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Updated Senate User Fee Bill Adds Patient, Rare Disease, Mobile App Provisions

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.

Telemedicine Industry Watches As Lawmakers Tweak Online Pharmacy Bill

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.

AHIMA To CMS: Stand Firm On ICD-10 Date, Penalize Those Not Complying

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.

AHA Survey Shows Hospitals Approve Of CMS' One Year ICD-10 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.

GAO: CMS Quality, Efficiency Incentives Slowed By Fraud And Abuse Laws

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.

CMS Spending Hike In Senate FDA User Fee Bill Offset By Generic Provisions

Provisions included in the Senate FDA user fee bill providing exclusivity for new antibiotics and pediatric drugs would increase direct spending by CMS and other federal health care programs, and increase subsidies for enrollees in health insurance exchanges, but would be offset by other measures, including a provision that would facilitate acquisition of drug samples by generic and biosimilar companies, leading to earlier entry of these products onto the market and thereby reducing spending by federal healthcare programs, according to the Congressional Budget Office.

Talks Continue On Valid Prescription, Track And Trace Measures Prior To User Fee Floor Votes

Lawmakers and stakeholders continue to debate issues related to valid prescriptions and track and trace provisions included in FDA user fee legislation in anticipation that the Senate bill could come to the floor as early as this week and the House could schedule floor action in the next two weeks, but it remains a long shot that the bills will be changed prior to conference, sources say.

Few Differences Remain In Drug Shortage User Fee Provisions, Penalties Unlikely

There are unlikely to be any major changes to drug shortage measures included in user fee legislation moving through the House and Senate -- such as the addition of civil monetary penalties for companies that fail to comply with new mandatory reporting requirements -- but lawmakers will have to hammer out a few differences between the two bills including whether to add biologics to the reporting requirements, require FDA to maintain a list of drugs in shortage and allow hospital systems to repackage medications in shortage situations, a key source says.

CMS Brushes Off OIG's Call To Force Part D Plan Sponsors To Self Report Unusual Pharmacy Billing

CMS has rejected for now the HHS Office of Inspector General's call for the agency to require that Medicare Part D plan sponsors self-report potential fraud and abuse incidents among pharmacies that might merit an investigation, and instead says it is taking several other steps to address questionable pharmacy billing practices.

OIG Report Finds Questionable Billing At Over 2,600 Part D Pharmacies

More than 2,600 pharmacies have questionable billing practices, with the majority of those being independent pharmacies, according to the HHS Office of the Inspector General.

Rx Drug

• Telemedicine Industry Watches As Lawmakers Tweak Online Pharmacy Bill
• Updated Senate User Fee Bill Adds Patient, Rare Disease, Mobile App Provisions
• Talks Continue On Valid Prescription, Track And Trace Measures Prior To User Fee Floor Votes

Medicare

• Daschle, Franken Tout Diabetes Prevention Efforts, Stakeholders Seek Updated USPSTF Proposals
• AHIMA To CMS: Stand Firm On ICD-10 Date, Penalize Those Not Complying
• AHA Survey Shows Hospitals Approve Of CMS' One Year ICD-10 Delay

Medical Devices

• Updated Senate User Fee Bill Adds Patient, Rare Disease, Mobile App Provisions
• Clinical Lab User Fee Measure Could Increase Support For CMS Oversight
• CMS Official Says Industry DME Competitive Bidding Proposal Would Fail

Congress

• Daschle, Franken Tout Diabetes Prevention Efforts, Stakeholders Seek Updated USPSTF Proposals
• Telemedicine Industry Watches As Lawmakers Tweak Online Pharmacy Bill
• Updated Senate User Fee Bill Adds Patient, Rare Disease, Mobile App Provisions

Food Safety

• Hamburg: FDA Food Programs Would Be Hit Hardest By Sequestration
• Food Advocates: FDA Needs To Put Some Programs On 'Backburner' For FSMA
• FDA Offers First Glimpse Into Supplement NDI Enforcement With Warning Letters