and … be very vigilant.” (F)
(A) The Next Plague Is Coming. Is America Ready?, by ED YONG , https://www.theatlantic.com/magazine/archive/2018/07/when-the-next-plague-hits/561734/
(B) Do we keep waiting for the next pandemic or try to prevent it?, by Seth Berkley https://www.statnews.com/2018/06/14/pandemic-prevention-ebola-drc-vaccines/?utm_source=STAT+Newsletters&utm_campaign=e1055e5b9f-MR_COPY_07&utm_medium=email&utm_term=0_8cab1d7961-e1055e5b9f-149527969
(C) Let’s not rely on vaccines, here’s how we can prepare for epidemics now, by MARIAN WENTWORTH, http://thehill.com/opinion/healthcare/391889-Lets-not-rely-on-vaccines-heres-how-we-can-prepare-for-epidemics-now
(D) WHO Is Concerned About Nipah Virus, As It Might Become The “Disease X”, by Joe Blair, https://www.healththoroughfare.com/disease/who-is-concerned-about-nipah-virus-as-it-might-become-the-disease-x/9110
(E) Platform developed for single-dose vaccines to treat viruses like Zika, Ebola, https://news.cgtn.com/news/3d3d674e3151444d78457a6333566d54/share.html
(F) ‘We are still at war’ with Ebola: WHO chief, https://www.srnnews.com/we-are-still-at-war-with-ebola-who-chief/
“HHS Secretary Alex Azar today testified before the Senate’s Committee on Health, Education, Labor, and Pensions (HELP) on the Trump administration’s blueprint to lower drug prices.
Among the administration’s top priorities, said Azar, was creating incentives for drug makers to lower list prices for drugs. “Everybody wins when list prices rise,” he said, “except for the patient.”
Azar said that the administration’s proposal to require disclosure of list prices in direct-to-consumer advertising would be one way to achieve this goal, and he explained that HHS believes that it currently has the authority to require this change to advertising through regulation, although he would welcome congressional action to reinforce its authority in this area.
He added that another approach would include moving away from a system that permits manufacturers’ rebates and toward fixed-price contracts or value-based contracts. Azar highlighted the fact that, concurrently with his testimony, the FDA issued new guidance for industry that clarifies how drug companies can share information with payers about drugs’ effectiveness and other measures of value that can help payers to make their formulary and reimbursement decisions.
Other key concerns for the administration, said Azar, are allowing for negotiation under Medicare Part B by merging Part B with Part D, creating more competition within the pharmaceutical marketplace by publishing names of companies that restrict access to samples of drugs for generic testing and issuing new guidance on Risk Evaluation and Mitigation Strategy requirements, and bringing down out-of-pocket costs by disallowing the use of so-called “gag clauses” that prohibit pharmacists from counseling patients on the lowest-price options for their prescribed drugs.” (JJ)
HOW HAS THIS POLICY ISSUE EVOLVED? to get a better understanding keep on reading the following “collage”
And look for future updates as this case develops.
“Insurance companies may be asking people to shell out more money for drug co-payments than the drugs actually cost, a new study suggests.
Generic drug co-payments in the U.S. exceeded the cost of medicines about 28 percent of the time – or for more than one in four prescriptions, researchers found…
Twelve of the 20 most commonly prescribed drugs involved overpayment rates above 33 percent…
To avoid overpayments, patients should always ask the pharmacist if their costs would be lower if they paid cash instead of using their insurance, ..
“Pharmacists might not be allowed to offer this information to patients due to `gag clauses’ but if patients ask, pharmacists can tell them,”” (A)
“When the patent on a brand-name drug expires, and one or more generic versions enter the market, you’d expect consumers to pay less for the generic. That isn’t necessarily the case, thanks to the middlemen known as pharmacy benefit managers.
In a speech last week, FDA Commissioner Scott Gottlieb took aim at these previously little-known but influential players in the health care system. He accused them of colluding with drug makers and insurers to develop “Kabuki drug-pricing constructs.” Gottlieb focused particularly on how such deals affect the generic market.
Once upon a time, drugs were made in manufacturing plants, bought by distributors, and delivered to retail and mail-order pharmacies, which sold the drugs to patients. The cost of drugs were financed through payments covered by insurance companies and patient copays. Today, insurance companies tend to outsource the drug benefit to pharmacy benefit managers. At first, these companies processed drug prescriptions for insurers and helped negotiate lower prices, saving money for insurers and employers…
PBMs use their size to negotiate drug prices with manufacturers, passing on a certain percentage of any rebates downstream to the insurance company and keeping rest of the spread for themselves…(B)
“The prices of some of the most popular brand-name drugs have increased by 12% on average each year from 2012 to 2017, based on Medicare Part D data, according to a report released by Sen. Claire McCaskill, D-Mo. That’s 10 times greater than the rate of inflation during that same period.
Though the number of these prescriptions decreased by 48 million in that window, profits increased by $8.5 billion. Twelve of the 20 medications included in McCaskill’s report saw prices increase by 50% between 2012 and 2017. For six drugs, prices increased by more than 100% during that period…
“Can you imagine if you went to an auto dealership and last year’s exact model was being sold at a 20% markup, and then you went back the next year and it had happened again?” McCaskill said in a statement. “That’s exactly what’s happening in the prescription drug industry, where the cost of identical drugs skyrockets year after year.” “ (C)
“President Trump announced his long-awaited proposal for tackling high drug costs in a speech at the Rose Garden Friday afternoon…
President Trump spared no sector of the drug distribution chain Friday in announcing his administration’s plan to lower prescription drug prices.
“Everyone is involved in this broken system — the drugmakers, insurance companies, distributors, and pharmacy benefit managers (PBMs) and many others contribute to the problem,” Trump said during an address in the sun-filled White House Rose Garden.
“The government is also partly responsible,” Trump added. “Previous leaders have turned a blind eye to this incredible abuse, but under this administration, we’re putting American patients first.”..
He also singled out Big Pharma for special criticism, noting that drug companies spent $280 million on lobbying last year, “more than tobacco, oil, and defense contractors combined.” (D)
“President Trump’s plan, dubbed “American Patients First,” seeks to increase competition, improve negotiation and create incentives to lower list prices of prescription drugs and out-of-pocket costs for consumers.
Here are six key proposals outlined in President Trump’s plan, as outlined by The New York Times.
1. Persuade other countries to pay more for prescription drugs. 2. Try to lower drug prices for Medicare.
3. Include more regulations on drug ads. 4. Ban “gag clauses” for pharmacists. 5. Rein in patent “games”
6. Fix the current rebate system.
Many of these proposals would need congressional action to move forward.” (E)
“President Trump vowed on Friday to “bring soaring drug prices back down to earth” by promoting competition among pharmaceutical companies, and he suggested that the government could require drugmakers to disclose prices in their ubiquitous television advertising.
But he dropped the popular and populist proposals of his presidential campaign, opting not to have the federal government directly negotiate lower drug prices for Medicare. And he chose not to allow American consumers to import low-cost medicines from abroad.
He would instead give private entities more tools to negotiate better deals on behalf of consumers, insurers and employers…
Mr. Trump and other Republicans are eager to show an achievement on health care this year to counter arguments by Democrats who say that Americans are losing coverage because of Mr. Trump’s efforts to sabotage the Affordable Care Act. Soaring pharmaceutical prices are directly hitting consumer wallets, and high-profile cases — like the sudden jump in the price of EpiPens or the jailing of the hedge fund manager Martin Shkreli, who greatly increased the price of a drug under his control — have turned pharmaceuticals into a hot political topic.
Republicans in Congress welcomed the president’s attention to high drug prices and promised to review his proposals, which Mr. Trump said would “derail the gravy train for special interests.”
Democrats embraced the opportunity to push health care back to the center of the political debate.” (F)
“One big idea not included in the blueprint is a call for the federal government to have Medicare negotiate drug prices. “We’re not calling for Medicare negotiation in the way that Democrats have called for,” one of the senior officials told reporters Thursday night.
Democrats blasted the speech, saying that Trump is turning his back on his campaign promise to stop the pharmaceutical industry from “getting away with murder.”
“The President spent last year pressing Congress to pass a massive tax cut — which gives away billions of dollars to drug companies and their executives who are already rich — but this year the President is apparently abandoning his campaign promise to authorize Medicare to negotiate directly with drug companies to lower prices,” House Committee on Oversight and Government Reform Ranking Member Elijah Cummings said in a statement Friday.
The pharmaceutical industry has spent heavily this year on lobbying the federal government, perhaps with Trump’s twice-delayed drug pricing plan in mind. According to a database maintained by the Center for Responsive Politics, spending by industry on lobbying this year totaled $84.8 million through April 24.” (G)
“The industry is now having the last laugh. In a speech Friday on drug pricing, President Trump completed his 180-degree turn on Candidate Trump’s promises. The White House’s new plan, as outlined, does seek to address high prescription-drug costs. “We will not rest until this job of unfair pricing is a total victory,” Trump said. But it doesn’t directly challenge the pharmaceutical industry and the direct role it plays in setting prices. Indeed, the new policy largely meets the goals of big pharma, signaling an ever-tightening bond between Trump and drug manufacturers…
Trump also seemed to take aim at a longtime industry foe in his speech: pharmacy benefits managers, or PBMs. PBMs function as industry middlemen, administering the prescription-drug programs for large insurance programs covering the majority of Americans. These companies handle negotiations between insurers and drug manufacturers on drug prices, including managing rebates from manufacturers that are designed to entice insurers into accepting certain medications on their plans. Drug manufacturers argue that PBMs have wrangled too-high rebates that they keep to themselves instead of passing on to consumers.
In its policy document, the White House vaguely committed to “requiring Pharmacy Benefit Managers to act in the best interests of patients.” Trump was much more forceful in his remarks. “We’re very much eliminating the middlemen,” Trump said, apparently referring to PBMs. “The middlemen became very, very rich.” (H)
“The commissioner of the Food and Drug Administration, Scott Gottlieb, on Thursday suggested that a key federal law on kickbacks could be reinterpreted by the government to help rein in the prices of prescription drugs.
Drug companies are currently being sued by lawyers who believe that the Byzantine system of rebates that flow between pharmacy benefit managers, drug manufactures, and insurers are really kickbacks. The current interpretation of the federal law shields these rebates from legal scrutiny.
But Gottlieb, in remarks delivered at the annual conference of the Food and Drug Law Institute, signaled that might change…
The pharmaceutical industry has engaged in a massive lobbying campaign to shift the blame for high drug prices from the manufacturers, who set the list prices, to pharmacy benefit managers and insurers, who help determine how the products are paid for through a system of rebates. It’s an issue that has also vexed lawmakers, who are questioning the “black box” of drug pricing.” (I)
“Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, recently vowed to bring “new science” to market faster, in hopes that patients benefit from treatment advances sooner…
On its face, this shift seems practical. The nature of pharmaceuticals has changed. Instead of developing broad-spectrum medicines that work for the masses, drugmakers are pursuing personalized therapies that work for — and thus only need to be tested in — much smaller populations whose conditions share the same genetic profiles. That can make large clinical trials seem wasteful.
But, if we’re not careful, the changes now underway may do more harm than good. It’s easy to argue that red tape is bad, especially when lives are at stake. But regulations were created for a reason, and history is rife with examples of what happens when we don’t have them.
