AARP reported on CNN’s investigation into Nuedexta. “A “little red pill” being aggressively marketed to long-term care residents is bringing in more than $100 million a year in Medicare money for its manufacturer, even though it “may be unnecessary or even unsafe,” CNN is reporting.”

“The drug, Nuedexta, is approved to treat pseudobulbar affect (PBA), a relatively rare condition marked by uncontrollable laughing or crying. However, the pill “is being propelled by a sales force focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, and high-volume prescribing and advocacy efforts by doctors receiving payments” from manufacturer Avanir Pharmaceuticals, CNN reported.”

The full report, which also contains details about possible health risks of Nuedexta, can be found at CNN.com.

The Washington Post reported how Big Pharma bullied and bought the Federal Drug Administration and Drug Enforcement Administration.  In April 2016, Congress stripped the DEA of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets.  For years, some drug distributors were fined for repeatedly ignoring warnings from the DEA to shut down suspicious sales of hundreds of millions of pills, while they racked up billions of dollars in sales. One internal DEA memo obtained by The Post and “60 Minutes” noted that the bill essentially eliminates the agency’s power to file immediate suspension orders of drug shipments. The new law “is fixing a problem that doesn’t need fixing,” a DEA official wrote.

The new law made it virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies. That powerful tool had allowed the agency to immediately prevent drugs from reaching the street.  The chief advocate of the law that hobbled the DEA was Rep. Tom Marino, a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar.

Political action committees representing the industry contributed at least $1.5 million to the lawmakers who sponsored or co-sponsored four versions of the bill, including nearly $100,000 to Marino and $177,000 to Hatch. Overall, the drug industry spent $106 million lobbying Congress on the bill and other legislation between 2014 and 2016, according to lobbying reports.

“The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.”

By then, the opioid war had claimed 200,000 lives. Overdose deaths continue to rise. There is no end in sight.  Drug industry officials and experts blame the origins of the opioid crisis on the overprescribing of pain pills by doctors.

CNN had a great article on the menace of a “little red pill” pushed on nursing home residents.  “The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe, a CNN investigation has found.”

“The pill, called Nuedexta, is approved to treat a disorder marked by sudden and uncontrollable laughing or crying — known as pseudobulbar affect, or PBA. This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker’s own figures, and it is most commonly associated with people who have multiple sclerosis (MS) or ALS, also known as Lou Gehrig’s disease.”

“Nuedexta’s financial success, however, is being propelled by a sales force focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company, CNN found.”

“Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.”

“Nuedexta is being increasingly prescribed in nursing homes even though drugmaker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients — prompting critics to liken its use to an uncontrolled experiment. The one study the company conducted solely on patients with Alzheimer’s (a type of dementia) had 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.”

“There has to be a diagnosis for every drug prescribed, and that diagnosis has to be real … it cannot be simply made up by a doctor,” said Kathryn Locatell, a geriatric physician who helps the California Department of Justice investigate cases of elder abuse in nursing homes. “There is little to no medical literature to support the drug’s use in nursing home residents (with dementia) — the population apparently being targeted.”

“Medicare is supposed to pay for drug uses that have been proven safe and effective for the population they are intended to treat or that have been otherwise supported by a specific collection of medical research. Nuedexta is currently only approved by the FDA for patients who have PBA. So experts say that Medicare coverage of the drug, which has been crucial to its financial success, relies on the diagnosis of this single condition. So-called “off-label” prescribing, in which doctors use the drug to treat patients who have not been diagnosed with PBA, would typically not be covered.”

Bloomberg reported the recent maneuver by Trump to sabotage ObamaCare as the law of the land.  Trump is halting subsidies which will cost the government almost $200 billion more on health insurance.  It all adds up to a hefty bill for taxpayers. The Congressional Budget Office estimated that ending the cost-sharing payments would increase the budget deficit by $194 billion over the next decade as subsidy outlays jump.

