A&B Healthcare Week in Review, April 8, 2016

I. REGULATIONS, NOTICES, & GUIDANCE

• On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and Part D Payment Policies and Final Call Letter. The Call Letter seeks to provide stable payments to plans, and make improvements to the program for plans that provide high quality care to the most vulnerable enrollees. CMS announced the annual MA capitation rate for each MA payment area for CY 2017 and the risk and other factors to be used in adjusting such rates. The capitation rate tables for 2017 can be found here. The new policies aim to improve the accuracy of payments to MA plans through a revised methodology, which will more accurately reflect the cost of care for dually eligible beneficiaries. CMS will also implement an interim adjustment to the Star Ratings to reflect the socioeconomic and disability status of a plan’s enrollees. Lastly, CMS is finalizing policies that will further combat opioid overutilization by encouraging safeguards before an opioid prescription is dispensed at the pharmacy and maintaining access to needed medications.
• On April 7, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the following Request for Information (RFI): Medicare Access and CHIP Reauthorization (MACRA) Act of 2015; Assessing Interoperability. The RFI notes that ONC intends to consider metrics that address the specific populations and aspects of interoperable health information described in section 106(b)(1)(B) of the MACRA. ONC is issuing this RFI to solicit input on the following three topics: (1) measurement population and key components of interoperability that should be measured; (2) current data sources and potential metrics that address section 106(b)(1) of the MACRA; and (3) other data sources and metrics ONC should consider with respect to section 106(b)(1) of the MACRA or interoperability measurement more broadly. Public comments are due June 3, 2016.
• On April 8, 2016, CMS issued a final rule entitled, “Medicaid Program; Deadline for Access Monitoring Review Plan Submissions.” In the November 2, 2015 Federal Register, CMS published a final rule with comment period entitled “Medicaid Program: Methods for Assuring Access to Covered Medicaid Services.” The final rule with comment period established that states must develop and submit to CMS an access monitoring review plan by July 1, 2016. This document revises the deadline for states’ access monitoring review plan submission to CMS until October 1, 2016.
• On April 1, 2016, CMS issued guidance entitled, “Guidance for Ending Special Enrollment Periods for Coverage during Calendar Year 2015.” As of April 1, 2016, CMS will no longer accept new requests that would enable consumers to enroll in a Qualified Health Plan (QHP) with 2015 coverage effective dates through the Federally-facilitated Marketplace, Federally-facilitated Marketplaces where States perform plan management functions, or State-based Marketplace using the Federal Platform using a Special Enrollment Period (SEP). SEP requests for 2015 coverage that are received on or before March 31, 2016 may be processed by CMS after April 1, 2015. However, as of April 1, 2016 all new SEP requests to CMS seeking 2015 coverage, with the exception of SEPs issued as a result of an eligibility appeal described below, will be given a coverage effective date no earlier than January 1, 2016 if eligible for retroactive coverage.
• On April 1, 2016, CMS issued a notice entitled, “Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP).” This notice provides a summary of changes, which states that DME CBP files have been updated in Chapter 23, Section 100.
• On April 1, 2016, CMS issued a notice entitled, “Claims Adjustment Reason Code (CARC) and Remittance Advice Remark Code (RARC) and Medicare Remit Easy Print and PC Print Update.” The purpose of this notice is to update the CARC and RARC lists and also instructs GDIT Medicare System (GMS) and Fiscal Intermediary Shared System (FISS) to update Medicare Remit Easy Print (MREP) and PC Print respectively.
• On April 1, 2016, CMS issued a notice entitled, “Corrections to Recoding in the Home Health (HH) Pricer Program.” The purpose of this notice is to install a corrected HH Pricer program. It also requires Medicare Administrative Contractors (MACs) to adjust claims to correct recoding errors that resulted in inaccurate payments.
• On April 1, 2016, CMS issued a notice entitled, “Provider Reimbursement Manual Part 1 - Chapter 31, Organ Acquisition Payment Policy.” Chapter 31 has been created to update, reorganize, and clarify Medicare’s payment policy regarding organ acquisition costs. This chapter also incorporates corrections to terminology to reflect current usage; revisions of text to clarify meaning; additions, deletions or corrections to cross references; and revisions of section titles. In addition, this chapter expands organ acquisition and donation payment policy for Organ Procurement Organizations and Certified Transplant Centers for kidneys and all other covered organ transplants provided to Medicare beneficiaries.
