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.
According to the Food and Drug Administration (FDA), additive manufacturing, also known as 3-D printing, is entering mainstream use in medical devices, both as an alternative device production method for traditional components and as a method to create patient-matched devices. FDA has begun to receive submissions using additive manufacturing for medical devices, and the agency sees “many more on the horizon.” As the use of additive manufacturing becomes more widespread, the FDA wants additional information on scientific and technical challenges associated with the use of such technology for medical devices, particularly with regard to process verification and validation to ensure patient safety. To that end, the FDA is hosting a public workshop on October 8 and 9, 2014 entitled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing.'' The meeting is intended to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to explore this issue in detail, including ways to provide a transparent evaluation process for future submissions. The workshop discussion may facilitate development of new draft guidances and/or standards for additive manufacturing of medical devices. Comments on the workshop topic will be accepted until November 10, 2014.
The House Energy and Commerce Committee has scheduled a May 21 hearing entitled “Keeping the Promise: Site of Service Medicare Payment Reforms,” which will focus on two bills that seek to equalize payments between different providers:
- The Medicare Patient Access to Cancer Treatment Act of 2014, which would establish payment parity under the Medicare program for ambulatory cancer care services furnished in the hospital outpatient department and the physician office setting.
- The Bundling and Coordinating Post-Acute Care (BACPAC) Act of 2014, which would provide bundled payments for post-acute care services under Medicare Parts A and B.
The Committee will examine whether such proposals can save money for beneficiaries and the Medicare program without compromising quality of care.
On May 20, the House Ways and Means Health Subcommittee is holding a hearing on current Medicare hospital issues, including the CMS two-midnights policy, short inpatient stays, outpatient observation stays, Recovery Audit Contractor audits, and the appeals backlog.
CMS has announced that the Advisory Panel on Hospital Outpatient Payment (HOP Panel) will hold its summer meeting on August 25-26, 2014. The purpose of the Panel is to advise CMS on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights under the Medicare hospital outpatient prospective payment system. The HOP Panel also advises CMS on hospital outpatient therapeutic services supervision issues. The deadline for presentations is July, 25, 2014, and the meeting registration deadline is August 1, 2014.
On Wednesday, April 30, 2014, the House Ways and Means Committee will focus on “Ideas to Improve Medicare Oversight to Reduce Waste, Fraud and Abuse." On May 1, the House Energy and Commerce Health Subcommittee is holding a hearing on “Telehealth to Digital Medicine: How 21st Century Technology Can Benefit Patients."
CMS is hosting a provider call on May 19, 2014 regarding the Clinical Laboratory Improvement Amendments (CLIA) Individualized Quality Control Plan (IQCP), which is a new, voluntary quality-control option for laboratories performing non-waived testing. The IQCP is intended to provide laboratories with more flexibility in customizing Quality Control (QC) policies and procedures according to test method and use, environment, and personnel competency.
On May 20, 2014, CMS is hosting another call to discuss the National Partnership to Improve Dementia Care in Nursing Homes, which includes as a goal reducing the use of unnecessary antipsychotic medications in nursing homes. This call will focus on efforts to monitor enforcement rates and track surveyor training completion; the role that activity professionals play in the mission to improve dementia care; and nonpharmacologic care approaches.
CMS is hosting a series of Special Open Door Forum calls to solicit feedback on data elements for a new “Suggested Electronic Clinical Template for Home Health.” Specifically, CMS seeks input on a list of clinical elements within a Suggested Electronic Clinical Template that would assist physicians when documenting the home health face-to-face encounter for Medicare purposes. Upcoming calls are scheduled for May 20, June 19, and July 16, 2014.
In early April, Reed Smith hosted an enlightening, industry-leading conference on post-acute care in Washington, D.C. The conference, entitled “Reed Smith 2014 Washington Health Care Conference: Focus on Post-Acute Care," brought together a panel of experts to discuss episodic care, bundling models, and alternative payment and delivery systems. The conference also featured other speakers who presented from the perspective of investors and Capitol Hill, along with a keynote address from American Enterprise Institute resident scholar Dr. Norman Ornstein.Continue Reading...