Drug approval has become so lax and relatively inexpensive, one recent study suggested that companies could theoretically test compounds they know to be ineffective with the hope of getting a false positive result that would enable them to market a worthless medicine at an enormous profit…
Dr. Gottlieb and others say that patients facing long odds and potentially fatal diseases don’t have time to wait for more clinical trials. That’s a fair point. Reasonable people can disagree over where the fulcrum between speed and evidence should be placed. But a new drug is only innovative if lives are extended or improved, and we can’t know if they will be without more data.” (J)
U.S. Food and Drug Administration chief, Scott Gottlieb, criticized pharmacy benefit managers, health insurers and drugmakers on Wednesday for “Kabuki drug-pricing constructs” that profit the industry at the expense of consumers…
“Patients shouldn’t face exorbitant out-of-pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries,” Gottlieb said at the meeting of America’s Health Insurance Plans (AHIP). “Sick people aren’t supposed to be subsidizing the healthy.”..
He criticized the health industry for failing to promote access to so-called biosimilar versions of drugs, and for pricing practices that harm consumers.
Biosimilars are copies of original drugs that are supposed to be as effective but cheaper. Kabuki is a form of Japanese theater characterized by dramatization and elaborate costumes.
Gottlieb said practices in the healthcare industry “obscure profit taking across the supply chain that drives up costs” and discourage competition.” (K)
“ “It looks like retail list price increases were flat last year. Is that because of President Trump’s tweets?” one Health and Human Services Department official asked at a briefing last month.
“There’s some reality to that. Manufacturers heard they were in the crosshairs, and a number of them came out and said they weren’t going to take their prices up above double digits,” a second HHS official responded.
Such an explanation would be a political boon for the Trump administration. But it is also, according to experts, likely untrue.
It’s true that spending on prescription drugs has slowed. Spending last year grew by just 0.6 percent after accounting for rebates and discounts, the slowest rate of growth since 2012. Net prices for brand drugs grew by just 1.9 percent, after taking into account rebates, discounts and other factors.
But experts argue that the slowdown has been driven by a series of factors unconnected to the White House. There have been relatively few (expensive) blockbuster drugs released over the past year. Fewer people are using some of the blockbuster drugs of years past. Pharmacy benefit managers continue to negotiate rebates to help bring down the prices people actually pay at the pharmacy counter. And generic prices are decreasing, too…,
Experts cast doubts, too, on the idea that mere rhetoric — like the kind likely to fill Trump’s coming speech on drug pricing issues next week — could ever have a meaningful impact on the prices patients face at the pharmacy counter.” (L)
“A drug-price sea change isn’t going to happen overnight, confirmed Health and Human Services (HHS) Secretary Alex Azar. “It will take time to reorder an entire complex multibillion-dollar system,” he says. Azar was formerly the president of Eli Lilly’s U.S. operations — the company is ranked 12th in revenues.
Azar cited “four major challenges”: • high list prices for drugs; • seniors and government programs overpaying for drugs due to lack of the latest negotiation toolsl; • high and rising out-of pocket costs for consumers; • and foreign governments free-riding off of American investment in innovation
The plan sets two basic types of reform: changes by the administration and changes by Congress.
At USA Today, Andy Slavitt labeled the plan a “huge relief for drug companies. There were no calls for negotiation or drug re-importation.” That means they escaped basically unscathed, and there is still no ability to negotiate drug prices by Medicare, payers, and other pharmacy benefits management programs which protects profits and hurts consumers, he says.
Call it as it is: Medicare is forbidden to negotiate drug prices. Other countries’ national health services can bargain drug prices to under half the amount paid by Medicare here: Australia and the United Kingdom are just two.” (M)
“When President Trump unveiled his plan to lower prescription drug prices in a Rose Garden speech last month, he said he would inject more competition into the market by bolstering negotiating powers under Medicare. But experts analyzing the plan warn of a possible side effect: The proposal could significantly increase out-of-pocket costs for some of the sickest people on Medicare.
At the heart of the president’s plan is a proposal to switch some expensive drugs from one part of Medicare to another part — moving them from Part B, the medical benefit created in the original 1965 Medicare law, to Part D, the outpatient drug benefit added by Congress in 2003.
Under Part D, the government contracts with private health insurance companies to manage the benefit and negotiate discounts with drugmakers. There is no such negotiation for the drugs covered by Part B, which are administered by infusion or injection in doctors’ offices or hospital outpatient departments.
But Medicare beneficiaries typically pay a larger share of the costs for Part D drugs. Many beneficiaries have supplemental insurance, such as a Medigap policy, to help pay their share of the bill for drugs covered under Part B. Medigap policies are not allowed to cover Part D expenses.
AARP, the lobby for older Americans, and advocates for cancer patients are already expressing concerns. The problems are not inevitable, they say, but will be difficult to solve.
“People may see a lot higher out-of-pocket costs if a drug moves from Part B to Part D,” said David M. Certner, the legislative policy director of AARP.” (N)
“Medicare recipients filled fewer prescriptions for pricey brand-name drugs — but spent more on such meds anyway, says a government report due out Monday. It blames rising manufacturer prices for squeezing older people and taxpayers.
The Health and Human Services inspector general’s office says it found a 17 percent drop in the overall number of prescriptions for brand-name medications under Medicare’s “Part D” drug program over a recent five-year period.
But beneficiaries’ share of costs for branded drugs went in the opposite direction. From 2011 to 2015, their annual costs rose by 40 percent, from $161 in 2011 to $225 on average. Data for 2011-2015 were the most recent available for the analysis.
“Increases in unit prices for brand-name drugs resulted in Medicare and its beneficiaries paying more for these drugs,” said the report. Rising Medicare payments for brand-name drugs “will continue to affect Part D and its beneficiaries for years to come.” (O)
“As part of President Donald Trump’s promise to curb high drug prices, the FDA posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.
The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.
The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples, and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid, which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.
Kymriah, a cancer drug that grew out of research conducted and supported by the National Institutes of Health, costs $475,000 for a one-time treatment.Novartis Pharmaceuticals Corporation” (P)
“On Aug. 30, the Food and Drug Administration approved a radical new cancer treatment that harnesses a patient’s immune system to attack tumor cells. The drug, known as Kymriah, grew out of research conducted and supported by the National Institutes of Health.
Seven weeks later the F.D.A. approved a second cancer therapy that uses similar technology. This treatment, Yescarta, “got its start right here at N.I.H.,” said Dr. Francis S. Collins, the director of the health institutes. It was developed by Kite Pharma using technology licensed from the N.I.H.
Kymriah costs $475,000 for a one-time treatment, and Yescarta goes for $373,000.
As President Trump vows to lower prescription drug prices, consumer advocates and health policy experts are increasingly saying that the government should insist on reasonable prices for drugs developed with taxpayer funds. New pharmaceuticals can seem miraculous — Kymriah and Yescarta are made from souped-up versions of a patient’s own immune cells — but they are useless if unaffordable, patient advocates say…
“We have an incredibly powerful, incredibly productive research and development program being run by N.I.H.,” Ameet Sarpatwari, an instructor at Harvard Medical School, said. “Taxpayers put in money that is paying big dividends, and yet we pay higher prices for prescription drugs than any other country. In effect, we have taxpayers paying twice.”
Officials at the health institutes say that nearly every new drug has some basis in research funded by their agency. But they oppose any stipulations that would limit or regulate the prices of drugs developed with the fruits of federal research.
Some in Congress disagree. Senator Ron Wyden, Democrat of Oregon, has been saying for years that federal health officials should focus on the affordability of drugs developed with the help of federal funds.” (Q)
“The Trump administration is shaming brand-name drugmakers who refuse to sell samples so generics can be made from their products. (Illustration created using Getty Images)
Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.
As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.”(R)
“President Trump’s plan to curb drug prices will allow Medicare to negotiate prices in a “more aggressive approach than has ever been tried before,” Health and Human Services Secretary Alex Azar said Monday.
And he can do much of it without Congress’ help, Azar said.
Azar, along with CMS Administrator Seema Verma and FDA Commissioner Scott Gottlieb, explained how they expect to execute the plan President Trump announced Friday aimed at curbing drug prices in the U.S.
And Azar said he intends to use his ability to regulate, modify programs, conduct demonstration programs and experiment through the Centers for Medicare and Medicaid Innovation.
“This pen has a lot of power at HHS,” Azar said, picking up a generic ballpoint pen that sat in front of him as he addressed a room of reporters. “And we intend to use the full scope of the power contained in this pen on any of these rather than sitting back and waiting for Congress.”
Here’s a look at what else he had to say about what his office can do with a pen.
Medicare negotiating power: “You’ve probably heard Medicare could save tons of money by directly negotiating drug prices. This just isn’t true,” Azar said, pointing to Congressional Budget Office estimates which support his statement.
Instead, Azar said the administration will issue a request for proposal to make new use of an alternative system for buying Part B drugs called a Competitive Acquisition Program and has called for HHS to merge Medicare Part B into Medicare Part D, which does have a system for negotiating prices.” (S)
“There were high expectations for Trump after a campaign in which he accused drug companies of “getting away with murder” with their unchecked prices, and vowed to take them on. Americans are unified in how they want their government to respond; 92% say it should use its negotiating power to reduce drug prices for Medicare. Sensing a populist wave, in one of his most important and surprising campaign pledges, then-candidate Trump said he would “negotiate like crazy.” He even promised that his negotiating skills would save taxpayers $300 billion annually…
So far Trump hasn’t made a dent. Since he became president, the prices of over 2,500 drugs already on the market have increased by at least double digits. That was all supposed the change with Trump’s big speech Friday. But even as he vowed to press on to “total victory,” there was no trace of even a fraction of $300 billion in savings, or any immediate relief for consumers.
Instead, Trump’s speech and accompanying “American Patients First” blueprint turned out to be a huge relief for drug companies. There were no calls for negotiation (there was even a recommended boost for drug companies to get higher overseas prices) or drug re-importation — the two campaign promises that would have had the biggest impact on consumers.” (T)
“Plenty of attention has been paid to the link between payments from pharmaceutical companies and the drugs a doctor prescribes, including opioids.
But a new study shows something as simple as a meal may be making the difference in just how many opioids are getting prescribed.
Published this week in JAMA Internal Medicine, researchers said they found physicians who received lunches from drug companies prescribed 9% more opioids than doctors who didn’t.
The increase took place even as the overall rate of opioid prescriptions was falling, he said.” (U)
“Medicare already negotiates drug prices. There’s long been a myth out there that within the Medicare prescription drug program, also known as “Part D,” Medicare doesn’t negotiate drug prices. But Medicare does negotiate drug prices, and has done so since the program was created in 2003.
As the Congressional Budget Office put it in a 2014 report, “The competitive structure of Part D gives plan sponsors significant incentive to hold down spending…sponsors use three main approaches: They encourage the use of less-expensive brand-name drugs, they negotiate lower prices for brand-name drugs, and they encourage the use of generic drugs.” (Emphasis added.)
This negotiating process is why Part D spending has come in massively under budget, representing the most successful cost-control experiment in Medicare’s history.
