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Yes, Providing Cancer Drugs In Multiple Vial Sizes Could Save Patients and Payers Money
On March 1, 2016, we published an article in the BMJ showing how in the US nearly $3 billion will be spent on discarded cancer drugs this year because companies package drugs in vials that contain too much of the drug for most doses, creating expensive leftover product. We proposed that companies in the US should either package drugs in more appropriate vial sizes to reduce the leftover amounts, or provide refunds for leftover drug. Since the time of our article’s publication, numerous Senators have written letters to the Food and Drug Administration (FDA) urging action on vial sizes, and calling for the Department of He...
Source: Health Affairs Blog - June 8, 2016 Category: Health Management Authors: Peter Bach, Rena Conti, Raymond Muller, Geoffrey Schnorr and Leonard Saltz Tags: Costs and Spending Drugs and Medical Technology Cancer Source Type: blogs

DOJ Announces Genentech and OSI Pharmaceuticals, LLC Settlement
The Department of Justice (DOJ) has announced that pharmaceutical companies Genentech and OSI Pharmaceuticals, LLC, will pay $67 million to resolve allegations that they made misleading statements about the effectiveness of the drug Tarceva to treat lung cancer. This settlement resolves allegations "that between January 2006 and December 2011, Genentech OSI Pharmaceuticals made misleading representations to physicians and other health care providers about the effectiveness of Tarceva to treat certain patients with non-small cell lung cancer, when there was little evidence to show that Tarceva was effective to treat those...
Source: Policy and Medicine - June 6, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

LGBT Protections In Affordable Care Act Section 1557
On May 13, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (HHS OCR) issued a historic new rule that codifies nationwide nondiscrimination protections for lesbian, gay, bisexual, and transgender (LGBT) people in health facilities, programs, and activities receiving federal funding. This rule confirms that Affordable Care Act Section 1557 prohibits discrimination against LGBT people in health insurance coverage and health care. Key provisions of the final rule that relate specifically to LGBT people include: Interpreting Section 1557’s sex nondiscrimination protections to include explicit p...
Source: Health Affairs Blog - June 6, 2016 Category: Health Management Authors: Kellan Baker Tags: Costs and Spending Equity and Disparities Following the ACA Insurance and Coverage Medicaid and CHIP Public Health Quality HHS OCR LGBT issues section 1557 transgender rights Source Type: blogs

Does A ‘One-Size-Fits-All’ Formulary Policy Make Sense?
Over the last decade, insurers have increasingly used step therapy, or “fail-first,” policies as a strategy to contain pharmaceutical costs. Step therapy requires patients to begin treatment for a medical condition on a typically less expensive drug, and only progress to more costly second-line drugs when the first-line therapy becomes ineffective or inappropriate. Step therapy shifts clinical decision-making away from physicians and toward centralized policies that define treatment steps for patient populations based on the potential for more cost-effective care. The rapid growth in the use of step therapy policies in...
Source: Health Affairs Blog - June 2, 2016 Category: Health Management Authors: Adrienne Chung, Joanna MacEwan and Dana Goldman Tags: Costs and Spending Drugs and Medical Technology Equity and Disparities Health Policy Lab Health Professionals Insurance and Coverage Payment Policy Quality Prescription Drugs step therapy Source Type: blogs

Wanna Fight Superbugs? Stop Overprescribing Government
Conclusion  Government is like antibiotics. Some amount is necessary. But overprescribing it makes things a lot worse. A good indication you’ve overdosed on the statist Kool-Aid is when you make dismissive comments like this one Emanuel levels at current antibiotic-tracking programs: “Unfortunately, they are voluntary.”
Source: Cato-at-liberty - June 1, 2016 Category: American Health Authors: Michael F. Cannon Source Type: blogs

America’s New Drug War
By STEVEN FINDLAY Earlier this month an 86-year old man in Florida killed his 78-year old wife.  He called 911 and when the cops arrived he confessed.  When asked why he did it, the man told authorities that the couple could no longer afford her medications.  She’d been sick for 15 years, the man said, and was often in pain.  News sources reported that the couple filed for bankruptcy in 2011.  At the time, they had $53,900 in liabilities, most in medical bills put on their credit card.   They lived primarily on social security.     There’s very likely more to this sad story, and it’s unclear why Medicare did...
Source: The Health Care Blog - May 29, 2016 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized Source Type: blogs

Understanding the CMS Proposed Rule for the Medicare Access and CHIP Reauthorization (MACRA) and the Merit-Based Incentive Payment System (MIPS)
As we have reported, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule to implement the Medicare Access and CHIP Reauthorization Act (MACRA). This is a significant rule with fundamental changes for Medicare. In our continuing coverage, we will provide a more detailed analysis of the regulation. Today, we look at the rule's content related to the Merit-based Incentive Payment System (MIPS). As a refresher, the rule creates a two-track Quality Payment Program. The first is called the Merit-based Incentive Payment System (MIPS) consolidates components of the Physician Quality Reporting System (...
Source: Policy and Medicine - May 23, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

