OVERNIGHT HEALTH: Smooth sailing — so far — for FDA bill

The pharmaceutical industry is pleased with the Senate bill, and an industry official said the process as a whole has gone swimmingly. The official said industry, the FDA and lawmakers all signed on to an early, bipartisan process, which they hope will prevent election-year politics from bogging down a bill that ultimately has to pass. Healthwatch has more on the bill’s surprisingly smooth path.

Pre-ACA, care was declining: Access to healthcare declined for U.S. adults in the decade leading up to the passage of the Affordable Care Act, a study found, prompting concerns that the trend will continue should the Supreme Court strike down the law. The study, conducted by researchers at the Urban Institute and published in the May edition of Health Affairs, described rising healthcare costs and pressure on Medicaid among the reasons for the decline in access.

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"If the key coverage provisions in the bill are ruled unconstitutional or repealed," researchers wrote, "projections indicate that the numbers of uninsured people will grow. ... Given what we observed over the past decade, we would be likely to see further deterioration in access to care for all adults — uninsured and insured alike."

AdvaMed wants exception: The IRS should treat medical devices differently from other products as it implements the Affordable Care Act’s device tax, the industry’s leading trade group said Monday. The IRS normally taxes products based on their sticker price, but the Advanced Medical Technology Association (AdvaMed) urged the IRS to subtract rebates and other discounts for medical devices.

AdvaMed said it “appreciates the likely reluctance of the IRS” to set different rules for the device industry, but argued that rebates and other discounts are especially common in the device industry. Companies can subtract rebates when they calculate their income taxes, AdvaMed said in formal comments to the IRS, so the same rules should apply for the new excise tax.

DOJ touts pharma bust: The Department of Justice (DOJ) announced that a global pharmaceutical company called Abbott Laboratories will pay $1.5 billion to resolve criminal and civil investigations into its practice of falsely advertising a drug to elderly dementia patients.

DOJ called the settlement the second-largest ever by a drug company.

Abbott had marketed its drug Depakote in nursing homes as a means for controlling agitation, aggression and schizophrenia when none of these uses had been approved by the FDA. The medication's only approved uses are for epileptic seizures, bipolar mania and migraine prevention.

The company maintained a special sales force for the effort, according to a press release.

"Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud," said James Cole, deputy attorney general, in a statement. 

HSA plans tied to savings:
Market-driven health plans could help the U.S. healthcare system save up to $57 billion annually if they were more widely adopted, according to a new study from RAND Corp. Study authors cautioned, however, that the reduction in enrollees' use of preventive services under the plans could lead to poorer health in the future.

Enrollees were found to "initiate healthcare less often and … receive fewer or less costly health services," according to study co-author Neeraj Sood, a RAND economist. The RAND study was the most comprehensive to date looking at consumer-directed health plans, which account for about 13 percent of all healthcare coverage provided by employers.

"Consumer-directed health plans can clearly have a significant impact on costs, at least in the short term," study leader Amelia Haviland said. "What we don’t yet know is whether the cutbacks in care they trigger could result in poorer health or health emergencies down the road."

Healthwatch's story is here.

Obesity epidemic to continue: A forecast released Monday shows that obesity in the United States will have risen by 2030, though not by as much as experts once predicted. The research, led by Duke University, predicted both a general leveling off, as well as an increase in instances of severe obesity, which is expected to double during the same time frame.

"We still have a very serious problem," Dr. William Dietz of the Centers for Disease Control and Prevention (CDC) told an audience at a major CDC meeting.

Some estimate that obesity-related health issues account for at least 9 percent of U.S. annual health spending, according to The Associated Press.

Pharmacies vs. benefit managers:
A new ad battle began this week between community pharmacies, who are pushing their agenda on Capitol Hill this week, and pharmacy benefit managers (PBMs). PBMs are arguing that their business model keeps drug costs low, while the National Community Pharmacists Association (NCPA) is touting the 340,000 U.S. jobs it says its member businesses provide.

The NCPA also criticized the Federal Trade Commission for approving a merger between two of the three largest U.S. PBMs — Express Scripts and Medco — saying that the organizations' "windfall profits will soar even further" as a result. A major PBM group had an answer in a new ad: "It's the drugstore lobby versus employers in the fight to reduce prescription drug costs," the Pharmaceutical Care Management Association (PCMA) stated.

Both organizations have new print or online advertisements out this week.

Read more from Healthwatch here.


Tuesday's agenda

The Energy and Commerce subcommittee on Health will mark up legislation reauthorizing FDA user fees. 

Health and Human Services Secretary Kathleen Sebelius will deliver remarks at a Public Service Town Hall at 9 a.m. Also speaking will be Transportation Secretary Ray LaHood and Secretary of Homeland Security Janet Napolitano.

Sebelius and Richard Gilfillan, director of the CMS Innovation Center, will make an announcement related to the 2010 healthcare law at 2:30 p.m.

The National Community Pharmacists Association will hold its second day of events at the Hyatt Regency on Capitol Hill. Among the speakers to address the group will be Sens. Jerry Moran (R-Kan.) and Sherrod Brown (D-Ohio), and Reps. Dave Camp (R-Mich.), Aaron Schock (R-Ill.) and Frank Pallone Jr. (D-N.J.). Hill staff will also be present on several panels.


State by state

The Kansas House is considering a bill creating a conscience exemption for pharmacists who don't want to fill prescriptions for contraception, the Lawrence Journal-World reports

Lawmakers in Alabama are struggling to nail down their next Medicaid budget, The Birmingham News reports.

A bill in New Hampshire would remove the term "mentally defective" from statutes describing certain victims of rape, The Associated Press reports.


Lobbying registrations


Ferguson Strategies / Celgene Corporation


Reading list

Acting CMS Administrator Marilyn Tavenner identified the agency's priorities in a speech to hospital executives, Modern Healthcare [registration required] reports.

The FDA could recommend at-risk populations take an HIV drug as a means of warding off the virus, which causes AIDs, The Wall Street Journal reports.

"Virtual" doctor visits are on the rise, Kaiser Health News reports.


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