Roll Call: Latest News on Capitol Hill, Congress, Politics and Elections
March 2, 2015

February 27, 2015

Consumer Group Says FDA Might Be Delaying Drug Label Rule

The consumer watchdog group Public Citizen suspects the Food and Drug Administration may be succumbing to influence from the drug industry and slow-walking a proposal that would allow generic drugmakers to update labels if safety problems arise once products are on the market.

CQ’s Georgina Gustin reports the group is cranking up pressure ahead of a March 27 public meeting on the rule change. The group in 2011 petitioned the agency, asking it to propose a rule that would clear the way for generic makers to update labels without agency approval.  In 2013, the agency proposed the rule, stating that it expects to release the final rule in December.

Currently, brand name and generic drugs must share the same label information as the original reference drug. But, the group says, when generics take over the market, brand name makers lose incentive to monitor post-market safety, leaving the job up to the generic makers – which lack the authority to update labels without FDA approval.

February 26, 2015

Ruling Against Health Care Subsidies Could Raise Premiums for Millions

Days ahead of oral arguments in the Supreme Court case challenging health law insurance subsidies, the consulting firm Avalere Health is projecting that nearly 7.5 million Americans could see premiums increase if justices rule for the plaintiffs and strip aid from consumers in those states that use the federal exchange

Eighty-seven percent of federal exchange customers currently receive a subsidy. Avalere said a ruling against the subsidy system means average monthly premium contributions for enrollees could increase between 122 percent and 774 percent, depending on the state. Residents in Alaska and Mississippi would see the highest percentage increases in their premium contributions.

The study assumes consumers do not switch plans following such a ruling. The loss of subsidies would be considered a qualifying event for a special enrollment period, giving consumers the option to buy a cheaper health plan. However, plans could be allowed to terminate contracts with the exchange under certain scenarios, which could reduce coverage offerings, Avalere said.

By Mike Christensen Posted at 12:29 p.m.

Republicans Miffed IRS May Exclude Occupations from Cadillac Tax

It may still be three years away, but the health care law’s “Cadillac Tax” is very much on the minds of some powerful Senate Republicans, who are miffed that the IRS is considering excluding some occupations from the levy. The 40 percent excise tax on high-cost health plans was designed to help pay for the law’s coverage expansion while discouraging overuse of generous health benefits and services that drive up medical spending. Unions, with their generous health packages, stood to be among the losers.
So the first IRS notice of rulemaking on how it intends to implement the tax caught the notice of some on the political right this week, by raising the possibility certain high-risk occupations could be excluded from applicable coverage. Senate Finance Chairman Orrin G. Hatch of Utah, along with Judiciary Chairman Charles E. Grassley of Iowa, sent a letter to Treasury Secretary Jacob J. Lew questioning whether the rule could provide carve-outs for occupations they maintain are mostly affiliated with organized labor is not the answer. As CQ’s Melanie Zanona reports, the letter requests that Lew answer how many of the employee categories referred to in the notice are unionized, which other consumers could be considered for an exemption and whether the department is contemplating delaying the regulation in any way.

The tax takes effect in 2018 and is one of the last provisions in the law that will be implemented.

February 25, 2015

HHS Auditor Prepares ACA Oversight Plan

The inspector general of the Health and Human Services Department  has devoted a large chunk of its annual work plan to monitoring the implementation of the Affordable Care Act, and this week released a health law oversight plan to focus on fraud, waste and abuse, program value, consumer safety and agency efforts to promote innovation. The IG expects 5-10 reports this year specifically focusing on the ACA.

The top priority will be reviews of insurance exchange operations and examination of exchange infrastructure, management and spending, plus the security of plan enrollment information. The IG also will examine internal federal and state process relating to an expanded Medicaid program, Medicare and Medicaid payment changes and program integrity, plus reviews of public health and preventive health grant programs

Initial reports planned for delivery over the next few months include a review of the accuracy of payments to health plans for premium tax credits and payments to federal insurance exchange contractors. Other reports this year include security reviews of state exchanges and an audit of grants to states to establish exchanges.


National Health Security Plan

When a natural or man-made disaster strikes, a local medical crisis usually follows. Health care facilities and public health agencies normally have disaster plans in place but often need higher level assistance. The Department of Health and Human Services this week released a revised national health security plan.

