Happy Friday the Thirteenth! On the Sunday, the FEHBlog bemoaned the fact that Congress has blocked HHS from issuing a unique patient identifier number. As it stands the IRS plans to use the Social Security Number for that purpose. Modern Healthcare reports that policymakers now are undertaking a related effort.
Federal health information technology policymakers, aided by a number of healthcare IT organizations, will take another stab at achieving industry consensus on how to best match patients to their electronic health records to improve patient safety and care coordination. The goal is to make sure healthcare providers have the right EHR for their patient and aren't mistakenly looking at the record for another person with the same name or birthday.Good luck. Maybe this effort will lead to a resurrection of the patient identifier number.
Monday was the deadline for submitting public comments on OPM's proposed rule on coverage of members of Congress and their official staffs in the health insurance exchanges next year. According to regulations.gov, over 59,000 comments were received. None have been posted yet.
The ACA regulators issued a technical release today (No. 2013-03) on the "Application of Market Reform and other Provisions of the Affordable Care Act to HRAs, Health FSAs, and Certain other Employer Healthcare Arrangements." Back in 1996, HIPAA made medical savings accounts ("MSAs'") available to individuals. Employers and their consultants became jealous of MSAs which allowed individuals to set up accounts to pay for health care. In 2002, the IRS came up with the concept of health reimbursement accounts which could be offered by employers to their employees. However, the account balances would be owned by the employer, not the participant. Shortly thereafter Congress created an MSA analog for employer sponsored plans known as health savings accounts. The balances in those accounts do belong to the participants. HRAs and HSAs teamed up with high deductible plans soon became available and still are available in the FEHBP. This technical guidance came out today because there was a question as to whether HRAs would survive the ACA's market reform prohibiting lifetime or annual benefit caps. This technical guidance explains how to preserve HRA's in the ACA world. Nothing is simple anymore. The guidance also addresses health care flexible spending accounts and employee assistance plans.
According to this Business Insurance article, an upshot of the technical guidance is that employers will not be able to fund an HRA that a retiree could use to obtain subsidized exchange coverage. The technical guidance explains that "An individual is not eligible for individual coverage subsidized by the Code § 36B premium tax credit if the individual is eligible for employer-sponsored coverage that is affordable (premiums for self-only coverage do not exceed 9.5 percent of household income) and that provides minimum value (the plan’s share of costs is at least 60 percent)." As the FEHBlog has noted, a retiree may opt for subsidized exchange coverage in lieu of employer sponsored coverage without have to meet these tests.
The Wall Street Journal has a story today about how the Food and Drug Administration published guidance on Monday to assist generic drug manufacturer in presenting applications to market a generic version of the inhalable asthsma drug Advair. According to the article this guidance may accelerate generic competition with the brand name manufacturer Glaxo Smith Kline when the window for a generic competitor opens in 2016. The article explains that
Many analysts had doubted that generics could hit the market by 2016 because of the difficulty of copying inhaled drugs and confusion about what regulators would require before approving copies.The FEHBlog does not have a problem with the FDA attempting to level the playing field.
Advair combines two drugs in a fine powder inhaled through an intricate device called a Diskus. Few generic companies have the know-how to make complicated inhaled drugs, and even the ones that do have found Advair a tough one to crack.
The stakes for Glaxo are high: Advair had global sales of £5 billion ($8 billion) last year, making up about 20% of Glaxo's global sales of £26.4 billion.
The challenge illustrates an important change in the generics wars. For years, the most profitable drugs—mostly pills made of chemicals—have been fairly easy for generics companies to copy, requiring a straightforward chemical synthesis. But a new wave of blockbusters include more complicated inhaled drugs and others made of complex biological ingredients. Replicating them requires skills that some generics makers don't have.
Also it's worth noting that the GAO just released a report on dental insurance coverage trends from 1996 to 2010.