When Medicare Part D was enacted in 2003, people on the left complained that it administered the program through private insurers and PBMs. They wanted Part D to be a government-run, single-payer program, and have long agitated for Part D to be changed in this way. That’s what people mean when they talk about Medicare directly negotiating drug prices. But the Congressional Budget Office has repeatedly evaluated this idea, and concluded that the effect would be “limited” and “modest,” because Part D plans already negotiate on Medicare’s behalf.” (V)
“The cost of prescription drugs can make an unaffordable Utah even tougher to live in. But the KSL Investigators found it pays to shop around to cut down high prescription drug costs if you’re paying cash rather than going through insurance.
It worked for one Utahn, who was quoted wildly different prices for the same medication…
When Olson’s health insurer denied the claim for the drug, he set out to pay cash at his local CVS Pharmacy. The price grounded him: $861.99 for a one month supply of pills.
“That was just a shocker,” said Olson. So he did something he’s never done before. He called another pharmacy. Costco quoted Olson a price of $37.07 for the exact same generic Provigil (Modafinil) CVS was charging $861.99 for. That one call saved him almost $825. That’s a 96 percent savings…
Consumer Reports price shopped recently too. It saved $131 on generic Plavix and $182 on generic Cymbalta. They price shopped five common medications and saved $862.
So what’s going on?… “There’s always a solution, you just want to find a pharmacy where the pharmacist or someone on the staff has time to take a few minutes and talk about the prices.”
We found other ways to cut down your prescription costs too. Ask if a different form of the drug is available that’s cheaper, like a capsule instead of a tablet, or a cream instead of a pill. And if you use insurance, ask if there’s a cheaper pharmacy you can order from. One of our colleagues saved nearly $60 on a common cholesterol drug by switching to a mail order pharmacy.” (W)
“FDA commissioner rattles healthcare industry with ‘warning shot’ over drug rebates. The healthcare industry is growing worried after the head of the FDA suggested that a federal law to prevent kickbacks should be used to rein in high drug prices. Wall Street analysts say FDA Commissioner Scott Gottlieb’s remarks signal that the administration could be more aggressive than it has been in taking on high drug prices and the drug rebate system. Gottlieb and Health and Human Services Secretary Alex Azar recently have been criticizing the rebate system used by insurers and drug middlemen, called pharmacy benefit managers, to negotiate for discounts to pharmaceuticals. The officials have said that consumers don’t receive enough of the discounts negotiated between payers and drugmakers. But Gottlieb surprised the healthcare industry Thursday during a speech before the Food, Drug and Law Institute in Washington. He said the federal government could re-examine if the rebates should no longer be exempt from a federal law that prohibits kickbacks…
Rick Weissenstein, an analyst with the Cowen Washington Research Group, wrote in a note Thursday. “Gottlieb is warning that if you don’t let the market work, you will be faced with more draconian solutions in the future.” (X)
“President Donald Trump.. ”said drug companies in the next two weeks will announce “massive drops in drug prices.” …… Trump said he would “take on one of the biggest obstacles to affordable medicines: the tangled web of special interests,” including drugmakers, insurers, distributors and pharmacy benefit managers.” (Y)
“Rebates are a key cog in the largely secretive pricing agreements ironed out between drugmakers and pharmacy benefit managers, the companies that manage prescriptions for insurers and large employers. Rebates have become more common in recent years, and some critics point to them as a factor behind soaring drug costs. Aetna and UnitedHealthcare say they want to make prescription drug pricing more transparent and simplify the process for customers.
Pharmaceutical companies offer rebates to benefits managers as a carrot to get their drugs included in formularies, or lists of covered drugs. These concessions are usually a percentage of the initial price set by the drugmaker, or the list price.
Pharmacy benefit managers typically pass rebates on to the insurers and large employers that hire them. Those clients often use the money to reduce their plan’s spending on drugs or the cost of coverage. Only 4 percent said they passed rebates directly to customers at the point of sale, or when they buy the drug, the Pharmacy Benefit Management Institute found in a 2017 report…
Aetna estimates that 3 million customers could receive rebates when it starts offering them next year, while UnitedHelathcare’s plan will initially apply to over 7 million people. Those are big numbers but small slices of the more than 67 million U.S. customers these companies cover in total.
In addition, CVS Health’s pharmacy benefits business offers point-of-sale rebates through plans that cover about 10 million of its 94 million customers…
Plus Trump has proposed giving rebates directly to Medicare prescription drug customers.” (Z)
“In the latest look at the financial ties between physicians and drug makers, a new analysis finds that oncologists who received payments for such activities as consulting or speaking were more likely to prescribe medicines sold by those companies.
Specifically, doctors who received either research funding or general payments — which included meals and travel expenses — were nearly twice as likely to prescribe a kidney cancer drug sold by a company that marketed the medicine. And the odds were 29 percent higher that doctors would prescribe a chronic myeloid leukemia sold by a company that provided such payments.” (AA)
“CVS Health will address this problem with a robust set of initiatives, including the new CVS Pharmacy Rx Savings Finder, which will enable the company’s retail pharmacists for the first time to evaluate quickly and seamlessly individual prescription savings opportunities right at the pharmacy counter.
The Rx Savings Finder will show pharmacy teams:
1. First, if the prescribed medication is on the patient’s formulary and is the lowest cost option available.
2. Second, if there are lower-cost options covered under the patient’s pharmacy benefit – such as a generic medication or therapeutic alternative with equivalent efficacy of treatment.
3. Third, if the patient may be able to save money by filling a 90-day prescription rather than a 30-day prescription.
4. Finally, if neither a generic nor a lower-cost alternative is available, other potential savings options for eligible or uninsured patients where allowed by applicable laws and regulation.
Pharmacists can also help patients enroll in the ExtraCare Loyalty Program and sign them up for Pharmacy and Health Rewards. Through Pharmacy and Health Rewards, patients receive $5 in ExtraBucks for every 10 prescriptions filled, earning up to $50 in ExtraBucks annually.” (BB)
“Two weeks after President Trump in May unveiled a plan to lower drug prices for Americans, promising “it will start to take effect very soon,” the drug company Bayer hiked the list prices of two cancer drugs by more than $1,000 per month.
Bayer wasn’t alone. A research note by Wells Fargo analyst David Maris found that although fewer drug-price increases occurred in May than in previous months, dozens of increases did occur.
“We believe drug pricing remains a risk for the pharmaceutical industry,” Maris wrote. “The President has highlighted lowering the cost of healthcare as a key objective and we do not expect the negative commentary around the cost of medicines will soon subside.”
Many of the price increases Maris tracked — particularly the double-digit-percentage increases — involved older, generic drugs. There were also price reductions on a slew of older medicines. But the 8 percent price increases that Bayer instituted are notable because the drugs, Stivarga and Nexavar, have already raised some concerns because of their cost. It is the second price increase for the two drugs in six months.
Stivarga, which is used for patients with colorectal, liver and gastrointestinal cancers, now carries a list price of about $16,860 per month. Nexavar, used in kidney, liver and thyroid cancers, carries a list price of about $18,670 per month. The prices for both drugs are now both 13 percent higher than they were during 2017.” (CC)
“The Food and Drug Administration will launch one of its first programs following the release of the Trump administration’s new drug price plan this week.
The agency will launch on Thursday a website that offers more details on the branded drugs generic drugmakers have trouble getting their hands on, said FDA Commissioner Scott Gottlieb, M.D. The website will retroactively include information on about 150 inquiries made about 50 brand-name medications and will be updated on ongoing basis in the future, he said.
Some drugs had several inquiries from generic drug manufacturers, while others may only have had one, he said.
The FDA head gave a look into the agency’s plans as part of the Trump administration’s overall strategy to lower drug prices at a briefing with reporters on Tuesday morning.
“Branded companies are on notice,” Gottlieb said.
It will also indicate which drugs require a Risk Evaluation and Mitigation Strategy (REMS) and which could make it harder for generic drug companies to acquire samples for development. The FDA will note if it sent an official letter to the brand-name drug company in the case, Gottlieb said.
Generic drug companies have long complained of impeded generic drug development by brand-name drug manufacturers who hinder access to samples. Increasing competition in the markets by encouraging generic drug and biosimilar development is a key element of the White House’s plan to lower drug prices, which was unveiled last Friday.” (DD)
“Pharmacy Benefit Managers arose simply because there was a lacuna in the healthcare market: put simply, nothing constrained the price of prescription drugs; Doctors would prescribe the drugs they thought necessary, pharmaceutical companies would charge whatever they wishes for drugs still on patent, and the insurance companies would foot the bill without any real recourse other than to raise their prices the following year.
Pharmacy Benefit Managers do two principal things: First, they negotiate prices for on-patent drugs. The high prices reported for new drugs are appropriately shocking, but those are not what insurance companies pay: they frequently negotiate a steep discount, which in turn allows insurance companies to keep premiums lower.
The second thing PBMs do is encourage competition in the drug market. They steer doctors to prescribe generic equivalents or other substitutes when available. For instance, while many activists decry the production of “me too” drugs that merely seek to duplicate existing drugs, rather than spending resources developing new drugs for other illnesses, such drugs allow PBMs to put pressure on the pharmaceutical company that makes the original drug to lower its prices.” (EE)
“If President Trump has his way, television viewers who see commercials for the drug Keytruda will learn not only that it can help lung cancer patients, but also that it carries a price tag of $13,500 a month, or $162,000 a year.
Viewers who see advertisements for Neulasta, a drug that reduces the risk of infections after chemotherapy, would learn that the list price for each injection is $6,200. And magazine readers would see a new bit of information in ads for Humira, the world’s best-selling drug, prescribed for rheumatoid arthritis and other autoimmune diseases: its list price, which has been widely reported as approximately $50,000 a year.
The disclosure of such data is perhaps the most eye-catching goal of Mr. Trump’s plan to lower drug prices. The president is determined to bring “price transparency” to the market in an effort to stimulate competition and overturn the current convoluted, opaque system in which everyone but the consumer benefits from higher prices, said Alex M. Azar II, the secretary of health and human services.” (FF)
“Doctors should get out of the business of making money off of providing prescription drugs to Medicare beneficiaries, Health and Human Services Secretary Alex Azar said Monday.
Currently, physicians who administer drugs paid for under Medicare Part B — which covers drugs administered in the physician’s office — pay for the drug themselves up front and then are reimbursed at the average sales price plus a 6% markup. This system “gets into the notion of physicians or facilities making money off the arbitrage between acquisition price and reimbursement,” Azar explained at a briefing with reporters following a speech he gave on President Trump’s plan to lower the cost of prescription drugs.
Instead, the administration is proposing a “competitive acquisition program” for Part B drugs. “The concept of the competitive acquisition program is not to have physicians take title to the medications they’re administering, but rather, have a competitive program where those drugs would be purchased and the capital outlay would occur elsewhere,” so the doctor doesn’t have to buy the drug “and the physician is paid … a fair, appropriate level of reimbursement for their services in administering the drug,” Azar said.” (GG)
“But don’t worry folks. Big Pharma has the solution. It’s called outcomes-based contracting. The basic idea — pay for this drug, and if it doesn’t work, you get your money back.
If you think this is a good deal, I have a bridge to sell you. But don’t take my word for it.
This study, appearing in the Annals of Internal Medicine, looks at the PCSK9 inhibitor evolocumab.
This is a novel lipid-lowering agent that comes in at a whopping $14,500 per year — the price the market will bear. Clinical trials show that this drug does save lives, at a cost of around $324,000 per quality-adjusted life year saved. Most health economists “value” a life-year at $100,000, so one could argue this drug costs more than three-fold what it is worth.
