A&B Healthcare Week in Review, January 29, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On January 29, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Expanding Uses of Medicare Data by Qualified Entities, that will expand access to analyses and data that will help providers, employers, and others make more informed decisions about care delivery. The new rules, as required by the Medicare Access and CHIP Reauthorization Act (MACRA), will allow organizations approved as qualified entities to confidentially share or sell analyses of Medicare and private sector claims data to providers, employers, and other groups who can use the data to support improved care. In addition, qualified entities will be allowed to provide or sell claims data to providers. The rule also includes strict privacy and security requirements for all entities receiving Medicare analyses or data, as well as new annual reporting requirements.
• On January 29, 2016, CMS announced the extension of temporary moratoria on the enrollment of new Medicare Part B ground ambulance suppliers and Medicare home health agencies, subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. These moratoria also apply to the enrollment of home health agencies and ground ambulance suppliers in Medicaid and the Children’s Health Insurance Program. Based upon consultation with law enforcement and consideration of the factors and activities described previously, CMS has determined that the temporary enrollment moratoria should be extended for an additional 6 months.
• On January 27, 2016, CMS issued a final rule entitled Medicaid Programs: Face-to-Face Requirements for Home Health Services. This final rule revises the Medicaid home health service definition consistent with section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) and section 504 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to add requirements that, for home health services, physicians document, and, for certain medical equipment, physicians or certain authorized non-physician practitioners (NPP) document the occurrence of a face-to-face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes. This rule also aligns the timeframes for the face-to-face encounter with similar regulatory requirements for Medicare home health services. In addition, this rule amends the definitions of medical supplies, equipment, and appliances. This rule is effective on July 1, 2016.
• On January 28, 2016, CMS issued a proposed rule on the Medicare Shared Savings Program: Accountable Care Organizations -- Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations. Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This proposed rule addresses changes to the Shared Savings Program that would modify the program’s benchmark rebasing methodology to encourage ACOs’ continued investment in care coordination and quality improvement, and identifies publicly available data to support modeling and analysis of these proposed changes. In addition, it would streamline the methodology used to adjust an ACO’s historical benchmark for changes in its ACO participant composition, offer an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program, and establish policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined. Comments appear to be due April 4, 2016.
• On January 28, 2016, CMS issued a CMCS Informational Bulletin on Alternative Benefit Plan Conforming Changes. This informational bulletin provides information to states about recent regulatory changes in Essential Health Benefit (EHB) standards affecting Medicaid Alternative Benefit Plans (ABPs). The bulletin includes information about conforming changes that may be needed in the following areas: EHB coverage standards for habilitative services and devices; updating the benchmark plan year used to define EHBs; prescription drug benefits and preventive services and supplies. This bulletin also address the state-required actions as a result of these changes, including state plan amendment (SPA) submissions and ABP public notice requirements.
• On January 27, 2016, the Center for Consumer Information and Insurance Oversight (CCIIO) released new guidance on Culturally and Linguistically Appropriate Services (CLAS) County Data. Public Health Service (PHS) Act section 2719 requires non-grandfathered group health plans and health insurance issuers offering non-grandfathered health insurance coverage to provide relevant notices in a culturally and linguistically appropriate manner. The regulations implementing section 2719 require these plans and issuers to make certain accommodations for notices sent to an address in a county meeting a threshold percentage of people who are literate only in the same non-English language. This threshold percentage is set at 10 percent or more of the population residing in the claimant’s county, as determined based on American Community Survey (ACS) data published by the United States Census Bureau.
• On January 27, 2016, CCIIO released Frequently Asked Questions on the CO-OP Program. The questions addressed include: What does it mean that “substantially all” of a CO-OP’s business be sales of QHPs? Can CO-OPs sell large group policies or participate in other health programs? When a CO-OP’s loans are converted to a surplus note, what does that mean for repayment of the loan? Is it true that a CO-OP will be considered to be in default if it has risk-based capital (RBC) below 500%? What are the implications if a CO-OP has an RBC below 500%? Can CMS waive or change the requirements for serving on a CO-OP board, which could help CO-OPs diversify board membership?
• On January 25, 2016, the Health Resources and Services Administration (HRSA) announced that annual 340B recertification is being postponed at this time. Once OPA has determined the new start date, you will receive the username and password necessary to start recertification.
