A&B Healthcare Week in Review, May 27, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• The Department of Health and Human Services (HHS) issued an updated Agency Rule List for Spring 2016. Among other things, the updated Rule List indicates that the expected release dates for several proposed and final regulations related to 340B have been delayed. The Rule List also includes a few new proposed rules that had not previously been listed in the Unified Agenda, including a proposed rule on Patient Medication Information. Additionally, the Rule List provides a “Final Action” date of March 2019 for the Centers for Medicare & Medicaid Services’ (CMS) Part B Drug Payment Model final rule. However, CMS has told reporters that the Agency has “not announced a change in timing and we continue to review comments.” Other CMS officials told reporters that the “Final Action” listed in this case reflects the statutory deadline for a final rule, not the expected timeframe by which the Agency intends to issue a final rule.
• On May 24, 2016, the Agency for Healthcare Research and Quality (AHRQ) published guidance entitled Patient Safety and Quality Improvement Act of 2005: HHS Guidance Regarding Patient Safety Work Product and Providers’ External Obligations. According to AHRQ, this guidance sets forth guidance for patient safety organizations (PSOs) and providers regarding questions that have arisen about the Patient Safety and Quality Improvement Act of 2005 and its implementing regulation. In particular, this guidance is intended to clarify what information that a provider creates or assembles can become patient safety work product (PSWP) in response to recurring questions. This guidance also clarifies how providers can satisfy external obligations related to information collection activities consistent with the Patient Safety Act and Patient Safety Rule. The guidance is effective as of the date of publication.
• On May 24, 2015, the Department of Veterans Affairs (VA) issued a proposed rule entitled Advanced Practice Registered Nurses. The VA is proposing to amend its medical regulations to permit full practice authority of all VA advanced practice registered nurses (APRNs) when they are acting within the scope of their VA employment. According to the VA, the proposed rulemaking would establish additional professional qualifications an individual must possess to be appointed as an APRN within VA. The proposed rulemaking would subdivide APRN's into four separate categories that include certified nurse practitioner, certified registered nurse anesthetist, clinical nurse specialist, and certified nurse-midwife. The proposed rulemaking would also provide the criteria under which VA may grant full practice authority to an APRN, and define the scope of full practice authority for each category of APRN. VA intends that the services to be provided by an APRN in one of the four APRN roles would be consistent with the nursing profession's standards of practice for such roles. Comments must be received by VA on or before July 25, 2016.
• On May 25, 2016, CMS issued a transmittal entitled Notice of New Interest Rate for Medicare Overpayments and Underpayments -3rd Qtr Notification for FY 2016 (R267FM). According to CMS, The Department of the Treasury has notified HHS that the private consumer rate has been changed to 10.00 percent. The new interest rate is effective April 19, 2016.
• On May 26, CMS released a transmittal entitled JW Modifier: Drug amount discarded/not administered to any patient (R3530CP). According to the transmittal, effective July 1, 2016, when processing claims for Part B drugs and biologicals (except those provided under CAP), the use of the JW modifier to identify unused drugs or biologicals that are appropriately discarded is required. Also, effective July 1, 2016, providers must document the discarded drugs or biologicals in patient's medical record.
• On May 26, 2016, the Center for Consumer Information and Insurance Oversight (CCIIO) issued a new Frequently Asked Question on Health Insurance Market Reforms and Marketplace Standards. Under the FAQ, CCIIO reiterates that for plans that must provide coverage of the essential health benefit (EHB) package under section 1302(a) of the Affordable Care Act, if an issuer imposes a waiting period before an enrollee can access a covered benefit, this would constitute a violation of the EHB requirements. However, CCIIO is revoking the existing exception to this prohibition on waiting periods and will no longer allow waiting periods for pediatric orthodontia.
• On May 27, 2016, CMS announced that the latest updated Affordable Care Act Federal upper limits (FUL) calculated in accordance with the Medicaid Covered Outpatient Drug final rule with comment are available on the Medicaid.gov website, here. States will have up to 30 days from the June 1, 2016 effective date to implement these updated FULs.
• On May 20, 2016, the following proposed rule was sent to the Office of Management and Budget for review: CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1656-P). According to OMB, this annual proposed rule would revise the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule would change the ambulatory surgical center payment system list of services and rates.