“Here’s why: The subsidies clamped by Trump, known as cost-sharing reductions, are paid to insurers, reimbursing them for lowering deductibles and other out-of-pocket costs for low-income people. If the funds vanish, insurers will make up for them by boosting the cost of health coverage for everyone. Many had already said they will charge more for plans next year, on the expectation that the administration would follow through on months of threats to end the payments.”

 More than eight in ten individuals who buy Obamacare plans also get help paying their premiums directly from the federal government. When their premiums climb, so does the cost to the Treasury.  Those subsidies cap how much people have to pay for insurance as a percentage of their income. Even if premiums climb, people who receive subsidies won’t pay more. The subsidies are available to people making as much as four times the federal poverty level, or just over $97,000 for a family of four.

People who make too much money to qualify for subsidies will now have to pay a much higher price for their health plans.

 

The Huffington Post reported on Medicaid cuts in Iowa.  “The aging population is fueling what some health experts call an “Alzheimer’s tsunami” for which Iowa, and the rest of the nation, is ill-prepared. Unless a cure is found, an estimated 7.1 million Americans age 65 and older could have Alzheimer’s by 2025, almost a 35 percent increase, according to the Alzheimer’s Association. Iowa’s 65-plus population is above the national average.   In South Carolina, the total number of cases of Alzheimers in 2015 was 86,000; 120,000 are expected by 2025, according to Alzheimer’s Association estimates.

But instead of preparing for the onslaught, Iowa and other states have begun tightening Medicaid, the only government program that pays for nursing home care, in ways that increase the burden on those with Alzheimer’s and their loved ones.

Medicaid, typically seen as the government health insurance program for people with low incomes and those with disabilities, spends about one-quarter of its $4.8 billion in annual funding in Iowa for nursing home care. The program pays for half the nursing home residents in the state, according to the Kaiser Family Foundation.

Already, Iowa’s move last year to a Medicaid system managed by three for-profit companies is affecting people diagnosed with Alzheimer’s and their caregivers.

Kathy Horan, vice president of AbbeHealth Aging Services, which operates adult day health centers in Marion, Cedar Rapids and Iowa City, said managed care organizations, or MCOs, that coordinate Medicaid recipients’ care have started to decrease the number of days covered at those centers.

ABC Action News reported the controversy surrounding a nursing home’s refusal to provide certain medicine to one of their residents. Zephyrhills Health and Rehab Center, which is operated by Adventist Health System, refuses to allow Charlotte Simpson pain relief by refusing to allow her to have the medical marijuana she has a legal prescription to take.  Simpson is confined to a wheelchair and suffers Parkinson’s Disease, arthritis and other ailments.

“You should see the condition she’s in. It’s horrible,” said Bert Greene, describing his mother Charlotte Simpson. “She’s got uncontrollably shaking, excruciating pain.”

Greene said after medical marijuana became legal in Florida, a doctor prescribed it for his mother and she applied for a compassionate use permit.

“When she was finally approved, and the medicine was delivered, they gave it to me and told me I had to take it home with me,” Greene said.

 

 

New York Magazine reported that health care premiums will increase significantly in 2018 because of Trump’s sabotage of the Affordable Care Act.  This week, health insurance plans across the country submitted their final rates for 2018, many requesting massive double-digit rate hikes and explicitly citing uncertainty around Congress and the president’s plans for the individual market.

“Right now, 2018 premiums for individual health policies under Obamacare are being decided by insurance companies without any certainty about one of the basic elements of the program: reimbursements to offset “cost sharing reductions” they are required to make to keep low-income consumers from bearing the brunt of high co-payments and deductibles. These reimbursements are currently stuck in limbo, as Trump refuses to promise to keep making them and bipartisan Senate negotiations to take the decision out of the president’s hands and authorize them legislatively crawl toward an uncertain conclusion.”

“In interviews with major publications, Donald Trump repeatedly threatened to destabilize the Affordable Care Act marketplaces — by abruptly halting subsidies to insurers — as a means of eroding popular support for the law. Meanwhile, his Health Department spread doubt about whether it would enforce the tax penalty for refusing to sign up for insurance; cut funding for the law’s outreach groups; slashed Obamacare’s advertising budget by 90 percent; spent a portion of the remaining ad budget on propaganda calling for the law’s repeal; cut the open-enrollment period by 45 days; and announced that it would be taking Healthcare.gov (where people can enroll in Obamacare online) offline for nearly every Sunday during that time period, for “maintenance” purposes.”

