A&B Healthcare Week in Review, November 6, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On October 30, 2015, the Office of Inspector General (OIG) released a policy statement entitled “OIG Policy Statement Regarding Hospitals That Discount or Waive Amounts Owed by Medicare Beneficiaries for Self-Administered Drugs Dispensed in Outpatient Settings”. The purpose of this Policy Statement is to assure hospitals that they will not be subject to Office of Inspector General (OIG) administrative sanctions for discounting or waiving amounts Medicare beneficiaries may owe for self-administered drugs (SADs) they receive in outpatient settings when those drugs are not covered by Medicare Part B, subject to the conditions specified herein. This Policy Statement is designed to address the question whether various guidance documents issued by the Centers for Medicare & Medicaid Services (CMS), including a Program Memorandum outlining changes in the Outpatient Prospective Payment System (OPPS) for calendar year 2003, require hospitals to bill and collect (or make good faith efforts to collect) their usual and customary charges for SADs that are not covered by Medicare Part B (Non-covered SADs) to comply with OIG’s fraud and abuse authorities.
• On October 30, 2015, the Department of Health and Human Services (HHS) released a notice entitled, “Notice of Interest Rate on Overdue Debts”. Section 30.18 of the Department of Health and Human Services' claims collection regulations (45 CFR part 30) provides that the Secretary shall charge an annual rate of interest, which is determined and fixed by the Secretary of the Treasury after considering private consumer rates of interest on the date that the Department of Health and Human Services becomes entitled to recovery. The rate cannot be lower than the Department of Treasury's current value of funds rate or the applicable rate determined from the "Schedule of Certified Interest Rates with Range of Maturities" unless the Secretary waives interest in whole or part, or a different rate is prescribed by statute, contract, or repayment agreement. The Secretary of the Treasury may revise this rate quarterly. The Department of Health and Human Services publishes this rate in the Federal Register. The current rate of 10.0%, as fixed by the Secretary of the Treasury, is certified for the quarter ended September 30, 2015.
• On November 2, 2015, CMS released a notice announcing that the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) will not finalize the draft Lower Limb Prostheses Local Coverage Determination (LCD) (DL33787) at this time. After a preliminary review of the public comments, CMS is convening a multidisciplinary Lower Limb Prostheses Interagency Workgroup (Workgroup) in 2016. The purpose of the Workgroup is to develop a consensus statement that informs Medicare policy by reviewing the available clinical evidence that defines best practices in the care of beneficiaries who require lower limb prostheses. The Workgroup will be comprised of clinicians, researchers, policy specialists, and patient advocates from different federal agencies. The Workgroup may also identify areas where evidence gaps exist related to the prescription of lower extremity prostheses, and make recommendations concerning the study designs and outcome measures that best inform patient oriented function, quality of life and service satisfaction in this realm. CMS will ensure there is opportunity for public comment and engagement on the Workgroup consensus statement and any related activities. CMS looks forward to working with the public to ensure appropriate access to prostheses.
• On November 3, 2015, the Food and Drug Administration (FDA) announced the availability of a guidance for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.” The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs and therapeutic biologic products for the treatment of HIV-1 infection.
• On November 3, 2015, the National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), announced the Challenge, “Addiction Research: There's an App for that”. With this Challenge, NIDA aims to develop novel mobile applications (apps) for future addiction research explicitly created on Apple Inc.'s ResearchKit framework. ResearchKit is open-source software which makes it easy for researchers and developers to create apps for specific biomedical research questions by circumventing development of custom code. Contestants will create the solicited app for use by addiction researchers to engage mobile device users in future society-changing research. The Challenge begins November 3, 2015. Submission Period: November 3, 2015 to April 29, 2016, 11:59 p.m., ET.
• On November 5, 2015, the FDA Office for Human Research Protections (OHRP) announced the availability of a draft guidance entitled “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.” The draft guidance is intended for institutions and IRBs that are responsible for the review and oversight of human subject research conducted or supported by HHS or regulated by FDA. The purpose of the draft guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings (also referred to in the guidance as minutes) that meet the regulatory requirements for minutes set forth in FDA and HHS regulations. The draft guidance also provides general recommendations on the type and amount of information to be included in the minutes. Comments are due January 4, 2015.
• On November 5, 2015, CMS issued a release (“Assuring Medicaid Beneficiaries Access to Hepatitis C Drugs”) regarding Medicaid beneficiary access to hepatitis C virus (HCV) drugs. The purpose of this letter is to advise states on the coverage of drugs for Medicaid beneficiaries living with hepatitis C virus (HCV) infections. Specifically, this letter addresses utilization of the direct-acting antiviral (DAA) drugs approved by the FDA for the treatment of chronic HCV infected patients. The letter reads, “CMS is aware that, given the costs of these new DAA HCV drugs, states have raised concerns about the budgetary impact to their Medicaid programs and beneficiary access to needed care. The agency shares these concerns…CMS is concerned that some states are restricting access to DAA HCV drugs contrary to the statutory requirements in section 1927 of the Act by imposing conditions for coverage that may unreasonably restrict access to these drugs”. 