But Amgen, the maker of evolocumab, has a deal for you. If you have a heart attack or stroke within 5-years of starting the drug, you get your money back.
The Annals paper quantifies what you should feel in your gut. Strokes and heart attacks are rare – only about 3% per year in the high-risk group that would be receiving evolocumab. That means that 97% of people are paying full price.
This drug, which is three times more expensive than it should be based on a value-model, is now “price-reduced” to 97% of its original value.” (HH)
“Mr. Jones enters the pharmacy expecting to pick up his prescription. But when he gets to the window, he gets a rude awakening. His acne cream is $200, much too expensive for him to afford. Mr. Jones (not his real name) was told that his doctor needed to fill out paperwork for the insurance to pay for his medication. He leaves the pharmacy upset, and without the prescription.
A study my colleagues and I recently published in JAMA Dermatology found that when patients like Mr. Jones do not pick up their prescriptions, out-of-pocket costs are the primary reason why.
These costs may be from copays or prior authorizations needed through a patient’s insurance. Even as the Affordable Care Act has made great strides in improving the insurance coverage gap in the U.S., more and more patients are now covered by high-deductible plans, leading to higher out-of-pocket costs.
As doctors, we are taught to think about safety and effectiveness when choosing treatments. But the reality is that these standards do not exist in a vacuum. In fact, they exist within fixed monetary constraints on an individual level and for the health system. The question is not simply: Should I prescribe drug A, which sometimes works, or drug B, which always works? Doctors must consider that drug A is 100 times cheaper, so we should probably try that first, unless there is sufficient injury or urgency to justify drug B. There is not necessarily a direct relationship between the cost of a medication and its effectiveness.” (II)
“Legislation would require licensing of pharmaceutical reps.
The legislation specifically targets pharmaceutical sales representatives, bad actors among the group, requiring all drug sales representatives to become licensed by the State Board of Medical Examiners.
“The reason for the bill is because of the consistent news reports, including a recent case where there’s been a plea of guilty, for pharmaceutical reps who are in fact using their positions to enhance the sale of their drugs over others, in particular the opioid market,” said state Sen. Joe Cryan, who is sponsoring the bill.
The bill is in response to a former Insys Pharmaceutical sales representative, admitting bribery and kickback schemes to get doctors to prescribe highly-addictive painkillers. The money was handed out under the guise of “speaker fees.” Investigations show doctors across the state received more than $1.5 million in so-called speaker fees in exchange for prescribing opioids from 2013 to 2015. Cryan, the bill’s sponsor, calls it drug dealers in pinstripe suits. (KK)
(A) Drug copays sometimes exceed costs, by Lisa Rapaport, https://uk.reuters.com/article/us-health-medicines-copays/drug-copays-sometimes-exceed-costs-idUKKCN1GP2P4
(B) A costly PBM trick: set lower copays for expensive brand-name drugs than for generics, by HAIDER WARRAICH, https://www.statnews.com/2018/03/12/pbm-copays-brand-name-drugs-generics/
(C) Report: Brand-name drug prices grew 10 times faster than inflation over last 5 years, by Paige Minemyer, https://www.fiercehealthcare.com/finance/rising-drug-prices-healthcare-costs-claire-mccaskill
(D) D.C. Week: Trump Announces Plan to Tackle High Drug Costs, by Shannon Firth, https://www.medpagetoday.com/washington-watch/washington-watch/72852
(E) 6 key proposals unveiled in Trump’s plan to combat rising drug costs, by Alia Paavola, https://www.beckershospitalreview.com/supply-chain/6-key-proposals-unveiled-in-trump-s-plan-to-combat-rising-drug-costs.html
(F) Trump Promises Lower Drug Prices, but Drops Populist Solutions, by Robert Pear, https://www.nytimes.com/2018/05/11/us/politics/trump-prescription-drugs-plan.html
(G) Pharma breathes easy as Trump’s drug pricing plan fizzles, by David Lim, https://www.biopharmadive.com/news/pharma-breathes-easy-as-trumps-drug-pricing-plan-fizzles/523380/
(H) Big Pharma Gets a Big Win From Trump, by Vann R. Newkirk II, https://www.theatlantic.com/politics/archive/2018/05/big-pharma-gets-a-big-win-from-trump/560219/
(I) Federal kickback law might be used to bring down drug prices, FDA commissioner suggests, by IKE SWETLITZ, https://www.statnews.com/2018/05/03/federal-kickback-law-drug-prices/
(J) Easier Drug Approval Isn’t Cutting Drug Prices, https://www.nytimes.com/2018/06/08/opinion/drug-approval-cutting-prices.html
(K) FDA’s Gottlieb blames industry ‘Kabuki drug pricing’ for high costs, by Yasmeen Abutaleb, https://www.reuters.com/article/us-usa-healthcare-gottlieb/fdas-gottlieb-blames-industry-kabuki-drug-pricing-for-high-costs-idUSKCN1GJ29H
(L) Can Trump use the bully pulpit to lower drug prices? Don’t bet on it, by ERIN MERSHON, https://www.statnews.com/2018/05/04/drug-prices-trump-effect/
(M) Will Trump’s Proposal Ease the Pain of Drug Prices?, Burroughs Healthcare Consulting Network
(N) Trump Plan to Lower Drug Prices Could Increase Costs for Some Patients, by Robert Pear, https://www.nytimes.com/2018/06/02/us/politics/medicare-drug-costs.html
(O) Report: Skimping can’t save seniors from upped prescription drug costs, https://www.cleveland.com/metro/index.ssf/2018/06/skimping_cant_save_seniors_fro.html
(P) Trump Admin Puts Brand-Name Manufacturers in Crosshairs, by Sydney Lupkin, https://www.medpagetoday.com/publichealthpolicy/publichealth/73086?utm_source=Sailthru&utm_medium=email&utm_campaign=PopMed_052418&utm_term=Pop%20Medicine
(Q) ‘Paying Twice’: A Push for Affordable Prices for Taxpayer-Funded Drugs, https://www.nytimes.com/2018/05/28/us/politics/drug-prices.html
(R) Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions, by Sydney Lupkin, https://khn.org/news/drugmakers-blamed-for-blocking-generics-have-milked-prices-and-cost-u-s-billions/
(S) Azar explains how HHS can address prescription drug prices ‘with a pen’, https://www.fiercehealthcare.com/hospitals-health-systems/azar-explains-how-medicare-will-negotiate?mkt_tok=eyJpIjoiTkRCbVpqUmpOemxqWVRFNSIsInQiOiJaRjkyRXlLb2ZLNkJIS0NWT2J3cjVkNVFTbTZBTzNuTHJiOUMyWDJIcnFWTnpFVUxzZ3FKZERPVCt1TkdsVW5Eb3N1YU5aTEkrcXNmTVpVVllEcTNqMU5XaVExMFExbWVNb3FMdzAxSHlwY21mc1hibnd1K3BwcTNTVVFFMTlUYyJ9&mrkid=654508
(T) Trump gave up bargaining chips on prescription drug prices, got nothing for them, by Andy Slavitt, https://www.usatoday.com/story/opinion/2018/05/16/donald-trump-caves-prescription-drug-prices-column/616070002/
(U) No free lunch? Study finds meals from pharma linked to uptick in opioid prescriptions, by Scott Hadlund, https://www.fiercehealthcare.com/hospitals-health-systems/no-free-lunch-study-finds-meals-from-pharma-linked-to-uptick-opioid?mkt_tok=eyJpIjoiWmpKaU4yWTJNbVJrTnpKbCIsInQiOiJscjZhXC9ZVWxCZW5kRXJ2YnMwdHQ1ek96Y3BaTnJjVHpxTEVqMkozdmVpdFlxK1NLSURBTyt6dk5WbVlIZG5QWjBCY1lhcTVKK09lOVNzWFNIVHZJbVgxbzdnRTlIWFE3WDV0ZVNzaTZMcDZCRFJ2SDlRK0p5NEtRS2tqd29ndnEifQ%3D%3D&mrkid=654508
(V) The Trump Plan To Reduce Prescription Drug Prices Will Have A Major Impact, by Avik Roy, https://www.forbes.com/sites/theapothecary/2018/05/14/the-trump-plan-to-reduce-prescription-drug-prices-will-have-a-major-impact/#5959b8c72691
(W) A little detective work can save you hundreds on prescription medications, https://www.ksl.com/article/46316110/a-little-detective-work-can-save-you-hundreds-on-prescription-medications
(X) Daily on Healthcare: FDA commissioner rattles industry, May 5, 2018
(Y) Voluntary Drug Price Cuts Coming in Two Weeks, Trump Says While Signing ‘Right-to-Try’ Bill, https://www.raps.org/news-and-articles/news-articles/2018/5/voluntary-drug-price-cuts-coming-in-two-weeks-tru
(Z) Insurers could pass drug price breaks onto consumers, by Tom Murphy, https://www.app.com/story/money/business/consumer/2018/04/13/insurers-drug-price-breaks-consumers/33780499/
(AA) Drug company payments appear to influence oncologists’ prescribing habits, by Ed Silverman, https://www.statnews.com/pharmalot/2018/04/10/drug-maker-payments-oncologists-prescribing/?utm_source=STAT+Newsletters&utm_campaign=431b02b011-MR&utm_medium=email&utm_term=0_8cab1d7961-431b02b011-149527969
(BB) The Health 202: UnitedHealthcare will hand some consumers more money for drug prices, by Paige Winfield Cunningham, https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2018/03/07/the-health-202-unitedhealthcare-will-hand-some-consumers-more-money-for-drug-prices/5a9ee55530fb047655a06b26/?noredirect=on&utm_term=.e8a80b9942e0
(CC) Two weeks after Trump unveiled plan to lower drug prices, two cancer drugs got a $1,000-per-month price hike, by Carolyn Y. Johnson, https://www.washingtonpost.com/news/wonk/wp/2018/06/08/two-weeks-after-trump-unveiled-plan-to-lower-drug-prices-two-cancer-drugs-got-a-1000-per-month-price-hike/?noredirect=on&utm_term=.7532c6feb089
(DD) Gottlieb: FDA to kick-start plans to increase competition in drug markets this week, https://www.fiercehealthcare.com/regulatory/scott-gottlieb-fda-drug-prices-trump-administration-generics?mkt_tok=eyJpIjoiWmpKaU4yWTJNbVJrTnpKbCIsInQiOiJscjZhXC9ZVWxCZW5kRXJ2YnMwdHQ1ek96Y3BaTnJjVHpxTEVqMkozdmVpdFlxK1NLSURBTyt6dk5WbVlIZG5QWjBCY1lhcTVKK09lOVNzWFNIVHZJbVgxbzdnRTlIWFE3WDV0ZVNzaTZMcDZCRFJ2SDlRK0p5NEtRS2tqd29ndnEifQ%3D%3D&mrkid=654508
(EE) Pharmacy Benefit Managers Are Not The Cause Of High Prescription Drug Prices, by Ike Brannon, https://www.forbes.com/sites/ikebrannon/2018/06/06/pharmacy-benefit-managers-are-not-the-cause-of-high-prescription-drug-prices/#1ec4d3836b9a
(FF) Requiring Prices in Drug Ads: Would It Do Any Good? Is It Even Legal?, by Robert Pear, https://www.nytimes.com/2018/05/19/us/politics/drug-prices-ads.html
(GG) Get Docs Out of Drug-Buying Business, HHS Chief Urges, by Joyce Frieden, https://www.medpagetoday.com/publichealthpolicy/healthpolicy/72869?xid=nl_mpt_DHE_2018-05-15&eun=g1223211d0r&pos=3&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202018-05-15&utm_term=Daily%20Headlines%20-%20Active%20User%20-%20180%20days
(HH) Drug Doesn’t Work? Get Your Money Back!, by F. Perry Wilson, https://www.medpagetoday.com/blogs/themethodsman/72110
(II) Expensive prescriptions have patients skipping their meds. What can doctors do about it?, by JULES LIPOFF, https://www.statnews.com/2018/04/03/doctors-cost-prescribing-medications/
(JJ) Azar Testifies on the Need to Reduce Drugs’ List Prices, Provider Group Raises Concerns, by Kelly Davio, http://www.centerforbiosimilars.com/news/azar-testifies-on-the-need-to-reduce-drugs-list-prices-provider-group-raises-concerns
(KK) Legislation would require licensing of pharmaceutical reps, by Briana Vannozzi, https://www.njtvonline.org/news/video/legislation-would-require-licensing-of-pharmaceutical-reps/
“Paul Jawor, who has just returned home from the African nation, admitted he was ‘very scared’ about the killer virus in a written account of his time on the ground…
Mr Jawor, a Doctors Without Borders and Médecins Sans Frontières water and sanitation expert, was sent to the DRC on May 20…
The current Ebola outbreak began in the poorly-connected region of Ikoko-Impenge and Bikoro – in the north east of the DRC.