BuzzFeed News revealed that the Trump administration had instructed the Health Department’s ten regional directors not to participate in state-based events promoting ACA enrollment, as they had for each of the past three years.

All available polling suggests that most voters now trust Democrats more than Republicans on the issue of health care — and believe that Trump is responsible for any problems with Obamacare, going forward.

King Trump has issued Executive Orders to create loopholes that will destroy the individual markets for health insurance.  Trump has been threatening to destroy the Affordable Care Act by executive order after the Republican Congress failed to repeal ObamaCare.  The basic idea appears to be an expansion of the kinds of entities who can take advantage of so-called “association health plans” — group insurance plans normally available to trade associations and other groups of business people — and then a reclassification of these plans so that they do not have to comply with Obamacare regulations. It’s sort of a Great Escape from Obamacare for small businesses and perhaps even individuals. The idea would mostly attract younger and healthier consumers seeking cheaper and skimpier health plans, leaving older, sicker, and therefore more expensive people to sink the remaining Obamacare exchanges with their costly problems.

The across-state-lines aspect of this plan — a big deal in the pre-Obamacare days when there were few if any national standards for health insurance — would not be nearly as significant as the exemption from Obamacare’s essential health benefits and preexisting-conditions requirements.

The idea of expanding and deregulating association health plans as a stand-alone initiative is especially dangerous when pursued separately from other conservative health-reform ideas that might help counteract some of its effects, such as subsidies for high-risk pools for “left behind” people with preexisting conditions, or more money for states to come up with their own ways of managing risk.

Health-policy wonk Tim Jost said of the proposed executive order that it would “destroy the small-group market …. We’ll be back to where we were before the Affordable Care Act.”

Loophole No. 1: Expanded Association Health Plans

Before Obamacare, associations were free to model their national plans around the regulatory requirements of any individual state. The Affordable Care Act put an end to this state of affairs, by subjecting association health plans to the same essential health-benefit requirements as individual small businesses.

Trump’s executive order calls on the secretary of Labor to expand the use of association health plans by making it easier for associations to form across state lines, and to band together for the exclusive purpose of purchasing health insurance.

This could allow new association health plans to grow so big, they qualify as large employers — and Obamacare does not require large employers to offer plans that cover essential health benefits. This would allow younger, healthier small businesses to exit the small-group market, thereby increasing premiums for the older, sicker businesses which are left behind.

And the Trump administration is reportedly considering an even more radical change, one that could effectively end Obamacare as we’ve known it. According to Vox, the White House may try to allow individuals to buy into cheap, skimpy association health plans. This could set off a death spiral in the individual market as healthy people flee for cheap association plans, thereby leading insurers to raise premiums (to defray the cost of covering an increasingly sick pool of enrollees), thereby leading even more healthy people to flee for cheap association plans, thereby leading insurers to raise premiums, etc., etc. …

Loophole No. 2: Lengthened duration of short-term insurance
Short-term health insurance policies are free from Obamacare’s regulatory requirements. They offer few services, and are designed for people during a temporary period of unemployment.  Before the Affordable Care Act, Americans could remain on short-term health insurance for up to a year. But to prevent healthy people from using the plans to avoid subsidizing the sick on the individual market, the Obama administration brought that limit down to three months.

Trump’s order calls for expanding access to short-term plans by reversing this rule. Once again, the effect would be to bleed healthy enrollees from the Obamacare exchanges. The effect, once again, would be to engineer a destabilizing increase in premiums for those in the individual market.

Dove Press had clinical guidelines on prescribing psychotropic medication for nursing home residents with dementia on their website.

Objective: The aim of this study was to identify factors influencing the prescribing of psychotropic medication by general practitioners (GPs) to nursing home residents with dementia.

