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IRS Punts On 'Families Glitch' In Final Premium Tax Regulation

The IRS on Friday revealed that it would issue future regulations detailing whether the family members of a worker whose employer offers health insurance benefits that meet the affordability threshold for self-only coverage would be eligible for advanced premium tax credits, punting on an issue that has received from key congressional Democrats and family advocates. An advocate, however, says that while the agency's regulations leave this issue open, the IRS appears to be “moving it the right direction.”

mHealth Regulatory Coalition, FDA Oppose Mobile App User Fee Measure

Companies developing mobile medical applications, FDA and other stakeholders have come out against a last-minute addition to the Senate user fee bill that would require an outside working group report to Congress on a proposed regulatory framework for health information technologies before FDA could issue final mobile medical application guidance. The mHealth Regulatory Coalition, Qualcomm and FDA all said on Friday that they do not support the Senate measure that they contend would put a de facto 18-month moratorium on FDA issuing long-awaited final guidance on mobile medical applications, and as a result would crush innovation and growth in this area.

CMS Rejects OIG's Call To Audit 1,700 Docs' E&M, Targets Top Billers

CMS says an Office of Inspector General proposal that the agency audit almost 1,700 physicians tagged by the OIG as billing evaluation and management services at consistently complex, and therefore expensive, levels, likely would not produce a high enough return on Medicare Audit Contractors' investment, and the agency instead has asked its contractors to target the top 10 billers in their jurisdictions.

CMS To Unveil E&M Comparative Billing Report In June, Eyes More Billing Reports

CMS will issue a comparative billing report June 4 addressing 5,000 providers' evaluation and management services, and the agency told the Office of the Inspector General that the report will include 1,700 physicians tagged in a recent OIG report as billing for the most complex, and therefore most expensive, E&M services more than 95 percent of the time. CMS conducted the comparative billing study instead of asking its contractors to conducts claims reviews of all 1,700 physicians, and may increasingly conduct such Medicare billing studies in other areas.

FDA Turns To Risk-Based Plan, New Office To Set Food Priorities Due To Resource Limits

FDA food center chief Mike Taylor said the agency is turning to a risk-based approach to set food safety priorities in the face of an enormous set of mandates outlined in the food safety law and limited resources to implement both the law and work on other food and veterinary medicine programs. He also said a new office of resource planning and strategic management will help strategically plan food and veterinary medicines budgets and IT priorities, but stressed that FDA still needs more resources to implement the food law.

CMS Warns Part D Plans Not To Transfer Prescriptions Without Consent

At the urging of retail pharmacies, CMS sent a warning notice to all Part D plan sponsors reminding them not to transfer beneficiary prescriptions to plan pharmacies, which are often mail order pharmacies, without express written consent from the beneficiary.

Holtz-Eakin Latest To Criticize MA Star-Rating Bonus Demonstration

The Medicare Advantage star-rating program does not encourage plans to improve their performance, reduces the number of plans, steers plans toward standards that do not necessarily meet seniors' needs and hurts the poor, according to a report by the American Action Forum.

Consumer Groups Focus On Implantable Devices In Final User Fee Push

As FDA user fee bills head to the full House and Senate, consumer and safety advocates are focusing their lobbying efforts on convincing lawmakers to add provisions that would institute additional safeguards for implantable medical devices, including measures that would reduce the number of products cleared through the 510(k) process, while acknowledging that limiting the use of recalled devices as predicates for new device clearances is not likely to be included in user fee legislation.