NHeLP Urges Action on High Drug Pricing

WASHINGTON, March 7, 2016--The National Health Law Program (NHeLP) sent a letter to Senators Ron Wyden and Chuck Grassley supporting the Senate Finance Committee's investigation into high prices for hepatitis C prescription drugs and barriers to access for Medicaid beneficiaries. 

The committee requested public comments in January 2016 on its investigation into biopharmaceutical company Gilead and Sovaldi and Harvoni, Gilead's breakthrough hepatitis C treatments. 

"As we have seen with HIV treatments, drug company profiteering and high costs prevent people from getting the care they need," said Wayne Turner, NHeLP staff attorney who led the successful 2014 HIV anti-discrimination complaint against four insurance companies. 

"When people with chronic diseases like hepatitis C are unable to afford treatments due to state restrictions or discriminating company policies, federal action is necessary."

In 2014, The AIDS Institute and NHeLP filed a complaint with the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) charging four Florida health plans with unlawful discrimination against people living with HIV and AIDS by placing all HIV medications, including generics, on the highest cost sharing tier, thus requiring enrollees to pay as much as 50 percent co-insurance for every HIV drug. 

In the complaint, the groups contend that such practices discourage people with HIV/AIDS from enrolling in the plans and violate the Affordable Care Act's (ACA) non-discrimination provisions. The ACA bans plans from discriminating against individuals based upon disability and prohibits them from discouraging enrollment by people with significant health needs.

"Since the passage of the Affordable Care Act, we have monitored Medicaid enrollment efforts across the country to ensure states are making every effort to help residents obtain adequate health insurance coverage, which should include affordable prescription drugs," said Jane Perkins, NHeLP legal director. 

"Restrictions on breakthrough treatments are blatantly illegal and violate federal Medicaid requirements and the ACA's non-discrimination provisions."

"Low-income individuals so often are the most in need of breakthrough treatments and are the least likely to afford them," said Abbi Coursolle, NHeLP staff attorney. "It is inherently unfair for Medicaid beneficiaries to be both denied treatments simply because they are expensive and unable to afford the two most widely used medications because of the company mark-up."

Stop Online Piracy Act endangers health of millions

The law of unintended consequences is a warning that an intervention in a complex system tends to create unanticipated and often undesirable outcomes

The Stop Online Piracy Act (SOPA) claimed by its sponsors to be the answer to protecting the intellectual property of Americans—an admirable goal—is the latest example that will without doubt lead to unintended consequences that will affect the health and well-being of millions of Americans by denying them access to safe, affordable medicines from reputable pharmacies in countries outside the U.S. .

Furthermore, the proposed legislation will not meet its goals, because it will create an unworkable and vague enforcement trigger that does not rely upon a system of law and courts, but instead that allows the Justice Department to cede to private entities the right to initiate action against individuals or websites, with such action carrying with it an assumption of guilt of the party being charged.

I shall leave it to Constitutional experts to illustrate the questionable constitutionality of SOPA. However, I believe it almost certainly will be used as a weapon against free speech and differences of opinion by some who will claim that a promotion of a product or service t violates the intellectual property right of the entity making the charge.

This includes, but is not limited to, the Pharmaceutical industry (Pharma)—an industry whose pricing practices have imposed the highest-cost drugs in the World upon Americans.

This has led to Americans using their common sense and exercising their right—and ability—to make personal health care decisions for more than a decade to purchase safe, affordable medicines. These are the very same ones that would cost at much as 60 percent more,if purchased in the U.S., rather than from reputable sources in other countries, countries whose standards of safety and efficacy meet or exceed those of the United States.

The passage of SOPA would endanger that capability by allowing Pharma to initiate actions against websites or individuals that Pharma could claim was promoting infringement upon its intellectual property rights.

I have mentioned unexpected consequences, Unfortunately, the stage for those consequences has been set by recognized consequences of the pricing of medicines in the U.S.

· As the skyrocketing costs of brand name drugs leave millions of Americans skipping doses or abandoning their prescriptions, investors representing 14 faith and health care organizations are petitioning the nation's top pharmaceutical companies to re-examine pricing for commonly used drugs like Lipitor, Plavix and Celebrex in an effort to make them more affordable;

· Cost of heart drugs makes patients skip pills, putting themselves at risk (Mayo Clinic);

· U.S. prescription drug spending will grow 93% during 2008-2018, exceeding all major categories of health expenditures (Centers for Medicare and Medicaid Services);

· Americans failing to fill prescriptions or not taking their medicines as prescribed because of costs of medicines (Consumer Reports);

· Bi-partisan identification of the problem of healthcare costs in resolving our fiscal crisis (Senator Richard Durbin (D-IL), former Senator John Danforth (R-MO);

· Reports of Seniors falling Into Doughnut Hole buying fewer drugs (Kaiser Family Foundation);

· As many as one in ten elderly people in the US, registered with Medicare, not have access to their prescribed medication because it is too expensive (Dr. Larissa Nekhlyudov and colleagues from Harvard Medical School);

It is staggering to consider the negative impact—an unexpected consequence--that will occur as millions of Americans who rely upon personal importation of their safe and affordable medicines find that they must now be without their vital medicines because of legislation supposedly designed to protect American intellectual propert without any consideration of its impact because of the proposal’s vague language.

