News and noteworthy information for November:

• CPT® Editorial Summary of Panel Actions
• 2016 Final Physician Fee Schedule
• 2016 Hospital Outpatient and Ambulatory Surgical Center Final Rule
• AMA Urges DOJ to Block Proposed Insurance Mergers
• Antitrust In Medicine
• National Association of Insurance Commissioners Urges Broader Health Networks
• New Chairmen for House Ways and Means Committee and Health Subcommittee
• Electronic Health Record Program – Meaningful Use
• MACRA Update
• Reauthorization of the Medical Device User Fee Amendments – FDA Hosts Stakeholder Meetings
• The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

 

CPT Editorial Summary of Panel Actions

The CPT® Editorial Panel met in early October in Philadelphia to consider proposals for new and revised CPT® codes. After each Editorial Panel meeting, a document is prepared and posted to the AMA’s website summarizing the actions that were taken by the Panel on each code application. Please note that codes that contain an ‘X’ (e.g., 228X1, 228X4, 630X1) are placeholder codes that are intended, through the first three digits, to give readers an idea of the proposed placement in the code set of the potential code changes. Codes are not assigned, nor exact wording finalized, until just prior to publication. Tabs 14, 15, 16 and 17 are proposals related to spine:

 

 
View the full Summary of Panel Actions here.

 

2016 Final Physician Fee Schedule

On October 30, 2015, the Centers for Medicare and Medicaid Services (CMS) released the final 2016 Physician Fee Schedule (PFS). In the final rule, CMS finalizes RVUs for Calendar Year (CY) 2016 for the PFS and other Medicare Part B payment policies to ensure that CMS payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This is the first PFS final rule since the repeal of the Sustainable Growth Rate formula by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The final rule goes into effect on January 1, 2016. CMS is accepting public comments on the final rule until 5 p.m. EST on December 29, 2015. Submit individual comments to the final rule at http://www.regulations.gov/#!documentDetail;D=CMS-2015-0081-2288 (Note: Click on the blue “Comment Now!” button in the upper right hand corner.)

View the full summary of the 2016 Final Physician Fee Schedule here.

View the RVUs and reimbursements spine code comparison spreadsheet here.

  

2016 Hospital Outpatient and Ambulatory Surgical Center Final Rule

On October 30, 2015, The Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2016 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) final rule. The final rule updates Medicare payment policies and rates for:

• hospital outpatient departments (HOPDs);
• ASCs; and
• partial hospitalization services provided by community mental health centers (CMHCs).

Additionally, the final rule makes refinements to quality reporting programs in these outpatient settings and makes changes to the Two Midnight Rule. The final rule goes into effect on January 1, 2016. CMS is accepting public comments on the final rule until 5 p.m. EST on December 29, 2015. Submit individual comments to the final rule at http://www.regulations.gov/#!documentDetail;D=CMS-2015-0075-0632 (Note: Click on the blue “Comment Now!” button in the upper right hand corner.)

View the full summary of the 2016 Hospital Outpatient and ASC final rule here.

View the APC, relative weights and payment rates spreadsheet for spine procedures in hospital outpatient and ASC settings here.

  

AMA Urges DOJ to Block Proposed Insurance Mergers

On September 8, 2015, the AMA released the 2015 edition of Competition in Health Insurance: A Comprehensive Study of U.S. Markets, which offers the largest and most complete picture of competition in health insurance markets for 388 metropolitan areas, as well as all 50 states and the District of Columbia. The study is based on 2013 data captured from commercial enrollment in HMOs, PPOs and POS plans. Based on the report:

• 70 percent of metropolitan areas had combined commercial markets (HMO+PPO+POS) that are highly concentrated.
• A single insurer had a 50 percent or greater share of the combined commercial market in 14 states and 38 percent of metropolitan areas.
• 46 states had two insurers with at least a 50 percent market share of the combined commercial market.
• The Anthem-Cigna merger would diminish competition in up to 111 metropolitan areas within all 14 states that Anthem currently operates.
• The Aetna-Humana merger would diminish competition in up to 58 metropolitan areas within 14 states.

Based on this information, on November 11, the American Medical Association (AMA) urged the United States Department of Justice to block Aetna’s proposed acquisition of Humana and Anthem’s proposed acquisition of Cigna concluding that the mergers will likely result in higher premiums for patients, a reduction in the quality of health insurance (e.g., less availability of providers, lower consumer service), and lower payment rates for physicians that lead to lower quality or quantity of the services that physicians are able to offer patients (e.g., less investment in newer technology). The AMA also testified twice in September before the House Judiciary Committee, met with key staff from both the US Senate and the House of Representatives and is engaging the National Association of Attorneys General and state Attorneys General to discuss the anticompetitive effects that the proposed mergers would likely have on the nation’s physicians.

