A&B Healthcare Week In Review, October 9, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On October 6, 2015, the Centers for Medicare & Medicaid Services (CMS) released a final rule with comment period entitled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017”. This final rule with comment period specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under the Medicare EHR Incentive Program. In addition, it changes the Medicare and Medicaid EHR Incentive Programs reporting period in 2015 to a 90-day period aligned with the calendar year. This final rule with comment period also removes reporting requirements on measures that have become redundant, duplicative, or topped out from the Medicare and Medicaid EHR Incentive Programs. In addition, this final rule with comment period establishes the requirements for Stage 3 of the program as optional in 2017 and required for all participants beginning in 2018. The final rule with comment period continues to encourage the electronic submission of clinical quality measure (CQM) data, establishes requirements to transition the program to a single stage, and aligns reporting for providers in the Medicare and Medicaid EHR Incentive Programs. The rule is expected to be published in the Federal Register on October 16, 2015.
• On October 16, 2015, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released a final rule entitled “2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications”. This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or “2015 Edition”) and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings. The 2015 Edition establishes the capabilities and specifies the related standards and implementation specifications that Certified Electronic Health Record Technology (CEHRT) would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) under the Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs) when such edition is required for use under these programs. The rule is expected to be published in the Federal Register on October 16, 2015.
• On October 2, 2015, the CMS Center for Medicaid and CHIP Services released an Informational Bulletin entitled “Annual Re-determination of Medicare Part D Low-Income Subsidy Deemed Status (Re-deeming)”. CMS is now preparing for the annual redetermination of Medicare Part D low-income subsidy (LIS) deemed status, also known as “redeeming.” This bulletin is to provide an update on the next steps in the process to ensure that states understand the process and their role in ensuring that dual eligible beneficiaries have timely, affordable, and comprehensive coverage under the Medicare Part D prescription drug benefit.
• On October 6, 2015, the Food and Drug Administration (FDA) announced that a proposed information collection entitled “Guidance for Industry on Generic Drug User Fee Cover Sheet” had been submitted to the Office of Management and Budget (OMB) for review and clearance. Comments are due November 5, 2015. The purpose of this notice is to solicit feedback on the collection of information in an electronic form used to calculate and pay generic drug user fees. Proposed Form FDA 3794, the Generic Drug User Fee Cover Sheet, requests the minimum necessary information to determine if a person has satisfied all relevant user fee obligations.
• On October 6, 2015, FDA announced a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Participation in the pilot is voluntary and is open to application holders of drugs with REMS. The pilot is intended to help application holders, FDA, and other interested stakeholders evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. This project also will help provide FDA with feedback on these topics from pilot participants and other interested stakeholders. Requests to participate in the REMS SPL pilot should be submitted by December 7th. The pilot will proceed for 4 months, from October 6, 2015 to February 3, 2016. This pilot may be extended as resources and needs allow.
• On October 6, 2015, FDA announced the availability of a guidance for industry entitled "Acceptability of Draft Labeling to Support ANDA Approval." This guidance provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs). It explains FDA's interpretation of the regulatory provision related to submission of copies of applicants' proposed labeling and clarifies that FDA's Office of Generic Drugs (OGD) will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA.
• On October 6, 2015, FDA announced the reopening the comment period for the "Established Conditions: Reportable Chemistry, Manufacturing, and Controls (CMC) Changes for Approved Drug and Biologic Products; Draft Guidance for Industry," published in the Federal Register of June 1, 2015. FDA is reopening the comment period to allow interested persons additional time to submit comments by January 4, 2016. More information on the extended comment period may be found here.