Fortunately, there is also recognition of the beneficial role of personal importation of vital medicines in protecting the health of Americans:

· Recognition of the ‘safety valve’ function of personal importation in preventing prescription medicine prices from going even higher “Basically, what’s going on with Canada is a little bit of leakage, It’s a release valve so that American consumers don’t get more upset with the prices’’ ( Arthur A. Daemmrich, assistant professor of business administration at Harvard Business School);

· Formation of a Congressional Caucus by Representatives Joanne Emerson (R-MO) and Peter Welch (D-VT) to work to lower prescription drug prices (Representative Emerson is a long-time supporter of personal importation of prescription medicines);

· Adoption of a new policy by the FDA facilitating importation of ingredients for pharmaceutical manufacture in the U.S. to address drug shortages in this country via reciprocal agreements with regulatory agencies in other countries, validating a process of reciprocity long advocated by supporters of personal importation;

· Numerous private and government support systems exist to help ease the cost for America's poor, but there are still millions of patients who are uninsured, and many who can't find cheap medicines in the U.S. look abroad To avoid high prices at home, U.S. patients have trekked to Canada for decades to buy their medicines… pharma companies and myriad industry-funded groups have scared Americans into believing that drugs from overseas pharmacies are inherently dangerous (American Enterprise Institiute);

· Introduction of legislation by Senators Al Franken (D-MN) and Amy Klobuchar (D-MN) supporting personal importation to relieve the growing problem of shortages of medicines in the U.S..

So it is now up to the House of Representatives to act, aware that if they sow the wind of SOPA, they will reap the whirlwind of endangering the health of millions of Americans who rely upon personal importation of their prescriptions medicines.

Nation’s Health Care Bill To Nearly Double By 2020

By Phil Galewitz

KHN Staff Writer

The federal health law, which will expand coverage to 30 million currently uninsured Americans, will have little effect on the nation's rising health spending in the next decade, a government report said today.

The report by the Medicare Office of the Actuary estimated that health spending will grow by an average of 5.8 percent a year through 2020, compared to 5.7 percent without the health overhaul. With that growth, the nation is expected to spend $4.6 trillion on health care in 2020, nearly double the $2.6 trillion spent last year.

Health law critics said the report confirmed their concerns. "Most of us understood the health reform law was about expanding coverage not cutting costs," said Joseph Antos, a health policy expert at the conservative-leaning American Enterprise Institute.

But White House Deputy Chief of Staff Nancy-Ann DeParle said the report showed Americans were getting a good deal. "The bottom line from the report is clear: more Americans will get coverage and save money and health expenditure growth will remain virtually the same," she said on the White House blog.

DeParle, who helped lead the White House efforts on the overhaul, said several delivery system reforms being tested under the health law will work to lower spending. "We know these new provisions will save money for the health care system, even if today’s report doesn’t credit these strategies with reducing costs," she said. She pointed to new programs that administration officials have said they hope to implement changing the way Medicare and Medicaid pay doctors and hospitals.

National health spending in 2010 grew at its slowest rate ever recorded – 3.9 percent – as a result of more Americans forgoing treatment because they had lost their jobs and their health coverage, said the report, which is being published online today by the journalHealth Affairs. In 2009, health spending grew by 4 percent.

The report estimates that spending on health will accelerate this year because the economy is expected to improve and people would have more disposable income to spend on medical care.

In 2014, when the major coverage expansions of the health law begin to take effect, national health spending is expected to grow 8.3 percent, according to the new analysis. But spending growth should return to its 6 percent historical average from 2015 to 2020 as some employers drop coverage and the so called "Cadillac tax" on high-cost insurance plans takes effect in 2018. "The effect is likely to be a slowdown in the growth of health services, health insurance premiums and health spending overall," the study said.

Meredith Rosenthal, a health economist at Harvard School of Public Health, said it is difficult to predict what impact the health law will have on slowing national health spending. "Many of the components of the law that are intended to control costs are still in draft form," she said citing experiments such as accountable care organizations and bundled payments that change how Medicare pays providers.

The number of Americans with employer-sponsored insurance will grow from 163 million last year to 170 million in 2014, the report estimated. But by 2020 that number is expected to drop to 168 million as a result of two factors: Baby Boomers joining Medicare and employers dropping health coverage for workers. Most of those workers would turn to new state insurance exchanges – or marketplaces –or Medicaid, the federal-state health program for low-income and disabled people.

The issue over how many employers would stop offering coverage has been a political flash point since the health law was approved in March 2010. Democrats maintain most employers would continue to provide coverage, but Republicans and other critics predict many companies would drop it because their workers will be able to go to new health exchanges. Starting in 2014, the health law requires all employers with 50 or more workers to provide coverage or pay a fine.

The Congressional Budget Office — the neutral scorekeeper — estimates that, by the end of the decade, 3 million fewer people will get health insurance from their employer. That’s slightly more than the Office of Actuary prediction.

