Latest Drugwonks' Blog
The visionary lies to himself, the liar only to others. -- Friedrich Nietzsche
You can fool some of the people all of the time and all of the people some of the time. But what about when it comes to election time?
The Big Lie of ObamaCare is “If you like you’re insurance you can keep it.” And it’s the lie that keeps on giving.
Here’s the latest from the pages of Modern Healthcare – a magazine without an agenda that plays it straight.
Extension of policies that don't comply with ACA called ploy
The Obama administration's decision Wednesday to allow people to keep insurance plans that don't comply with the Patient Protection and Affordable Care Act for an additional two years was quickly criticized by ACA opponents as a midterm-election-year ploy, even as administration officials were denying politics was involved in the decision.
Regardless of the motivation, the change likely will irk insurers hoping to sign up as broad a spectrum of the public, especially healthy people, as possible in compliant plans offered on exchanges.
“Plans need to know the parameters in which they have to work so they can make the best decisions for the consumers they serve moving forward,” said Jeff Drozda, CEO of the Louisiana Association of Health Plans, which counts both large payers and small regional plans as its members.
Last month, during an earnings call, Humana expressed disappointment in the number of enrollees it had from the exchanges at that point and blamed the company's woes on the transitional policy, for example.
“We believe this change will result in an overall deterioration of the risk pool and ACA-compliant plans as more previously underwritten members have stayed with their current carriers rather than enter the exchanges,” Humana President and CEO Bruce Broussard said.
Administration officials Wednesday, confirming media reports that started surfacing early this week, announced insurers could renew noncompliant policies that begin on or before Oct. 1, 2016. That means some customers can stay on these plans into 2017.
This is an extension of a decision made in November when the president gave states the ability to allow noncompliant policies to continue. Originally these plans were only meant to last until October 2014, right before midterm elections in November.
High-ranking administration officials who spoke on background to reporters Wednesday insisted multiple times that the potential backlash of thousands of people receiving policy cancellation notices right before heading to the polls played no part to the extension.
Instead, they said, the extension gives 500,000 consumers in these plans time to make the choice of staying in their current policy a little longer or joining a new marketplace plan. They added that it's likely all of these consumers will make the switch to a compliant plan by 2016, but if they do not, HHS now has the discretion to extend the transitional policy for a third year.
The more than 20 states that chose not to allow consumers to keep noncompliant plans will now have another opportunity to do so as long as the plans are still active, they said. People now in compliant plans can't go back to ones that don't meet the standards.
Beyond any administration concern about midterm elections, concern about the tax penalty these individuals were facing likely also played a role in the decision, said one ACA observer. Before the new extension, if a person didn't have a compliant ACA plan by the end of the enrollment period in 2015, he or she would have been hit with a levy worth up to 2% of income when filing taxes in 2016.
“Without the extension, a lot of people may get hit with the tax penalty and that could lead to a political fallout,” said Ning Liang, co-founder of a new website that helps people compare and sign up for ACA-compliant plans on HealthCare.gov.
The change is likely to provide scant political cover to Democratic congressional candidates facing broad attacks over the administration's healthcare policy, some said.
“I think, at this point, consumers have wised up and are asking some demanding questions,” said Peter Pitts, president of the Center for Medicine in the Public Interest. “This extension further demonstrates the disingenuous nature in how certain political candidates are presenting the Affordable Care Act to their constituents”
“The problem is you can't unshoot the gun,” said David Hogberg, a healthcare policy analyst at the National Center for Public Policy Research. “People are going to remember that the administration violated a very serious promise that people could keep their plans and I suspect Republicans will use that to no end this November.”
The extension gives Republicans one more change to the Affordable Care Act to criticize. Grace-Marie Turner, president of the Galen Institute, a conservative research organization, noted that her organization has tracked at least 19 changes made, most by executive order, to the ACA since it became law.
California Assemblywoman Susan A. Bonilla has partnered with the California Pharmacists Association and the California Healthcare Institute to introduce legislation (AB 2418) that improves the process for medical patients to obtain their prescription drugs and follow their doctor's instructions on taking their medications.