The goal of the National Health Security Strategy is to “strengthen and sustain communities’ abilities to prevent, protect against, mitigate the effects of, respond to, and recover from disasters and emergencies.” The national plan is a fundamental element of federal public health policy and sets specific objectives for the next four years. The strategic objectives are:

  • Build and sustain healthy, resilient communities.
  • Enhance the national capability to produce and effectively use both medical countermeasures and non-pharmaceutical interventions.
  • Ensure comprehensive health situational awareness to support decision-making before incidents and during response and recovery operations.
  • Enhance the integration and effectiveness of the public health, healthcare, and emergency management systems.
  • Strengthen global health security.


Early Bird Filers Gain Health Law Subsidy Reprieve

About 50,000 tax filers who were given incorrect information about subsidies they received under the health law and had already filed their 2014 returns won’t have to pay anything else they might owe because it was the government’s mistake.

Centers for Medicare and Medicaid Services officials announced last week that about 800,000 tax filers, which could be more than 1 million individuals, got incorrect tax statements. Principal Deputy Administrator Andy Slavitt said some of those people may have gotten tax refunds that were too big, while others didn’t receive all they were owed.

A Treasury Department spokesperson said Tuesday that people who have filed do not need to amend their returns. “The IRS will not pursue the collection of any additional taxes from these individuals based on updated information in the corrected forms,” said the spokesperson.

The remaining people affected, who have not yet filed their returns, should wait until they get corrected forms as early as next week.

But Treasury officials are encouraging people who have filed already to check if their refunds should have been bigger and re-file their taxes if need be to recoup the difference. If the taxpayer sees that the monthly premium for the local benchmark plan on the original form is less than the premium listed on the corrected form, it may be worth refiling.

“Individuals may want to consult with their tax preparers to determine if they would benefit from filing amended returns,” said the spokesperson.

The tax problem is separate from longstanding concerns about whether some consumers underestimate how much they would earn and took subsidy credits last year that were too generous. If someone claimed too much of a credit to discount the price of their insurance premium, that person will have to pay it back.

H&R Block Inc. estimated in an analysis Tuesday that about 52 percent of people who enrolled in private health insurance through marketplaces last year are learning that they got subsidies that were too high and have to pay them back. People have had to return an average of about $530, which decreased their tax refund by about 17 percent, the company said. On the flip side, about 33 percent of marketplace customers overestimated their income and are getting bigger refunds than they expected, with the average amount totaling $365 on average, an approximately 11 percent boost.

February 24, 2015

IRS Offers Guidance on Health Insurer and Cadillac Plan Taxes

The Internal Revenue Service is offering guidance on two complicated tax topics initiated by the 2010 Affordable Care Act. The health law is partially funded by an annual fee on health insurers. The fee has been in place since 2013 and new rules set to be published on Thursday set regulations for the fee for 2015. The tax is not applicable to employers who self-insure, non-profit insurers and voluntary employee benefit groups. The new rule notice offers guidance on the tax agency’s effort to clarify the definition of an entity covered by the tax. Last week, Louisiana Republican Rep. Charles Boustany, Jr. blasted the whole idea of the insurer fee as one of the ways the health law increases the cost of insurance premiums. Boustany touted legislation repealing the fee.

Separately,the health law seeks to cull the use of expensive health plans that add to health system spending. On Monday, the IRS issued a notice describing the process it will use to determine a new excise tax on high-cost, employer-sponsored plans. The tax adds a 40 percent charge on “excess benefits” in plans often dubbed “Cadillac” plans. The excise tax is due to start in 2018. The IRS is seeking comments on how the tax agency will define applicable coverage, the amount categorized as “high cost” and dollar limits on coverage.

February 23, 2015

CMS Releases Wide-Ranging Exchange Rule

Next year’s open enrollment period for people buying insurance in health law marketplaces will run from Nov. 1 through Jan. 31, 2016, under a 476-page rule released late Friday that affects the plans created under the statute.