• On January 29, 2016, the Centers for Disease Control and Prevention (CDC) issued an Agency Information Collection Request on Developing a Self-Management Tool for Individuals with Systemic Lupus Erythematosus. The proposed information collection will assess a prototype CDC SLE self-management tool that is in development to ensure that the tool is usable and useful to members of the target audience. The tool is expected to be comprised of multiple SLE self-management resources that may include, but are not limited to: Education resources about fatigue management, pain management, healthy diet, and exercise; symptom trackers; medication trackers; appointment calendars; resources about communication with family, friends, and co-workers about SLE; and strategies for coping with depression and anxiety. CDC plans to make the tool available in an electronic format (web-based or a native mobile application) and will consider making it available as a printed resource, depending on the feedback obtained during the testing process. The information collection will also gauge the needs of the target audience(s), tool format and delivery method(s), and the tool’s clarity, relevance, salience and appeal. A series of focus groups with women with a diagnosis of SLE, and one-on-one telephone interviews with men with a diagnosis of SLE will be conducted to assess the tool. The same discussion guide will be used for all information collections.
• On January 29, 2016, the CDC issued an Agency Information Collection Request on the National Program of Cancer Registries Cancer Surveillance System. According to the CDC, In 2012, the most recent year for which complete information is available, more than 580,000 people died of cancer and more than 1.5 million were diagnosed with cancer. It is estimated that 13.8 million Americans are currently alive with a history of cancer (2). In the U.S., state-based cancer registries are the only method for systematically collecting and reporting population based information about cancer incidence and outcomes such as survival. These data are used to measure the changing incidence and burden of each cancer; identify populations at increased or increasing risk; target preventive measures; and measure the success or failure of cancer control efforts in the U.S.
• On January 29, 2016, the Department of Health and Human Services (HHS) issued an Agency Information Collection Request on the Surgeon General’s Pledge to Stem the Opioid Epidemic. This information request involves collecting information from users for this pledge which recruits doctors, dentists, nurses, and physician assistants to utilize their unique position in the community and in their practice to take notice of the opioid crisis and commit to taking action that could save lives.
• On January 28, 2016, CMS issued an Agency Information Collection Request on the Medicaid Drug Use Review (DUR) Program. This notice sets out a summary of the use and burden associated with the information collection. According to CMS, States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. These profiles must reflect at least the patient’s name, address, telephone number, date of birth/age, gender, history, e.g., allergies, drug reactions, list of medications, and pharmacist’s comments relevant to the individual’s drug therapy. The State must conduct RetroDUR which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact. Annual reports are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of States’ DUR programs. The information submitted by States is reviewed and results are compiled by CMS in a format intended to provide information, comparisons and trends related to States’ experiences with DUR. The States benefit from the information and may enhance their programs each year based on State reported innovative practices that are compiled by CMS from the DUR annual reports.
• On January 28, 2016, CMS issued an Agency Information Collection Request on the Physician Quality Reporting System (PQRS) and the Electronic Prescribing Incentive (eRx) Program Data Assessment, Accuracy and Improper Payments Identification Support. The incentive and reporting programs have data integrity issues, such as rejected and improper payments. This four year project will evaluate incentive payment information for accuracy and identify improper payments, with the goal of recovering these payments. Additionally, based on the project’s results, recommendations will be made so that we can avoid future data integrity issues. Data submission, processing, and reporting will be analyzed for potential errors, inconsistencies, and gaps that are related to data handling, program requirements, and clinical quality measure specifications of PQRS and eRx program. Surveys of Group Practices, Registries, and Data Submission Vendors (DSVs) will be conducted in order to evaluate the PQRS and eRx Incentive Program. Follow-up interviews will occur with a small number of respondents.
• On January 27, 2016, the Food and Drug Administration (FDA) issued a Notice on Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications. The underlying regulation relates to Agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any combination of: (1) A drug and a device; (2) a device and a biological product; (3) a biological product and a drug; or (4) a drug, a device, and a biological product. The second purpose of the regulation is to enhance the efficiency of Agency management and operations by providing procedures for classifying and determining which Agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant's recommendation as to which Agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision.
• On January 27, 2016, FDA issued a Notice of Guidance on Bioequivalence Recommendations for Lamotrigine. FDA is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled “Draft Guidance on Lamotrigine.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lamotrigine extended-release tablets.
• On January 27, 2016, FDA issued a Notice of Product-Specific Bioequivalence Recommendations. FDA is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
• On January 26, 2016, HHS issued a Notice of Interest Rate on Overdue Debts. The current rate of 9¾%, as fixed by the Secretary of the Treasury, is certified for the quarter ended December 31, 2015. This interest rate will be applied to overdue debt until the Department of Health and Human Services publishes a revision.
