HHS has not specified if states might be responsible for ongoing exchange costs in situations where the federal government partners with a state on an insurance exchange or runs a federal exchange in lieu of a state exchange, an uncertainty that complicates decisions by states on which exchange model to pursue.

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.

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.

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.

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.

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.

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.

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.

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.

The Generic Pharmaceutical Association is urging Sens. Jeff Bingaman (D-NM) and David Vitter (R-LA) to scrap a an amendment curbing so-called pay-for-delay drug patent settlements, saying the group would no longer support the FDA user fee bill if the provision is added.

HHS officials during a recent meeting revealed additional details on the risk adjustment methodology the department may use when it operates the health law program in states, but cautioned attendees that its intentions are not final policy.

Senate Majority Leader Harry Reid (D-NV) is urging senators to be ready to quickly pass the FDA user fee legislation bill on Monday (May 21), warning that if he is forced to instead hold a cloture vote, debate on the bill could not begin until Wednesday (May 23).

HHS' decision to allow any health plans meeting certification requirements to be deemed qualified health plans in the federally-run exchange disappointed a consumer advocate who had wanted the department to choose an active purchasing exchange, but the decision pleased the insurance industry which has long argued that a “clearinghouse” approach is a better model.

Former Senate Majority Leader and DLA Piper consultant Tom Daschle said Tuesday that diverting money from -- or fully repealing -- the health reform law's Prevention and Public Health trust fund to offset other spending is “extraordinarily shortsighted” and argued that efforts such as combating diabetes should rise above politics and be addressed regardless of the election or the fate of the health law.

The health information industry is urging CMS to firmly reject any efforts by providers to further delay ICD-10 implementation and says the agency should penalize those that don't come into compliance after the proposed year-long implementation delay.

A survey of almost 1,000 hospitals found that 70 percent thought a short-term delay of no more than 12 months would make the transition to ICD-10 easier by giving the providers a chance to handle different and often competing priorities, but the survey also revealed that larger hospitals are having a much easier time with the transition than small hospitals which reported they lacked resources and trained staff to complete the transition.

A key telemedicine industry official said lawmakers are making progress in revamping legislation aimed at curbing illegal online pharmacies to ensure the bill does not affect legitimate telehealth services and online pharmacies' role in medical homes, but cautioned the industry remains concerned that the potential user fee rider could interfere with the doctor/patient relationship.

An updated Senate user fee bill unveiled late Tuesday adds provisions related to mobile medical applications guidance, rare diseases and patient participation in medical product discussions, with further changes expected in a manager's amendment before the legislation hits the Senate floor, a source close to the issue says.

HHS on Wednesday (May 16) released long-awaited guidance on the implementation of a federal fallback exchange that HHS will operate in states that are not ready to operate a completely state-run exchange.

A recent Government Accountability Office report contends that fraud and abuse laws intended to prevent kickbacks and ensure appropriate patient safeguards have a chilling effect on innovative health care delivery and payment reforms focused on financial incentives for quality and efficiency.