• On April 4, 2016, the National Institutes of Health (NIH) issued a request for nominations entitled, “National Institutes of Health, National, Heart, Lung, and Blood Institute’s National Asthma Education and Prevention Program Coordinating Committee.” The National Heart, Lung, and Blood Institute of the National Institutes of Health (NHLBI) is requesting nominations for members to serve on the newly constituted National Asthma Education and Prevention Program Coordinating Committee. The Committee’s primary mission is to provide advice to the NHLBI and other Federal agencies on matters concerning asthma and to facilitate efficient and effective exchange of information on asthma activities among the member agencies, and voluntary health organizations in order to enhance coordination of asthma-related programs and activities. Nominations must be received by April 29, 2016.
• On April 4, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued an information collection request (ICR) entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Proposed Project: Protection and Advocacy for Individuals with Mental Illness (PAIMI).” SAMHSA is seeking comments on information collection burdens from the proposed PAIMI reports that State Mental Health Agencies would be required to file with SAMSHA. Public comments are due by June 4, 2016.
• On April 5, 2016, the Food and Drug Administration (FDA) issued a notice entitled, “Charter Renewals: Bone, Reproductive and Urologic Drugs Advisory Committee.” FDA announced the charter renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee. The FDA Commissioner has determined that it is in the public interest to renew the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 23, 2018.
• On April 5, 2016, the Health Resources and Services Administration (HRSA) issued a notice entitled, “Petitions: National Vaccine Injury Compensation Program.” This is a notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
• On April 5, 2016, the Centers for Disease Control and Prevention (CDC) issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Program of Cancer Registries Cancer Surveillance System.” 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. Public comments are due by May 5, 2016.
• On April 5, 2016, NIH issued a notice entitled, “Prospective Grant of an Exclusive Patent License for Commercialization: Boron Neutron Capture Therapy for Skin Cancer.” This is notice announces that NIH is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/155,085, filed April 30, 2015, entitled “Boron Mimics Of Amino Acids And Uses Thereof,” to Beijing Lanyears Communication Technology. The contemplated exclusive license may be limited to boron neutron capture therapy for skin cancer. Public comments are due April 20, 2016.
• On April 5, 2016, the Department of Veteran Affairs (VA) issued a final rule entitled, “Health Care for Certain Children of Vietnam Veterans and Certain Korea Veterans: Covered Birth Defects and Spina Bifida.” This rule amends the regulations concerning the provision of health care to birth children of Vietnam veterans and veterans of covered service in Korea diagnosed with spina bifida, except for spina bifida occulta, and certain other birth defects. In the proposed rule published on May 15, 2015, VA proposed changes to more clearly define the types of health care VA provides, including day health care and health-related services, which the VA defined as homemaker or home health aide services that provide assistance with Activities of Daily Living or Instrumental Activities of Daily Living that have therapeutic value.
• On April 5, 2016, the FDA issued an updated Center of Drug Evaluation and Research (CDER) List of Licensed Biological Products to include the newly approved biosimilar Inflectra.
• On April 5, 2016, the FDA issued guidance entitled, "Guidance: Contents of a Complete Submission for the Evaluation of Proprietary Names." This guidance describes the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission. Accurate identification of medications is critical to preventing medication errors and potential harm to the public.
• On April 5, 2016, CMS released a MLN Matters® Special Edition article entitled, “Updates to Medicare's Organ Acquisition and Donation Payment Policy.” This article is intended to assist providers and suppliers by offering information and resources to clarify Medicare’s organ acquisition and donation payment policy for organ procurement, transplant, and histocompatibility laboratory services provided to Medicare beneficiaries. The information does not convey any new or changed policy, but conveys clarification language in the “Provider Reimbursement Manual (PRM),” CMS Pub. 15-1, chapter 31. This clarification is provided to ensure appropriate reporting of organ acquisition costs, including those in a living Kidney Paired Donation (KPD) exchange, to achieve proper Medicare reimbursement.