The rule is a catch-all regulation affecting many aspects of the federal marketplace. The regulation touches on protections for insurers that prevent them from experiencing deep financial losses, user fees for the federal marketplace, cost-sharing subsidy information, changes to medical loss ratio calculations, new requirements for provider networks and directories and small business marketplace rules.

Many of the provisions of the rule were finalized as the Centers for Medicare and Medicaid Services proposed last year.

The total maximum out-of-pocket costs that a person with marketplace coverage would have to pay in 2016 is $6,850 for individual coverage and $13,700 for family coverage. The final rule requires plans to have updated provider directories.

The rule will help consumers get medications that are not on a plan’s formulary, or official list of medicines, by changing the process by which a consumer can request coverage and requires an external review of a request if the health plan denies the initial request.  It also clarifies that cost-sharing for drugs obtained through the exceptions process must count toward the annual limit on a consumer’s out-of-pocket costs. The rule also ensures that issuers’ formularies are developed based on expert recommendations.

Mulling Implications of Not Renewing CHIP Funding

The State Children’s Health Insurance Program (CHIP) is poised for a possible rocky-road ahead if Congress does not renew funding later this year. The CHIP program is a means-tested program providing health insurance coverage to low-income children and pregnant women. It is a joint project to the federal government and the states. Federal regulations set basic requirements and the states can design their own programs. In 2013 CHIP enrollment totaled 8.4 million and federal and state CHIP expenditures totaled $13.2 billion.

Federal funding for the CHIP program expires on Sept. 30, 2015 and funding renewal is a high bipartisan congressional priority but debate on a re-authorization bill is likely to extend to close to the deadline. If lawmakers are unable to agree on a renewal bill, the portion of federal CHIP funding assigned to the ongoing effort to expand Medicaid will be covered through regular Medicaid funding, but other state CHIP programs are subject to funding restrictions covered by ‘maintenance of effort’ rules included in the Affordable Care Act. The program maintenance rules require states to maintain current eligibility levels for CHIP children.

The Congressional Research Service recently provided lawmakers with a report (CQ subscription) describing the impact to maintenance of effort rules for ongoing CHIP programs if funding expires in September. The report notes:

The states are provided a couple of exceptions to the MOE requirement: (1) states may impose waiting lists or enrollment caps to limit CHIP expenditures, and (2) after September 1, 2015, states may enroll CHIP-eligible children in qualified health plans in the health insurance exchanges. In addition, in the event that a state’s CHIP allotment is insufficient to fund CHIP coverage for all eligible children, a state must establish procedures to screen children for Medicaid eligibility and enroll those who are Medicaid eligible. For children not eligible for Medicaid, the state must establish procedures to enroll CHIP children in qualified health plans in the health insurance exchanges that have been certified by the Secretary of Health and Human Services to be “at least comparable” to CHIP in terms of benefits and cost sharing.

This Week: HHS Budget Hearings Shadowed by Exchange Enrollment Tax Woes

Congress returns from a recess break and this week dives into an examination of fiscal 2016 spending bill requirements. Health and Human Services Secretary Sylvia Burwell will defend HHS agency funding at Wednesday and Thursday House committee hearings. However, Burwell will likely be quizzed mostly on other topics such as health exchange enrollment estimates plus exchange development and contingency planning. Burwell will also get an opportunity to explain a recently announced expanded enrollment period for people who didn’t comply with the health law’s individual mandate in 2014 and the release of erroneous subsidy data to 800,000 tax filers currently preparing their 2014 tax forms. A House hearing this week will focus on the tax implications of the exchange enrollment process. Also, a Senate hearing on Thursday reviews medical and public health preparedness.

The Senate Commerce, Science and Transportation Committee on Thursday is scheduled to mark up legislation (S 142) sponsored by Democratic Sen. Bill Nelson of Florida that would direct the Consumer Product Safety Commission to issue a childproof packaging rule for liquid nicotine, which is used to refill electronic cigarettes.

Today, the US Department of Agriculture and the Department of Health and Human Services formally published a notice seeking public feedback on the 2015 Dietary Guidelines Advisory Committee Scientific Report. The new guidelines seek to change public behavior on sugary drinks and continues an effort to reduce meat consumption.