• On October 7, 2015, the Department of Health and Human Services Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP), announced a public Town Hall Meeting to respond to questions related to the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking (NPRM) that HHS and fifteen other federal departments and agencies published in the Federal Register on September 8, 2015, (80 FR No. 173, pp. 53933-54061). The goal of the NPRM is to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM seeks comments on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. To be assured consideration, comments on the NPRM must be received no later than December 7, 2015. The purpose of the public Town Hall meeting is for OHRP, HHS agencies, and other Common Rule departments and agencies to provide responses to questions from the public about the NPRM during the open public comment period in order to clarify the NPRM proposals and better inform public comment on the NPRM. The public will be able to ask questions during the Town Hall Meeting, and to submit questions before the meeting. Details about how to submit questions before the Town Hall Meeting are provided below. The public Town Hall Meeting will be held on October 20, 2015, from 9 a.m. to 5 p.m. at the Hubert H. Humphrey Building, 200 Independence Ave., SW, Great Hall, Washington, DC 20201. The meeting may be viewed via webcast as well.
• On October 6, 2015, the HHS Health IT Standards Committee Advisory Meeting announced updated dates for meetings of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). These meetings will be open to the public. 2015 Meeting Dates and Times: • October 6, 2015, from 9:30 a.m. to 3:00 p.m./Eastern Time • November 3, 2015, from 9:30 a.m. to 3:00 p.m./Eastern Time • December 10, 2015, from 9:30 a.m. to 12:30 p.m./Eastern Time. For meeting locations, web conference information, and the most up-to-date information, please visit the calendar on the ONC website, http://www.healthit.gov/FACAS/calendar.
• On October 6, 2015, the Office of Inspector General (OIG) released a policy reminder entitled “Information Blocking and the Federal Anti-Kickback Statute”. The release, part of the HHS “National Health IT Week”, represents “…the opportunity to remind the public about how information blocking may affect safe harbor protection under the Federal anti-kickback statute”.
• On October 8, 2015, the FDA announced that a proposed information collection activity entitled “Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products” had been submitted to OMB for review and clearance. This information collection approval request is for FDA guidance on the procedures for formal meetings between FDA and sponsors or applicants regarding the development and review of PDUFA products. The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings.
• On October 8, 2015, the FDA announced the availability of a guidance for industry entitled “Integrated Summary of Effectiveness.” This guidance describes how an integrated summary of effectiveness (ISE) should be prepared by industry for new drug applications (NDAs) and biologics license applications (BLAs). This guidance is intended to improve the quality of drug applications by describing what efficacy information should be submitted so that FDA can make a regulatory decision on an application. This guidance finalizes the draft guidance issued August 28, 2008.
• On October 8, 2015, FDA announced the availability of a final guidance for industry entitled “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA’s current thinking on adverse event reporting for these outsourcing facilities.
• On October 9, 2015, CMS announced an opportunity for the public to comment on an information collection activity entitled “Hospital Wage Index Occupational Mix Survey and Supporting Regulations in 42 CFR, Section 412.64”. Section 304(c) of Public Law 106-554 amended section 1886(d) (3) (E) of the Social Security Act to require CMS to collect data every three years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program, in order to construct an occupational mix adjustment to the wage index, for application beginning October 1, 2004 (the FY 2005 wage index). Comments on the information collection proposal are due December 8, 2015.
• On October 9, 2015, FDA solicited comments on research entitled "Quantitative Information in Direct-to-Consumer Television Advertisements." The objective of this research is to test consumers' understanding of quantitative information about prescription drugs in DTC television advertisements (ads). Comments will be due 60 days after the item is published in the Federal Register, which is expected to be October 13th.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On Wednesday October 7, 2015, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies convened a hearing to discuss funding for the National Institutes of Health (NIH). Witnesses for the hearing included Francis Collins, director, National Institutes of Health; Douglas Lowy, acting director, National Cancer Institute; Griffin P. Rodgers, director, National Institute of Diabetes and Digestive and Kidney Diseases; Walter J. Koroshetz, director, National Institute of Neurological Disorders and Stroke; Jon R. Lorsch, director, National Institute of General Medical Sciences; and Nora D. Volkow, director, National Institute on Drug Abuse. More information on the hearing may be found here.

House of Representatives

• On October 7, 2015, President Barack Obama signed into law H.R. 1624, the “Protecting Affordable Coverage for Employees Act” (Public Law No. 114-60). Currently, under the Affordable Care Act (ACA), employers with 51 to 100 employees are small employers, but before January 1, 2016, states have the option to treat them as large employers. (Under PPACA, health insurance offered in the small group market must meet certain requirements that do not apply to the large group market, including the requirement to cover the essential health benefits.) This bill amends the ACA and the Public Health Service Act to include employers with 51 to 100 employees as large employers for purposes of health insurance markets.