• On April 6, 2016, the Office of the Inspector General (OIG) released a final notice entitled, “Termination of OIG Advisory Opinion No. 06-09,” which concerned a nonprofit, tax-exempt, charitable organization's proposals to subsidize Medicare Part D premium and cost-sharing obligations owed by financially needy patients with end-stage renal disease and chronic kidney disease
• On April 6, 2016, the Office of Management and Budget (OMB) received a proposed rule for review entitled, “FY 2017 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (CMS-1645-P).” This annual proposed rule would update the payment rates used under the prospective payment system for Skilled Nursing Facilities for fiscal year 2017.
• On April 5, 2016, CMS issued a transmittal entitled, “Payment for Purchased Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.” This transmittal directs CMS shared systems maintainers to implement claims processing systems changes to allow expatriate beneficiary claims to process and pay for purchased items when certain criteria are met in accordance with Medicare policy.
• On April 7, 2016, HRSA issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations.” ‘The notice indicates that the purpose of the information collection revision is to include an addendum to the Pharmaceutical Pricing Agreement (PPA) to incorporate the administrative requirement for manufacturer integrity provisions directly addressed in the Affordable Care Act. Public comments are due May 7, 2016.
• On April 7, 2016, CMS issued an ICR notice that deals with a number of information collections including: (1) State Medicaid Eligibility Quality Control Sampling Plan; (2) State Medicaid Eligibility Quality Control Sample Selection Lists; (3) Payment Error Rate Measurement in Medicaid and the State Children's Health Insurance Program; (4) Medicaid and State Children's Health Insurance Plan (SCHIP) Managed Care; (5) Payment Error Rate Measurement - State Medicaid and SCHIP Eligibility.” Public comments are due June 7, 2016.
• On April 7, 2016, the Agency for Healthcare Research and Quality (AHRQ) issued an ICR entitled, “Agency Information Collection Activities; Proposals, Submissions, and Approvals: Hospital Survey on Patient Safety Culture Comparative Database.” The Hospital SOPS Comparative Database consists of data from the AHRQ Hospital Survey on Patient Safety Culture. Hospitals in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. Public comments on this survey are due by June 7, 2016.
• On April 7, 2016, the Department of Defense (DOD) issued a notice of extension entitled, “TRICARE Demonstration Project for the Philippines.” The purpose of this demonstration is to validate an alternative approach to providing healthcare services for those beneficiaries covered under the TRICARE Standard option in the Philippines, controlling costs, eliminating any balance billing issues, and ensuring that the billing practices comply with regulatory requirements. During the initial two years of the demonstration project, significant reductions in providers under Pre-Payment Review has been observed, resulting in less fraudulent claim investigations.
• On April 7, 2016, NIH issued a notice entitled, “Charter Renewals: National Science Advisory Board for Biosecurity.” The purpose of the notice is to announce the renewal of the Charter for the National Science Advisory Board for Biosecurity for an additional two-year period.
• On April 7, 2016, NIH issued a notice entitled, “Cooperative Research and Development Agreements (CRADA): Development of an Assay to Detect Genetic Markers Related to Elevated Serum Tryptase in Familial Tryptasemia and Mast Cell Activation Disorders.” NIH seeks to enter into a CRADA with a commercial partner to collaborate on the development and commercialization of an assay to detect a genetic variation related to mast cell activation disorders. Interested CRADA collaborators must submit a confidential proposal summary before or on June 8, 2016.
• On April 7, NIH issued a notice entitled, “Exclusive Licenses: Therapeutics and PMA-approved Diagnostics for Alzheimer's disease (Intranasal Delivery), etc.” This notice is contemplating the grant of a start-up exclusive license to AestasRx Inc., which is located in North Carolina, to practice the inventions embodied in the following patents: U.S. Patent 8,597,660, issued December 3, 2013. Public comments are due by April 22, 2016.
• On April 2, 2016, OMB received an FDA-proposed rule for review entitled, “Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products.” The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antimicrobial agents in consumer antiseptic hand wash.