Event Notices

• June 7 - 8, 2016, the VA Commission on Care will hold its monthly meeting. The purpose of the Commission is to examine the access of veterans to health care from the Department of Veterans Affairs and strategically examine how best to organize the Veterans Health Administration, locate health care resources, and deliver health care to veterans during the next 20 years. Any members of the public wishing to attend the meeting may register their intentions by emailing the Designated Federal Officer, John Goodrich, at john.goodrich@va.gov. Remote attendees joining by telephone must email Mr. Goodrich by 12:00 p.m. (EDT) on Monday, June 6, 2016, to request dial-in information. The public may also submit written statements at any time for the Commission’s review to commissiononcare@va.gov.
• June 21 - 22, 2016, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council) will hold a meeting. The confirmed times and agenda items for the meeting will be posted on the website for the Advisory Council at http://www.hhs.gov/ash/carb/ when this information becomes available. Pre-registration for attending the meeting in person is required to be completed no later than June 18, 2016; public attendance at the meeting is limited to the available space. The meeting also can be accessed through a live webcast on the day of the meeting.
• June 22, 2016, the Department of Defense’s Uniform Formulary Beneficiary Advisory Panel will hold a meeting to review and comment on recommendations made to the Director of Defense Health Agency, by the Pharmacy and Therapeutics Committee, regarding the Uniform Formulary.
• June 29, 2016, the White House will host a Cancer Moonshot Summit at Howard University in Washington, DC. According to the announcement, “hundreds of leaders across the health, academic, private industry, and philanthropic sectors will join together with patients, survivors and advocates for a national summit. This will make the first time that individuals and organizations spanning the entire cancer community and beyond will all convene under the national charge of doubling the rate of progress toward ending cancer as we know it.”

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On Monday, Senator Bill Cassidy (R-LA) and Rep. Pete Sessions (R-TX) rolled out legislation to address issues arising out of the Affordable Care Act (ACA) – but not repeal the ACA in full. Dubbed, the “World’s Greatest Healthcare Plan Act of 2016”, the bill would repeal individual and employer mandates and provide states with alternative coverage options, by “eliminating certain mandates under PPACA, while retaining essential consumer protections, by promoting health savings accounts to pay for such coverage and long-term care coverage, while permitting States to continue coverage as provided under PPACA.”
• The Senate is not in session next week.

House of Representatives

• On May 23, 2016, the House Ways & Means Committee held a markup of a number of bills, including H.R. 5273, the “Helping Hospitals Improve Patient Care Act.” More information about this markup may be found here. The Committee reported the bill, as amended, out of Committee by voice vote.
• On May 24, 2016, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, “Medicare and Medicaid Program Integrity: Combatting Improper Payments and Ineligible Providers.” Witnesses for this hearing included: Shantanu Agrawal, Deputy Administrator and Director of the Center for Program Integrity, Centers for Medicare and Medicaid Services (CMS); Seto Bagdoyan, Director of Audit Services, Forensic Audits, and Investigative Service, U.S. Government Accountability Office (GAO); and Ann Maxwell, Assistant Inspector General for the Office of Evaluation and Inspections, Department of Health & Human Services-Office of the Inspector General (HHS-OIG).
• On May 25, 2016, the House Energy and Commerce Subcommittee on Health held a hearing entitled, “Examining Cybersecurity Responsibilities at HHS.” Witnesses for this hearing included: Ms. Samantha Burch, Senior Director, Congressional Affairs, Healthcare Information and Management Systems Society North America; Mr. Joshua Corman, Director, Cyber Statecraft Initiative, Atlantic Council; Mr. Mac McMillan, Chief Executive Officer, CynergisTek, Inc.; and Mr. Marc Probst, Vice President and Chief Information Officer, Intermountain Healthcare, on behalf of College of Healthcare Information Management Executives.
• On May 26, 2016, House Energy and Commerce Committee leaders sent a letter to HHS questioning the U.S. Food and Drug Administration’s (FDA) current approach to regulating off-label communications. The letter, sent by full committee Chairman Fred Upton (R-MI) and Health Subcommittee Chairman Joseph Pitts (R-PA), also expressed a willingness on the part of the Committee to work with the FDA to institute responsible policy solutions. Reps. Upton and Pitts wrote, “We are writing to express our concerns about the Department of Health and Human Services’ (HHS) current position on the Food and Drug Administration’s (FDA) regulation of medical product manufacturer communications, including the proactive dissemination of truthful and non-misleading information that is outside the scope of a product’s FDA-approved labeling. … Recent litigation has raised significant questions about FDA’s authority to restrict such communication.”
• On May 25, 2016, a bipartisan group of 116 House Members, led by Reps. Tom Price (R-GA) and James McGovern (D-MA), sent a letter to asking CMS urging the Agency to refrain from pursuing a home health prior authorization initiative. “We ask you to withdraw the proposed demonstration for prior authorization of home health services in order to avoid health risks to patients, delays or disruptions in patient care and unnecessary restrictions on patient access to home health services,” wrote lawmakers.
• The House is not in session next week.