• Wednesday October 7, 2015, the House Veterans’ Affairs Committee convened a hearing entitled "A Call for System-Wide Change: Evaluating the Independent Assessment of the Veterans Health Administration." The hearing was rescheduled from September 30th. More information on the hearing may be found here.
• On October 8, 2015, the House Energy & Commerce Health Subcommittee convened a hearing entitled “Examining Legislative Proposals to Combat our Nation's Drug Abuse Crisis”. Witnesses for the hearing included Michael Botticelli, Director, National Drug Control Policy (NDCP), Executive Office of the President;Richard Frank, Assistant Secretary for Planning and Evaluation at HHS; and Jack Riley, Deputy Administrator, Drug Enforcement Administration (DEA). During the hearing the Committee discussed the following legislation:
  • H.R. 2536, the Recovery Enhancement for Addiction Treatment (TREAT) Act: The bill would increase the number of patients that a qualifying practitioner dispensing narcotic drugs for maintenance or detoxification treatment is initially allowed to treat from 30 to 100 patients per year. The legislation allows a qualifying physician, after one year, to request approval to treat an unlimited number of patients under specified conditions.
  • H.R. 2805, the Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015: A bill to address prescription opioid abuse and heroin use.
  • H.R. 2872, the Opioid Addiction Treatment Modernization Act: A bill to amend the Controlled Substances Act to modernize the treatment of opioid addiction, and for other purposes.
  • H.R. 3014, the Medical Controlled Substances Transportation Act of 2015: This bill amends the Controlled Substances Act to allow a physician to transport controlled substances to another practice setting or disaster area if the physician is registered to dispense, or conduct research with, controlled substances listed on schedules II, III, IV, or V, and the physician enters into a specific agreement with the Drug Enforcement Administration (DEA). The agreement must require a physician to provide advance notification to the DEA, limit the duration of transport to 72 hours, and maintain records of the controlled substances dispensed.
  • H.R. 3537, the Synthetic Drug Control Act of 2015: A bill to amend the Controlled Substances Act to clarify how controlled substance analogues are to be regulated, and for other purposes.
  • H.R. 3691, the Improving Treatment for Pregnant and Postpartum Women Act of 2015: A bill to amend the Public Health Service Act to reauthorize the residential treatment programs for pregnant and postpartum women and to establish a pilot program to provide grants to State substance abuse agencies to promote innovative service delivery models for such women.
  • H.R. ___, the Co-Prescribing to Reduce Overdoses Act of 2015: A bill to provide for the Secretary of Health and Human Services to carry out a grant program for co-prescribing opioid overdose reversal drugs.

More information on the hearing may be found here.

• On Thursday October 8, 2015, the House Armed Services Subcommittee on Military Personnel convened a hearing entitled “Update on Military Suicide Prevention Programs". Witnesses for the hearing included Dr. Keita Franklin, Director, Suicide Prevention Office, Office of the Secretary of Defense; Lieutenant General James C. McConville, Deputy Chief of Staff, G1, U.S. Army; Rear Admiral Ann M. Burkhardt, Director, 21st Century Sailor Office, U.S. Navy; Major General Burke Whitman, Director Marine and Family Programs, U.S. Marine Corps; and Lieutenant General Mark Ediger, Surgeon General, USAF, U.S. Air Force. More information on the hearing may be found here.
• On Friday October 9, 2015, the House Budget Committee convened a markup of the fiscal 2016 budget resolution reconciliation package. The Committee voted along party lines 21-11 to approve reconciliation instructions, which would repeal much of the ACA. The measure now moves for a House vote. More information may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On October 6, 2015, the Medicaid and CHIP Payment and Access Commission (MACPAC) published new Medicaid and CHIP data. Two new MACPAC-commissioned analyses examine efforts that could inform future policy for children’s coverage and behavioral health. A new Mathematica Policy Research study prepared under contract to MACPAC sheds light on how states met the ACA requirement to move so-called “stair-step” children from separate CHIP programs to Medicaid. Twenty-one states covered this group of low-income children in separate CHIP prior to the ACA’s enactment. The report describes 10 of these states’ experiences with the transition, which could inform future large-scale transitions of children’s coverage. MACPAC also engaged the State Health Access Data Assistance Center (SHADAC) at the University of Minnesota to look into the features that characterize Medicaid behavioral health integration efforts across the country. The resulting catalog covers 19 such programs currently underway.