"Poor medication adherence costs the US health system $290 billion dollars in other health care expenditures, such as emergency room visits and unnecessary physician office visits," said Jon Roth, Chief Executive Officer for the California Pharmacists Association. "Assembly member Bonilla's legislation will go a long way to improving medication adherence by allowing patients to receive their medication in a way that is most convenient to them and all those medications to be synchronized with all their other drugs, resulting in the best chance for a patient to successfully complete all of their prescriptions."
Specifically, this bill:
* Allows patients to opt out of their health plan’s mandatory mail order program if they prefer to obtain their prescription drugs from a community pharmacy.
* Streamlines prescription medications by placing the patient’s medications on the same refill schedule.
* Allows patients who run out of prescription eye medications because of accidental spillage or who use more than 70% of their eye drops to be eligible for an early refill.
Pharmacy programs seem to be the best way forward, and there’s hard data to back that up. Case in point – the successful Appointment-Based Model program being used at Thrifty White, a Midwest chain of pharmacies. (For more information on the Thrifty White program, see the article, Adherence and persistence associated with an appointment-based medication synchronization program, from the December 2013 edition of the Journal of the American Pharmacists Association
By creating processes that support and improve patient access to medications; patients experience better health outcomes and improved quality of life. Patients who pick up their medications at their local pharmacy have the opportunity to talk with their pharmacist about how to properly take their medications and to understand the positive benefits of taking their medications.
The launch of Human Longevity Inc., by Craig Venter, Bob Hariri and Peter Diamandis is predicated on the assumption that the only way to get enough people take enough risk for such undertakings is to create a commercial enterprise. Calico (the Google anti-aging venture) and HLI are examples of how private companies and capital markets can achieve what governments and anti-capitalist types can only talk about.
Recently, a news account implied that there was something wrong in the CEO of Gilead being worth over a $ billion. As if somehow someone who invested 20 years and billions in developing treatments that are effectively cures for AIDS and Hep C should be not be rewarded. We celebrate the Forbes 400 Richest People in the world for their billions and their charity but not the people who lead firms that make longer life possible for billions.
Yes, many new medicines have retail prices that make one gasp. Cancer drugs that cost $90K and Hep C drugs that ring in at $84 K. They could be cheaper but that would require cutting the amount of time and money needed to pass through the FDA. (By comparison, average cost of private four year college is $160K) Setting aside that on average the sticker price is about 20-50 higher than actual charges these new medicines displace more expensive and less effective treatment and allow people to lead healthier, longer lives.
These new treatments are a bargain. We forget that while medicines may be pricey, disease is always much more costly. Unfortunately, under Obamacare health plans are sticking more people with a bigger share of the cost. This moved is designed to discourage use by the people in greatest need and direct outrage away from insurers to drug companies, their executives and their net worth. That's bad policy and immoral to boot.
Some want to tie higher executive compensation to lower prices of medicines. Apart from the bureaucratic nightmare such a system would require, that would mean eliminating the connection between return on investment and the value of innovation. Would anyone think of requiring that the compensation of Steve Jobs or Elon Musk should increase only if they make cheaper products? All such proposals do is drive the capital, risk taking and profits into other industries like apps, entertainment and fashion.
In announcing the launch of HLI Craig Venter noted: “This is a very expensive undertaking. The only way to do that is to make it so the data is so meaningful that it has commercial value,” Dr. Venter said. “If it doesn’t, then this will be a very short-lived phenomenon.”
Translation: if we don't reward risk taking on behalf of human health, both will shrink. Killing rewards for medical innovation kills people.
Senator Charles Schumer is urging Health and Human Services Secretary Kathleen Sebelius “to overturn the government’s approval of a new powerful prescription opioid, Zohydro ER” (hydrocodone), “until it has been made abuse-proof.” According to reports, Schumer “believed there was a ‘decent chance’ that” Sebelius would revoke the FDA approval.
Whatever your position on the issue of opiods, the proper venue for this decision is not the office of the Secretary of HHS but rather the office of the FDA Commissioner.
And Senator Schumer should know better.
Chuck, can you say, "Plan B?