Access more information at the following link: http://www.ama-assn.org/ama/pub/news/news/2015/2015-09-08-analysis-anthem-cigna-aetna-humana-mergers.page

 

Antitrust In Medicine

Morgan Lorio, MD, FACS, Chair of ISASS Coding & Reimbursement Task Force

View full article here. 

Article Preview:

“Since 2000, we as U.S.-based physicians have seen a dramatic rise in health system (hospital) and insurer mergers. Just recently, the American Medical Association (AMA) issued a statement to the United States Department of Justice (DOJ) to block the planned mergers of health insurance giants Anthem and Cigna and Aetna and Humana… These proposed insurer mergers will impact the national market as we potentially go from five major private payers to three; the unintended consequences of these mergers have not yet been quantified relative to lost future potential competition.

…Similarly, hospital mergers have expanded rapidly to brace for the impact of insurer mergers and Obamacare. As these combined mergers collide, consumers and providers are crushed in the handshake. The DOJ has never before faced mergers sufficient to destroy competition by merger transactions…. Physicians are already experiencing decreased time with patients, postponement of new equipment or practice expansion and reductions in staff in order to meet practice expenses and EMR documentation while transitioning to new “value based payments.”  Furthermore, physicians are more motivated to seek opportunities outside medicine or to retire early. Physicians must instead become leaders, regain our dignity through sustainable practices and relentlessly advocate for our patients.”

 

National Association of Insurance Commissioners Urges Broader Health Networks

The National Association of Insurance Commissioners (NAIC) is the standard-setting and regulatory support organization in the United States created and governed by the chief insurance regulators from the 50 states, Washington D.C. and five U.S. territories. NAIC is currently working to update its 1996 network adequacy model act which is used as a template to draft/update state statutes which regulate the insurance industry. As part of the update, NAIC is recommending new standards to address complaints from consumers about limited access to doctors and hospitals in health plans sold under the Affordable Care Act. These limited networks of health care providers are becoming a common feature of many new insurance policies offered on the health insurance marketplace/exchange as physicians are increasingly being dropped from insurance networks. These “narrow networks” often do not include the range of providers needed for specialized patient care and patients are increasingly seeing “surprise bills” from insurance companies for services performed by physicians they thought were in-network.

NAIC developed the updated model legislation by engaging stakeholders in an 18-month drafting process. ISASS signed on to an AMA letter to the NAIC urging consideration of the following principles when finalizing the model: require prior approval of networks before health plans are sold; require states to institute measureable quantitative standards for network adequacy; and include stronger protections for tiered networks. NAIC voted at their fall meeting (November 19-22) to approve the model state legislation which provides a template for states to increase regulator oversight of provider networks and require greater health plan transparency.

View the AMA letter here.

View the final draft model legislation here: http://www.naic.org/documents/committees_b_exposure_draft_proposed_revisions_mcpnama74.pdf

 

New Chairmen for House Ways and Means Committee and Health Subcommittee

Representative Kevin Brady (R-TX) has been selected to serve as Chairman of the powerful Ways and Means Committee, where he will oversee tax laws and large entitlement programs, such as Social Security and Medicare. The Committee Chair post became vacant when Representative Paul Ryan (R-WI) was elected to serve as Speaker of the House. Brady is from a solidly Republican district north of Houston and served as Chairman of the Trade Subcommittee until 2013 when he became chair of the Health Subcommittee where he led many of the House Republicans’ efforts to repeal the Affordable Care Act.

Representative Pat Tiberi (R-OH) has been selected to fill the vacancy of Rep. Kevin Brady and will serve as Chairman of the Health Subcommittee of the House Committee on Ways and Means. “I look forward to working with Chairman Brady and other members of the subcommittee to find opportunities to improve the quality, affordability and accessibility of health care, while creating the foundation for a patient-centered health care system for all Americans,” Tiberi said.

 

Electronic Health Record Program – Meaningful Use

On November 2, the American Medial Association sent a letter to members of the U.S. House and members of the U.S. Senate expressing frustration with Stage 3 of the Electronic Health Record Meaningful Use Program and urged Congressional intervention to reform and refocus the Program. The letter was signed by more than 110 state and specialty societies including ISASS.

Letter to U.S. House

Letter to U.S. Senate

On November 5, Rep. Tom Price, MD (R-GA) introduced H.R. 3940, the “Meaningful Use Hardship Relief Act of 2015” which would grant CMS the authority to grant blanket hardship exceptions to physicians, hospitals and other affected providers for 2015.

