A&B Healthcare Week in Review, February 19, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On February 19, 2016, the Centers for Medicare & Medicaid Services (CMS) released the “2017 Advance Notice and Draft Call Letter,” which proposed updates to the Medicare Advantage (MA) and Part D programs. CMS proposed the following: a new Risk Adjustment Model which has separate coefficients for partial benefit dually eligible beneficiaries, full benefit dually eligible beneficiaries, and non-dually eligible beneficiaries; creating a coding pattern adjustment reflective of the statutory minimum; using a higher percentage of encounter data-based risk scores; a new analytical adjustment for a subset of Star Rating measures that is meant to adjust for plans serving dual eligible enrollees and/or enrollees receiving the low income subsidy (LIS); updates intended to address drug utilization within the Part D program; continuing a waiver and payment policy for Employer Group Waiver Plans (EGWP) Part C plans for 2017; and to estimate a low income subsidy indicator for Puerto Rico that simulates which enrollees would qualify for the low income subsidy if residing in the 50 states. The final 2017 Rate Announcement and Call Letter, including the final Medicare Advantage and FFS growth percentage and final benchmarks will be published by Monday, April 4, 2016. Comments or questions may be submitted electronically to the following address: AdvanceNotice2017@cms.hhs.gov. All comments must be received by 6:00 PM Eastern Standard Time on Friday, March 4, 2016.
• On February 16, 2016, CMS and America's Health Insurance Plans (AHIP) announced that commercial payer enrollees—including those covered by UnitedHealth Group, Aetna, Anthem, Cigna, Health Care Service Corp., Humana, Kaiser Permanente and the Blue Cross Blue Shield Association—as well as Medicare patients will be covered by new quality measures. The Core Quality Measures Collaborative will cover accountable care organizations, patient-centered medical homes and primary care providers, among other groups. The CMS will implement the new core measures across applicable Medicare programs “while eliminating redundant measures that are not part of the core set.” Health insurers have been calling for the CMS to align quality standards for public programs such as Medicare and Medicaid with commercial plans, arguing that it is difficult for plans to implement different sets of standards unless the giant public health-care program has the same requirements. Physicians have also argued that they are faced with too many redundant and conflicting quality measures that often don't improve care delivery.
• On February 12, 2016, the CMS Center for Consumer Information and Insurance Oversight (CCIIO) released a guidance entitled, “The Transitional Reinsurance Program’s Contribution Collections for the 2015 Benefit.” The transitional reinsurance program collects contributions from health insurance issuers and certain self-insured group health plans (collectively, “contributing entities”) at an annual per capita contribution rate to fund reinsurance payments to issuers of non-grandfathered reinsurance eligible market plans, the administrative costs of operating the reinsurance program, and the general fund of the U.S. Treasury for the 2014, 2015 and 2016 benefit years. For the 2015 benefit year, HHS anticipates that it will have $7.7 billion in reinsurance contributions to be used for reinsurance payments.
• On February 19, 2016, OMB started reviewing an overhaul of the rules for Medicaid managed care plans. The proposed version of the wide-ranging rule, released in May 2015, included a national medical loss ratio that worried Medicaid managed care plans; network adequacy standards; alignment of managed care programs with Medicare and private exchange plans; addition of long-term care services; and a new grading system similar to Medicare Advantage star ratings, among other provisions. The rulemaking marks the first time CMS has proposed changes to Medicaid managed care rules since the program was created more than a decade ago.
• On February 16, 2016, the Center for Disease Control and Prevention (CDC) issued a notice entitled, “Agency Forms Undergoing Paperwork Reduction Act Review,” which acts as an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Public comments are due March 16, 2016. The comments should address whether the proposed collection of information is necessary for the proper performance of the functions of the agency and ways to enhance the quality, utility, and clarity of the information to be collected.
• On February 16, 2016, CMS released a notice entitled, “Off-Cycle Update to the Inpatient Prospective Payment System (IPPS) Fiscal Year (FY) 2016 Pricer,” which serves as a change request to implement changes to the FY 2016 IPPS Pricer in compliance with Section 601 of the Consolidated Appropriations Act 2016. The notice is intended for hospitals submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries and which are paid using the FY 2016 IPPS Pricer. This change will be implemented on April 4, 2016.