The study authors stressed their projections could vary depending on many factors, including the overall state of the economy and how quickly people sign up for new coverage.

"These projections are definitely uncertain and that increases as we move along in the projection period," said Sean Keehan, a study author and an economist in the Office of the Actuary.

The Medicare actuaries acknowledged that they were off on one of their estimates last year. At that time, they predicted that national spending in 2009 would grow by 5.8 percent, instead of the 4 percent growth that the report said actually occurred. Keehan said one of the factors helping push that prediction off the mark was that fewer people than expected joined COBRA plans after losing their jobs and that resulted in fewer people with health coverage and less spending.

The office also predicted last year about 375,000 people would sign up for new Pre-existing Condition Insurance Plans by 2013. But since the plans began a year ago under the health law, only about 20,000 people have signed up.

CMS Chief Actuary Rick Foster attributed the lack of public awareness of the new insurance pools for the less-than-anticipated participation. He said his office took into account the low participation rates in making estimates for enrollment in Medicaid and insurance exchanges starting in 2014.

The report estimated about 13.9 million people would enroll in new state-based insurance exchanges in 2014 and the number of uninsured would drop by nearly 20 million in that year. Given how many millions of eligible people don’t sign up today for Medicaid, that prediction is highly speculative, said Steven Findlay, an analyst at Consumers Union.

US Drug Watchdog says Recalled Pain Drugs Darvocet and Darvon could kill

Publisher’s Note: The following release from US Drug Watchdog adds to a growing body of evidence that calls into question the intent of the pharmaceutical industry as it attempts to persuade policy-makers that it should have a major policy-making role in oversight of determination of the safety of safe, affordable prescription medicines from licensed, registered pharmacies in Tier One countries. To elevate an industry that is—or should be—subject to the strictest governmental oversight to a prominent role to help determine the processes of the agency—in this instance, the FDA—that is charged with providing oversight of that industry’s manufacturing processes is completely irrational, particularly when that industry (Pharma) has a proven record of manufacturing processes that expose Americans to potential harm to their health as well as proven fraud. The release follows:

The US Drug Watchdog is calling the recalled pain pills Darvocet, Darvon, or the generic propoxyphene some of the most lethal drugs ever sold in the United States, and is urging all US citizens to stop taking Darvocet, Darvon, or the generic version propoxyphene pain pills immediately.

“We are astonished with how many people we have talked with, who took Darvocet, or Darvon, had a heart attack, developed severe heart rhythm issues, and now are either medicated to control their heart beat, or they have a pacemaker. This should be on the national news every day," the group says.

The US FDA ordered a recall of these drugs on November 10th 2010, yet there is a worry that most consumers have not yet heard of the recall.

US Drug Watchdog says, "22 million US citizens have used the recalled pain pills Darvocet, Darvon. These recalled pain pills can cause severe heart problems including, heart attacks, sudden deaths, or severe heart damage.

“We need to hear from every Darvocet, Darvon, or propoxyphene user, who has developed severe heart issues, or heart problems."

For more information please call the US Drug Watchdog at 866-714-6466, or contact the group via its web site at http://USDrugWatchdog.com

"We don't think-we know the recalled Darvocet, Darvon, or the generic version propoxyphene are still being used by millions of US citizens, these specific types of pain pills have been associated with heart rhythm issues, heart attacks, sudden death, and many users now have pacemakers, because of the damage done by these widely used medications," the group continues

"These pain pills have killed completely innocent US citizens, and our number one goal is to identify every individual in the United States, who has used the recalled Darvocet, or Darvon, and then developed heart rhythm issues, heart attacks, or other severe complications, including having to now have a heart pacemaker.

“We now fear it’s in the 10,000's.

"If you, or a loved one has suffered from abnormal heart rhythms, heart attacks, or other heart problems while taking Darvon, Darvocet, or the generic propoxyphene, please call us immediately at 866-714-6466." Darvocet, or Darvon victims can also contact the US Drug Watchdog via its web site at http://USDrugWatchdog.com

What are some typical symptoms experienced by many Darvocet, or Darvon pain pill users?

The US Drug Watchdog indicates the serious side effects that they are aware of with respect to Darvocet, or Darvon users are as follows:

Heart Arrhythmia

Heart Attack

Suicide

Overdose

Sudden Death

The US Drug Watchdog , the premier private pharmaceutical watchdog in the United States, concludes with the following alert:

"The Internet, and cable TV are loaded with advertisements, about compensation for Darvocet, or Darvon users, ads talking about Darvocet, or Darvon class actions, and or lawsuits, related to heart attacks, or heart rhythm problems.

“Unfortunately, the vast majority of the attorneys, or law firms advertising for help with heart conditions, heart attacks, or even sudden death after using the recalled Darvocet, or Darvon are middlemen marketing law firms-not the actual trial law firms, that will prosecute these cases.

"We want to make certain the Darvocet, or Darvon victims get to the actual trial law firms, or attorneys, that have the best record in achieving significant results for their clients-not a middleman marketing law firm." http://USDrugWatchdog.com
Federal Case No. 2:10-cv-04455

Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2011/01/18/prweb8071777.DTL#ixzz1BOOEkfLV