On November 6, 2014, the Senate Appropriations Committee is holding a hearing on the U.S. government response to the Ebola outbreak. This follows an October 24 House Oversight Committee hearing on coordination of a multi-agency response to the Ebola crisis, along with an October 16 House Energy and Commerce Committee hearing on the U.S. public health response to the Ebola outbreak.
CMS is hosting a conference call for inpatient rehabilitation facility (IRF) providers regarding the IRF Quality Reporting Program on October 29, 2014. Specifically, CMS will discuss data collection and submission information for outcome measures related to hospital-onset methicillin-resistant Staphylococcus aureus (MRSA) bacteremia and Clostridium difficile infection (CDI), which IRF providers are required to report to CMS beginning January 1, 2015.
HHS Office of Medicare Hearings and Appeals (OMHA) Hosting Second Medicare Appellant Forum (Oct. 29)
On October 29, 2014, the OMHA is hosting its second OMHA Medicare Appellant Forum. The meeting will update OMHA appellants on the status of OMHA operations and discuss OMHA and CMS initiatives designed to mitigate the Medicare appeals backlog at the OMHA-level of the administrative appeals process. The deadline for in-person registration is October 28, and registration for remote/webinar attendance ends October 24.
On October 23, 2014, CMS is hosting a call on 2013 Quality and Resource Use Reports (QRURs) for physician group practices and physician solo practitioners. The 2013 QRURs contain quality and cost performance data that will be used in determining the applicable Value-Based Payment Modifier for 2015.
The Advisory Panel on Hospital Outpatient Payment will be holding its first semi-annual meeting for 2015 on March 9-10, 2015. The purpose of the Panel is to advise CMS on (1) the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and (2) hospital outpatient therapeutic services supervision issues. Registration will be open January 19 through February 20, 2015. CMS will accept comments and presentations for the agenda until February 6, 2015.
MedPAC is meeting on October 9 and 10, 2014 to discuss a variety of Medicare policy issues, including: international comparison of rates paid to hospitals; sharing risk in Medicare Part D; potentially inappropriate opioid use in Medicare Part D; the next generation of Medicare beneficiaries; private-sector initiatives to manage post-acute care; and validating relative value units in Medicare’s fee schedule for physicians and other health professionals.
HHS Workshop: Integrating Plans for Long-Term Services and Supports & Health Care Delivery through Health IT (Oct. 16)
On October 16, 2014, the Administration for Community Living (ACL) and the HHS Office of the National Coordinator on Health Information Technology (ONC) are holding a public workshop entitled “Putting the Person at the Center: Integrating Plans for Long-Term Services and Supports and Health Care Delivery through Health Information Technology.” The workshop will focus on the use of health information technology to enable a person-centered approach for planning and delivering long-term services and supports and health care, including how to improve communication and collaboration among community-based organizations and health care partners. The agenda includes care planning, technology and integration; key opportunities and challenges; and delivery and payment reform policy levers. The registration deadline for the event is October 10, 2014.
CMS is hosting a call on November 5, 2014 to discuss implementation issues associated with the transition to ICD-10 on October 1, 2015. The call will cover the following topics: final rule and national implementation; Medicare Fee-For-Service testing; the Medicare Severity Diagnosis Related Grouper (MS-DRG) Conversion Project; partial code freeze and annual code updates; plans for national coverage determinations and local coverage determinations; home health conversions; and claims that span the implementation date.
On October 8, 2014, CMS is hosting a call to discuss its plans to begin publicly reporting Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Star Ratings on the Hospital Compare website. CMS intends to begin the HCAHPS Star Ratings reporting in April 2015.
Yesterday the FDA issued final guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which includes recommendations for medical device manufacturers on cybersecurity management and information that should be included in a pre-market submission. The recommendations are intended to supplement previous FDA guidances, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” and “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software.”
In a related development, on October 21-22, 2014, the FDA is holding a public workshop on “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.” Through the workshop, FDA seeks to encourage collaboration among stakeholders, identify challenges, and discuss strategies and best practices for promoting medical device cybersecurity.
On September 17, 2014, CMS is hosting a call on negative payment adjustments that could apply under several Medicare quality reporting programs in 2016. Specifically, the call will offer instructions on how eligible professionals and group practices can avoid the 2016 Physician Quality Reporting System negative payment adjustment, satisfy the clinical quality measure component of the EHR Incentive Program, and avoid the automatic CY 2016 Value-Based Modifier downward payment adjustment.