• On February 16, 2016, the Food and Drug Administration (FDA) issued a final order entitled, “Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems.” This final order will require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
• On February 16, 2016, FDA issued a notice entitled, “Requests for Nominations: Public Advisory Panels of the Medical Devices Advisory Committee.” The FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. The FDA is also requesting nominations for nonvoting industry representatives to serve on certain device Panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. All nominations must be in by March 16, 2016.
• On February 16, 2016, The U.S. Department of Health and Human Services’ (HHS) Electronic Government Office (EGOV) issued a Notice entitled, “Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request.” EGOV has submitted an ICR to OMB for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0005. The ICR will expire on July 31, 2016. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Public Comments are due April 18, 2016.
• On February 17, 2016, CMS issued a notice entitled, “Screening for the Human Immunodeficiency Virus (HIV) Infection.” The change request (CR) is intended for physicians, other providers, and suppliers who submit claims to MACs for human immunodeficiency virus (HIV) infection screening services provided to Medicare beneficiaries. CR 9403 informs MACs that the CMS has determined that the evidence is adequate to conclude that screening of HIV infection for all individuals between the ages of 15-65 years is reasonable and necessary for early detection of HIV, and it is appropriate for individuals entitled to benefits under Part A or enrolled in Part B.
• On February 17, 2016, HHS issued a notice entitled, “Requests for Nominations: Technical Review Panel on the Medicare Trustees Reports.” In accordance with the provisions of Federal Advisory Committee Act (FACA), and after consultation with the General Services Administration (GSA), the Secretary of HHS has determined that the reestablishment of the Technical Review Panel on the Medicare Trustees Reports is in the public interest. This Panel shall advise the HHS Secretary about the econometric and actuarial techniques and economic assumptions utilized in the Hospital Insurance (HI) and Supplementary Medical Insurance (SMI) Trust Fund reports, thus enhancing her ability to fulfill duties and responsibilities. All nominations must be submitted by March 3, 2016.
• On February 17, 2016, FDA issued a guidance for industry entitled, “Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations.” The guidance is intended to help sponsors determine the amounts and types of safety data to collect in late-stage premarket and postapproval clinical investigations based on what is already known about a drug's safety profile. Sponsors collect extensive safety data in clinical investigations of drug and biological products conducted to support marketing approval (premarket) and after approval (postapproval).
• On February 17, 2016, FDA issued a guidance for industry entitled, “Immunogenicity-Related Considerations for Low Molecular Weight Heparin.” This guidance discusses how applicants for low molecular weight heparin (LMWH) products should provide information on impurities and their potential impact on immunogenicity.
• On February 18, 2016, CMS issued a Medicare Coverage Determination entitled, “Screening for Cervical Cancer With Human Papillomavirus (HPV) Testing—National Coverage Determination (NCD).” The notice is intended for physicians and other providers submitting claims to MACs for services provided to Medicare beneficiaries. CR 9434 announces that CMS has determined that, effective for dates of service on or after July 9, 2015, evidence is sufficient to add Human Papillomavirus (HPV) testing under specified conditions.
• On February 19, 2016, FDA issued a guidance entitled, “Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,” which requested public comments. The guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. Public comments are due April 19, 2016.
• On February 19, 2016, FDA issued a notice entitled, “Determinations of Regulatory Review Periods for Purposes of Patent Extension: BREO ELLIPTA.” FDA has determined the regulatory review period for BREO ELLIPTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. Public comments are due April 19, 2016.
• On February 19, 2016, NIH issued a notice entitled, “Production of Attenuated Respiratory Syncytial Virus Vaccines.” This is notice indicates that the National Institute of Allergy and Infectious Diseases (NIAID) is contemplating the grant of an exclusive license to practice the production of attenuated respiratory syncytial virus vaccines. Public comments are due March 6, 2016.