Event Notices

• November 20, 2015: The Department of Health and Human Services announced a public forum to explore pharmaceutical innovation, access, affordability and better health. The forum will take place at HHS in Washington, D.C. on November 20 and will be broadcast live via webcast. Visit: http://www.hhs.gov/hhspharmaceuticalforum for additional information.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On November 2, 2015, President Barack Obama signed into law a budget agreement and debt limit increase. Passed by the Senate last week and by the House on October 28th, the Bipartisan Budget Act of 2015 (H.R. 1314) would lift separate caps on defense and non-defense spending in equal amounts in fiscal 2016 and fiscal 2017. Among other things, the legislation would reform the Disability Insurance program, prevent a pending increase in certain Medicare Part B premiums, provide and fully offset spending cap relief, and suspend the debt ceiling (until March 15, 2017). A section-by-section summary may be found here. The President’s statement on the measure may be found here. It reads, “This agreement is a reminder that Washington can still choose to help, rather than hinder, America’s progress, and I look forward to signing it into law as soon as it reaches my desk.” A Congressional Budget Office (CBO) score of the bill may be found here. Regarding the debt limit increase, the newly enacted legislation (HR 1314) will suspend the $18.1 trillion debt limit until March 15, 2017, when the borrowing ceiling would reset at the level of debt at that time.

House of Representatives

• On November 3, 2015, the House Energy & Commerce Health Subcommittee convened a hearing entitled “Examining Legislation to Improve Medicare and Medicaid”. Panel I featured Representative Lynn Jenkins (R-KS) as the sole witness. Panel II witnesses were Katharine Iritani, Director, Health Care Team, Government Accountability Office (GAO), and Anne Schwartz, PhD Executive Director Medicaid and CHIP Payment and Access Commission (MACPAC).
  
  During the hearing, the following pieces of legislation were discussed:
• Amendment to H.R. 1362, Medicaid REPORTS Act: To amend title XIX of the Social Security Act to require States to submit a report at least once a year on sources of funds used to finance the non-Federal share of expenditures under such title, and for other purposes.
• H.R. ____, Quality Care for Moms and Babies Act: To amend title XI of the Social Security Act to improve the quality, health outcomes, and value of maternity care under the Medicaid and CHIP programs by developing maternity care quality measures and supporting maternity care quality collaboratives.
• Amendment to H.R. 1361, Medicaid HOME Improvement Act: Eliminating the state option to reduce the Medicaid home equity exemption amount for purposes of determining eligibility for long-term care assistance.
• H.R. 2151, Improving Oversight and Accountability in Medicaid Non-DSH Supplemental Payments Act: To amend title XIX of the Social Security Act to improve the calculation, oversight, and accountability of non-DSH supplemental payments under the Medicaid program, and for other purposes.
• H.R. 2878, to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2015

In her opening statements, Katharine Iritani of GAO discussed the results of a GAO report entitled “Medicaid: Improving Transparency and Accountability of Supplemental Payments and State Financing Methods” (GAO-16-195T).

More information on the hearing may be found here.