February 20, 2015

Hospital Use of Electronic Health Records on the Rise, CDC Says

The number of hospital emergency departments using electronic health records rose from 46 percent in 2006 to 84 percent in 2011, according to a new analysis by the National Center on Health Statistics.

The number of hospital outpatient departments using an electronic health system rose from 29 percent in 2006 to 73 percent in 2011, according to the NCHS, which is part of the Centers for Disease Control and Prevention.

The findings mirror previous information about the growing use of electronic health records, in large part because providers that participate in Medicare and Medicaid have financial incentives to build electronic health systems that meet certain criteria — and they are penalized if they don’t.

Electronic health records are beneficial in meeting the goals of the Department of Health and Human Services’ move toward a more value-based system rather than one in which payments are based on volume.

HHS Offers Enrollment Reprieve

Health and Human Services officials said on Friday that the department will give consumers who face a tax penalty for not having health care coverage in 2014 almost another seven weeks, from March 15 through April 30, to buy health insurance this year.

The original deadline for buying insurance was Feb. 15, although people who did not finish their application have until Feb. 22 to complete it.

HHS officials also said that the administration sent 800,000 people incorrect information in January about the subsidies they got in 2014, which would affect their tax refunds. The administration will send out corrected forms in March.

By Paul Jenks Posted at 11:12 a.m.

Dietary Guidelines Target Sugar and Meat

A federal dietary policy advisory committee on Thursday announced recommendations that “seek a paradigm shift to an environment in which population health is a national priority.” The panel’s recommendations are included in Dietary Guidelines for Americans in 2015, which updates recommendations offered in 2010. The new guidelines stress a need for a cultural change for individuals and communities toward healthier lifestyle choices. The release of the new recommendations kicks off a 45-day comment period, where the food industry, agriculture groups, and public health advocates will weigh in.

The report offers Americans a specific target for change: sugar. The committee says that sugar-sweetened beverages should be replaced with healthier options like water and not drinks with low-calorie sweeteners. However, the report spares coffee and alcoholic drinks and even suggests some benefits from including coffee and alcohol in a dietary program.

The report also adds to earlier guidelines and urges continuing the dietary shift from meat-heavy meals to more plant-based foods to improve health and the environment. The report does not call for the end of meat in U.S. diets, adding, “that no food groups need to be eliminated completely to improve sustainability outcomes over the current status.” But the committee defined a healthy diet as one “lower in red and processed meats; and low in sugar-sweetened foods and drinks and refined grains.”

February 19, 2015

IRS Offers Some Relief on Employer Coverage Reimbursement

The administration has quietly bowed to pressure from small businesses on taxing employers who offer cash reimbursement to employees to purchase health insurance. The IRS and Department of Labor reminded taxpayers last year that premium reimbursement through health reimbursement accounts does not absolve the employer from the requirement to offer health coverage. The employer will still be subject to an excise tax for failure to provide coverage.

On Wednesday, the IRS announced transition relief from the tax until June 30, 2015. The tax agency justified the delay due to the slow development of small business insurance exchanges and some employers may need more time to obtain group health coverage. Iowa Republican Sen. Charles E. Grassley quickly welcomed the tax enforcement delay and Louisiana Republican Rep. Charles Boustany, Jr. urged a permanent delay of the tax.

February 18, 2015

Next Month in Congress: Physician Payment Fix

When Congress returns for a new legislative work period next week, lawmakers will be forced to make a decision on extending, adjusting or overhauling the Medicare physician payment system. Doctors treating Medicare beneficiaries would see their fees reduced by about 21 percent if Congress doesn’t act before a current payment adjustment expires on March 31. The payment formula has been adjusted to avoid a payment cut 17 times since 2003.

Action on the payment change will not be easy. The Congressional Budget Office earlier this month increased by $30.5 billion the price tag of a repeal and replacement of the current payment formula. According to the updated CBO estimates, a nine-month patch that freezes current payment rates would cost $12 billion over the fiscal 2015 to 2025 time span, while a freeze through the end of 2016 would cost $30.4 billion over the same period.

The price tag calculations are important because Republican lawmakers have generally insisted that any payment adjustment or overall fix must be paid for with other spending cuts or new taxes.  Previous physician payment measures have usually tagged other Medicare provider payments to offset the cost of fixing physician payments.

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