• On January 26, 2016, FDA issued an Agency Information Collection Request on Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation. The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public. The PHS guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collection of information described in this guideline is intended to provide general guidance on the following topics: (1) The development of xenotransplantation clinical protocols; (2) the preparation of submissions to FDA; and (3) the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures.
• On January 26, 2016, FDA issued Notice of Guidance on Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals). FDA is extending the comment period for the draft guidance for Industry and Food and Drug Administration Staff entitled "Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals')." A notice of the availability of the draft guidance and our request for comments appeared in the Federal Register of December 31, 2015. The Agency is taking this action due to the unanticipated high-level of interest from external stakeholders and the medical device community and will allow interested persons additional time to submit comments. Comments on the draft guidance are now due by March 29, 2016.
• On January 26, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued Agency Information Collection Request on Screening, Brief Intervention, and Referral to Treatment (SBIRT) Cross-Site Evaluation. SAMHSA is conducting a cross-site external evaluation of the impact of programs of screening, brief intervention (BI), brief treatment (BT), and referral to treatment (RT) on patients presenting at various health care delivery units with a continuum of severity of substance use. SAMHSA’s SBIRT program is a cooperative agreement grant program designed to help states and Tribal Councils expand the continuum of care available for substance misuse and use disorders. The program includes screening, BI, BT, and RT for persons at risk for dependence on alcohol or drugs. This evaluation will provide a comprehensive assessment of SBIRT implementation; the effects of SBIRT on patient outcomes, performance site practices, and treatment systems; and the sustainability of the program. This information will allow SAMHSA to determine the extent to which SBIRT has met its objectives of implementing a comprehensive system of identification and care to meet the needs of individuals at all points along the substance use continuum. To evaluate the success of SBIRT implementation at the site level, a web-based survey will be administered to staff in sites where SBIRT services are being delivered—referred to as performance sites.
• On January 25, 2016, FDA issued a notice of Guidance on Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices. FDA is issuing this draft guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. This draft guidance is not final nor is it in effect at this time.
• On January 25, 2016, FDA issued a Notice on International Drug Scheduling; Convention on Psychotropic Substances: Acetylfentanyl; MT-45; para-Methoxymethylamphetamine (PMMA); a-Pyrrolidinovalerophenone (a-PVP); para-Methyl-4-methylaminorex (4,4'-DMAR), etc. FDA is providing interested persons with the opportunity to submit written comments, and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/or public meeting will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2016. This notice is issued under the Controlled Substances Act (the CSA). Comments are due by February 25, 2016.
• On January 25, 2016, FDA issued a Notice soliciting Requests for Nominations: National Mammography Quality Assurance Advisory Committee. FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) for the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the NMQAAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice. Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by February 25, 2016, (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by February 25, 2016.
• On January 25, 2016, the CDC issued a Notice soliciting Requests for Nominations: Advisory Committee on Immunization Practices (ACIP). The ACIP consists of 15 experts in fields associated with immunization, who are selected by the Secretary of the U. S. Department of Health and Human Services (HHS) to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the CDC on the control of vaccine-preventable diseases. The role of the ACIP is to provide advice that will lead to a reduction in the incidence of vaccine preventable diseases in the United States, and an increase in the safe use of vaccines and related biological products. The committee also establishes, reviews, and as appropriate, revises the list of vaccines for administration to children eligible to receive vaccines through the Vaccines for Children (VFC) Program. The deadline for receipt of all application materials (for consideration for term beginning July 1, 2017) is November 4, 2016. All files must be submitted electronically as email attachments to: Ms. Stephanie Thomas, ACIP Secretariat, Email: SThomas5@cdc.gov.  
• On January 25, 2016, the CDC issued a final rule on Medical Examination of Aliens: Medical Screening Process to amend its regulations governing medical examinations that aliens must undergo before they may be admitted to the United States. Based on public comment received, HHS/CDC did not make changes from the NPRM published on June 23, 2015. Accordingly, this FR will: revise the definition of communicable disease of public health significance by removing chancroid, granuloma inguinale, and lymphogranuloma venereum as inadmissible health-related conditions for aliens seeking admission to the United States; update the notification of the health-related grounds of inadmissibility to include proof of vaccinations to align with existing requirements established by the Immigration and Nationality Act (INA); revise the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction; clarify and revise the evaluation requirements for tuberculosis; clarify and revise the process for the HHS/CDC-appointed medical review board that convenes to reexamine the determination of a Class A medical condition based on an appeal; and update the titles and designations of federal agencies within the text of the regulation.