Subjects and methods: GPs with experience in nursing homes were recruited through professional body newsletter advertising, while 1,000 randomly selected GPs from south-eastern Australia were invited to participate, along with a targeted group of GPs in Tasmania. An anonymous survey was used to collect GPs’ opinions.

Results: A lack of nursing staff and resources was cited as the major barrier to GPs recommending non-pharmacological techniques for behavioral and psychological symptoms of dementia (BPSD; cited by 55%; 78/141), and increasing staff levels at the nursing home ranked as the most important factor to reduce the usage of psychotropic agents (cited by 60%; 76/126).

Conclusion: According to GPs, strategies to reduce the reliance on psychotropic medication by nursing home residents should be directed toward improved staffing and resources at the facilities.

The Telegram reported the Aug. 7 death and cover-up of Walter E. Haddad.  State and federal agencies investigated the suspsicious circumstances surrounding the death of Haddad who died after he fell and hit his head, and nursing home staff covered up the fall rather than send him to the hospital.

The report said that after hearing a loud thud about midnight on Aug. 6, a certified nurse assistant and a licensed practical nurse found Mr. Haddad lying on the floor and they put him back in his bed.  No assessment by a registered nurse was done. The CNA told investigators that he did not report the fall, as required by the facility, because the LPN had asked him not to.

“However, staff did not complete a thorough clinical evaluation or neurological assessment on (Mr. Haddad), which resulted in a delay of transfer to the hospital for evaluation of possible injury,” investigators said in the report.

Mr. Haddad’s daughter, Lorna Haddad, took issue with the report. She said staff should have been more careful because they knew that her father, who helped found the nursing home, had a history of falls. The retired accountant had moved into the nursing home last year, after Parkinson’s disease left him prone to falls. She said notification of his fall risk was posted throughout his area of the facility.

“I think the report is meaningless,” she said. “The fact that he didn’t have an alarmed bed or an alarmed chair is alarming.”

The report in general said professional standards of quality were not met because of the actions or inactions of the staff.  Every time a patient falls, injury or not, they’re required to call the physician and the patient’s family.

The morning after he fell, Mr. Haddad told several staff about the incident. The only thing that they did was to give him Tylenol. When Mr. Haddad’s family came to visit, he told them that he had fallen the night before and hit his head. Staff told the family that there was no report of a fall and that Mr. Haddad may have been mistaken or confused. When his speech became slurred and he complained of neck pain, he was taken to the trauma unit at UMass Memorial Medical Center, where he died.

The Santa Fe New Mexican reported that Casa Real nursing home in Santa Fe owned and operated by Preferred Care Partners Management Group has at least temporarily improved persistent quality-of-care problems enough to resume billing Medicare and Medicaid for newly admitted residents.  Casa Real is one of only two homes in Santa Fe that accept Medicare and Medicaid patients.

For more than two months, Casa Real had been barred from charging Medicare or Medicaid for new residents after the Centers for Medicare and Medicaid Services found the nursing home wasn’t in compliance with federal care standards.

Inspections this year turned up a long list of problems, including medication errors, expired food and drugs on shelves, unreported resident injuries and assault, poor care of bed sores, nursing understaffing and inadequate safeguards against the spread of dangerous infections.

The former director of nursing at Casa Real from May to August has accused management of forging patient records in an attempt to show the facility was in compliance with care standards dealing with monitoring of medication effects on residents.  Of course, she was soon fired.

The August inspection found residents weren’t receiving medications as directed by their physicians and that the nursing home wasn’t doing enough to ensure that residents didn’t receive unnecessary drugs, including psychotropic medications.

The federal agency in May designated Casa Real as a “special focus facility” because of its poor record of complying with care standards, and it said the nursing home would be subject to more frequent inspections. The designation is given to the nation’s poorest-performing nursing homes and is meant to address the “yo-yo” problem of facilities routinely falling in and out of compliance with care standards.

The state Attorney General’s Office is suing Preferred Care, alleging it has defrauded Medicaid by having insufficient staff to meet the needs of residents at its Santa Fe nursing homes, as well as its facilities in five other New Mexico communities. Preferred Care has denied the allegations.