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.

CMS Call on 2013 Physician Quality and Resource Use Reports (Oct. 23)

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. 

Hospital Outpatient Payment Advisory Panel Meeting (March 9-10, 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 Meeting on Medicare Policy Issues (Oct. 9-10)

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 Call: Transitioning to ICD-10 (Nov. 5)

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.

CMS Call: Hospital Appeals Settlement Update (Oct. 9)

CMS is hosting a call on October 9, 2014 to provide additional information on its proposed administrative agreement for acute care hospitals and critical access hospitals to resolve certain appeals of patient status denials. All administrative agreement requests are due to CMS on October 31, 2014.

CMS Call on Hospital Compare/HCAHPS Star Ratings (Oct. 8)

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.

FDA Releases Final Medical Device Cybersecurity Guidance, Schedules Workshop on Topic

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.

CMS Call: How to Avoid 2016 Negative Payment Adjustments under Medicare Quality Reporting Programs

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.

CMS Offers Settlement to Acute Care Hospitals, CAHs to Resolve Patient Status Denial Appeals

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.

ICD-10-CM/PCS Coordination and Maintenance Committee Meetings (Sept. 23-24)

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.

FDA Public Hearing on the Implementation of Generic Drug User Fee Amendments (Sept. 17)

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.

FDA Meeting on Biomarker Development (Sept. 5)

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.

CMS Plans Series of Calls this Month on Medicare Dialysis Quality Programs

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 Call on Medicare DMEPOS, Ambulance Prior Authorization Initiatives (June 17)

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

Open Payments/Sunshine Act: CMS Registration Overview Call

On June 12, 2014, CMS is hosting a National Provider Call to explain Physician Payment Sunshine Act “Open Payments Program” registration requirements and the upcoming review and dispute process.

FDA Workshop to Focus on 3-D Printing of Medical Devices

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.

House Panel to Consider Bundled Post-Acute Care, Cancer Care Payment Parity Bills

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.

Older Entries

May 14, 2014 — House Panel to Examine Medicare Hospital Issues (May 20)

May 10, 2014 — Next CMS Hospital Outpatient Payment Advisory Panel Meeting Set for August 25-26

April 28, 2014 — Congressional Hearings this Week to Focus on Medicare Fraud, Telehealth

April 22, 2014 — Individualized Quality Control Plan for CLIA Laboratory Non-Waived Testing (May 19)

April 22, 2014 — CMS Call: National Partnership to Improve Dementia Care in Nursing Homes (May 20)

April 18, 2014 — CMS to Host Calls on Electronic Clinical Template for Home Health Orders

April 17, 2014 — Highlights from Reed Smith's Post-Acute Care Conference

March 25, 2014 — Reed Smith Hosting Washington Health Care Conference: Focus on Post-Acute Care on April 4, 2014 - One Week Left to Register

March 25, 2014 — CMS Public Meeting on Clinical Lab Codes (July 14)

March 24, 2014 — CMS Call: Applying for the 2015 Medicare Shared Savings Program (April 8)

March 3, 2014 — MedPAC Meeting to Address Various Medicare Payment Policies (March 6-7)

February 24, 2014 — FDA to Overhaul an OTC System That "Isn't Working"

February 24, 2014 — CMS Sets Dates for 2014 HCPCS Public Meetings

February 18, 2014 — FTC Workshop on Health Care Competition (March 20-21)

February 11, 2014 — CMS to Host "Physician Compare Town Hall Meeting" (Feb. 24)

January 30, 2014 — CMS Call on Partnership to Improve Dementia Care in Nursing Homes (Feb. 26)

January 28, 2014 — CMS Special Open Door Forum on Hospital Inpatient Criteria/2-Midnight Benchmark (Feb. 4)

January 6, 2014 — House Panel to Examine Medicare "Extenders" Policy

January 6, 2014 — Office of Medicare Hearings and Appeals (OMHA) Medicare Appellant Forum (Feb. 12)

January 6, 2014 — CMS Call: ESRD Quality Incentive Program Payments (Jan. 15)

January 6, 2014 — CMS Call: 2-Midnight Benchmark for Inpatient Hospital Admissions (Jan. 14)

December 9, 2013 — CMS Town Hall Meeting on IPPS New Technology Add-on Payments (Feb. 12)

December 9, 2013 — Hospital Outpatient Payment (HOP) Advisory Panel Meeting - March 10-11, 2014

November 25, 2013 — CMS Call on Medicare Physician Quality Reporting in 2014 (Dec. 17)

November 25, 2013 — CMS Call Regarding the Medicare Physician Value-Based Payment Modifier (Dec. 3).