III. REPORTS, STUDIES, & ANALYSES

• On May 23, 2016, the Congressional Budget Office (CBO) released a cost estimate of S. 800, Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act (as reported by the Senate Committee on Health, Education, Labor and Pensions on April 4, 2016). According to CBO, S. 800 would clarify the purpose of the National Center for Medical Rehabilitation Research (the Center) at the National Institutes of Health (NIH) and would require the director of the Center to update its research plan at least every five years. CBO estimates that implementing S. 800 would cost $317 million over the 2017-2021 period, assuming appropriation of the necessary amounts. Pay-as-you-go procedures do not apply because enacting S. 800 would not affect direct spending or revenues.
• On May 24, 2016, the HHS Office of Inspector General (OIG) released a report entitled, New York Made Correct Medicaid Claim Adjustments (A-02-14-01006). The OIG concluded that the New York State Department of Health used the correct Federal medical assistance percentages when processing Medicaid claim adjustments for both public and private providers during the period October 2008 through June 2011. Accordingly, this report contains no recommendations.
• On May 24, 2016, the OIG released a report entitled, Medicaid: Vulnerabilities Related to Provider Enrollment and Ownership Disclosure (OEI-04-11-00590). The OIG recommended that CMS (1) work with State Medicaid programs to identify and correct gaps in their collection of all required provider ownership information, (2) provide guidance to State Medicaid programs on how to verify the completeness and accuracy of provider ownership information, (3) require State Medicaid programs to verify the completeness and accuracy of provider ownership information, (4) ensure that State Medicaid programs check exclusions databases as required, (5) work with State Medicaid programs to educate providers on the requirement to report changes of ownership, (6) work with State Medicaid programs to review providers that submitted nonmatching owner names and take appropriate action, and (7) increase coordination with State Medicaid programs on collecting and verifying provider ownership information in Medicaid and Medicare. CMS concurred with all of these recommendations.
• On May 24, 2016, the OIG released a report entitled, Medicare: Vulnerabilities Related to Provider Enrollment and Ownership Disclosure (OEI-04-11-00591). The OIG recommended that CMS (1) review providers that submitted nonmatching owner names and take appropriate action, (2) educate providers on the requirement to report changes of ownership, (3) increase coordination with State Medicaid programs on the collection and verification of provider ownership information in Medicare and Medicaid, and (4) ensure that its contractors check exclusions databases as required. CMS concurred with all of these recommendations.
• On May 24, 2016, the OIG released a report entitled, Medicaid Enhanced Provider Enrollment Screenings Have Not Been Fully Implemented (OEI-05-13-00520). The OIG recommended that CMS (1) assist States in implementing fingerprint based criminal background checks for all high risk providers, and (2) assist States in overcoming challenges in conducting site visits. To facilitate substitution of screening results and minimize variation between Medicare and Medicaid, we recommend that CMS (3) enable States to substitute Medicare screening data by ensuring the accessibility and quality of Medicare data, (4) develop a central system where States can submit and access screening results from other States, (5) strengthen minimum standards for fingerprint-based criminal background checks and site visits, and (6) work with States to develop a plan to complete their revalidation screening in a timely way. CMS concurred with all six of these recommendations.
• On May 24, 2016, the CBO released its Panels of Advisers for 2016.
• On May 25, 2016, the OIG released a report entitled, Connecticut Did Not Comply With Federal and State Requirements for Critical Incidents Involving Developmentally Disabled Medicaid Beneficiaries (A-01-14-00002). OIG recommended that the State agency (1) work with the Department of Developmental Services (DDS)to develop and provide training for staff of DDS and group homes on how to identify and report critical incidents and reasonable suspicions of abuse or neglect, (2) work with DDS to develop a data-exchange agreement and related analytical procedures to ensure DDS access to the Medicaid claims data in Connecticut's Medicaid Management Information System to detect unreported and unrecorded critical incidents, (3) work with DDS to update DDS policies and procedures to clearly define and provide examples of potential abuse or neglect that must be reported, and (4) coordinate with DDS and the Connecticut Office of Protection and Advocacy for Persons with Disabilities to ensure that any potential cases of abuse or neglect that are identified as a result of new analytical procedures are investigated as needed.
• On May 26, 2016, the OIG released a report entitled, Incomplete and Inaccurate Licensure Data Allowed Some Suppliers in Round 2 of the Durable Medical Equipment Competitive Bidding Program That Did Not Have Required Licenses (A-05-13-00047). OIG recommended that CMS: (1) complete the research required to determine whether 14 suppliers had a proper license and make a licensure determination regarding those suppliers; (2) identify all applicable State licensure requirements to prevent suppliers that do not have all currently required licenses from receiving contracts in future rounds of the competitive bidding program; and (3) work with State licensing boards to better coordinate, identify, and maintain an accurate and complete licensure database of currently required State licenses. CMS concurred and discussed steps it had and will take regarding the first two recommendations. CMS did not concur with the third recommendation.
• On May 26, 2016, the OIG released a report entitled, The Centers for Disease Control and Prevention Did Not Award President's Emergency Plan for AIDS Relief Funds for 2013 in Compliance With Applicable HHS Policies (A-04-14-04021). OIG concluded that the Centers for Disease Control and Prevention (CDC) did not award President's Emergency Plan for AIDS Relief (PEPFAR) funds for fiscal year 2013 in compliance with HHS and internal policies. For all 30 Funding Opportunity Announcements (FOAs) in OIG’s judgmental sample, CDC did not comply with 1 or more HHS or internal policies in some awards.
• On May 27, 2016, the CBO released a cost estimate of H.R. 4599, Reducing Unused Medications Act of 2016 (as passed by the House of Representatives on May 11, 2016). CBO estimates that enacting H.R. 4599 would reduce direct spending by about $122 million over the 2017-2026 period. Pay-as-you-go procedures apply because enacting the legislation would affect direct spending. The legislation would not affect revenues or spending subject to appropriation.

