Health plans newly created or significantly amended after Sept. 22 will have to adhere to a new federal appeals process that allows consumers to challenge initial claims denials/rescissions. The U.S. Departments of Health and Human Services (HHS), Labor, and the Treasury issued an interim final rule July 23 for group health plans and health insurance issuers under the Patient and Affordable Care Act.

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The U.S. Department of Health and Human Services (HHS) announced July 29 that states may now apply for their share of $51 million in grant money to establish health insurance exchanges (HIEs). HHS also is requesting public comment as the agency develops the rules and standards HIEs should be required to meet. Read more »

The U.S. Department of Health and Human Services (HHS) announced July 29 that it is temporarily withdrawing the Breach Notification for Unsecured Protected Health Information final rule from administrative review. “Given the Department’s experience to date in administering the regulations,” HHS said, further consideration has been deemed necessary.  Read more »

Last year, approximately 162 million doses of the H1N1 vaccine were distributed and roughly 90 million were administered. What happened to the remaining 72 million doses? The federal government estimates that as many as 40 million of those vaccines have expired, and the rest are sitting in cold storage somewhere.

Under the government’s Voluntary Central Vaccine Recovery Program, physicians in May were allowed to ship expired H1N1 vaccine doses, free of charge, to a facility contracted with the U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). Physicians will get another chance to unload their expired vaccines sometime this fall, the CDC said.

As for H1N1 vaccines that haven’t expired, physicians should hold on to them until sufficient quantity of the 2010-2011 seasonal vaccine is available, HHS spokesman Bill Hall said. These doses can still be used in patients at high risk for contracting the virus, such as those traveling to the Southern Hemisphere, according to the CDC.

CDC’s Advisory Committee on Immunization Practices (ACIP) recommends that for the 2010–2011 flu season, children aged 6 months to 8 years who did not receive any doses of a monovalent 2009 influenza A(H1N1) vaccine should receive two doses of a 2010-11 seasonal influenza vaccine, regardless of previous influenza vaccination history.

The 2009 H1N1 virus, which was first identified April 2009, will be included in the 2010-2011 seasonal influenza vaccine starting this fall, according to the Food and Drug Administration (FDA).

The World Health Organization (WHO) has recommended that the Northern Hemisphere’s 2010–2011 seasonal influenza vaccine contain the following three vaccine viruses:

• an A/California/7/2009 (H1N1)–like virus,
• an A/Perth/16/2009 (H3N2)–like virus, and
• a B/Brisbane/60/2008–like virus.

Approximately 170 million doses of seasonal flu vaccine expected to be available in the United States this year should begin shipping sometime in late September, according to an ACIP June 2010 meeting presentation.

The first 1 million doses of smallpox vaccine were delivered to the Strategic National Stockpile (SNS), according to a U.S. Department of Health and Human Services (HHS) July 14 press release. The Danish manufacturer, Bavarian Nordic, is expected to deliver another 19 million doses sometime between now and 2013 as part of a BioShield contract administered by the Biomedical Advanced Research and Development Authority (BARDA), a part of the HHS Office of the Assistant Secretary for Preparedness and Response.

The modified Vaccinia Ankara (MVA) or Imvamune is intended for use in people who have weakened immune systems in the event of an emergency, such as a bioterrorism attack.

Bavarian Nordic, awarded the $505 million contract in 2007, is reportedly developing a freeze-dried version of Imvamune, which the company says may have an improved shelf life, reduce storage costs, and simplify transportation logistics.

In other news, the Assistant Secretary for Preparedness and Response announced July 13 a $54 million multiple year contract with Emergent BioDefense Operations Lansing (EBOL), for the domestic development of the anthrax vaccine in the company’s Lansing, Mich. facility. If product is licensed, according to a MedicalCountermeasures.gov press release, the manufacturing capacity for anthrax vaccine will increase multifold.

Sources: HHS July 14 press release, Medical Counter Measures July 13 press release

South Weymouth, Mass. South Shore Hospital reported July 19 a massive security breach conceivably affecting some 800,000 individuals—including patients, physicians, employees, donors, volunteers, and vendors. Back-up computer files containing 14 years’ worth of personal health and financial information were lost while in transit to a data management company hired to destroy them.

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The U.S. Department of Health and Human Services (HHS) announced July 8 proposed regulations under the Health Insurance Portability and Accountability Act (HIPAA) that are intended to further strengthen the privacy of personal health information (PHI).

“The benefits of health IT can only be fully realized if patients and providers are confident that electronic health information is kept private and secure at all times,” said Georgina Verdugo, HHS Office for Civil Rights (OCR) director at HHS.

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The U.S. Department of Health and Human Services’ (HHS) updated July 7 HealthCare.gov’s Hospital Compare website with quality data on the rates of outpatient magnetic resonance imaging (MRI) for low back pain, outpatient re-tests after a screening mammogram, and two ratios that explain how frequently outpatient departments gave patients “double” computed tomography (CT) scans “when a single scan may be all that is needed.”

“This new update to CMS’ Hospital Compare feature will help patients and their families better compare quality at America ’s hospitals. And thanks to this new update this year,  for the first time, Medicare patients can see how efficiently facilities use certain types of imaging equipment and keep them safe from exposure to potentially harmful radiation that may not be necessary,” said HHS Secretary Kathleen Sebelius. Read more »

The U.S. Department of Health and Human Services (HHS) announced July 1 the establishment of a new Pre-existing Condition Insurance Plan (PCIP) that offers coverage to uninsured Americans who have been unable to obtain health coverage because of a pre-existing health condition.

The PCIP will provide a new health coverage option for Americans who have been uninsured for at least six months, have been unable to get health coverage because of a medical condition, and are a U.S. citizen or are residing in the United States legally.

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Office of Inspector General (OIG) audit and investigative activity between Oct. 1, 2009 and March 31, 2010 resulted in expected recoveries amounting to approximately $3.1 billion, according to the agency’s Semiannual Report to Congress.

This dollar amount is considerably lower than the $20.97 billion the OIG said it expected to recover in its Semiannual Report to Congress for the period of April 1, 2009 through Sept. 30, 2009. Read more »