A&B Healthcare Week in Review, November 14, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On November 13, 2015, the Department of Health and Human Services (HHS), the Internal Revenue Service (IRS), and the Employee Benefits Security Administration (EBSA) jointly released a rule entitled “Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections”. This document contains final regulations regarding grandfathered health plans, preexisting condition exclusions, lifetime and annual dollar limits on benefits, rescissions, 2 coverage of dependent children to age 26, internal claims and appeal and external review processes, and patient protections under the Affordable Care Act (ACA). It finalizes changes to the proposed and interim final rules based on comments and incorporates sub-regulatory guidance issued since publication of the proposed and interim final rules. The document is expected to be published in the Federal Register on November 18th, and will go into effect 60 days thereafter.
• On November 11, 2015, the Centers for Medicare and Medicaid Services (CMS) released a notice entitled “Medicare Program; CY 2016 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts”. This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2016 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2016, the inpatient hospital deductible will be $1,288. The daily coinsurance amounts for CY 2016 will be: (1) $322 for the 61st through 90th day of hospitalization in a benefit period; (2) $644 for lifetime reserve days; and (3) $161.00 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period. This notice is effective on January 1, 2016. The document is expected to be published in the Federal Register on November 16th.
• On November 10, 2015, CMS released a notice entitled “Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2016”. This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2016. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2016, the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts, and the transfer amount equal to the reduction in premiums payable as a result of amendments made by the Bipartisan Budget Act of 2015. The monthly actuarial rates for 2016 are $237.60 for aged enrollees and $282.60 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2016 is $121.80, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00. (The 2015 standard premium rate was $104.90.) The Part B deductible for 2016 is $166.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, they will have to pay a total monthly premium of about 35, 50, 65, or 80 percent of the total cost of Part B coverage plus $4.20, $6.00, $7.80, or $9.60. Section 1844(d) of the Social Security Act, as added by section 601(b) of the Bipartisan Budget Act of 2015, provides for a transfer from the general fund to the Part B account of the SMI Trust Fund. This transfer of $7,440,648,000 consists of $5,237,880,000 in reduced premium revenue for enrollees age 65 and older, and $2,202,768,000 in reduced premium revenue for enrollees under age 65. The document is expected to be published in the Federal Register on November 16th. A CMS press release may be found here.
• On November 10, 2015, CMS released a notice entitled “Medicare Program; CY 2016 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement”. This annual notice announces Medicare’s Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2016. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the "uninsured aged") and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2016, for these individuals will be $411. The premium for certain other individuals as described in this notice will be $226. The document is expected to be published in the Federal Register on November 16th. A CMS press release may be found here.
• This week CMS announced that the agency has modified the additional documentation request (ADR) limits for the Recovery Auditor program for providers. The revised limits will be effective January 1, 2016. Each provider’s annual limit will be based on the number of Medicare claims paid in the previous year that are associated with their 6-digit CMS Certification Number (CNN) and the provider’s National Provider Identifier (NPI) number. More information may be found here.
• On November 13, 2015, CMS released a quarterly notice listing CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2015, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On November 13, 2015, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH or Center) announced the 2015 Experiential Learning Program (ELP) General Training Program. This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to request to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information regarding the ELP General Training Program. The notice is expected to be published in the Federal Register on November 16th, and comments will be due 30 days thereafter.

Event Notices

• February 3, 2016: FDA has announced a public workshop entitled “Eighth Annual Sentinel Initiative Public Workshop.” Convened by the Center for Health Policy at the Brookings Institution and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA’s Sentinel Initiative, including an overview of the transition from the Mini-Sentinel pilot to the full Sentinel System, and key activities and uses of the Sentinel System accomplished in 2015. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel projects. The public workshop will be held on February 3, 2016, from 9 a.m. to 4 p.m., Eastern Standard Time (EST) at the Renaissance Washington, DC Dupont Circle Hotel, 1143 New Hampshire Ave. NW., Washington, DC 20037.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On November 10, 2015, the Chairs and Ranking Members of the Senate Finance and Health, Education, Labor and Pensions (HELP) Committees issued a letter to CMS and the HHS Office for Civil Rights (OCR) requesting information on how HHS is working to support and protect victims of identity theft in light of recent data breaches. The letter reads, “Data breaches in the healthcare industry have surged in the past year due to major cyberattacks…In total, OCR’s breach portal indicates that nearly 154 million individuals were affected by 1367 reported data breaches at healthcare organizations. We are concerned that data theft will continue to rise and will result in an increase in medical identity theft”.
• On November 10, 2015, the Senate passed the Military Construction and Veterans Affairs and Related Agencies Appropriations Act of 2016. The Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2016 provides FY2016 appropriations to the Department of Defense (DOD) for military construction, military family housing, the U.S. share of the North Atlantic Treaty Organization Security Investment Program, and base closures and realignments. The bill also provides appropriations to the Department of Veterans Affairs (VA) for veterans benefit and health care programs, Departmental Administration, and the National Cemetery Administration. The House passed the measure in April. The bill, which allocates $79.74 billion in discretionary funding for the VA and Pentagon, passed by a vote of 93-0.