IV. OTHER HEALTH POLICY NEWS

• On May 25, 2016, the Ohio Department of Insurance announced that it has requested to liquidate Coordinated Health Mutual, Inc., the state’s health insurance Co-Op, which provides health insurance to nearly 22,000 Ohioans under its InHealth Mutual brand. “Our examination of the company’s financials made it clear that the company’s losses would prevent it from paying future claims should its operations continue,” Lt. Gov. Mary Taylor, also Ohio Director of Insurance, said. This marks the 13th Co-Op to fold.
• On May 24, 2016, CMS released the first ever Public Use File for the Medicare Current Beneficiary Survey (MCBS). The MCBS 2013 Access to Care public use file (MCBS PUF) provides the first publicly available MCBS file for researchers interested in the health, health care use, access to and satisfaction with care for Medicare beneficiaries, while providing the very highest degree of protection to the Medicare beneficiaries’ protected health information. The MCBS PUF is prepared from data collected in 2013 from over 13,000 community dwelling Medicare beneficiaries and contains standard demographic variables, such as age categories, race/ethnicity and gender, as well as information about health conditions, access to and satisfaction with care, type of insurance coverage, and information on utilization, such as the number of fee-for-service claims per beneficiary for certain health care event types. Additionally, the file was designed to facilitate use of the file to explore issues related to health equity and health disparities. The MCBS 2013 ATC PUF is available free for download, along with its accompanying documentation, here.
• On May 25, 2016, CMS released a Request for Proposal (RFP) for Hospital Improvement and Innovation Networks (HIINs). The HIINs, which will be part of the Quality Improvement Organization (QIO) initiative, will continue the good work started by the Hospital Engagement Networks (HENs) under the Partnership for Patients initiative. These organizations will tap into the deep experience, capabilities and impact of QIOs, hospital associations, hospital systems, and national hospital affinity organizations with extensive experience in hospital quality improvement. The HIINs will engage and support the nation’s hospitals, patients, and their caregivers in work to implement and spread well-tested, evidence-based best practices.