06 Sep Weekly E-bulletin

FDA Bans 40 Percent of Antibacterial Soaps

The FDA last week banned the sale of soaps containing certain antibacterial chemicals, saying industry had failed to prove they were safe to use over the long term or more effective than using ordinary soap and water. In all the F.D.A. took action against 19 different chemicals and has given industry a year to take them out of their products. About 40 percent of soaps — including liquid hand soap and bar soap – contain the chemicals. Triclosan, mostly used in liquid soap, and triclocarban, in bar soaps, are by far the most common. Click here for the FDA announcement. Click here for the NY Times report.

California OKs “Surprise” Medical Costs Bill To Protect Patients; Other States Considering

California lawmakers have approved legislation to protect patients from surprise medical bills and the Governor is expected to sign it. The contentious bill would mean patients only had to pay in-network rates if, for example, they had a surgery covered by insurance but were put under by an out-of-network anesthesiologist. There wasn’t a single dissenting vote in the state assembly. Click here for more information.

Former CMS Chief Recommends MACRA Changes

As Congress gets back to work this week, there is growing interest in the new physician payment formula (MACRA) and whether CMS will delay its implementation from its January 1 starting date.　 Many physician and other health care organizations have called for at least a six month delay and offered numerous recommendations for changing the proposal.　 Some of the most interesting changes are recommended by former CMS administrator　Mark McClellan and fellow researchers at Duke’s health policy center in the latest edition of Health Affairs. Click here.

Health Exchange Rule Changes Would Account for Rx Costs

CMS last week issued a proposed rule to govern how Obamacare exchanges will operate in 2018. The proposal would change Obamacare’s risk adjustment program to account for prescription drug data. Currently, the government determines which plans have sicker enrollees, and thus should receive assistance, based on claims data.　 The proposed change will likely be seen as a win by insurers and drugmakers that have argued that insurance plans will be more accurately paid based on the health status of their enrollees if the cost of prescription drugs is taken into account. . Click here for the CMS fact sheet. Click” here”:http://http://s3.amazonaws.com/public-inspection.federalregister.gov/2016-20896.pdf for the proposed rule.

• Health exchanges could be in trouble.　 Click here for a NY Times report on what could be done to fix them.

House Committee Launches EpiPen Investigation; Manufacturer to Offer Generic

The House Oversight Committee has launched an investigation into the pricing of Mylan’s EpiPen by sending letter to Mylan requesting company documents by Sept. 12, stating that the company has a “virtual monopoly” on the auto-injector used to treat severe allergic reactions. The Committee also asked the company for a committee briefing on the issue. Mylan also announced that it would offer a generic alternative at half the current cost of $600. Click here for the Committee letter and here for Mylan’s announcement.

HHS Awards $53 Million to Combat Opioid Abuse in U.S.

HHS announced last week that it has awarded $53 million throughout the United States to combat prescription opioid and heroin abuse. The grants to 44 states, the District of Columbia and four tribal entities come from both the Substance Abuse and Mental Health Services Administration and the Centers for Disease Control and Prevention. Click here to see where the funds are going.

• Nurses in Boston are playing an increasingly direct role in the managing the opioid abuse epidemic. Click here.

FDA Announces New Label Requirements for Opioids

FDA announced class-wide drug labeling changes that require boxed warnings and patient-focused medication guides for prescription opioid analgesics, opioid-containing cough products and benzodiazepines with information about the risks associated with using these medications at the same time. The number of patients prescribed both an opioid analgesic and benzodiazepine increased by 41 percent between 2002 and 2014, according to FDA. For more from FDA, click here.

Prescription Drug Monitoring Varies by State; Opioid Use Impacted

Prescription drug monitoring programs (PDMP) aimed at reducing doctor shopping by opioid users varies tremendously in each state, according to a new Pew analysis. The data may help explain why the computerized prescription registries have yet to significantly cut opioid abuse. For example, besides Mississippi, only five states – Tennessee, Kentucky, Delaware, Maine and New York – had more than 80 percent of prescribers enrolled in the system, while fewer than 20 percent were enrolled in Nebraska, Texas, California, Wisconsin, Maryland, Connecticut and Florida. There were no data from 10 states and Washington, D.C. To read the report, click here.

CDC Declares Sepsis a Medical Emergency

The CDC has released a report saying sepsis is a medical emergency that requires prompt diagnosis and treatment, and noting that 80% of cases originate outside of the hospital and 72% of patients with sepsis have chronic diseases demanding regular medical care. Children younger than 1, adults over 65, and patients with chronic conditions or weakened immune systems are particularly at risk.　 Click here here for the CDC report.　 Click here for the Washington Post story.

House Committee Announces Hearing on CMMI

The House Budget Committee will hold a hearing on Sept. 7th on CMS’ Center for Medicare and Medicaid Innovation (CMMI). In the Committee’s media advisory, they questioned whether the center exceeded its legal authority in the design of recent payment tests, citing specific concerns about mandatory participation in certain programs. Announced witnesses include the Congressional Budget Office, think tanks, and physician groups. Click here for more from the Committee.

IRF and LTCH Quality Reports Available

Inpatient Rehabilitation Facility (IRF) and Long-term Care Hospital (LTCH) Quality Reporting Program (QRP) Provider Preview Reports are available until September 30, 2016 for review by facilities. Performance data can be reviewed on each quality measure prior to public display on the IRF Compare or LTCH Compare websites. Corrections to the underlying data will not be permitted during this time. However, facilities can request a CMS review during the 30-day preview period if they believe the data is inaccurate.? Click here the IRF page and here for the LTCH page.

Some Medicare Advantage Plans Overcharged the Government: Study

More than three dozen just-released audits reveal how some private Medicare plans overcharged the government for the majority of senior patients that they treated, often by overstating the severity of certain medical conditions, such as diabetes and depression. Through a Freedom of Information Act lawsuit, the federal audits of 37 Medicare Advantage programs reveal overpayments from 2007. In 2014, Medicare paid the health plans more than $160 billion. For more from the Center for Public Integrity, click here.

FDA To Review “Off-Label” Use of Drugs, Devices

The FDA has announced it will hold a meeting Nov. 9-10, to solicit feedback about how drug and device companies communicate information about the unapproved uses of their products. FDA only lets companies promote their products by using information on the FDA-approved label, even though health care providers can legally treat patients with a drug or device for an “off-label” use. Click here more information on the meeting.