• On October 7, 2015, the HHS OIG released a report entitled “State Medicaid Agencies Can Significantly Reduce Medicaid Costs for Durable Medical Equipment and Supplies”. In previous audits of four state Medicaid agencies, OIG found that states could have achieved $18.1 million on the purchase of selected durable medical equipment (DME) items had they obtained pricing comparable to pricing under Round 1 of Medicare's Competitive Bidding Program. Since issuing the previous audit reports, OIG identified $12 million in additional cost savings for the selected DME items that the four states could have obtained by using pricing comparable to Medicare's Round 2 Competitive Bidding and National Mail-Order Programs. The agency determined that opportunities exist for these States to lower provider reimbursement rates, resulting in approximately $30.1 million in potential cost savings for the States and the Federal Government. OIG recommended that CMS (1) seek legislative authority to limit State Medicaid DME reimbursement rates to Medicare program rates and (2) encourage further reduction of Medicaid reimbursement rates through competitive bidding or manufacturer rebates. CMS concurred with these recommendations.
• On October 5, 2015, the Kaiser Family Foundation released a report entitled “Medicare Part D at Ten Years: The 2015 Marketplace and Key Trends, 2006-2015”. Since 2006, Medicare beneficiaries have had access through Medicare Part D to prescription drug coverage offered by private plans, either stand-alone prescription drug plans (PDPs) or Medicare Advantage prescription drug plans (MA-PD plans). Now in its tenth year, Part D has evolved due to changes in the private plan marketplace and the laws and regulations that govern the program. This report presents findings from an analysis of the Medicare Part D marketplace in 2015 and changes in features of the drug benefit offered by Part D plans since 2006.

IV. OTHER HEALTH POLICY NEWS

• On October 7, 2015, CMS announced the launch of a new Comprehensive ESRD Care (CEC) Accountable Care Organization (ACO) dialysis model. In the CEC Model, dialysis facilities, nephrologists, and other providers have joined together to form ESRD Seamless Care Organizations (ESCOs) to coordinate care for ESRD beneficiaries. ESCOs will be financially accountable for quality outcomes and Medicare Part A and B spending, including all spending for dialysis services, for their ESRD beneficiaries. The CEC Model includes separate financial arrangements for ESCOs with large and small dialysis organizations. ESCOs with participation by a dialysis facility or facilities owned by a large dialysis organization, which is an organization that owns 200 or more dialysis facilities, will be eligible to receive shared savings payments, but will also be liable for shared losses, and will have higher overall levels of risk compared with their smaller counterparts. ESCOs with participation by a dialysis facility or facilities owned by a small dialysis organization, which is an organization that owns fewer than 200 dialysis facilities, will be eligible to receive shared savings payments, but will not be liable for shared losses. More information on the model, including a list of participating organizations, may be found here.
• On October 7, 2015, CMS announced results of the first shared savings performance year for the Comprehensive Primary Care (CPC) initiative. According to the announcement, in 2014, PC practices showed positive quality results, with hospital readmissions lower than national benchmarks and high performance on patient experience measures, particularly on provider communication with patients and timely access to care. Additionally, CMS announced that during this first shared savings performance year, the initiative decreased Medicare Part A and Part B spending compared to spending targets while achieving high quality outcomes. The CPC initiative generated a total of $24 million in gross savings overall (excluding the CPC care management fees).
• On October 8th and 9th, the Medicare Payment Advisory Commission (MedPAC) convened October meetings to discuss a number of issues related to Medicare payment policy. A copy of the agenda, as well briefs, presentations, and transcripts as they become available, may be found here.