Event Notices

• April 18 & 19, 2016, the VA will convene a conference on the Commission on Care. The purpose of the Commission, as described in section 202 of the Veterans Access, Choice, and Accountability Act of 2014, is to examine the access of veterans to health care from the VA and strategically examine how best to organize the Veterans Health Administration (VHA), locate health care resources, and deliver health care to veterans during the next 20 years.
• April 25, 2016, HHS will hold a meeting with the President's Advisory Council on Faith-based and Neighborhood Partnerships. Photo ID and RSVP by April 20, 2016 are required to attend the event. Please RSVP to Ben O’Dell at partnerships@hhs.gov.
• April 29, 2016, HHS will convene a meeting with the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of the April meeting considering recommendations made by each of the three subcommittees for updates to the 2016 National Plan. Additional presentations in the afternoon will include an update on the Dementia Friendly America campaign, planning progress towards a Care and Services Summit, and federal workgroup updates.
• May 3, 2016, SAMHSA’s Center for Substance Abuse Treatment (CSAT) National Advisory Council will meet in a closed teleconference meeting.
• May 5, 2016, the Indian Health Services (IHS) will convene a meeting entitled, “American Indian/Alaska Native (AI/AN) Lesbian, Gay, Bisexual, Transgender and Two-Spirit (LGBT2S) Health Issues.” IHS is continuing to seek feedback from the LGBT2S community by holding a series of public teleconferences. In these teleconferences, participants will be asked to comment on several key dimensions of the health needs of the AI/AN LGBT2S community.
• May 17 & 18, 2016, HRSA will hold a meeting with the National Advisory Council on Migrant Health. The purpose of the meeting is to discuss services and issues related to the health of migratory and seasonal agricultural workers and their families and to formulate recommendations for the Secretary of HHS.
• May 24 & 25, 2016, HHS will hold a meeting with the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) to continue discussions and possibly develop recommendations regarding People Living with HIV/AIDS. During this meeting, PACHA members will have discussions regarding Health System Transformations, community approaches to implementing the Updated National HIV/AIDS Strategy, and a panel making the case for food as medicine. The meeting will be open to the public.
• June 7 & 8, 2016, HRSA will convene a meeting with the National Advisory Council on Nurse Education and Practice (NACNEP). The purpose of the 133rd NACNEP meeting is to explore strategies to prepare registered nurses (RNs) to address the complex health needs of populations within an evolving health care delivery system.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On April 6, 2016, the Senate Health, Education, Labor and Pensions (HELP) Committee convened a full committee markup entitled, “Executive Session: S. 2700, S.185, S.2713, S. 2742, S. 2512.” S. 2713, Advancing Precision Medicine Act of 2016, as amended, was advanced by a 20-2 roll call vote. Sen. Rand Paul (R-KY) and Sen. Warren voted against the bill. The other four bills, as amended, S. 2742, S.2700, S. 2512, S. 185, were advanced by voice vote.
• On April 6, 2016, the Senate Special Committee on Aging convened a hearing entitled, “Finding a Cure: Assessing Progress Toward the Goal of Ending Alzheimer’s by 2025.” The witnesses included Ronald Petersen, Chair of National Alzheimer's Project Act (NAPA) Advisory Council on Alzheimer's Research, Care, and Services; David Hyde Pierce, Former Member of NAPA's Advisory Council on Alzheimer's Research, Care and Services; Polly Bradley, Director of Adult Day Services at the Southern Maine Agency on Aging; Lisa Baron, Executive Director of Memory Care Home Solutions.
• On April 7, 2016, the Senate Foreign Relations Subcommittee on Africa and Global Health Policy convened a hearing entitled, “A Progress Report on the West Africa Ebola Epidemic.” The witnesses included Amanda Glassman, Director of Global Health Policy at the Center for Global Development; Alan Knight, Chairman of the Ebola Private Sector Mobilization Group; Raj Panjabi, Co-founder and CEO of Last Mile Health; Sophie Delauney, Adviser for Medecins Sans Frontieres.
• On April 7, 2016, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies convened a hearing entitled, “NIH Budget.” The witnesses included Francis Collins, Director of the National Institutes of Health (NIH); Douglas Lowy, Acting Director of the National Cancer Institute (NCI); Walter Koroshetz, Director of the National Institute of Neurological Disorders and Stroke (NINDS); Richard Hodes, Director of the National Institute on Aging (NIA); Christopher Austin, Director of the National Center for Advancing Translational Sciences (NCATS); Nora Volkow, Director of the National Institute on Drug Abuse (NIDA).