It has since travelled 80 miles (130km) north to Mbandaka, a port city on the river Congo – an essential waterway – with around 1.2 million inhabitants.
Virologists fear there is a ‘major concern’ it will spread to Kinshasa – 364 miles (586km) south on the river, where 12 million people live.
The city, which is the capital of the DRC, has an international airport with regular flights to European cities Zurich, Frankfurt and Brussels.” (A)
Medical investigators will need to overcome the rural region’s extreme logistical hurdles to reconstruct transmission chains, vaccinate contacts and halt the spread…
Epidemiologists working in the remote forests have not yet identified the first case, nor many of the villagers who may have been exposed. Investigators will need to overcome extreme logistical hurdles to reconstruct how the virus was transmitted, vaccinate contacts and halt the spread.
“For an epidemic to be under control, you need a clear epidemiological picture,” said Dr. Henry Gray, the emergency coordinator for Doctors Without Borders.
“If you don’t know the stories of the people involved — who their families were, what their jobs were, where they went to weddings and funerals — then you don’t know the epidemic.”..
The W.H.O. is monitoring more than 900 contacts throughout Équateur province. As the vaccination program expands to the Bikoro and Iboko communities, where most cases have been reported, teams are relying on contact tracing to identify the most urgent recipients.
“This is where everything gets more complicated,” …The villages surrounding Bikoro and Iboko are among the most isolated and densely wooded pockets of Congo. Aid workers must use motorbikes to navigate cratered dirt roads that flood during the rainy season. Maps of some regions are incomplete, and vast gaps in cellular service thwart efforts to report data to central operations.
“Following the virus’s narrative may sounds easy to do on a suburban street outside Chicago,” said Dr. Salama. “But when you’re traveling hundreds of kilometers in a forest by motorbike to find each person, that’s very different epidemiological work.” …
Until investigators identify the index case, it is impossible to discern whether the first patient detected in April was truly the first human case or the hundredth, according to Dr. Gianfranco Rotigliano, the regional director of Unicef. Until then, it is impossible to quantify the crisis.
“These are the early days of the outbreak,” Dr. Salama said. “There can be lulls. We’ve seen that before. But there only needs to be one event — a super-spreader, like a funeral — to cause an explosion.”” (B)
“Globally, we must address three issues to tackle Ebola and other deadly pathogens. One is community engagement. Lack of trust between responders and communities has resulted in patients fleeing isolation, as well as likely missed cases and contacts. Ebola emerged in a remote community; it is essential to understand community perspectives and structure and to gain trust and enlist the community’s strengths to stop the disease.
Another issue is WHO’s effectiveness. The African Regional Office of WHO now has many staff with the needed technical and operational excellence, and the Geneva-based emergency program is more effective than before. But WHO country offices in DRC and elsewhere are not nearly as effective as they need to be. Tedros Adhanom Ghebreyesus, coming up on his first anniversary as WHO Director General, has unveiled a potentially transformative general program of work. His leadership will be essential for these ambitious goals and inspiring rhetoric to overcome operational and managerial weaknesses at WHO headquarters in Geneva, as well as in some regional and many country offices.” (C)
“The Trump administration has walked back its proposal to reclaim $252 million in unspent Ebola funds on Tuesday, which experts lauded as a welcome shift in the administration’s approach to global health leadership ― especially amid the new Ebola outbreak…
When President Donald Trump moved to cut the money the same week the current Ebola outbreak was announced in the Democratic Republic of the Congo, the public outcry from global health experts and Congress was swift. They argued that Trump was undermining the U.S. leadership role in world health issues.
Their concerns were compounded by the early May departure of Rear Adm. Tim Ziemer, formerly the National Security Council’s head of global health security; the breakup of his team into other divisions; and the April departure of White House homeland security adviser Tom Bossert, another champion of global health investment.
As Ronald Klain, the former Ebola czar under President Barack Obama, told HuffPost at the time: “Proposing a rescission of Ebola contingency funds on the very day that a new Ebola outbreak is announced is badly misguided; forcing out the two top officials in charge of epidemic response at the White House ― Tom Bossert and Tim Ziemer ― is even worse. Doing it all at the same time shows a reckless disregard for the dangers we face.””
Also disquieting was the fact that the U.S. waited a full two weeks after the first announcement of U.K. funds for the latest Ebola outbreak to announce its own full contribution of $8 million from the U.S. Agency for International Development.” (D)
“Companies and other players involved in the development of experimental Ebola drugs are jockeying to have their products tested in the outbreak in the Democratic Republic of the Congo, part of a chaotic and politically charged effort to use them in the midst of a crisis….
Experts say the maneuvering for space in which to try vaccines and drugs brings to mind the frantic days of the West African Ebola outbreak, when there were so many research teams in the field that a free-for-all of experimental testing ensued. Most of the clinical trials produced little in the way of insight into what actually might work against Ebola.
There’s a “rush to evaluate [treatments] because the window of opportunity for evaluating these interventions is always going to be short,” said Ross Upshur, a physician and ethicist who was on the WHO panel…
“If we don’t use the opportunity to learn in this situation, we’ll never be able to know which is better than the other in terms of the drugs,” said Dr. Peter Salama, the WHO’s deputy director-general for emergency response…
“It’s not a simple effort to do this sort of trial in this kind of environment,” Salama said.” (E)
(A) Ebola outbreak in the Democratic Republic of Congo that is feared to have killed 27 people is a ‘race against time’, aid worker warns, by STEPHEN MATTHEWS, http://www.dailymail.co.uk/health/article-5821781/Ebola-outbreak-DRC-race-against-time-aid-worker-warns.html
(B) As Aid Workers Move to the Heart of Congo’s Ebola Outbreak, ‘Everything Gets More Complicated’, https://mobile.nytimes.com/2018/06/01/health/ebola-congo-outbreak.html?rref=collection%2Ftimestopic%2FEbola&action=click&contentCollection=timestopics®ion=stream&module=stream_unit&version=latest&contentPlacement=1&pgtype=collection
(C) Still not ready for Ebola, http://science.sciencemag.org/content/360/6393/1049.full
(D) Trump Walks Back A Disastrous Ebola Funding Cut And Experts Sigh In Relief, by Lauren Weber, https://www.huffingtonpost.com/entry/trump-walks-back-ebola-funding-cut_us_5b183d68e4b0599bc6dffd4d
(E) Ebola outbreak opens way to chaotic jockeying to test experimental drugs, by HELEN BRANSWELL, https://www.statnews.com/2018/05/30/ebola-experimental-treatments/
Trump’s Justice Department says the ACA is unconstitutional (June 6th)
“The Justice Department will not defend the Affordable Care Act in court, and says it believes the law’s individual mandate — the provision the Supreme Court upheld in 2012 — has become unconstitutional…
The details: The ACA’s individual mandate requires most people to buy insurance or pay a tax penalty. The Supreme Court upheld that in 2012 as a valid use of Congress’ taxing power.
When Congress claimed it repealed the individual mandate last year, what it actually did was drop the tax penalty to $0.
So the coverage requirement itself is still technically on the books. And a group of Republican attorneys general, representing states led by Texas, say it’s now unconstitutional — because the specific penalty the Supreme Court upheld is no longer in effect…
What to watch: The argument against it is by no means a slam dunk. For starters, critics — now including the Justice Department — will have to prove that people are still being injured by the remaining shell of the individual mandate, even without a penalty for non-compliance.” (S)
Prequel: Part 1. Obamacare/ Trumpcare.
From REPEAL & REPLACE to WRECK & REJOICE (from Obamacare to Trumpcare) (April 25, 2017)
“Some conservative activists unable to surrender their long-held dream of repealing Obamacare are poised to release a long-shot plan next month to resurrect their failed effort, despite massive political odds against such a measure ever becoming law anytime soon.
But these conservatives are right about one thing: Republicans don’t have a coherent health-care message this election cycle. And they need one…
The latest plan is being forged by leaders at the conservative think tanks Heritage Foundation and the Galen Institute, along with former senator Rick Santorum and Yuval Levin of the Ethics and Public Policy Center. They’ve been meeting regularly over the past eight months to craft a recommendation for Congress to repeal much of the ACA’s coverage requirements and taxes, turn over some of its spending to states through block grants and expand the use of tax-free health savings accounts.” (A)
“Politically, the now-defunct assessment had been that passing a health-policy overhaul would scare too much of the public in an election year, making it a nonstarter. The growing understanding, though, is that Republicans are already at risk of losing to a “blue wave” this fall anyway, and that bold action to energize conservative grassroots might be the only way to stop the wave.
The Left is going to be energized this fall regardless of what Congress does, and those parts of professional suburbia that just won’t vote for Republicans under Trump also aren’t going to become even more anti-GOP than they already are. Indeed, as this is exactly the demographic that suffers the most under Obamacare, it might be slightly less likely, not more, to oppose the GOP if Republicans do actually pass reform.
But giving conservative voters a “win” on Obamacare would surely drive up Republican turnout.
Substantively, the bill design has evolved since January. It still uses the basic template of last year’s Graham-Cassidy bill, but only in the sense that it would remain a system of block grants to the states. As in January, it still envisions a significant expansion of health savings accounts — indeed, from January’s thought of doubling the existing number of HSAs, the new plan now may quadruple them — and also a guarantee that individuals served by state-government-run plans can opt-out and use the money in private markets instead.” (B)
“At the end of last year’s prolonged health care battle, many Americans breathed a sigh of relief. Some may have let down their guard too soon.
That’s because it’s clear the war on health care is far from over. Or, more precisely, the war has shifted from a ground war to a cold war. It’s shifted from major clashes in Washington, DC, heavily covered by the media, to more obscure battlefields: the states and the offices at the Health and Human Services Department where regulatory policymaking is done.