In order to avoid a penalty under the Meaningful Use program, eligible professionals must attest that they met the requirements for Meaningful Use Stage 2 for a period of 90 consecutive days during calendar year 2015. However, CMS did not publish the Modifications Rule for Stage 2 of Meaningful Use until October 16, 2015 – meaning that by the time eligible professionals were informed of the requirements, fewer than the 90 required days for reporting remained in the calendar year. Physicians are facing significant financial penalties due to this delay, which leaves less than the allotted time to report in this year. The new rules also add additional requirements, leaving physicians no time to upgrade systems and change workflows to meet the new program measures in 2015.

CMS has acknowledged this and has stated in a FAQ document that followed the release of the rule that eligible entities may apply for a hardship exemption if they are unable to attest due to the lateness of the rule.  They have also announced that they will broadly grant these exceptions for 2015. However, the statue requires that hardship exemptions be granted on a case-by-case basis only. This means that hundreds of thousands of eligible professions will be required to apply for exemptions and that CMS will be required to act on each application individually.

It would be both equitable and more efficient for eligible professionals, as well as for CMS, for Congress to allow for an expedited hardship exemption process for participants for the year 2015. CMS has indicated in Congressional staff briefings that it would welcome providing them with the authority to grant a blanket exception for 2015, which would help alleviate a huge administrative burden. H.R. 3940 would grant CMS the authority to grant blanket hardship exceptions to physicians, hospitals and other affected providers for 2015. The link to the full text of the legislation is listed below. Consider reaching out to your congressman to urge them to cosponsor this measure.

Full Text of H.R. 3940

 

MACRA Update

On September 28, the Centers for Medicare and Medicaid Services (CMS) released a Request For Information (RFI) for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). This RFI seeks public comment on Section 101 of MACRA, which:

• Repeals the Medicare Sustainable Growth Rate methodology for updates to the physician fee schedule (PFS) and implements scheduled PFS updates;
• Adds the new Merit-based Incentive Payment System (MIPS) for eligible professionals, sunsets payment adjustments under the current initiatives for the Physician Quality Reporting System, Value-Based Payment Modifier, and the Medicare EHR Incentive Program, and consolidates aspects of those programs into the new MIPS; and
• Promotes the development of Alternative Payment Models (APMs) by providing incentive payments for certain eligible professionals who participate in APMs and by encouraging the creation of additional Physician-Focused Payment Models.

ISASS recently signed on to the AMA letter to CMS recommending ten broad principles CMS should consider when implementing the law.

View the letter here.

 

Reauthorization of the Medical Device User Fee Amendments – FDA Hosts Stakeholder Meetings

FDA will host meetings to discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA), a program which funds a significant portion of its medical device regulatory review activities. MDUFA was passed into law in 2002 under the Medical Device User Fee and Modernization Act and subsequently reauthorized in 2007 under the FDA Amendments Act and in 2012 under the FDA Safety and Innovation Act. The most recent iteration, known as MDUFA III, was intended to dramatically increase the funding for FDA’s Center for Devices and Radiological Health in return for improvements to review times for medical devices.

The statutory authority for MDUFA expires September 30, 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program, and that FDA hold discussions with representatives of patient and consumer groups at least monthly during FDA’s negotiations with the regulated industry. The FDA has convened stakeholder meetings in September and October and has additional meetings scheduled on November 30, December 18, January 11 and February 16 in Silver Spring, Maryland.

More Information can be found at the following link: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm458184.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

  

The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

Posted on November 12, 2015 by FDA Voice

By: Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W.

Article Preview

“Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms. The metrics and assessment tools being developed are key parts of the Case for Quality (CfQ). We are working with a wide variety of stakeholders–including the medical device industry, patients, other governmental and academic colleagues, and payer/provider counterparts–to identify and promote practices that will result in higher quality devices… The outcomes of the CfQ will allow stakeholders to focus resources on activities with the greatest impact on assuring that patients and users receive high-quality devices. This effort brings together metrics, successful quality practices, and our partnerships with stakeholders to promote quality and excellence in the medical device industry. It reflects our commitment to ensuring that devices perform as intended, meeting FDA’s mission of protecting and promoting public health.”

Full Text of Article: http://blogs.fda.gov/fdavoice/index.php/2015/11/the-case-for-quality-working-with-stakeholders-to-improve-the-safety-of-medical-devices-for-patients/?source=govdelivery&utm_medium=email&utm_source=govdelivery