From the good folks at policymed.com …
A new draft guidance document released by the U.S. Food and Drug Administration (FDA) aims to clarify the ways in which a pharmaceutical or medical device manufacturer may use scientific and medical literature to promote its products, even if the literature doesn't conform to the product's FDA-approved uses. FDA's guidance forms a checklist of sorts that companies will need to check against each instance of literature they wish to promote.
FDA's new draft guidance document, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, is meant to provide life science companies with a checklist for making sure they stay within the acceptable limits of promotion of scientific and medical publications. The guidance is a revision of a 2009 draft guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. As noted by Regulatory Focus, that guidance came under fire from life science companies, which argued that it restricted their ability to "promote the public health" by distributing scientific information informing the safe and effective use of their products.
In an accompanying statement, the FDA stated that it's currently working on additional guidance on scientific exchange, responding to unsolicited requests for off label information, and interactions with formulary committees.
This draft guidance shows that the agency is getting the message that it must conform its policies and practices to the First Amendment," said Coalition for Healthcare Communication Executive Director John Kamp in a released statement. "Manufacturers should be able to distribute truthful information – in the form of journal articles, medical textbooks and practice guidelines."
In an Industry Leaders Alert, Kamp also stated: "These actions, combined with recent guidance on social media and a new study on the effectiveness of current warnings on TV commercials, suggest that the FDA is serious on updating critical marketing policies, perhaps in recognition of the First Amendment challenges it faces is defending current policy."
"While these are small steps forward, they are significant nonetheless and will enable more reasonable communication between regulated companies and medical professionals, leading to more efficient and effective patient care. The new draft guidance also supports our case with CMS that journal reprints and reference textbooks should be exempt from reporting under the Sunshine Act."
Israel is finally off the USTR’s “Special 301” list.
(The Special 301 list identifies countries that do not provide "adequate and effective" protection of intellectual property rights or "fair and equitable market access to United States persons that rely upon intellectual property rights.)
For many years the Israeli government, under pressure from Teva (Israel’s “national champion” in pharma), pursued a misguided resistance to bringing their national IP regime into full compliance with its WTO obligations.
But in recent years the mood has been shifting as more policy-makers woke up to the fact that you can have thriving generics manufacturers and a thriving innovative biopharmaceutical industry. IP, after all, is the cornerstone to a thriving life sciences industry.
According to Israel’s Minister of Economy, Naftali Bennett, "We've shown maturity and responsibility in one of the most significant areas to international trade as we have committed, and I believe that the important vote of confidence in the U.S. and recognition of the strength of the intellectual property regime in Israel, will assist us in maintaining Israeli industrial development and dissemination of knowledge, innovation and capabilities to many countries.”
Globally, every nation that’s home to a robust innovative life sciences sector offers strong and (in many cases) improving IP environments. If Israel wants to maintain its competitiveness, it needs to be competitive in IP.
Israel now has an IP sector worthy of its potential in the high value added IT, Life Sciences and other high value-added, knowledge intensive sectors. Mazel tov.
At a time when certain circles in India, South Africa, and Brazil are arguing to weaken their national IP standards, Israel has taken a significant step to secure its place in the winner’s circle.
It’s time to add a gold IP star to the Star of David.
L’chaim!
The FDA’s suggested changes to the Nutrition Facts Panel (aka, “the food label”) comes almost exactly 11 years after the FDA first announced its intentions.
These “new” changes are actually follow-through on the FDA’s 2003 Obesity Working Group recommendations. I was pleased to serve on that committee and am thrilled that our suggestions are finally being implemented.
Labels have not kept up with the supersizing of food. The Nutrition Facts Panel should empower consumers to make wise nutritional choices. The NFP was created via the 1990 Nutritional Labeling and Education Act, and the “E” in NLEA has been silent long enough.
Unfortunately, that does not include most people (who thought that the ACA meant "free healthcare") and members of Congress (who didn't read the bill -- like Nancy Pelosi) -- but it's going to make a lot of difference to to a lot of people in November.
NEW YORK (AP) - The new health care law may raise insurance premiums for 11 million small business employees and lower rates for 6 million others.
That's an estimate from a report by the Centers for Medicare & Medicaid Services, part of the Department of Health and Human Services.
The report says higher rates are partly due to the law's requirement that premiums can no longer be based on a person's age. That has sent premiums higher for younger workers, and lower for older ones.