Yet this quieter fight could prove to be just as dangerous to the public…
Protections for people with preexisting conditions — as many as 130 million Americans, and growing every day — are also under attack. The Trump administration is using its executive authority to approve the sale of junk insurance plans that had been outlawed or severely limited under President Barack Obama…
Mostly, Americans want this assault on their ability to care for their families to end so we can begin the process of building back what has been allowed to erode. Americans want to pay less, not more, for health insurance. They don’t want insurance companies to be given unlimited authority again.
They want to see Medicaid strengthened, not weakened. They want the basic dignity of being able to afford medication and an end to the constant fear that grips so many that if they get sick, they will lose everything.
Americans didn’t want last year’s war on Obamacare, and they don’t want this new cold war either.” (C)
“These Congressional plans would lower your costs if: You own a small business. You’d no longer have to pay the penalty if you don’t provide insurance. You own a medical devices company or a tanning salon. You’d no longer have to pay Obamacare taxes. A repeal would affect you even more if you are in one of the states that reduce the 10 essential benefits. It would lower your costs if you are healthy or young.
They would increase your costs if: You have a chronic disease. You are older. The Congressional plans allow insurance companies to charge seniors five times what they charge younger people. Obamacare limited that to three times. Your costs would skyrocket if you are a senior who loses Medicaid coverage under the plan. Many seniors need Medicaid to cover the out-of-pocket Medicare costs. You become pregnant. Many states would drop this from the essential benefits. You need an abortion. The plans prohibit insurance companies sold on the exchanges from covering abortion services. Your company only provided coverage because the ACA mandated it. You are one of the 22 million people who received subsidies or the Medicaid expansion. You use mental and behavioral health services, including drug rehab. The House plan includes $2 billion to pay states for drug treatment. That’s not enough to offset the cuts to Medicaid and insurance companies who drop coverage for these services. You decide to reapply for health insurance after a lapse of 63 days. You’d have to pay a 30 percent premium increase. You are a Planned Parenthood patient. The Senate plan defunds the organization for just one year.” (D)
“This would appear to be Republicans’ last-ditch attempt (well, their latest last-ditch attempt) to repeal Obamacare. It seems broadly similar to the bill from late last year, Graham-Cassidy, but drops the attempt to reform traditional Medicaid.
Hill-watchers are skeptical this effort will go anywhere before the elections later this year. It would require the GOP to pass a budget resolution, craft a bill that meets the requirements of the Senate’s “reconciliation” process (meaning, among other things, that all provisions must affect the budget), bring together the support of 50 of the Senate’s 51 Republicans, and push the legislation through the House as well…
Regarding perks for holdout senators, Spiro suggests the new legislation will “bribe” Senators Lisa Murkowski and Susan Collins. (Murkowski’s Alaska expanded Medicaid; voters in Collins’s Maine approved expansion in a referendum, but the governor is refusing to implement it.)
Remember, if the GOP loses more than one senator, the bill goes down in flames. And beyond Paul, Murkowski, and Collins, that includes John McCain, who sank the previous effort, and whose health problems have been keeping him home from D.C. So a lot rides on whether all these folks find the new formula (A) acceptable in terms of how it treats their own states and (B) something they’re willing to defend in public.” (E)
“On Tuesday, Sen. Bill Cassidy (R-LA) released a policy white paper with ideas he claimed would “make health care affordable again.” By and large, however, the plan would do no such thing.
Some of the plan’s ideas—promoting consumer transparency in health care, for instance, promoting primary care, and cracking down on monopolistic practices that impede competition—have merit, although people can quibble with the extent to which Washington can, or should, solve those problems.
However, those specific solutions have at their core a deeply flawed framework. That framework not only contradicts itself, but it leaves Obamacare’s fundamental architecture in place—indeed, would expand upon it in at least one respect. While Cassidy’s paper decries that Obamacare premiums more than doubled from 2013 to 2017, his plan would do very little to control the skyrocketing price of coverage on the individual market.
Cassidy bases his plan on a state-based block-grant funding model, similar to the legislation he and Sen. Lindsey Graham (R-SC) developed last fall. Cassidy cites various state experimental programs to argue that a block-grant approach would allow more room for innovation.
However, the last sentence of the proposal undermines the rest of the discussion: “Flexibility to states would not jeopardize protections for individuals with pre-existing conditions.” That phrase implies that Cassidy believes, as the Graham-Cassidy bill indicated, that Obamacare’s federal insurance requirements regarding pre-existing conditions should remain in place.” (F)
“The foundation also says the “new path” would build on the reform plan offered last year by GOP Sens. Lindsey Graham of South Carolina; Bill Cassidy of Louisiana; Ron Johnson of Wisconsin, and Dean Heller of Nevada.
The plan is also reportedly backed by former Pennsylvania Republican Sen. Rick Santorum and was crafted with the help of the American Enterprise Institute and the Galen Institute.
Sources said last week that the plan would include financial help to low-income residents, an effort that could help garner some Democratic support, especially from senators facing re-election in swing states or conservative-leaning ones.
Yet supporters will also face the challenge of getting Republican leaders of the GOP-controlled Senate to vote on such legislation, considering the chamber has repeatedly failed to pass such legislation after it has cleared the House.” (G)
“The White House has been quietly but constructively supportive of the project, I am told, and should provide strategic and communications support this time that is well planned, rather than the more seat-of-the-pants effort we all saw last year. Pence, in particular, has been personally engaged.
It would be typical of this White House to insist on a strategy that its own party’s congressional leadership hates with an abiding passion but cannot publicly denounce because it involves Obamacare. But what’s the political theory behind reversing the stand-pat posture of the GOP heading toward the midterms? If you guessed “base mobilization,” you get a gold star on your calendar…
Politically, the now-defunct assessment had been that passing a health-policy overhaul would scare too much of the public in an election year, making it a nonstarter. The growing understanding, though, is that Republicans are already at risk of losing to a “blue wave” this fall anyway, and that bold action to energize conservative grassroots might be the only way to stop the wave…
In the end conservatives will probably be unable to convince enough Republicans that this is a good idea in time to set into motion all the things that would have to happen (most notably that budget resolution) to make Santorum’s dream a reality. But if the president’s Twitter account gets behind it, anything could happen.” (H)
“According to data from Gallup and Sharecare, the number of uninsured Americans rose by 1.3 percentage points in 2017. This is what the start of a death spiral looks like.
Three states have announced preliminary 2019 premium-rate requests for Obamacare individual-market policies, and the numbers don’t look good…
It is not hard to see why prices might spike. Thanks to Republican efforts to sabotage Obamacare, the pool of individual-market enrollees is getting smaller and sicker – and, as a result, much more expensive…
The net effect of all these changes: Younger, healthier and cheaper enrollees are getting siphoned out of the Obamacare marketplace. Older, sicker and more expensive people are sticking around, because they actually need coverage.
This pool of remaining enrollees raises average costs for insurers, who then raise premiums, which drives out additional relatively healthy people, which pushes premiums up further. And so on.” (I)
“An independent federal study found President Donald Trump’s planned expansion of short-term health plans will see higher enrollment and cost more than previously predicted, according to The New York Times.
Here are four things to know from the report.
1. The short-term policies have skimpier protections than employer-based and ACA marketplace insurance, as they aren’t required to provide benefits like maternity care, prescription drug coverage and preventive care. In February, President Trump’s administration projected a few hundred thousand Americans would sign up for the short-term plans.
2. However, a recent study from CMS’ Chief Actuary Paul Spitalnic pegs enrollment at 1.4 million people in the first year of the policy, and 1.9 million by 2022, according to the NYT… (J)
“Democrats run on GOP health care ‘sabotage’. Candidates have a unified message blaming Republicans for ‘sabotaging’ the health law.
They’ve got a unified message blaming Republicans for “sabotaging” the health care law, leading to a cascade of sky-high insurance premiums that will come just before the November midterm elections. They’re rolling out ads featuring people helped by the law. And Tuesday, they’re starting a campaign to amplify each state’s premium increases — and tie those to GOP decisions.
That’s a big change from four election cycles of reluctance to talk about Obamacare on the stump. During those campaigns, red-state Democrats were often on the defensive, dodging accusations they imposed government-run health care on unwilling Americans, made it impossible for people to keep their doctors and health plans, and caused double-digit premium increases every year.
Now, even those Democrats see Obamacare as a political advantage. The Affordable Care Act has grown significantly more popular. And as Republicans learned last year when they failed to repeal it, the public had scant interest in taking away coverage from millions of Americans, including low-income and vulnerable people on Medicaid. Democrats are also seizing the issue of rising prescription drug prices — another health care cost problem for which the public holds the GOP responsible, according to polls.” (K)
“… Expanding health coverage is a winning issue for Democrats; trying to take it away is a losing issue for Republicans. Why would the G.O.P. want to keep charging into that buzz saw?
But the growing popularity of key parts of Obamacare is precisely the reason Republicans are highly likely to make a last-ditch effort to kill the A.C.A. For them, it’s now or never.
Here’s what history tells us: Expansions of the social safety net are relatively easy to demonize before they happen — before people get to see what they actually do. Opponents declare that they’ll destroy freedom, that they’ll be wildly expensive, that they’ll be a national disaster. American politics being what it is, opponents of a stronger safety net also tap into racial resentment, convincing white voters that new programs will benefit only Those People.
Once social programs have been in effect for a while, however, and it turns out that they neither turn America into a hellscape nor break the budget — and also that they end up helping people of all races — they become part of the fabric of American life, and very hard to reverse…” (L)
“The viability of the health-insurance exchanges depends on getting enough people, particularly healthy people, to sign up. Ending the individual mandate removed one means of pressuring likely healthier people into buying insurance in the marketplaces. Furthermore, the Trump administration has made several decisions that will alter the quality of benefits people receive under the ACA. In the fall of 2017, the administration announced it would stop making “cost sharing reduction” payments, which had compensated insurers for the losses they incurred by reducing out-of-pocket expenses for lower-income households receiving insurance through an exchange plan. At the time, President Trump denounced these payments as a “bailout” for the insurance companies, but many observers worried that the move would further undermine already unstable insurance markets. As well, in recent months, the administration has been planning regulatory changes that would allow states to offer coverage that does not include the essential health care benefits included in the ACA and pays a smaller percentage of health care costs.
HHS has also given the green light to states to challenge one of the underlying principles of the Medicaid expansion. One of the truly novel features of the ACA was that it extended Medicaid to cover everyone whose income is below 138 percent of the federal poverty level, no matter what their personal circumstances and with no need to meet criteria of deservingness. Yet, acting on guidance issued by the Trump administration in early 2018, nearly 20 states are developing requirements for people to engage in paid work or unpaid “community engagement” as a condition of Medicaid participation.” (M)
“Following the passage of the ACA, the health-care law faced numerous legal challenges, culminating in a controversial 5–4 decision by the Supreme Court in 2012 to uphold the ACA, with Chief Justice John Roberts delivering the deciding vote…
Roberts’ view that the individual mandate amounts to a tax, despite the language of the bill and repeated denials by the Obama administration that the ACA raises taxes, has been the subject of much criticism, but it could now serve as the basis for eliminating the entire law, thanks in large part to the tax reform bill Congress passed in December.