November 13, 2013 — CMS Call on IRF Quality Reporting Requirements (Nov. 14)

November 11, 2013 — CMS Call on Inpatient Hospital Admissions 2-Midnight Policy (Nov. 12)

November 11, 2013 — CMS Special Open Door Forum on LTCH Quality Reporting (Nov. 21)

November 11, 2013 — CMS Update on Medicare IVIG Demonstration (Nov. 22)

October 30, 2013 — CMS Call on Dementia Care in Nursing Homes (Nov. 25)

October 29, 2013 — CMS Call to Discuss Streamlined Access to PECOS, EHR, and NPPES (Nov. 15)

September 24, 2013 — CMS Call on Two Midnight Benchmark for Inpatient Hospital Admissions (Sept. 26)

September 12, 2013 — CMS Call on 2015 Value-Based Payment Modifier (Sept. 24)

August 27, 2013 — CMS Call on Draft Electronic Clinical Template for Lower Limb Prostheses (Sept. 11)

July 29, 2013 — CMS Call: ICD-10 Basics (Aug. 22)

July 29, 2013 — In Advance of Sunshine Act Reporting, CMS Releases Physician & Industry Resources

July 5, 2013 — CMS Call on EHR Incentive Program Clinical Quality Measures (July 23)

July 5, 2013 — CMS Call: PQRS Reporting and the Value-based Payment Modifier (July 25)

June 26, 2013 — HHS Seeks Comments on IRB Assessment of Risks in Standard of Care Interventions Research; Aug. 28 Meeting Scheduled

June 25, 2013 — CMS Call on PQRS Reporting and the Value-based Payment Modifier (July 31)

June 25, 2013 — CMS Call on Improving Dementia Care in Nursing Homes (July 10)

June 6, 2013 — CMS Call on Suggested Electronic Clinical Template for Lower Limb Prostheses (June 13)

June 6, 2013 — CMS Call on PQRS and eRx Incentive Program Payment Adjustment (June 18)

June 6, 2013 — CMS Hosts Calls on Medicare Shared Savings Program Application Process

June 6, 2013 — CMS Call on Medicare and Medicaid EHR Incentive Programs and Certified EHR Technology (June 27)

June 5, 2013 — HHS-Operated Risk Adjustment Data Validation Stakeholder Meeting (June 25)

June 5, 2013 — Advisory Panel on Hospital Outpatient Payment Meeting on August 26-27

June 5, 2013 — House SGR Reform Efforts Continue - Hearing Today

May 30, 2013 — CMS to Host July 10, 2013 Meeting on New Clinical Laboratory Test Payment Determinations

May 11, 2013 — Senate Finance Members Seek Physician Input on SGR Reform

May 8, 2013 — CMS Call on New Medicare Data Portal (May 16)

May 3, 2013 — CMS Sunshine Act Update: Covered Teaching Hospitals Listing, Industry Efforts, CMS Provider Call

April 15, 2013 — PCORI Comparative Effectiveness Data Infrastructure Event (April 23)

April 15, 2013 — CMS Meeting on Billing and Coding with Electronic Health Records (May 3)

April 8, 2013 — CMS Call: ESRD Low-Volume Payment Adjustment (April 24)

March 25, 2013 — CMS Call on Transitioning to ICD-10 in 2013 (April 18)

March 25, 2013 — CMS Call: PQRS Group Practice Reporting Option and Registry Reporting (April 16).

