News and noteworthy information for January:
- 2016 Physician Fee Schedule Correction Notice
- CGS Finalizes LCD for MIS SIJ Fusion
- FDA Releases Draft Guidance on Public Notification of Medical Device Risks
- Califf Confirmation as FDA Commissioner Garners Opposition
- CMS Announces 2015 PQRS Data Submission Deadlines
- CMS Updates Open Payments Data and Adds New Features to Website
- EHR Incentive Programs
- EHR Hardship Exemption Process
- What’s Next for the EHR Incentive Programs?
- Senate HELP Committee Releases Draft Bipartisan EHR Legislation
- Some Employer Health Plans Lack Outpatient Surgery Coverage
- Research & Reimbursement Course Scheduled for ISASS16
2016 Physician Fee Schedule Correction Notice
On January 11, 2016, the Centers for Medicare and Medicaid Services (CMS) released the 2016 Physician Fee Schedule (PFS) Correction Notice. CMS adjusted some of the RVUs published in the 2016 Final PFS resulting in slight increases or decreases to each CPT code. Additionally, the Medicare conversion factor used to calculate reimbursement rates was reduced from $35.8279 to $35.8043. The impact to the spine codes relates to slight increases/decreases in Practice Expense RVUs and Malpractice RVUs. RVU changes in spine codes from the 2016 Final PFS to the 2016 PFS Correction Notice are detailed in this spreadsheet.
CGS Finalizes LCD for MIS SIJ Fusion
CGS Administrators, LLC, the Medicare Administrative Contractor covering Kentucky and Ohio, finalized its Local Coverage Determination (LCD) for minimally invasive sacroiliac joint fusion (MIS SIJ fusion). The final LCD references ISASS prevalence data and coverage criteria for coverage of MIS SIJ fusion and allows for coverage of the procedure when eight specific coverage criteria have been met. The LCD is effective for services performed on or after February 1, 2016.
FDA Releases Draft Guidance on Public Notification of Medical Device Risks
On December 31, the U.S. Food and Drug Administration (FDA) released draft guidance, “Public Notification of Emerging Postmarket Medical Device Signals”, intended to describe the Agency’s policy for notifying the public about medical device “emerging signals” in order to issue early warnings about device safety risks, even before those concerns have been assessed and validated. The FDA describes “emerging signals” as a newly recognized type of adverse event associated with a medical device, an increase in the severity or frequency of reporting of a known event, new product-product interactions, device malfunctions or patient injuries potentially related to improper device use or design, or a reduction in benefit to the patient.
The FDA will consider multiple factors when evaluating and communicating about medical device emerging signals such as seriousness of the adverse event(s); magnitude of the risk; magnitude of the benefit; strength of the evidence of a causal relationship between the use of a device and the adverse event; anticipated time for completion of initial FDA assessment and development of recommendations; and accuracy and availability of information already in the public domain.
The FDA is accepting public comments on the draft guidance at Regulations.gov until March 29, 2016.
Califf Confirmation as FDA Commissioner Garners Opposition
Four senators have now raised objections to Dr. Robert Califf’s nomination by President Obama to serve as Commissioner of the U.S. Food and Drug Administration (FDA). In November 2015, Senator Lisa Murkowski (R-AK) announced her intent to block the confirmation of Dr. Califf as a means of pushing back against the FDA on its decision to approve genetically engineered salmon for human consumption. On January 25, Senator Edward Markey (D-MA) announced he placed a hold on Dr. Califf’s nomination until the FDA reforms its approval process for opioid painkillers and the following day, Senator Bernie Sanders (I-VT) also announced a hold on the confirmation citing Dr. Califf’s close ties to the pharmaceutical industry and lack of commitment to lowering drug prices. Senator Joe Manchin (D-WV) said he plans to filibuster the nominee sharing Senator Sanders’ concerns with Dr. Califf’s strong ties to the pharmaceutical industry and questioning his ability to tackle the ongoing opioid epidemic.
The Senate Committee on Health, Education, Labor and Pensions has already voted to confirm Dr. Califf as FDA commissioner; the nominee must now be confirmed by a vote of the full Senate. A “hold” is a procedural tool designed to prevent or postpone a nominee from receiving a full confirmation vote on the Senate floor. Although these four senators have raised objections, Califf seems to have broad-based support in the Senate. It has not yet been determined when a confirmation vote will be held in the Senate.
CMS Announces 2015 PQRS Data Submission Deadlines
Data submission for calendar year 2015 Physician Quality Reporting System (PQRS) measures began January 1. Eligible professionals and group practices who report to PQRS using certified EHR technology or an EHR data submission vendor may submit 2015 data through February 29. Those who report using the Group Practice Reporting Option Web Interface may submit data through March 11, and those who report using a qualified PQRS registry or clinical data registry may submit data through March 31. Eligible professionals and group practices must meet PQRS data reporting requirements for 2015 to avoid a 2% payment reduction in 2017.