• On January 27, 2016, the Office of Management and Budget (OMB) received for a review a Notice entitled Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018 (CMS-2396-PN).
• On January 27, 2016, OMB received for review a proposed rule entitled Programs of All-Inclusive Care for the Elderly (PACE) Update (CMS-4168-P). This proposed rule would update the PACE regulations published on December 8, 2006. The rule would improve the quality of the existing regulations, provide operational flexibility and modifications, and remove redundancies and outdated information. These updates are intended to ensure the health and safety of PACE participants.
• On January 25, 2016, OMB received for review a proposed rule entitled ONC Health IT Certification Program: Enhanced Oversight and Accountability.

Event Notices

• January 28, 2016: The Medicaid and CHIP Payment and Access Commission (MACPAC) convened a meeting at the Horizon Ballroom of the Ronald Reagan and International Trade Center, 1300 Pennsylvania Ave NW, Washington, DC. The agenda and meeting materials are available here.
• February 1, 2016: The Physician-Focused Payment Model Technical Advisory Committee will hold a meeting to receive information about MACRA implementation and about payment models currently being tested by the Center for Medicare & Medicaid Innovation within CMS. The meeting will be held in Room 5051 of the Wilbur J. Cohen Federal Building, 330 Independence Ave SW, Washington, DC, 20201. The public may attend the meeting in-person or listen via audio teleconference.
• February 10 & 11, 2016: CMS will host the following webinars to provide an overview of the Covered Outpatient Drugs final rule with comment that was displayed in the Federal Register on January 21, 2016.
  • Wednesday, February, 10, 2016, 12:30 – 2:00 p.m. ET: This webinar will be geared towards drug manufacturers and those with responsibilities or involvement in government pricing/programs.
  • Thursday, February 11, 2016, 12:30 – 2:00 p.m. ET: This webinar will be geared toward the pharmacy industry including retail community pharmacies and pharmacy trade organizations.
• March 16, 2016:Food and Drug Administration/Xavier University PharmaLink Conference; Increasing Product Confidence. The FDA Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled “FDA/Xavier University PharmaLink Conference: Increasing Product Confidence”. The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, featuring presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom, to create synergies focused on finding solutions which make a difference.
• March 31, 2016: CMS this week announced a new date for the public conference to discuss potential improvements to the HHS Risk Adjustment methodology for the 2018 benefit year and beyond. More information on the announcement may be found here.
• April 15, 2016: Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting. AHRQ coordinates the development of sets of common definitions and reporting formats (Common Formats) for reporting on health care quality and patient safety. In order to support the Common Formats, AHRQ has provided technical specifications to promote standardization by ensuring that data collected by Patient Safety Organizations (PSOs) and other entities are clinically and electronically comparable. The purpose of this notice is to announce a meeting to discuss the Common Formats. This meeting is designed as an interactive forum where software developers and PSOs can provide input on the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ’s technical specifications and implemented, or plan to implement, the formats electronically.
• May 4 - 6, 2016: Food and Drug Administration/Xavier Medical Device Conference. FDA Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled "FDA/Xavier Medical Device Conference (MedCon)." This 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On February 4, 2016, the Senate Finance Committee will hold a hearing to consider the nomination of Mary Katherine Wakefield to be Deputy Secretary of Health And Human Services, among others. The hearing will be held in 215 Dirksen Senate Office Building at 10am.
• On January 27, 2016, the Senate Judiciary Committee held a hearing on Attacking America’s Epidemic of Heroin and Prescription Drug Abuse, with three panels of witnesses ranging from US Senators, a Governor, Federal Agencies, a Chief of Police, Advocates, and health professionals.
• On January 28, 2016, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs. The sole witness was Dr. Janet Woodcock, MD, Director for the Center for Drug Evaluation and Research at FDA.
• On January 19, 2016, the Senate HELP Committee announced its schedule for considering a number of biomedical innovation bills. On February 9th, the Committee will consider a number of bills focused on advancing therapies for rare diseases and medical rehabilitation research. On March 9th, the Committee will markup legislation aimed at “modernizing” the FDA and National Institutes of Health (NIH). More information about the schedule is available here.

House of Representatives

• The House of Representatives was not in session this week, due to the recent blizzard – Winter Storm Jonas (or #snowzilla). More information about the House Floor Schedule may be found here.
• On February 2, 2015, the House will consider the Veto Message on H.R. 3762 (Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015 (Sponsored by Rep. Tom Price / Budget Committee)).