House of Representatives

• The House has adjourned and will reconvene on Tuesday, April 12, 2016.
• On April 6, 2016, the House Energy & Commerce Committee issued a press release praising the Senate HELP Committee for passing five more bipartisan bills as part of its medical innovation package that is similar to the House passed H.R. 6, the 21st Century Cures Act. “Time is short for millions of patients, and we are grateful to Chairman Alexander (R-TN) and Ranking Member Murray (D-WA) for their diligence and hard work in putting together a companion to 21st Century Cures,” said Energy & Commerce Committee Chairman Rep. Fred Upton (R-MI), Health Subcommittee Chairman Rep. Joe Pitts (R-PA), full committee Ranking Member Rep. Frank Pallone (R-NJ), Health Subcommittee Ranking Member Rep. Gene Green (R-TX), and Rep. Diana DeGette (D-CO), who was a lead sponsor of the House bill. “The effort to deliver #CuresNow is not Republican or Democrat, but something we can only achieve together. We look forward to continuing our work and momentum with all stakeholders, including the White House, in order to make 21st Century Cures a reality for patients across the country.”

III. REPORTS, STUDIES, & ANALYSES

• On April 4, 2016, OIG released a report entitled, “Opportunities for Program Improvements Related to States' Withdrawals of Federal Medicaid Funds.” OIG found that CMS has not issued guidance instructing States on the appropriate extent and timing of Medicaid withdrawals. Additionally, OIG stated that CMS did not publish formal guidance instructing States on how to handle the funds in annualized Payment Management System (PMS) accounts, and all three States that we audited withdrew funds from inappropriate accounts. Finally, OIG found that CMS does not require States to reconcile their total Federal Medicaid funds withdrawn with their Federal share of net expenditures.
• On April 7, 2016, OIG released a report entitled, “North Carolina Did Not Always Make Correct Medicaid Claim Adjustments.” Of the 9.2 million claims OIG reviewed, the State agency processed 1.9 million claims using incorrect FMAPs resulting in no impact. However, the remaining 7.3 million claims were paid using incorrect FMAPs resulting in a net overpayment. As a result, the State agency received $1.6 million (Federal share) more in Federal reimbursement than it was entitled to. These errors occurred because the State agency did not have adequate internal controls to process claim adjustments in accordance with Federal requirements.
• On April 7, 2016, OIG released a report entitled, “Wyoming Claimed Unallowable Federal Reimbursement for Some Medicaid Physician-Administered Drugs.” OIG found that the State agency did not invoice manufacturers for rebates associated with $2.6 million ($1.3 million Federal share) in physician-administered drugs. Of this amount, $2.3 million ($1.2 million Federal share) was for single-source drugs, and $286,000 ($143,000 Federal share) was for top-20 multiple-source drugs. Because the State agency's internal controls did not always ensure that it invoiced manufacturers to secure rebates, the State agency improperly claimed Federal reimbursement for these single-source drugs and top-20 multiple-source drugs.

IV. OTHER HEALTH POLICY NEWS

• On April 7 & April 8, 2016, the Medicare Payment Advisory Commission (MedPAC) convened its April meeting. MedPAC staff presented on the following topics: Mandated report: Developing a unified PPS for post-acute care; Improving Medicare Part D; Medicare Part B drug and oncology payment policy issues; Using encounter data for risk adjustment in Medicare Advantage; Hospice and Medicare spending; Measuring low-value care; Preserving access to emergency care in rural areas; and Status report on CMS’s financial alignment demonstration for dual-eligible beneficiaries. More information about this meeting may be found here.
• On April 5, 2016, the Federal Trade Commission (FTC) released a new web-based tool for developers of health-related mobile apps, which was designed to help the developers understand what federal laws and regulations might apply to their apps. The guidance tool asks developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. “Mobile app developers need clear information about the laws that apply to their health-related products,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection. “By working with our partner agencies, we’re helping these businesses build apps that comply with the law and provide more protection for consumers.”