• On November 3rd, the House Ways and Means Health Subcommittee convened a hearing to examine the health care law's Consumer Operated and Oriented Plan (CO-OP) program. More information on the hearing may be found here.
• On Thursday November 5th, the House Energy and Commerce Subcommittee on Oversight and Investigations will convene a hearing entitled "Examining the Costly Failures of Obamacare's CO-OP Insurance Loans." More information on the hearing may be found here.
• On Tuesday November 3rd (opening statements only) and Wednesday November 4th, the House Energy and Commerce Health Subcommittee convened a markup of the following bills:
  • HR 2017 — Common Sense Nutrition Disclosure Act
  • HR 2446 — A bill to amend title XIX of the Social Security Act to require the use of electronic visit verification for personal care services furnished under the Medicaid program, and for other purposes.
  • HR 2646 — Helping Families in Mental Health Crisis Act
  • HR 3014 — Medical Controlled Substances Transportation Act
  • HR 3537 — A bill to amend the Controlled Substances Act to clarify how controlled substance analogues are to be regulated, and for other purposes.
  • HR 3716 — Ensuring Terminated Providers are Removed from Medicaid and CHIP Act
  • HR 3821 — Medicaid Directory of Caregivers Act
• The Subcommittee advanced all seven bills to be next considered by full committee. Six of the bills were approved by voice vote. H.R. 2646, the Helping Families in Mental Health Crisis Act passed by a vote of 18 to 12 (CBO score here). More information on the hearing may be found here.
• On November 5, 2015, Energy and Commerce Committee Chairman Fred Upton (R-MI) announced the creation of a Medicaid Task Force. Upton announced that Health Subcommittee Vice Chairman Brett Guthrie (R-KY) will chair the task force. “Medicaid was created 50 years ago to help the nation’s most vulnerable, and we owe it to folks to ensure we fulfill that promise of quality care,” said Chairman Upton. “Rep. Guthrie and all the members of the task force will be important stewards as we work to strengthen and sustain Medicaid for years to come.” More information may be found here.
• On November 5, 2015, the House Ways and Means Committee elected Representative Kevin Brady (R-TX) as Chairman, to replace now-Speaker Paul Ryan (R-WI). More information may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On November 2, 2015, the HHS Office of Inspector General (OIG) released the fiscal year 2016 OIG Work Plan, which summarizes new and ongoing OIG reviews with respect to HHS programs and operations. The document may be accessed here.
• On November 3, 2015, GAO released a report entitled “Medicaid: Improving Transparency and Accountability of Supplemental Payments and State Financing Methods” (GAO-16-195T). The report states that GAO has found that complete and reliable data are lacking on the tens of billions in Medicaid supplemental payments states often make, hindering transparency and oversight. For instance, in a November 2012 report, GAO found that Congress and CMS have acted to improve transparency and accountability for one type of Medicaid supplemental payment known as disproportionate share hospital (DSH) payments, made for uncompensated care costs experienced by hospitals serving low-income and Medicaid patients. However, the report notes, gaps in oversight remain for non-DSH supplemental payments. GAO concluded in an April 2015 report that payments that greatly exceed costs raise questions about whether they are economical and efficient as required by law, and the extent to which they are ultimately used for Medicaid services. GAO found that CMS generally does not require or otherwise collect data from states on sources of funds to finance Medicaid, nor ensure that the data it does collect are accurate and complete. As a result, GAO said, CMS cannot fully assess the appropriateness of states’ financing or the extent to which the increased reliance on providers and local governments serves to provide fiscal relief to states or improve access.
• On November 3, 2015, CMS unveiled an interactive mapping tool available showing geographic comparisons, at the state, county, and ZIP code levels, of de-identified Medicare Part D opioid prescription claims within the United States. This new mapping tool allows the user to see both the number and percentage of opioid claims at the local level and better understand how this critical issue impacts communities nationwide. The data used in this mapping tool is from 2013 Medicare Part D prescription drug claims prescribed by health care providers and does not contain beneficiary information.

IV. OTHER HEALTH POLICY NEWS

• On November 2, 2015, HHS Secretary Sylvia Burwell announced that Montana had become the 30th state to expand its Medicaid program under the Affordable Care Act (ACA). “With today’s agreement, Montana becomes the 30th state, plus the District of Columbia, to expand Medicaid under the Affordable Care Act. This agreement will bring much needed access to health care coverage to more than 70,000 low-income Montanans,” said Secretary Burwell. “The administration looks forward to working with other states to expand Medicaid by designing programs that meet state’s needs while providing needed services to residents and significant economic benefits to states.
• On November 3, 2015, CMS announced that HealthCare.gov is piloting a new beta feature that allows consumers to search plans by their preferred provider or health facility. Some consumers will be part of a pilot that allows them to use the beta Doctor Lookup feature as they compare their coverage options in window shopping or when selecting a plan. “The Doctor Lookup feature at HealthCare.gov is a direct result of consumer demand,” said Kevin Counihan, CEO of the Health Insurance Marketplace. “Our goal is to provide consumers with relevant, personal and more up-to-date information about a plan before enrolling. We thank the Marketplace health plans who have now made this information available to the public.”
• The Medicare Payment Advisory Commission (MedPAC) convened a series of meetings in Washington D.C. on September 5th and 6th in NW Washington DC. More information on the meetings, including presentations and transcripts as they become available, may be found here.
• On November 5, 2015, CMS announced that the agency is partnering with the New York State Department of Health (NYSDOH) and the Office for People with Developmental Disabilities (OPWDD) to test a new model for providing Medicare-Medicaid enrollees with a more coordinated, person-centered care experience. This partnership will create a program demonstration known as Fully Integrated Duals Advantage for Individuals with Intellectual and Developmental Disabilities (FIDA-IDD) to better serve individuals with intellectual and developmental disabilities who are eligible for both Medicare and Medicaid and will focus on these individuals’ long-term care needs. New York State and CMS is working with Partners Health Plan to offer this FIDA-IDD program in New York City, Long Island, and Rockland and Westchester Counties. Voluntary enrollment in the program will begin no sooner than April 1, 2016. This demonstration for individuals with intellectual and developmental disabilities shares the general goals and structure of the Fully Integrated Duals Advantage (FIDA) Demonstration, which is already operating in New York, but the two demonstrations involve different populations and Medicare-Medicaid Plans. Other important distinctions between the two demonstrations are that the FIDA-IDD Demonstration does not allow for passive enrollment of eligible individuals and includes a benefit package tailored to support individuals with intellectual and developmental disabilities. More information may be found here.
• On November 6, 2015, the Supreme Court agreed to rule on a challenge to the ACA’s birth control mandate, which requires employers to provide female employees with health insurance that includes access to certain forms of birth control without cost-sharing. There are seven cases in all. More information may be found here.