Reed Smith Hosting Washington Health Care Conference: Focus on Post-Acute Care on April 4, 2014 - One Week Left to Register
On April 4th, 2014, Reed Smith will host its inaugural Washington Health Care Conference at The Mayflower Renaissance Hotel in Washington, D.C. With a keynote from Dr. Norman Ornstein, this year’s conference will focus on post-acute care, bringing together leading industry professionals for a discussion on several important issues, including:
Governing in Polarized America: The Prospects for Policy in 2014 and Beyond (Keynote)
- Dr. Norman Ornstein, Resident Scholar, American Enterprise Institute, and weekly columnist for National Journal and The Atlantic
Policy discussion on episodic care, bundling models, and alternative payment and delivery systems
- Mike Cheek, Vice President for Medicaid and Long Term Care Policy, American Health Care Association
- Judy Feder, Professor, Georgetown University McCourt School of Public Policy, and Urban Institute Fellow
- Dr. Barbara Gage, Fellow, Managing Director, Engelberg Center for Health Care Reform, Brookings Institution
- Dr. Vincent Mor, Ph.D., Florence Pirce Grant Professor of Community Health, Public Health Program, Brown University School of Medicine
Wall Street perspective: the current appetite for deals
- Jay Barnes, Senior Vice President, Healthcare Investment Banking, Jefferies LLC
Hill briefing on Medicare legislation
- Cate McCanless, Senior Policy Advisor, Brownstein Hyatt Farber Schreck
Limited seating is still available for this complimentary program. If you are interested in registering, please email Lindsay Korenich at email@example.com. For more information about this conference, click here.
CMS is holding a public meeting on July 14, 2014 to receive comments on the appropriate basis for establishing payment amounts for new or substantially revised HCPCS codes being considered for Medicare payment under the clinical laboratory fee schedule for 2015. The meeting also provides a forum for those who submitted reconsideration requests regarding final determinations made last year on new test codes.
On April 8, 2014, CMS is hosting a call on how to prepare for the Medicare Shared Savings Program application process for the January 1, 2015 start date. Among other things, the call will cover accountable care organization (ACO) structure and governance, application key dates, and the Notice of Intent to Apply submission process.
On March 6-7, 2014, the Medicare Payment Advisory Commission (MedPAC) is meeting to discuss a number of Medicare payment and policy issues, including: site-neutral payments for select conditions treated in inpatient rehabilitation facilities and skilled nursing facilities; developing payment policies to promote the use of services based on clinical evidence; measuring quality in Medicare delivery systems; payment for primary care; aligning Medicare benchmarks across payment models; and Medicare Advantage risk adjustment.
The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”
Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.” Additional details are available after the jump.Continue Reading...
CMS has announced that it is holding series of meetings in May and June to discuss pending application for the 2015 Healthcare Common Procedure Coding System (HCPCS) update. The dates are as follows:
- May 20 & 21, 2014 -- Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents
- May 28, 2014 -- Supplies and Other
- June 3, 2014 -- Durable Medical Equipment (DME) and Accessories; and Orthotics and Prosthetics (O&P).
Additional information, include preliminary coding determinations, will be posted in advance of each meeting.
The Federal Trade Commission (FTC) has scheduled a workshop on March 20-21, 2014 to examine developments in the U.S. health care industry, including those related to implementation of health care reform legislation and other trends related to cost, quality, access, and care coordination. Specifically, the workshop will address the following five topics:
- Professional Regulation of Health Care Providers -- how accreditation, credentialing, licensure, and scope of practice rules may affect competition and consumers.
- Innovations in Health Care Delivery -- including retail clinics and telemedicine that may offer significant cost savings while maintaining or improving quality of care and expanding consumer access to care.
- Advancements in Health Care Technology – implications of technology such as electronic health care records, health data exchanges, technology platforms for health care payers and providers, and certain other consumer-oriented technological advances.
- Measuring and Assessing Quality of Health Care – how developments in measuring and assessing health quality may impact competition and health care choices.
- Price Transparency of Health Care Services – how improved price transparency impacts costs to consumers and its potential to facilitate price coordination among health care providers.