E&C Committee Hearing on CMS Medicare Part B Demonstration
Discussion Patient Access A large portion of the hearing focused on the demonstration's impact on patient access. A lengthy list of Representatives expressed concern about the ability of patients to receive needed treatments in areas where the model has pricing reforms preventing doctors from being able to afford the drugs. Ms. Block, a patient advocate, however, made known that she and her personal physician got together and read the regulation; neither one of them felt that any specific part of the demonstration would give rise to issues with patient access. Stakeholder Engagement Another contentious issue discus...
Source: Policy and Medicine - May 17, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Is High Prescription Drug Spending Becoming Our New Normal?
This report concluded there was value in these therapies but also raised concerns about whether their effects will translate into lower rates of heart attack and stroke. Further, ICER concluded that a discount of 67 percent off the drugs’ list price would better represent their overall benefit. ICER’s assessment is still in draft form and it remains unclear whether the report will have any effect. Nevertheless, such work is a step in the right direction. Other entities are developing alternative methods to evaluate prescription drugs. The American Society for Clinical Oncology has sought comment on its proposed val...
Source: Health Affairs Blog - May 17, 2016 Category: Health Management Authors: Leigh Purvis and Crystal Kuntz Tags: Costs and Spending Drugs and Medical Technology Featured Payment Policy Quality Big Pharma Biosimiliar Comparative Effectiveness FDA PCSK9 inhibitors Sovaldi specialty drugs Source Type: blogs

HHS Issues Health Equity Final Rule
On May 13, the Office of Civil Rights (OCR) of the Department of Health and Human Services (HHS) issued a final rule implementing section 1557 of the Affordable Care Act. The rule finalizes a proposed version issued in September of 2015, analyzed in this blog at that time. The final rule was accompanied by a press release, summary, and series of fact sheets. Section 1557 of the ACA provides that an individual shall not, on the basis of race, color, national origin, sex, age, or disability, be excluded from participation in, denied the benefits of, or subjected to discrimination under any health program or activity of whi...
Source: Health Affairs Blog - May 14, 2016 Category: Health Management Authors: Timothy Jost Tags: Equity and Disparities Featured Following the ACA Insurance and Coverage Medicaid and CHIP Medicare age discrimination disability discrimination health equity national origin discrimination racial discrimination sex discrimination Source Type: blogs

Datapalooza: MACRA, EHR Reform and Working with Doctors – Not Against Them
BY ANDY SLAVITT There’s a bit of a checklist for speaking at Datapalooza. Thank Niall. Mention Todd Park. Remark at how big the event has gotten compared to last year. Recap how much progress has been made. Refer to yourself as a “data geek” . Also, have in my notes “Good not to follow Farzad or Aneesh” . Perhaps even make some news with an announcement or grant or contest. Several of my colleagues did this and I share their excitement. But I’m not going to make news. Instead, I’m going to relay a bit of my personal experience with health care innovation and technology as my goal is to leave this job with not...
Source: The Health Care Blog - May 12, 2016 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized Source Type: blogs

Actually, Medical Errors are the Leading Cause of Death
By SAURABH JHA, MD Josef Stalin famously said: one death is a tragedy; one million is a statistic. Perhaps 250, 000 preventable deaths from medical errors, according to an analysis by Makary and Daniel in the BMJ, maketh a Stalin. The problem with Makary’s analysis, which also concluded that medical errors are the third leading cause of death, isn’t the method. Yes, the method is shaky. It projects medical errors from a series of thirty five patients to a country of 320 million, which is like deciding national spice tolerance on what my family eats for dinner. The problem with Makary’s analysis isn’t that it is ful...
Source: The Health Care Blog - May 10, 2016 Category: Consumer Health News Authors: John Irvine Tags: THCB Source Type: blogs

Looking Back From 2019: Why the Republicans Nationalized Healthcare
By JOE FLOWER It was the Mother of unintended consequences. By the time of the 2016 elections, health plans, hospitals and health systems had squeezed and consolidated and trimmed and cut costs under the gun of lower Medicare reimbursements and the new rules of Obamacare — but mostly they had adapted. Most of them had survived. On November 9, the country woke to find itself with a Republican President-elect, a Republican majority in the House, and a Republican majority of 55 in the Senate. The Grand Old Party was dedicated to repealing #EveryWord of the Affordable Care Act, the hated Obamacare which was, after all, “...
Source: The Health Care Blog - May 8, 2016 Category: Consumer Health News Authors: John Irvine Tags: THCB Uncategorized Donald Trump Futurists Joe Flower Nationalized Healthcare Source Type: blogs

A Controversial New Demonstration In Medicare: Potential Implications For Physician-Administered Drugs
According to an August 2015 survey, 72 percent of Americans find drug costs unreasonable, with 83 percent believing that the federal government should be able to negotiate prices for Medicare. Recently, Acting Administrator of the Centers for Medicare and Medicaid Services (CMS) Andy Slavitt commented that spending on medicines increased 13 percent in 2014 while health care spending growth overall was only 5 percent, the highest rate of drug spending growth since 2001. Some of the most expensive drugs are covered under Medicare’s medical benefit, Part B, because they are administered by a physician. They are often admini...
Source: Health Affairs Blog - May 3, 2016 Category: Health Management Authors: Kavita Patel and Caitlin Brandt Tags: Costs and Spending Featured Medicare Payment Policy Quality Avastin CMMI Lucentis Medicare Part B oncology care model prescription drug coverage Source Type: blogs

Health Affairs May Issue: Prescription Drugs, Global Health & More
This study is an extension of Bai and Anderson’s 2015 Health Affairs study about hospitals with the highest markup over Medicare allowable costs. States investing more in social services and public health had healthier residents Policy makers are now placing more emphasis on the role of social determinants in influencing individual and population health. To date, though, little has been known about the correlation between state spending for social services and public health and the health of individuals. Elizabeth Bradley of Yale University and coauthors broke new ground by finding that people living in states that spen...
Source: Health Affairs Blog - May 2, 2016 Category: Health Management Authors: Lucy Larner Tags: Elsewhere@ Health Affairs Featured Health Affairs journal Source Type: blogs