News and noteworthy information for February:
- NGS Issues Final LCD on MIS SIJ Fusion
- Califf Confirmed as FDA Commissioner
- FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings
- President Obama Releases Proposed Budget for FY2017
- Senate HELP Committee Action
- Public-Private Partnership to Develop Health Care Quality Measures
- CMS Extends the Attestation Deadline for the EHR Incentive Programs
- Medicare Final Rule – Reporting and Returning of Self-Identified Overpayments
- Research & Reimbursement Course Scheduled for ISASS16
NGS Issues Final LCD on MIS SIJ Fusion
NGS Medicare, the Medicare Administrative Contractor covering 9.5 million Medicare beneficiaries in Illinois, Minnesota, Wisconsin, Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont recently 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 April 1, 2016.
NGS is the seventh of the eight Medicare Administrative Contractors to provide coverage for MIS SIJ fusion. First Coast Service Options covers the state of Florida and is now the only Medicare Administrative Contractor yet to provide coverage for MIS SIJ fusion.
Califf Confirmed as FDA Commissioner
The Senate voted 89-4 on February 24 to confirm Robert Califf, MD as commissioner of the Food and Drug Administration (FDA). Dr. Califf is a cardiologist and currently serves as FDA’s deputy commissioner of medical products and tobacco. Before joining the FDA, Dr. Califf served as the founding director of the Duke Clinical Research Institute.
Senator Edward Markey (D-MA), Senator Bernie Sanders (I-VT) and Senator Joe Manchin (D-WV) all placed holds on the confirmation vote citing Dr. Califf’s close ties to the pharmaceutical industry and to publicly pressure the FDA to take action on prescription drug prices and to address the opioid epidemic. Earlier in the week, the Senate voted 80-6 to invoke cloture to end the Democratic filibuster clearing the way for a confirmation vote on the Senate floor.
In early February, the FDA announced a broad review of the agency’s policies on opioids and reforms aimed at combatting opioid abuse. The reforms include convening an expert panel before approving any new drug application for an opioid that does not have abuse-deterrent properties; improving access to naloxone and medication-assisted treatment options for patients with opioid use disorders; and strengthening requirements to study a drug after it has come to market.
FDA Looks to Bring Payers to the Table at Device Pre-Submission Meetings
The Regulatory Affairs Professional Society reports that “the US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence gathering with sponsors before clinical trials begin…” (posted to raps.org on 2/23/16; article written by Michael Mezher)
Access the FDA Notice in the Federal Register here.
President Obama Releases Proposed Budget for FY2017
On February 9, President Obama released his $4.1 trillion budget proposal; this begins the budgeting process for fiscal year 2017, which begins October 1. House and Senate budget hearings are currently underway where agency heads present their budget request and answer committee members’ questions. The following provides information on proposed health-related spending:
- CMS – The Centers for Medicare and Medicaid Services is requesting a total budget of $1 trillion for fiscal year 2017—a $20.6 million increase over the enacted budget for FY2016. For FY2017, the Office of the Actuary has estimated that gross current spending on Medicare benefits will total $709.4 billion, with $192.9 billion in gross fee-for-service Part B spending. The proposed FY2017 Medicare budget includes a package of Medicare legislative proposals that will save a net $419.4 billion over ten years through delivery system reform, improving beneficiary access to care, addressing the rising cost of pharmaceuticals, more closely aligning payments with costs of care, and making structural changes that will reduce federal subsidies to high‑income beneficiaries. It is estimated that these proposals, along with tax proposals included in the FY2017 proposed budget, would help extend the life of the Medicare Hospital Insurance Trust Fund by over 15 years.
- FDA – The U.S. Food and Drug Administration is requesting a total budget of $5.1 billion for fiscal year 2017 – an eight percent increase over the enacted budget for FY2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative.
- CDC – The Centers for Disease Control and Prevention is requesting a total budget of $11.8 billion for fiscal year 2017—an $87 million increase over the enacted budget for FY2016. The FY2017 budget request includes an increase of $40 million to expand the ability to detect, respond to, and prevent antibiotic resistant infections across healthcare settings and in the community as well as an increase of $10 million to fully expand efforts to promote opioid prescribing guideline dissemination and uptake.
- NIH – The National Institutes of Health is requesting a total budget of $33.1 billion for fiscal year 2017—an $825 million increase over the enacted budget for FY2016. in FY 2017, NIH will focus on the following priority themes: foundation for discoveries: basic research; the promise of precision medicine; applying big data and technology to improve health; and stewardship to inspire public trust. The budget request includes $33.1 billion to support biomedical research, providing about 10,000 new and competing NIH grants.
Senate HELP Committee Action
On February 9, the Senate Committee on Health, Education, Labor & Pensions (HELP) advanced its biomedical innovation agenda by passing seven bills with bipartisan support. These seven bills along with the bills scheduled for mark up on March 9 and April 6 serve as a companion Senate legislative package to the House’s 21st Century Cures Act. The following bills passed committee on February 9:
- The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030)
- The FDA Device Accountability Act of 2015 (S. 1622)
- The Next Generation Researchers Act (S. 2014)
- The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act (S. 800)
- The Advancing Research for Neurological Diseases Act of 2015 (S. 849)
- The Preventing Superbugs and Protecting Patients Act (S. 2503)
- The Improving Health Information Technology Act (S. 2511)
Public-Private Partnership to Develop Health Care Quality Measures
On February 16, the Centers for Medicare and Medicaid Services (CMS) and America’s Health Insurance Plans (AHIP), the national trade association representing the health insurance industry, announced an agreement on a set of clinical quality measures that will be used to measure physician quality across payer types. The quality measures cover seven broad areas: primary care, cardiology, gastroenterology, HIV and Hepatitis C, medical oncology, obstetrics and gynecology, and orthopedics.
This effort is aimed at streamlining clinical quality reporting for physicians and clinicians who oftentimes report multiple quality measures to multiple payers. CMS, commercial plans, Medicare and Medicaid managed care plans, purchasers, physician and other care provider organizations, and consumers worked together to identify core sets of quality measures that payers have committed to using for reporting as soon as feasible. This announcement is the first from the group, which plans to add more measure sets and update the current measure sets over time.
CMS Extends the Attestation Deadline for the EHR Incentive Programs
The Centers for Medicare & Medicaid Services (CMS) extended the attestation deadline for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs to Friday, March 11, 2016 at 11:59 p.m. ET, from the original deadline of Monday, February 29.
Eligible professionals participating in the Medicare EHR Incentive Program can attest through the CMS Registration and Attestation System. To attest to the EHR Incentive Programs in 2015, eligible professionals may select an EHR reporting period of any continuous 90 days from January 1, 2015 (the start of the 2015 calendar year) through December 31, 2015.
Medicare Final Rule – Reporting and Returning of Self-Identified Overpayments
On February 11, the Centers for Medicare & Medicaid Services (CMS) published a final rule that requires Medicare Parts A and B healthcare providers and suppliers to report and return overpayments by the later of the date that is 60 days after the date an overpayment was identified, or the due date of any corresponding cost report, if applicable. A separate final rule was published in the May 23, 2014 Federal Register that addresses Medicare Parts C and D overpayments. Under this final rule, overpayments must be reported and returned only if a person identifies the overpayment within six years of the date the overpayment was received. This final rule provides that providers and suppliers must use an applicable claims adjustment, credit balance, self‑reported refund, or another appropriate process to satisfy the obligation to report and return overpayments.
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/