Today's News and Commentary

About pharma

In a crafty move, FDA may have found a way to dampen controversy over a $375,000 rare-disease drug: Here’s what competition can do. Earlier this year the FDA approved Firdapse, a drug manufactured by Catalyst to treat adult Lambert-Eaton myasthenic syndrome ( a muscle weakness disease). Since it was an orphan drug, it was also granted 7 years of market exclusivity. Because of its unique status, the company announced a $375,000 price tag. However, the FDA just approved the same drug, this one made by Jacobus Pharmaceuticals, called Ruzurgi. The difference is the latter approval was for children with the same condition. Once approved, either drug can be used to treat people of all ages. While Ruzurgi’s price has yet to be announced, Catalyst stock dropped 44% in anticipation of price competition.

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Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency:The final rules about advertising drug prices on television have been issued. If the wholesale acquisition cost is $35 or more per month, the advertisement must contain the statement: “ “The list price for a [30-day supply of ] [typical course of treatment with] [name of prescription drug or biological product] is [insert list price]. If you have health insurance that covers drugs, your cost may be different.” The terms take effect 60 days after publication in The Federal Register.

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Alphabet's GV leads funding in gene editing company Verve Therapeutics: Continuing a trend to cross-sector involvement, Alphabet Inc’s venture capital arm (GV) “led a $58.5 million investment to launch Verve Therapeutics, a new biotech focused on developing therapies that edit the human genome to treat heart diseases…Verve plans to target adults at risk of coronary artery disease, the leading cause of death worldwide, by editing their genes to mirror those of people whose naturally occurring genes have been associated with a lower risk of heart disease and heart attacks.” How much would you pay for such a treatment?

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Judge tells HHS to revisit 340B after ruling cuts 'unlawful': The 340B program allows certain hospitals and other healthcare providers to buy discount drugs from the manufacturers in order to provide them to Medicaid or free-care patients. These providers could then charge Medicare and Medicaid up to 6% over the average national sales price of drugs. Recently, CMS cut rates to to 22.5% less than the average sales price— a change that would result in a $1.6 billion payment reduction. In a lawsuit by multiple hospital entities challenging this reduction, DC District Court Judge Rudolph Contreras ruled it was unlawful. This decision was a truly big win for eligible providers. Now we will have to wait for the appeal.

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Study: Payers, PBMs hinder drug access for autoimmune patients: Researchers at Emory University graded insurance companies for their coverage of autoimmune drugs to treat Crohn’s disease, multiple sclerosis, psoriasis, psoriatic arthritis and rheumatoid arthritis. They found that: “86% of Medicare Advantage plans received an F for coverage of autoimmune drugs and 48% of private insurers received an F. Within private insurers, another 50% of companies rated a C and not one received an A.” Since these drugs are very expensive treatments, it is reasonable to recommend step therapy if all medicines in a class are equally effective but vary in price. However, imposing high out of pocket payments for patients as a cost reduction strategy makes no sense, since these drugs are not discretionary purchases.

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About healthcare IT

Feds Want To Show Health Care Costs On Your Phone, But That Could Take Years: In a related story to the tv advertising rule above, HHS is proposing regulations in anticipation of consumers’ ability to price compare healthcare services on the phone. For example, such comparisons will likely have disclaimers about variance by insurance.

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Lawmakers call for delay in implementing interoperability rules: CMS has been pushing for IT interoperability implementation. But yesterday, Sen. Lamar Alexander, R-Tenn. (chair of the Senate Health, Education, Labor and Pensions ((HELP)) Committee) called for a delay of two new rules. He cited provider and payer costs and and the ability to comply with the rules in a relatively short amount of time.

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FDA clears first AI-powered mobile app to catch heart murmurs: Prior artificial intelligence healthcare apps have been geared to voice recognition, input of lab data, or recording patient information (like pulse or EKG readings). This one listens for heart murmurs. Is the stethoscope on its way out?

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Allscripts' Practice Fusion receives grand jury subpoena related to EHR certification, anti-kickback concerns: Allscripts recently bought Practice Fusion, knowing it had engaged in some questionable practices. In return for a deeply discounted price of $100million, as opposed to more than $1billion, Allscripts said it would assume all future liabilities. Now that contingency has come. In its latest SEC filing, Allscripts reported: “ In March 2019, Practice Fusion received a grand jury subpoena in connection with a related criminal investigation. The document and information requests received by Practice Fusion relate to both the certification Practice Fusion obtained in connection with the U.S. Department of Health and Human Services’ Electronic Health Record Incentive Program and Practice Fusion’s compliance with the Anti-Kickback Statute and HIPAA as it relates to certain business practices engaged in by Practice Fusion.” The article also mentions past problems at Greenway and eClinicalworks.

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About the public’s health

Prediabetes puts your health at risk, but reversing it is "very doable," experts say: The main message is not new (diet and exercise can help stave off diabetes for those on the cusp of the disease). However, the statistics are very disturbing: “According to the Centers for Disease Control and Prevention, more than 1 out of 3 adults in the United States — approximately 84 million people — have prediabetes . Yet, 90 percent of those affected do not know they have it.” How many people would change their behavior if they knew they were prediabetic?

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Vital Signs: Pregnancy-Related Deaths, United States, 2011–2015, and Strategies for Prevention, 13 States, 2013–2017:Speaking of prevention, the CDC found that 60% of pregnancy-related deaths are preventable. Causes vary by when the death occurred after delivery.

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Strengthening national health security and preparedness helps build a culture of health: The 2019 Robert Wood Johnson Foundation health preparedness index shows continued improvement, but overall the U.S. scores only 6.7/10. Domain scores range from a high of 8.3 for Health Security Surveillance to a low of 4.9 for Healthcare Delivery. (The latter measure has not statistically improved in the past few years.)

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U.S. Library of Medicine Digital Collections: This new website has 906 video presentations on health-related topics. It is a fascinating historical archive. For example, on the first page is an audio recording with accompanying photos of President Roosevelt’s speech dedicating the National Institute {not Institutes at that time] of Health on October 31, 1940.

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About health insurance

Kaiser Permanente building infrastructure to 'connect the dots' for social determinants: This article is a nice review of what Kaiser Permanente is doing to address social determinants of healthcare for its members.

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Do People Who Sign Up for Medicare Advantage Plans Have Lower Medicare Spending? This research from the Kaiser Family Foundation showed that Medicare Advantage (MA) plan members had lower costs than traditional Medicare beneficiaries the year before they switched to a MA plan. The conclusion was that CMS payments to MA plans may be too high.
The better health of HMO members (Medicare or commercial plans) is not a new finding. What has been shown in the past is that for patients matched by health status, the HMO plan provided the same quality of care at a lower price. Further, MA payments are health status adjusted. Recently, CMS allowed MA plans to offer enhanced services that traditional Medicare does not cover.
More analysis needs to be done on this issue before making any payment policy changes.

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Individual Insurance Market Performance in 2018: Insurance company performance under the ACA was very rocky over the first few years. This research shows that finances are now on a stronger footing. Specifically, “individual market insurers saw better financial performance in 2018 than in all the earlier years of the ACA and returned to, or even exceeded, pre-ACA levels of profitability.” The Medical Loss Ratio has declined from a peak of 103% in 2015 to 70% last year. It is expected plans will need to rebate $800 million to subscribers for going under the 80% individual/small group target.

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