Event Notices

• February 23, 2016: CDC announced a meeting lead by the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR) and Lead Poisoning Prevention (LPP) Subcommittee. The meeting is open to the public with limited space. There will be a discussion on the blood lead testing and health surveillance strategies for the residents of Flint, Michigan.
• February 29, 2016: The National Institutes of Health (NIH) announced the NIH Rare Disease Day event which will raise awareness about rare diseases, the people they affect and current research collaborations.
• March 1, 2016: FDA announced a notice of a public advisory committee meeting which will be open to the public. The Science Board will provide advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs.
• March 18, 2016: FDA announced the following public workshop entitled, “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.” The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness. The public workshop which had been scheduled for January 25, 2016, was postponed due to unanticipated weather conditions and rescheduled for March 18, 2016.
• April 12, 2016: FDAannounced a public meeting with the Pediatric Advisory Committee to provide advice and recommendations to the Agency on FDA’s regulatory issues.
• April 15, 2016: FDA announced a forthcoming meeting of the Nonprescription Drugs Advisory Committee of the FDA. The meeting will be open to the public. The purpose of the meeting is for the committee to provide advice and recommendations to the Agency on FDA’s regulatory issues.
• September 15, 2016: FDA announced a public meeting with the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee. The purpose of the meetings is to provide advice and recommendations to the Agency on FDA's regulatory issues.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• The Senate has adjourned this week and will reconvene on Monday, February 22, 2016.
• On February 13, 2016, Senate Majority Leader Mitch McConnell (R-KY) released the following statement in regard to the passing and replacement of Supreme Court Justice Antonin Scalia. “The American people should have a voice in the selection of their next Supreme Court Justice. Therefore, this vacancy should not be filled until we have a new President.” Senator Elizabeth Warren (D-MA) quickly denounced her Republican colleague by stating, “Senator McConnell is right that the American people should have a voice in the selection of the next Supreme Court justice. In fact, they did — when President Obama won the 2012 election by five million votes.”
• On February 17, 2016, nearly two-thirds of the members of the Senate and more than 300 House members have asked the head of the Medicare agency not to cut payments for the Medicare Advantage program. Senators Mike Crapo (R-ID) and Charles Schumer (D-NY) were joined by 59 of their Senate colleagues in sending a letter to CMS urging the Medicare agency to protect more than 16 million seniors enrolled in Medicare Advantage (MA) by maintaining current payment levels in 2016. The Senate letter states that, “Regulatory policy changes that affect the program's funding, year after year, are creating disruption and confusion among beneficiaries who are looking for consistency and predictability and can damage a program that offers value for beneficiaries… We urge you to provide needed stability to the MA program that will protect MA enrollees from disruptive changes in 2016.” On the same day, Rep. Brett Guthrie (R-KY) and Patrick Murphy (D-FL) were joined by 306 of their colleagues in the House of Representatives in sending a similar letter to CMS, urging the agency to protect MA payments and beneficiary access to MA plans. The House letter called it “critically important to preserve the Medicare Advantage program as a model for modernizing the Medicare program as a whole.” The coordinated approach taken “is a powerful example of how to move away from episodic, fee-for-service toward high quality, value-based care.”
• On February 17, 2016, AHIP convened a Capitol Hill briefing session entitled, “Medicare Advantage: Delivering Value for Beneficiaries through Innovation.” AHIP hosted a panel discussion with Medicare Advantage (MA) experts to examine how changes to the MA risk adjustment system impact innovative approaches that are driving value and improving care for MA beneficiaries. The session was moderated by Marilyn Tavenner, President & CEO, AHIP. The speakers for the panel included Dr. Balu Gadhe, Regional Medical Officer, CareMore; Tom Kornfield, Vice President, Avalere; and Tom Hutchinson, Strategic Advisor, Epstein, Becker & Green.

House of Representatives

• The House has adjourned this week and will reconvene on Tuesday, February 23, 2016.
• On February 17, 2016, Energy and Commerce Subcommittee on Health announced a hearing entitled, “The Fiscal Year 2017 HHS Budget,” which will convene on Wednesday, February 24, 2016, at 10 a.m. in room 2123 of the Rayburn House Office Building. HHS Secretary Sylvia Burwell will provide testimony on the department’s proposed budget. Burwell will be the sole witness.
• On February 18, 2016, Energy and Commerce Subcommittee on Health Chairman Joe Pitts (R-PA) and subcommittee Vice Chairman Brett Guthrie (R-KY) sent a letter to CMS stating that they are worried that there's a lack of oversight in how state Medicaid programs use provider taxes to fund their expenditures. They asked for a response within 30 days of the agency's receipt of the letter. Provider taxes must cover all providers within a specific category and must be at the same rate for all providers within the category, according to Medicaid regulations. States that fail to meet the requirements can lose their federal Medicaid funding.
• On February 18, 2016, Thirty-eight House members showed support for charity premium assistance and asked CMS to take action to require health insurers to accept premium payments from some nonprofit charities for some beneficiaries. “We request that CMS modify the final rule or take other regulatory action to include qualified nonprofit charitable organizations as a category of entities from whom insurers are required to accept third-party premiums,” including patient advocacy organizations, patient assistance organizations, places of worship and local civic groups, the letter said.