March 25, 2013 — CMS Call on Medicare Shared Savings Program Application Process (April 9 & 23)

March 13, 2013 — Implementation of Medicare Ordering/Referring Provider Edits (March 20 Call)

March 8, 2013 — CMS Call: "2013 PQRS and eRx Claims-Based Reporting Made Simple" (March 19)

March 8, 2013 — CMS Call: ESRD Quality Incentive Program (March 13)

March 8, 2013 — National Provider Call: Hospital Value-Based Purchasing FY 2015 Overview (March 14)

February 18, 2013 — CMS Announces Dates for 2013 HCPCS Public Meetings

February 18, 2013 — ICD-9-CM Coordination and Maintenance Committee Meeting (March 5, 2013)

February 15, 2013 — CMS Call: How to Avoid a 2014 eRx and 2015 PQRS Payment Adjustment (Feb. 19)

February 14, 2013 — March Meeting of the Advisory Panel on Hospital Outpatient Payment (March 11, 2013)

January 23, 2013 — CMS to Host Call on Future Development of the Quality Improvement Organization (QIO) Program (1/24)

January 14, 2013 — CMS Call to Focus on Improving Dementia Care in Nursing Homes (Jan. 31)

January 11, 2013 — CMS Call on Meaningful Use Stage 1 & 2 (Jan. 16)

January 11, 2013 — Access Board Committee to Meet on ACA Medical Diagnostic Equipment Standards (Jan. 22-23)

January 11, 2013 — FDA To Hold Workshop on Accessible Standardized Medical Device Labeling (April 29-30)

December 14, 2012 — PQRS and eRx Incentive Program National Provider Call (Dec. 18)

December 14, 2012 — CMS Call on ACA Medicare DSH Payment Provisions (Jan. 8, 2013)

December 5, 2012 — House Panel Schedules Hearing on Implementation of ACA's Exchanges and Medicaid Expansion (Dec. 13)

December 3, 2012 — CMS Medicaid Drug Pricing Webinar: Draft Federal Upper Limits and Draft Survey of Retail Prices (Dec. 5)

November 29, 2012 — CMS Schedules Feb. 5 Meeting on FY 2014 IPPS New Tech Add-on Applications

November 28, 2012 — Upcoming FDA Public Meeting: Framework for Pharmacy Compounding/State and Federal Roles (Dec. 19)

November 12, 2012 — MACPAC Meeting on Medicaid Policy Issues (Nov. 15)

November 12, 2012 — Meeting on ACA Medical Diagnostic Equipment Access Standards (Dec. 3-4)

October 31, 2012 — MedPAC Meeting on Medicare Policy Issues (Nov. 1-2)

October 15, 2012 — CMS Calls on IRF, LTCH Quality Reporting (Oct. 18)

October 15, 2012 — CMS Provider Call: PQRS Informal Review (Oct. 23)

October 11, 2012 — OIG to Host "Outlook 2013" Webcast (Oct. 24)

October 10, 2012 — IRS Schedules Hearing on Proposed Rules for Charitable Hospitals (Dec. 5)

October 8, 2012 — CMS Call on Medicare Provider Enrollment (Oct. 10)

September 27, 2012 — FDA Meetings on Patient-Focused Drug Development Initiative

September 25, 2012 — CMS Call: Manual Medical Review of Therapy Claims (Sept. 26)

September 24, 2012 — CMS Call: Preparing Physicians for ICD-10 Implementation (Oct. 25)

September 24, 2012 — CMS Call: Hospital Value-Based Purchasing for FY 2013 (Oct. 4).

September 24, 2012 — National Provider Call: Physician Quality Reporting System and E-Prescribing Incentive Program (Sept. 25)

September 24, 2012 — CMS Call on Medicare Prior Authorization for Power Mobility Devices Demonstration (Sept. 26)

September 24, 2012 — CMS to Host ASC Quality Reporting Webinar (Sept. 26)

September 12, 2012 — CMS Monthly Calls on ACA Provider Issues - Medicaid Expansion Call on Sept. 13

September 5, 2012 — CMS Call: Stage 2 Requirements for the Medicare/Medicaid EHR Incentive Programs (Sept. 13)

September 4, 2012 — PCORI Workshops on Research Topic Selection

September 4, 2012 — MedPAC Meeting on Medicare Policy Issues (Sept. 6-7)

August 31, 2012 — CMS Open Door Forum on Manual Medical Review of Therapy Claims (Sept. 5)

August 16, 2012 — IRS Schedules Nov. 9, 2012 Hearing on ACA Branded Prescription Drug Fee

August 16, 2012 — CMS Call to Focus on ACO Educational Opportunities (Aug. 27)

August 16, 2012 — CMS Forum on LTCH Quality Reporting (Aug. 30)