CMS Updates Open Payments Data and Adds New Features to Website
On January 19, the Centers for Medicare and Medicaid Services (CMS) updated the Open Payments dataset, consistent with the values published on June 30, 2015. The total value before this update was $9.9 billion. The updated Open Payments dataset reflects:
- Changes made to records
- Changes to delays in publication flags
- Changes to disputed records
- Records that were deleted
This financial data was submitted by applicable manufacturers and applicable group purchasing organizations. Every year, CMS will update the Open Payments data at least once to include updates from disputes and other data corrections made since the initial publication of the data. The updates affect all types of payments or transfers of value to physicians and teaching hospitals and physician ownership or investment interests.
Additionally, CMS added new features to the Open Payments Data website including:
- A homepage tool where individuals can search for a doctor by name
- A snapshot of Open Payment facts
- Sections to explore and download data
Visit the Open Payments website to check your profile.
EHR Incentive Programs
EHR Hardship Exemption Process
On January 22, the Centers for Medicare and Medicaid Services (CMS) announced important changes to the Medicare EHR Incentive Program hardship exception process to reduce burden on clinicians, hospitals, and critical access hospitals. These changes are a result of recent legislation, the Patient Access and Medicare Protection Act, which established that the Secretary may consider hardship exceptions for “categories” of eligible professionals, eligible hospitals, and critical access hospitals that were identified on CMS’ website as of December 15, 2015. Prior to this law, CMS was required to review all applications on a “case-by-case” basis.
CMS has posted new, streamlined hardship applications, reducing the amount of information that eligible professionals, eligible hospitals, and CAHs must submit to apply for an exception. The new applications and instructions for a hardship exception from the Medicare Electronic Health Records Incentive Program 2017 payment adjustment are available here.
Importantly, eligible professionals that wish to use the streamlined application must submit their application by March 15, 2016.
In addition, CMS has determined that groups of providers may apply for a hardship exception on a single application. Under the group application, multiple providers and provider types may apply together using a single submission.
What’s Next for the EHR Incentive Programs?
In a blog post released on January 19, CMS Administrator Andy Slavitt and HHS Acting Assistant Secretary Karen DeSalvo provide expanded insight into the future of Meaningful Use. Visit the CMS EHR Incentive Programs website for more information on the programs.
Senate HELP Committee Releases Draft Bipartisan EHR Legislation
On January 20, the Senate Health, Education, Labor and Pensions (HELP) Committee released draft legislation aimed at improving electronic health records. Chairman Lamar Alexander (R-TN) said “the goals of the draft electronic health records bill are decreasing unnecessary physician documentation; enabling patients to have easier access to their own health records; making electronic health records more accessible to the entire health care team, such as nurses; stopping information blocking—or intentional interference with access to personal health information; ensuring the government’s certification of a records system means what it says it does; and improving standards.” The bipartisan legislation is part of a package of bills the committee will consider at markups in February, March and April to serve as companions to 21st Century Cures legislation passed by the House last year.
Some Employer Health Plans Lack Outpatient Surgery Coverage
Jay Hancock with Kaiser Health News reports that after Federal regulators last year said so-called “skinny plans” without inpatient hospital benefits were not compliant with the Affordable Care Act, “insurance administrators and many cost-conscious employers are purporting to meet the rules with a new version that excludes another major category: outpatient surgery. The new plans may not survive regulatory scrutiny any more than the old ones did, some experts believe. Leaving such procedures out of a plan can save money for employers but leave workers with crippling bills.”
Research & Reimbursement Course Scheduled for ISASS16
The ISASS Research Committee and the ISASS Coding & Reimbursement Task Force will host an exciting new session, “The Good, the Bad and the Ugly – Reimbursement in a Value-Based World: A Forum for Surgeons and Industry” at ISASS16 in Las Vegas. The session will take place on Friday, April 8 from 3:30 to 4:30 p.m. and will focus on the linkage between research and advocacy. The chairs of both committees, Dr. Lisa Ferrara and Dr. Morgan Lorio, will moderate the session which will consist of presentations of several research papers and an open discussion focused on the following themes: surgeon work and the valuation of spine procedures; measuring clinical and economic outcomes in spine surgery; use of technology in maximizing patient outcomes and cost effectiveness; harnessing the power of data to build advocacy plans and shape policy; and setting the agenda for the future of spine surgery. Don’t miss out on this informative and timely session at ISASS16.
Register for ISASS16: http://globreg.com/isass2016/