House of Representatives

• The House of Representatives was not in session this week. The House calendar may be accessed here.

III. REPORTS, STUDIES, & ANALYSES

• On November 6, 2015, the Congressional Budget Office (CBO) released a report entitled “Monthly Budget Review: Summary for Fiscal Year 2015”. CBO reports that in fiscal year 2015, which ended on September 30, the federal budget deficit totaled $439 billion—$44 billion less than the shortfall in 2014. Fiscal year 2015 was the sixth consecutive year in which the deficit declined as a share of the nation’s gross domestic product (GDP). The deficit peaked at 9.8 percent of GDP in 2009; it fell to 2.8 percent in 2014 and to 2.5 percent in 2015. According to the report, outlays for the three largest entitlement programs—Social Security, Medicare, and Medicaid—rose by $37 billion (or 4 percent), $34 billion (or 7 percent), and $48 billion (or 16 percent), respectively. Medicare spending, which rose by less than 3 percent in 2014, grew more rapidly in 2015. That development occurred in part because spending for Part A (Hospital Insurance) grew by more than 4 percent in 2015, after declining slightly in 2014, and in part because spending for the prescription drug benefit under Part D grew by nearly 17 percent. Medicaid spending grew significantly in 2015, largely because the provisions of the ACA that led to increased enrollment were in effect for only the last nine months of fiscal year 2014 but for all of fiscal year 2015. With that growth, Medicaid spending has risen by almost one-third in the past two years. Combined outlays for the three programs were equal to 48 percent of federal spending and 9.9 percent of GDP in 2015, the highest shares ever.
• On November 11, 2015, Avalere released a study which finds that only 16 percent of silver exchange plans in 2015 cover all top HIV drug regimens with cost sharing less than $100 per month per regimen. While almost half of plans include all 10 of the most commonly used HIV regimens on their formularies, many plans charge higher out-of-pocket costs for these drugs. These findings highlight differences in the benefits found in the exchange market when compared to other potential sources of coverage for people with HIV, the report said.

IV. OTHER HEALTH POLICY NEWS

• On November 13, 2015, the Supreme Court granted review in Whole Woman’s Health v. Cole, involving the “undue burden” standard for state laws that restrict the availability of abortions. (The Supreme Court ruled in 1992 that states can regulate abortion unless it "places an undue burden on women".) The Court agreed to hear a challenge to two new restrictions in the Texas law: doctors who perform abortions must have the right to send patients to a full-scale hospital no further than thirty miles from the clinic, and each clinic must have the same facilities as a surgical center. This June, the Supreme Court voted 5-4 to grant an emergency appeal from clinics at risk of closing over the new laws, which were due to go into effect on 1 July.
• On November 12, 2015, CMS released an Open Enrollment Snapshot for 2016 Health Insurance Marketplace coverage. Similar to last year, each week, CMS will release weekly Open Enrollment snapshots for the HealthCare.gov platform, which is used by the Federally-facilitated Marketplaces and State Partnership Marketplaces, as well as some State-based Marketplaces. These snapshots provide point-in-time estimates of weekly plan selections, call center activity and visits to HealthCare.gov and CuidadoDeSalud.gov. The “snapshot” for week 1, November 1st through 7th, may be found here.
• On November 12, 2015, CMS announced that it has awarded 16 16, two-year Special Innovation Projects (SIPs), to 10 regional Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs). The SIPs address healthcare quality issues such as early detection and management of sepsis, advance care planning, colorectal cancer screening, and disease management in rural settings among other critically important healthcare quality issues. The list of 2015 SIPs can be found on the Quality Improvement Organization Program website (http://qioprogram.org/cms-awards-16-partnership-driven-special-innovation-projects-10-qin-qios).