III. REPORTS, STUDIES, & ANALYSES

• On February 16, 2016, the Congressional Budget Office (CBO) released a report entitled, “Letter to the Honorable Tom Price Regarding Spending for Means-Tested Programs in CBO’s Baseline, 2016–2026,” which stated that Medicaid spending shot up by 35 percent from 2008 to 2010, during the most recent recession, both because of enrollment growth and as a result of a temporary increase in the federal matching rate. In CBO’s baseline projections, mandatory outlays for means-tested programs are projected to grow at an average annual rate of 4.3 percent, compared with an average rate of 5.5 percent for non-means-tested programs.
• On February 16, 2016, CBO released a report entitled, “S. 2368, Audit & Appeals Fairness, Integrity, and Reforms in Medicare Act of 2015,” which analyzed the cost estimate of S. 2368. CBO estimates that enacting S. 2368 would increase direct spending by about $1.7 billion over the 2016-2026 period. In addition, implementing the bill would cost approximately $35 million over that same period, assuming appropriation of the necessary amounts. Pay-as-you-go procedures apply because enacting the legislation would affect direct spending. The legislation would not affect revenues.
• On February 16, 2016, the Office of Inspector General (OIG) released a report stating that not all of Minnesota Marketplace’s internal controls were effective in ensuring that individuals were enrolled in qualified health plans according to federal requirements. OIG recommended that the Minnesota marketplace redetermine, if necessary, the eligibility of the sample applicants for whom we determined that verifications were not performed according to Federal requirements.
• On February 16, 2016, the Government Accountability Office (GAO) released a report entitled, “Medicaid: Efforts to Exclude Nonemergency Transportation Not Widespread, but Raise Issues for Expanded Coverage.” GAO contacted the 30 states that expanded Medicaid under the Patient Protection and Affordable Care Act (PPACA) as of September 30, 2015 and reviewed relevant documents and interviewed officials in the 3 states that have taken efforts to exclude the nonemergency medical transportation (NEMT) benefit. GAO found that States' efforts to exclude NEMT benefits from enrollees who are newly eligible for Medicaid under PPACA are not widespread.

IV. OTHER HEALTH POLICY NEWS

• On February 14, 2016, Gov. Rick Snyder asked the federal government to expand Medicaid coverage to people under 21 and pregnant women who have been exposed to Flint's lead-contaminated water. In a statement released Sunday, Snyder says about 15,000 more Flint residents would benefit if the government approves the request. The governor says the state would help by lining up doctors and behavioral health specialists and providing other services.
• On February 15, 2016, the Florida Office of Insurance Regulation issued a Consent Order approving, with additional requirements, Aetna Inc.’s application to acquire 100% of the issued and outstanding voting securities of Humana Health Insurance Company of Florida, Inc., Humana Medical Plan, Inc., Careplus Health Plans, Inc., and CompBenefits Company. The proposed acquisition of Humana, Inc. is still subject to review by the U.S. Department of Justice and the Florida Attorney General, under standards that may be materially different than those utilized by the Office. Aetna and Humana shareholders approved the proposed acquisition in October 2015. Conversely, on February 19th, the Florida Office of Insurance Regulation fined Humana $500,000 fine for failing to cooperate with investigators as part of a market investigation into a complaint that the company discriminated against HIV/AIDs patients by placing all drugs, including generics, in high-cost tiers.
• On February 17, 2016, The Department of Justice settled False Claims Act allegations with 51 hospitals over Medicare claims for implantable cardioverter defibrillators (ICDs), representing the latest round of settlements in an ongoing investigation. The DOJ alleged that the settling hospitals implanted ICDs in patients within a prohibited 40-day or 90-day waiting period under Medicare coverage guidelines after a patient has a heart attack or heart surgery, respectively. The DOJ said the Medicare program's national coverage determination for the device provides that ICDs generally shouldn't be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty. Principal Deputy Assistant Attorney General Benjamin C. Mizer said in a statement that the settlements “demonstrate the Department's continued vigilance in pursuing hospitals and health systems that violate Medicare's national coverage rules.”
• On February 17, 2016, CMS released a list of essential community providers (ECPs) covering medically underserved people with which health plans must contract for the 2017 benefit year. The list is intended to assist issuers with identifying providers that qualify as meeting network standards for plans sold in the Affordable Care Act exchanges under 45 CFR 156.235.
• On February 18, 2016, U.S. Court of Appeals for the Eleventh Circuit ruled in the case Eternal Word Tel. Network, Inc. v. HHS that the Affordable Care Act regulations designed to ensure that large employee health plans pay for contraception doesn't violate the organizations' religious rights. The Eleventh Circuit said the accommodation didn't violate the Religious Freedom Restoration Act (RFRA) because it represented the least restrictive means of serving a compelling governmental interest in ensuring women's health and assuring that women receive health benefits that meet their needs. The Supreme Court is scheduled to hear oral argument on the issue March 23.
• On February 18, 2016, Governor Matt Mead (R-WY) urged lawmakers to expand the state's Medicaid program as they continue working on the state budget. The governor, who for three years has supported expansion of Medicaid, said that such an expansion would bring an economic benefit to the state, which faces a revenue shortfall. The state receives $2.3 billion in federal money each year, the governor said. “Medicaid expansion would add to that total.” he said. “I support including language that protects the state should the federal government renege on their financial promise. We lose about $310,000 every day that could be going to help our citizens. It's time to act.”