The estimate is far from certain, partly because many small businesses renewed their policies in 2013. Renewing before the end of the year allowed them to avoid higher premiums that went into effect Jan. 1, when coverage was required to conform to the law.
Also limiting the certainty of the estimate is the fact that the report looks at three specific provisions of the Affordable Care Act. Employers' decisions will be based on more factors, according to the Centers for Medicare & Medicaid Services.
Humana is working with CoverMyMeds, a health IT company, to roll out an electronic prior authorization model that enables physicians to simplify prescription prior authorization requests so patients can get quicker access to their medications.
According to an article in Medical Practice Insider, Prior authorization (PA) is a complex process that is often daunting and monotonous for medical practice managers. It is also costly in terms of economics and human life, in particular when PA requirements lead to patient medication needs “falling through the cracks,” as some patients abandon their prescriptions due to the confusion and delay of the approval process.
The original goal of PA was to save money, requiring physicians to justify to health plans the need for medications, diagnostic tests and procedures, but it has led to pharmacists having to spend an average of five hours per week handling PA requests. This is non-reimbursable time that is better served on direct patient care.
A nationwide physician survey indicates that more than 69 percent of physicians typically wait several days to receive a PA from an insurer for a prescribed drug, while 10 percent wait more than a week. While more than 52 percent of office-based prescribers utilize electronic prescribing methods, most of them continue to use paper-based methods for obtaining PA of medications from health plans, causing unnecessary delays for patients.
Under the agreement with CoverMyMeds, physicians submit drug prior authorizations directly to the insurer through an online portal. The requests begin processing immediately, and providers receive a notification of the status of the member’s prior authorization, sometimes while the patient is still at the provider’s office, Humana said in a news release.In a pilot of the model, Humana found that one quarter of prior authorizations placed received a response electronically within minutes of submission. Physicians who used it overwhelmingly said the website was user friendly, and many found it helpful to receive an online status of their prior authorization determination.
“Depending on the prescription, some medications require prior authorization before coverage, which, as of now, is a time-consuming process for all parties,” said Scott Greenwell, chief pharmacy officer of Humana Pharmacy Solutions, in the release, adding that prescriptions can now be approved and ready in real-time.
Well done, Humana!
Whose responsibility is it to build confidence in both the pharmacovigilance process as well as the urgent importance of the proposition? It’s the job of the regulatory body that oversees the both the procedures and the actions that derive from post-marketing reports. That means the FDA.
Whose responsibility is it to build confidence in both the pharmacovigilance process as well as the urgent importance of the proposition? I believe it’s the job of the regulatory body that oversees the both the procedures and the actions that derive from post-marketing reports. That means the FDA.
Small is the new Big means we must think differently about pharmacovigilance. While we must continue to capture adverse event data, we must also strive to capture Substandard Pharmaceutical Events (SPEs). SPEs occur when a product does not perform as expected—perhaps because of API or excipient issues. SPEs can arise because of an issue related to therapeutic interchangeability. When it comes to 21st-century pharmacovigilance, we have to both broaden and narrow our views about bioequivalence to the patient level.
The FDA is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, CDER Director, Dr. Janet Woodcock said at the Bloomberg health-care summit. The FDA is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, she said.
The agency now collects such information only during inspections. The thrust of the effort would be to head off potential concerns before the agency wields penalties such as banning products from troubled factories. “We want to use leading indicators. These people aren’t in trouble yet but they could be.”
Per Peggy Hamburg, “All companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.” Hamburg said the new office will “improve our oversight of quality throughout the lifecycle of a pharmaceutical product.”
Congressional hearings are scheduled to hear from doctors, researchers and patient advocates Feb. 26 in a briefing on whether substandard generic drugs are reaching the U.S. medical system from overseas. The briefing will feature Harry Lever, a Cleveland Clinic cardiologist who has said generic drugs for heart failure made by India-based companies often don’t work the way they should.
The FDA is working with groups such as the Pharmaceutical Research and Manufacturers of America and American Association of Pharmaceutical Scientists to determine how often it will ask drugmakers to submit quality data.
Small is the new Big. That’s big news – and it’s about time.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