On January 1, 2019, the Tax Cuts and Jobs Act eliminates the penalty on those who do not purchase qualifying health insurance plans. The fine is currently $695 per adult, up to a family maximum of $2,085, or 2.5 percent of income, whichever is greater. Without the penalty, the Affordable Care Act’s individual mandate can no longer reasonably be considered a tax, and thus the entire basis upon which Roberts built his defense of the law has evaporated.”.. (N)
““Obamacare repeal may be closer than you think.” That was the headline from the Washington Examiner’s Quin Hillyer late last week. It was enough to send a shiver down my spine.
In the column (self-identified as opinion), Hillyer lays out that former Sen. Rick Santorum, Vice President Mike Pence and the minds behind the Graham-Cassidy Obamacare repeal plan haven’t given up their work. It could still be revived, he argued, especially now that the bipartisan health care talks have fallen apart. What do Republicans have to lose in pursuing their signature campaign promise, given that Democrats are already very energized for the 2018 midterms while GOP voters seem demoralized?..
So how seriously should we take this? Are these just the extended death rattles of the GOP’s Obamacare failure? Or could the last act of the 115th Congress be another run at repeal?
To be clear, I don’t have any reason to doubt Hillyer’s reporting that Obamacare repeal planning is still underway and top Republicans, up to and including the vice president, are taking an interest. But I made the rounds today with the K Street insiders who guided us through the health care fight last year, and I found a lot of skepticism.
”I believe the part where they are working on something,” one GOP health care lobbyist told me. “I don’t believe there is any way it gets further than any of the previous attempts in this Congress. What’s the path to victory?”
Another Republican lobbyist laid out the problems in more detail”… (O)
“It would be a tactical and moral mistake for Democrats to not use [Obamacare] to expand coverage as much as possible.”
Health insurance on Affordable Care Act (ACA) exchanges could be effectively free for families making less than $100,000 a year if state-level legislators were willing to “game the complex design” of Obamacare to create state-run health insurance companies, according to a progressive think tank.
Jon Walker, a health-care policy analyst and writer for the People’s Policy Project, last month outlined a six-step plan showing how state lawmakers could make the federal government pay for health insurance for most residents. It would involve creating a government-run health insurance company to sell insurance on ACA exchanges; requiring insurance be sold at one price for people of all ages (as is already required in New York and Vermont); driving private insurance companies off the state exchanges; and automatically enrolling people who qualify for tax credits into free coverage.”.. (P)
“Healthcare policy experts, business leaders, and patient advocates praised Gov. Phil Murphy’s endorsement of a state requirement that residents obtain medical insurance or face a fine, a move they said will help protect recent gains in insurance coverage, control premium prices, and ensure New Jersey still receives billions in federal funding.
Murphy signed Democratic-backed legislation Wednesday, making New Jersey the second state — after Massachusetts — to create its own individual mandate. The law requires those without health coverage to pay a tax penalty starting next year, when the federal mandate that is part of the national Affordable Care Act is scheduled to end. He also approved a measure to create a healthcare reinsurance fund, fueled by industry fees and federal dollars, to help offset the costs of the most expensive treatments…
“The truth is that most people are unaffected by the mandate because they already have coverage from a job, Medicare, or another source,” said Joel Cantor, a Rutgers professor and director of the health policy center. “But there is plenty of evidence that the mandate will help keep premiums down, and when people hear that they are much more likely to say they support the idea. “ (Q)
“Conservative groups gear up for another summer Obamacare war, but they may be flying solo…
The recommendation, which is being spearheaded by former Sen. Rick Santorum, R-Pa. and includes participation from the Heritage Foundation, would convert the law’s Medicaid expansion and insurance subsidies into block grants provided to states. These changes would not apply to traditional Medicaid. The group is targeting June to coincide with the initial release of rates for Obamacare in most states. Several states have released major rate hikes for Obamacare next year, blaming Trump administration policies and the repeal of the individual mandate’s penalties for the boost in premiums. The goal is to have the Senate take up the block grant recommendation this summer. “Our plan will come out in June and then they have July and part of August really to get their work done,” the source said. “There is really no way you are going to have an impact on 2019 [Obamacare coverage year] premiums unless they act this summer.” (R)
(A) The Health 202: Conservative activists aren’t giving up their Obamacare repeal dream, by Paige Winfield Cunningham, https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2018/05/29/the-health-202-conservative-activists-aren-t-giving-up-their-obamacare-repeal-dream/5b0c18101b326b492dd07eb9/?noredirect=on&utm_term=.fe81c1aa642f
(B) Obamacare repeal may be closer than you think, by Quin Hillyer, https://www.washingtonexaminer.com/opinion/obamacare-repeal-may-be-closer-than-you-think
(C) The Republican cold war on the Affordable Care Act, by Andy Slavitt, https://www.vox.com/the-big-idea/2018/5/14/17350818/affordable-care-act-repeal-attacks-gop-medicaid-preexisting-condition-health
(D) Obamacare Repeal and Replacement Plans, by Kimberly Amadeo, https://www.thebalance.com/congressional-plans-to-repeal-and-replace-obamacare-4160599
(E) Obamacare Repeal: One More Time, with Feeling, by Robert VerBruggen, https://www.nationalreview.com/corner/obamacare-repeal-2018-republicans-attempt-again/
(F) Sen. Bill Cassidy’s New Health Plan Is Obamacare On Steroids, by Christopher Jacobs, https://thefederalist.com/2018/06/01/sen-bill-cassidys-new-health-plan-obamacare-steroids/
(G) Conservative groups, congressional Republicans appear poised for another try at ObamaCare repeal, by Joseph Weber, http://www.foxnews.com/politics/2018/05/26/conservative-groups-congressional-republicans-appear-poised-for-another-try-at-obamacare-repeal.html
(H) Conservatives Plan One More Obamacare Repeal Effort Before the Midterm Wave, by Ed Kilgore, http://nymag.com/daily/intelligencer/2018/04/could-gop-try-a-final-obamacare-repeal-bid-before-midterms.html
(I) Opinion: The slow, continuing decline of Obamacare, by Catherine Campell, https://www.northjersey.com/story/opinion/columnists/2018/05/15/opinion-slow-continuing-decline-obamacare/612623002/
(J) Trump’s health insurance plan could inflate federal spending $38.7B over next decade, by Morgan Haefner, https://www.beckershospitalreview.com/payer-issues/trump-s-health-insurance-plan-could-inflate-federal-spending-38-7b-over-next-decade.html
(K) Democrats are confidently running on Obamacare for the first time in a decade, by DAVID GREENBERG, https://www.politico.com/story/2018/05/15/democrats-embrace-obamacare-2018-539411
(L) The Plot Against Health Care, by Paul Krugman, https://www.nytimes.com/2018/05/31/opinion/republicans-health-care.html
(M) Eight years of attacks and Obamacare still stands by Daniel Béland, Philip Rocco, and Alex Waddan, http://policyoptions.irpp.org/magazines/may-2018/eight-years-attacks-obamacare-still-stands/
(N) How President Trump Could End Obamacare With A Single Tweet, by Justin Haskins and Sarah Lee, http://thefederalist.com/2018/05/07/president-trump-end-obamacare-single-tweet/
(O) 6 reasons Obamacare repeal (probably) isn’t coming back in 2018, by Dylan Scott, https://www.vox.com/policy-and-politics/2018/4/30/17304184/obamacare-repeal-probably-dead
(P) State Lawmakers Could Make Obamacare Free for Most—If They Want, by Dennis Carter, https://rewire.news/article/2018/06/01/state-lawmakers-make-obamacare-free-want/
(Q) MURPHY SIGNS LAW TO CREATE NJ’S OWN HEALTH INSURANCE MANDATE, by LILO H. STAINTON, http://www.njspotlight.com/stories/18/05/31/murphy-signs-law-to-create-nj-s-own-health-insurance-mandate/
(R) Daily on Healthcare: Get ready for the summer Obamacare war, June 2nd
(S) Trump’s Justice Department says the ACA is unconstitutional, by Sam Baker, https://www.axios.com/trumps-justice-department-says-aca-is-unconstitutional-06f8714d-7606-4104-9982-f057786828a7.html
Perhaps read this first
“Should the terminally ill have the RIGHT-TO-TRY non-FDA approved therapies?”
Highlight and click on
“President Donald Trump signed the “Right to Try Act” Wednesday, a measure aimed at helping terminally ill patients access drug treatments that are yet to be fully approved by the Food and Drug Administration.
Trump, at a White House ceremony surrounded by patients and families who will be affected by the legislation, said his administration “worked hard on this” but said repeatedly he didn’t understand why it hadn’t been done before.
The bill will give terminally ill patients the right to seek drug treatments that remain in clinical trials and “have passed Phase 1 of the Food and Drug Administration’s approval process” but have not been fully approved by the FDA. Some opponents of the bill argue that the legislation won’t change much but could have a detrimental effect on how the FDA safeguards public health.
“With the passage of this bill, Americans will be able to seek cures,” Trump said adding they will finally be given “the right to try.” (A)
“Opponents of the law say Trump’s promises to help thousands or even hundreds of thousands are grossly unrealistic. It isn’t clear that any patients have successfully utilized the dozens of state laws that attempt to give patients a similar pathway for expanded treatments…
Supporters say the new law gives dying patients an important reprieve from overly cumbersome FDA rules, and from what they call a slow-moving bureaucracy that can delay access to time-sensitive treatments.
Opponents have cautioned that the legislation will undermine FDA’s authority and open vulnerable, desperate patients up to “snake oil salesmen.” They point out, too, that the FDA already has a process in place for approving such requests and grants some 99 percent of them, often within a short time frame…
In a statement, Gottlieb said the agency stands ready to implement the new law “in a way that seeks to protect [patients’] autonomy, their safety, and the safety of others following in their paths.” (B)
“Despite good intentions – and the legislation’s name – right to try legislation grants no rights. It would merely grant permission for a patient to try to get experimental medication from a pharmaceutical company.
Patients would be allowed to try experimental drugs, but nothing in the legislation would make it mandatory for pharmaceutical companies to provide these medications.
The reasons for a company to withhold a drug are many. Giving access to preapproval drugs can be costly, particularly given the limited supply, and almost no medical insurance will cover experimental treatments. Access to the drugs will likely only be feasible for wealthy Americans who can afford to pay for the treatment, as well as the consequences of any negative side effects out of pocket.
Many drug companies also worry that making the drug available without approval opens them up to lawsuits if the drugs prove ineffective or have unforeseen side effects. The current federal right to try proposal does provide some protections for companies in this regard, but until those protections have been tested in court, it is likely companies will remain cautious.
Providing the drug to patients outside of clinical trials can also be disruptive to the approval process because it can lead to data on negative clinical outcomes outside the highly controlled trial setting…” (C)
“Opponents also argue it gives “false hope” to patients, since drugmakers aren’t required to give unapproved medicines to patients who ask for them.
Supporters say, however, it will provide new treatment opportunities for terminally ill patients who have exhausted existing options.
“While a long time coming, today is a monumental win for patients desperately seeking the ‘right to try’ investigational treatments and therapies,” said Energy and Commerce Committee Chariman Greg Walden (R-Ore.) and health subcommittee chairman Michael Burgess (R-Texas).