• The House Energy & Commerce Health Subcommittee was scheduled to hold a hearing on Examining Medicaid and CHIP's Federal Medical Assistance Percentage last week. However, the hearing has been postponed. Additional updates will follow when available.
• On February 4, 2015, the House Energy & Commerce Health Subcommittee will hold a hearing entitled Examining Implementation of the Biologics Price Competition and Innovation Act. The hearing will take place in 2123 Rayburn House Office Building at 10am. Witnesses have not yet been announced.
• On February 4, 2015, the House Oversight and Government Reform Committee will hold a hearing entitled Developments in the Prescription Drug Market: Oversight. The hearing will take place in 2154 Rayburn House Office Building at 9am. Witnesses scheduled to testify include: Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA; Mr. Howard B. Schiller, Interim Chief Executive Officer, Valeant Pharmaceuticals International, Inc.; Mr. Martin Shkreli, Former Chief Executive Officer, Turing Pharmaceuticals LLC; Ms. Nancy Retzlaff, Chief Commercial Officer, Turing Pharmaceuticals LLC; and Mr. Mark Merritt, President and CEO of PCMA.
• On January 26, 2016, Ways and Means Chairman Kevin Brady (R-TX) released the following statement in reaction to the CBO report on federal spending and the 2026 exhaustion date of Medicare’s Hospital Insurance Trust Fund. “Our entitlement programs are unsustainable. In 2015, for the first time, federal health care spending — which includes Medicare, Medicaid and Obamacare — outpaced all other entitlement programs. And it shows no signs of slowing. Spending on major federal health care programs will nearly double over the next ten years from $1.1 trillion in 2016 to $2 trillion 2026. Despite all this spending, CBO has once again confirmed what we all know: Medicare as we know it is unsustainable and we need to act now to save it. In ten short years, the Hospital Insurance Trust Fund that seniors rely upon will be exhausted. And if we remain on this same path, America’s seniors are going to find it harder to access care and see their doctors. Obamacare didn’t solve the problem. Instead, it raided over $700 billion from Medicare to pay for a new open-ended entitlement and, as predicted, its claims of slowing health care spending are exaggerated. True reforms are needed now to save Medicare for current and future generations."

III. REPORTS, STUDIES, & ANALYSES

• On January 25, 2016, the Congressional Budget Office (CBO) issued its full report on The Budget and Economic Outlook: 2016 to 2026. In 2016, the federal budget deficit will increase, in relation to the size of the economy, for the first time since 2009, according to the Congressional Budget Office’s estimates. If current laws generally remained unchanged, the deficit would grow over the next 10 years, and by 2026 it would be considerably larger than its average over the past 50 years, CBO projects. Debt held by the public would also grow significantly from its already high level. CBO anticipates that the economy will expand solidly this year and next. Increases in demand for goods and services are expected to reduce the quantity of underused labor and capital, or “slack,” in the economy—thereby encouraging greater participation in the labor force by reducing the unemployment rate and pushing up compensation. That reduction in slack will also push up inflation and interest rates. Over the following years, CBO projects, output will grow at a more modest pace, constrained by relatively slow growth in the nation’s supply of labor. Nevertheless, in those later years, output is anticipated to grow more quickly than it has during the past decade.
• On January 25, 2015, the HHS Office of Inspector General (OIG) released a report entitled Most Children With Medicaid in Four States Are Not Receiving Required Dental Services (OEI-02-14-00490). OIG found that three out of four children did not receive all required dental services, with one in four children failing to see a dentist at all. All four States reported that they do not routinely track whether children are receiving all the required services. In addition, two of the four States had policies that do not allow payment for particular services in accordance with their periodicity schedules. The States reviewed by OIG reported facing shortages of participating dental providers and challenges in educating families about the importance of regular dental care. While the States reported that they employ a variety of strategies to address these problems and CMS has taken some positive steps in this area, OIG continues to have concerns that children are not receiving required dental services. OIG provided CMS with eight recommendations designed to monitor and ensure that children with Medicaid receive all of their EPSDT required dental services.
• On January 25, 2015, the OIG released a report entitled North Carolina Department of Health and Human Services Did Not Always Claim Costs Under CDC Prevention and Public Health Fund Awards in Accordance with Federal Requirements (A-04-14-04028). OIG recommended that the State agency (1) refund to the Federal Government the $50,000 in unallowable costs and (2) improve its controls, which would have saved an estimated $493,000 of costs charged to CDC PPHF awards, to ensure that costs charged to Federal awards comply with Federal requirements and that Federal funds are used efficiently and effectively to advance Federal award goals and objectives. The State agency generally concurred with the recommendations and described the actions it would take to implement necessary corrective actions.