In an effort to reduce the backlog in Medicare appeals related to certain short-stay hospital claims, CMS is offering an "administrative agreement" providing partial payment to hospitals that drop their appeals. Specifically, CMS would provide a payment equal to 68% of the net payable amount to acute care hospitals or critical access hospitals (CAH) willing to resolve their pending appeals (or waive their right to request an appeal) for inpatient-status claim denials with dates of admissions prior to October 1, 2013, and where the patient was not a Part C enrollee. Such denials involve services that may have been reasonable and necessary, but the contractor contends that treatment on an inpatient basis was not. A hospital may not choose to settle some claims and continue to appeal others, and certain hospitals could be excluded from participating in the settlement based on pending False Claims Act investigations. Also note that PPS-excluded hospitals are not eligible to participate in this program. CMS is encouraging eligible hospitals with such claim denials "to make use of this administrative agreement to alleviate the burden of current appeals on both the hospital and Medicare system." Hospitals should send their request for agreement by October 31, 2014 or request an extension from CMS. CMS is hosting a national provider call on September 9, 2014 to discuss the settlement process.
CMS is hosting ICD-10-CM/PCS Coordination and Maintenance Committee meetings in September to provide a public forum to discuss proposed code changes to the ICD-10-CM and ICD-10-PCS. The meeting scheduled for September 23 will address procedure code issues, while the September 24 meeting is devoted to diagnosis code issues.
This post was written by Jennifer Pike and Vicki Morris
On September 17, 2014 the Food and Drug Administration (“FDA”) is holding a public hearing at the College Park Marriot Hotel and Conference Center, in Hyattsville, MD, to discuss the Agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and its obligations under GDUFA as set forth in the GDUFA Commitment Letter accompanying the legislation. The central purpose of GDUFA is to help speed the delivery of safe and effective generic drugs to the public and to reduce costs to industry. GDUFA requires manufacturers to pay a user fee to supplement FDA’s costs of reviewing generic drug applications and inspecting facilities. Per the GDUFA Commitment Letter, the user fees enable the Agency to reduce a backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.Continue Reading...
CMS Call on Expanded Medicare Prior Authorization for Power Mobility Devices Demonstration (Aug. 12)
CMS is hosting a conference call on Tuesday, August 12, 2014 to discuss its planned expansion of its current demonstration project testing a prior authorization (PA) process for Medicare power mobility device claims. This demonstration was launched on September 1, 2012 in seven states with what CMS describes as “high populations of fraud- and error-prone providers” – California, Illinois, Michigan, New York, North Carolina, Florida, and Texas. CMS now seeks to extend the program to 12 additional states beginning October 1, 2014: Pennsylvania, Ohio, Louisiana, Missouri, Maryland, New Jersey, Indiana, Kentucky, Georgia, Tennessee, Washington, and Arizona. The CMS call is intended to provide an opportunity for suppliers and providers to receive information and ask questions about the expanded demonstration.
On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early- and late- phase clinical trials, and (2) emerging best practices for successful biomarker-based programs (including codevelopment of in vitro diagnostic devices and use of biomarkers as outcome measures in clinical trials). Public input from the meeting will be used to identify opportunities for biomarker-related regulatory guidance, improve understanding and consistency in regulatory review of therapeutic product applications that incorporate biomarkers in clinical trial designs, and identify potential strategies to facilitate scientific exchanges in regulatory and non-regulatory contexts. For more information on the meeting, which is being held in collaboration with Brookings Institution, and for early registration deadlines to attend the live meeting, see the FDA announcement. FDA will also accept comments on this topic through November 5, 2014.
On July 10, 2014, CMS is hosting a national provider call to discuss the new Five Star Rating system that will be added to Dialysis Facility Compare (DFC) in October 2014. Among other things, the call will address the methodology used to calculate the ratings and how to access and preview the ratings. In addition, CMS is holding a provider call on July 16 on the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP), a pay-for-performance initiative that ties a facility's quality scores to payment during a payment year (PY). The call will focus on the preliminary ESRD QIP PY 2015 Performance Score Report, which previews how well facilities scored on the relevant quality measures. Finally, a July 23 call will focus on PY 2017 and PY 2018 ESRD QIP provisions in the upcoming ESRD prospective payment system proposed rule.
CMS is hosting a Special Open Door Forum on June 17, 2014 to provide an overview regarding new Medicare prior authorization initiatives impacting durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers and ambulance suppliers. Specifically, the call will cover the Medicare Expanded Prior Authorization Demonstration for Power Mobility Devices (PMDs) Demonstration, the Hyperbaric Oxygen and Repetitive Scheduled Non-Emergent Ambulance Transport prior authorization models, and a recent proposed rule to require prior authorization for certain DMEPOS.