“With ‘right to try’ being the law of the land, we are confident that the Trump Administration, and FDA Commissioner [Scott] Gottlieb, will take both congressional intent and the safety of patients into consideration when implementing this important law.” (D)
“It allows certain patients to ask drugmakers for medicines that have passed Phase 1 of the FDA approval process but haven’t been approved yet and are still undergoing testing. Patients must have exhausted other options and be unable to participate in a clinical trial. Drugmakers aren’t obligated to give patients the requested experimental medicines.
Critics say the legislation undermines the FDA’s authority to regulate drugs and could leave patients vulnerable to medicines that might not work or may even be harmful. The agency already runs an “expanded access” program where seriously ill patients can apply to gain access to experimental treatments.
Commissioner Scott Gottlieb has said the agency grants 99 percent of these requests. In a statement Wednesday, Gottlieb said the FDA is ready to implement the “right-to-try” legislation.
“The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines,” he said.” (E)
““The Administration believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physicians,” the White House said in its statement of support Monday.
Opponents, meanwhile, say the legislation will allow “snake oil salesmen” to take advantage of desperate patients and could ultimately weaken or undermine the FDA’s authority to regulate drugs. They point out, too, that the FDA already has a system in place for granting terminally ill patients access to experimental therapies, often within a tight timeframe. Though opponents said the more refined version of the legislation was an improvement, they said it still failed to address many of their concerns.
“The legislation would roll back essential patient safeguards and could result in patients being harmed by unproven, and potentially unsafe, therapies,” a coalition of patient groups, including the American Cancer Society Cancer Action Network, Friends of Cancer Research, and the National Organization for Rare Disorders, wrote in a letter to lawmakers.. “Furthermore, the legislation would significantly restrict FDA’s ability to stop access to an experimental therapy and would remove expert consulting requirements on dosing and other important safety measures currently provided by FDA.”” (F)
“The president said the issue was “very personal” for him.
“As I proudly sign this bill, thousands of terminally ill Americans will have the help, the hope and the fighting chance — and I think it’s going to be better than chance — that they will be cured, that they will be helped, that they will be able to be with their families for a long time, or maybe just for a longer time,” Trump said. “But we’re able to give them the absolute best we have at this current moment, at this current second. We’re going to help a lot of people. It’s an honor to be signing this.” “ (G)
“A program known as compassionate use, or expanded access, has been in place since the 1970s. It allows patients with a serious disease or condition to obtain experimental medicines; the Food and Drug Administration says it authorizes 99 percent of the requests for expanded access that it receives.
The new national law — like similar laws in more than three dozen states — allows patients and doctors to ask drug companies directly for access to the experimental drugs, rather than wait for approval by the agency.
Yet these laws “do not ensure that manufacturers will provide the drug or that insurance companies will cover the cost,” according to a policy report from Rice University. Obtaining the medicines from manufacturers can be more cumbersome than going through the Food and Drug Administration’s existing program, the report found.
Colorado enacted the first right-to-try law in 2014. Since then, “there have been no documented cases of anyone receiving access, because of a right-to-try law, to an experimental product that would not have been available via the F.D.A.’s expanded access program,” a 2017 study by researchers from New York University concluded.
Alison Bateman-House, a professor of medical ethics and an author of the study, called it “extremely unlikely” that the national right-to-try law would directly save hundreds of thousands of lives, given that drug companies are using — and accustomed to — the existing process.” (H)
“Most experimental drugs are nowhere close to being effective, or carry side effects outweighing their benefits. But if they were, who could afford to try them?
“The law gives the right to pay, not the right to try,” says Arthur Caplan, head of medical ethics at New York University’s School of Medicine, who also studies compassionate access to medication. The law, he explains, doesn’t come with a budget, leaving patients paying out-of-pocket for unproven treatments. Insurance companies are unlikely to help out; they’re not even required to cover all the drugs that are approved by the FDA.
Medical costs are already the leading cause of bankruptcy in the US. Under “right to try,” a cancer patient could end up paying additional hundreds of thousands of dollars for experimental treatment, on top of their existing costs. False hope could tempt sick Americans to poor financial decisions, argues Caplan. “You are asking terminally ill people to spend their family’s savings on drugs that don’t work,” he says.” (I)
“Today, 40 states have passed similar laws. And on Wednesday, President Trump will sign a national Right to Try Act into law. In the states, Right to Try has not been a partisan issue. In most instances, it passed without a single dissenting vote…
But, sadly, this spirit of bipartisanship did not translate to Washington. Only 22 House Democrats voted for the final bill that Trump will sign. In August, a version introduced by Sen. Ron Johnson, R-Wis., passed the Senate by unanimous consent, but stalled in the House, which eventually passed a more limited bill from Rep. Greg Walden, R-Ore. Last week, Senate Republicans tried to accommodate Democratic objections by bringing up the Walden bill for a vote, but Senate Minority Leader Charles Schumer blocked it from coming to the floor. So the House passed the Johnson version, with Democrats nearly united in opposition.
In other words, Democrats in Washington managed to take an issue that unified thousands of legislators from both parties in 40 states, and turned it into a divisive, party-line vote. Thanks to Trump, Americans facing terminal diagnoses will now have a new chance at life. How tragic — and pathetic — that Democrats refused to join him in making that happen.” (J)
“From now on, these patients — in fact, practically anyone who has been diagnosed with any life-threatening disease or condition, whether or not he or she is near death — will be able to choose to trust doctors and drug companies alone to look out for their well-being…
Under the new law, without the FDA’s expert guidance, companies will have even more reason to turn down requests for experimental medicines. Those inclined to provide the drugs, if they’re wise, will continue to do so only through the FDA’s existing channel — as Janssen Pharmaceuticals has decided to do. The company says that the FDA may be “uniquely aware” of available safety data.
FDA Commissioner Scott Gottlieb has pledged to carry out the new law in a way that promotes access and protects patients. But he has no authority to do anything except issue guidance and receive annual summaries from companies providing investigational drugs.
A word of advice to doctors and patients who choose to sidestep the FDA: Proceed with care, and don’t count on a miracle.” (K)
(A) Trump signs ‘Right to Try Act’ aimed at helping terminally ill patients seek drug treatments, by Allie Malloy, https://www.cnn.com/2018/05/30/politics/right-to-try-donald-trump/index.html
(B) Trump signs right-to-try legislation, making controversial measure law of the land, by ERIN MERSHON, https://www.statnews.com/2018/05/30/trump-signs-right-to-try/
(C) What is “right to try” and will it help terminally ill patients? by Morten Wendelbo, Timothy Callaghan, https://www.cbsnews.com/news/right-to-try-bill-trump-signing-will-it-help-terminally-ill-patients-today-2018-05-30/
(D) Trump signs ‘right to try’ drug bill, by Jessie Hellmann, http://thehill.com/policy/healthcare/389908-trump-signs-right-to-try-bill-for-terminally-ill-patients
(E) President Trump signs ‘right-to-try’ bill for experimental drugs, by Angelica LaVito,| https://www.cnbc.com/2018/05/30/trump-signs-right-to-try-legislation-on-experimental-medicines.html
(F) Congress passes ‘right-to-try’ measure, sending hard-fought bill to Trump’s desk, https://www.statnews.com/2018/05/22/house-vote-right-to-try/?utm_source=STAT+Newsletters&utm_campaign=cdfd050a18-MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-cdfd050a18-149527969
(G) Trump signs ‘Right to Try,’ says it will save ‘tremendous number of lives’, by Brooke Singman, http://www.foxnews.com/politics/2018/05/30/trump-signs-right-to-try-says-it-will-save-tremendous-number-lives.html
(H) Trump Oversells New ‘Right to Try’ Law, by Linda Qiu, https://www.nytimes.com/2018/05/30/us/politics/fact-check-trump-right-to-try-law-.html
(I) Who pays for the “right to try” experimental medicine?, by Annalisa Merelli, https://qz.com/1292947/under-the-right-to-try-act-who-pays-probably-not-insurance/
(J) Thiessen: Terminally ill thank GOP for ‘Right to Try’, by MARC A. THIESSEN, https://www.mercurynews.com/2018/05/30/thiessen-terminally-ill-can-thank-republicans-for-right-to-try-investigational-drugs/
(K) A ‘Right to Try’ That Americans Didn’t Need, https://www.bloomberg.com/view/articles/2018-05-31/a-right-to-try-that-americans-didn-t-need
I taught full time in the Baruch MBA in Health Care Administration program from 1972 to 1975, then was a health care administrator for over thirty years, finishing for seventeen years as President & CEO of LibertyHealth/ Jersey City Medical Center, where we built a replacement safety-net hospital (it took 15 years), played a key role on September 11th, 2001, and once again became a medical school affiliated teaching hospital (having been free-standing for decades).
After retiring from LibertyHealth, I returned to the Baruch program for four years as Adjunct Professor and started writing case studies. I developed case studies based on my CEO experiences. Interestingly case studies on failures provided better Lessons Learned than cases on successes. I also used Harvard Case Studies, and invited “Visiting” Professors to present cases typically related to the new realities of Obamacare, mostly C-Level executives I was still in touch with from my first stint at Baruch. I was very proud of what they had accomplished and shared.
In retirement I have watched health care disruption become so complex that there are few, if any, up-to-date case studies. So I developed a method of “raw” contemporaneous cases studies each developed by curating news articles into a coherent thread, after a topic has called out to me. Topics come from navigating the system (think out-of-network physicians, for example), news feeds, and friends and family.
Now, my Career Capstone Project is to bring “raw” cases to AUPHA that can be used in real-time, meaning they can start a discussion for immediate use in class. For example if I was teaching now I would be doing a contemporaneous cases on the opioid crisis, tracking the implications of medicinal/ recreational marijuana, and the stealth plan to reintroduce Trumpcare before Congress adjourns for the mid-term election.
Here’s my way of developing a case:
A. Spend some time looking at the case format at http://doctordidyouwashyourhands.com/
B. To identify CCCS topics sign-up for daily automatic health care news feeds. For example:
1. STAT https://www.statnews.com/
2. MedPageToday https://www.medpagetoday.com/
3. Becker’s Hospital Review https://www.beckershospitalreview.com/
4. Healthcare Dive https://www.healthcaredive.com/
5. FierceHealthcare https://www.fiercehealthcare.com/
6. New York Times
7. Hospital Association Daily News Clips
C. Set up Google Alerts https://www.google.com/alerts https://support.google.com/websearch/answer/4815696?hl=en (for example: Amazon. health care; medical/ recreational marijuana; cost of prescription/ generic drugs; Ebola; Emerging viruses; flu; health care disruption; health care innovation; health insurance; hospital innovation;.; ObamaCare; opioid crisis; Trump Care; Zika)
D. Select topics to follow and make a folder for each (for example: Amazon+, precision medicine, Zika, marijuana, antibiotics; insurance; flu, hospitals; Obamacare/ TrumpCare; opioid crisis; prescription and generic drugs, right-to-try)
E. Then every day from News Feeds select articles on your topics and move them to the appropriate folder.
F. When you are inspired to write a “case” start a Word document, then go to the case folder and select key points from the articles, and cut and paste them to the Word document. As well capture article title, author and hyperlink.
G. Move the key points around until you have created a story.
H. Then label each point A,B.C…and move article title, author and hyperlink to footnotes at the end of the case.
I. Then write an introduction to the case.
Jonathan M. Metsch, Dr.P.H.