• On January 25, 2015, the OIG released Advisory Opinion 16-01 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby [names redacted] (the "Requestors") would indirectly contract with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for their policyholders and, in turn, would provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay).

IV. OTHER HEALTH POLICY NEWS

• On January 25, 2016, at a town hall in New Hampshire, Presidential nominee Donald Trump reportedly called for Medicare Part D drug price negotiations. Trump told the crowd of about 1,000 people in Farmington, New Hampshire, that Medicare could "save $300 billion" a year by getting discounts as the biggest buyer of prescription drugs. Said Trump: "We don't do it. Why? Because of the drug companies."
• On January 29, 2016, Eli Lilly & Co. and Anthem issued two policy papers detailing proposals on: (1) facilitating more robust communication between health plans and drug developers prior to drug approval; and (2) addressing legal and regulatory barriers to value-based payment arrangements.
• On January 28, 2016, CMS released the draft Affordable Care Act Federal upper limits calculated in accordance with the Medicaid Covered Outpatient Drug final rule with comment (CMS-2345-FC). CMS notes that the final Affordable Care Act FULs will be published in late March 2016 and will be effective on April 1, 2016 to coincide with the effective date of CMS-2345-FC. States will have up to 30 days from the April 1, 2016 effective date to implement the FULs. Thereafter, the FULs will be updated monthly on the Medicaid.gov website, and will be effective on the first date of the month following the publication of the update. States will, likewise, have up to 30 days after the effective date to implement the FULs. Below is the link to the January 2016 draft Affordable Care Act FULs and the Methodology and Data Elements Guide used to calculate the Affordable Care Act FULs.
• On January 28, 2016, the White House issued an Executive Memorandum on the White House Cancer Moonshot Task Force. The memo states: “Cancer is a leading cause of death, and cancer incidence is expected to increase worldwide in the coming decades. But today, cancer research is on the cusp of major breakthroughs. It is of critical national importance that we accelerate progress towards prevention, treatment, and a cure -- to double the rate of progress in the fight against cancer -- and put ourselves on a path to achieve in just 5 years research and treatment gains that otherwise might take a decade or more.” It establishes membership, missions and functions, transparency and reporting, and other requirements of the Task Force.
• On January 28, 2016, CMS introduced the first patient experience of care star ratings on Home Health Compare. Known as Home Health Care Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) Survey star ratings, these measures evaluate patients’ experiences with home health agencies. Home Health Compare is the agency’s public information website that provides information on how well Medicare-certified agencies provide care to their patients. The HHCAHPS Survey star ratings report patients’ experiences of care ranging from one star to five stars using data from patients (or the family or friends of patients) that have been treated by the agency. Five stars is the highest rating and reflects the best patient experience. There are over 11,000 agencies with data on Home Health Compare, and more than 6,000 of them now have patient care experience star ratings.
• On January 26, 2016, the CMS Office of Minority Health (CMS OMH), released a new Guide to Preventing Readmissions among Racially and Ethnically Diverse Medicare Beneficiaries. The Guide was developed in collaboration with the Disparities Solutions Center at Massachusetts General Hospital and the National Opinion Research Center (NORC) at the University of Chicago as part of the CMS Equity Plan for Improving Quality in Medicare, and is designed to assist hospital leaders and stakeholders focused on quality, safety, and care redesign in identifying root causes and solutions for preventing avoidable readmissions among racially and ethnically diverse Medicare beneficiaries.
• On January 27, 2016, CMS released the November 2015 monthly report on state Medicaid and Children's Health Insurance Program (CHIP) eligibility and enrollment data. These data were reported by state Medicaid and CHIP agencies as part of the Medicaid and CHIP Performance Indicator process. Overall, Medicaid and CHIP enrollment has increased by 14.1 million lives since October 2013.
• On January 27, 2016, CMS released the weekly Exchange Enrollment Snapshot for the week of January 17 through January 23 (Week 12). CMS found that about 8.9 million consumers have signed-up for health coverage through the HealthCare.gov platform or had their coverage automatically renewed. This week’s snapshot includes weekly and cumulative data for enrollment through HealthCare.gov, a breakdown of cumulative data for 38 states using the HealthCare.gov platform, and cumulative data for local markets. Overall, net plan selections for Week 12 totaled 103,172. Over the same time period, net new plan selections totaled 144,971.