Roll Call: Latest News on Capitol Hill, Congress, Politics and Elections
November 26, 2014

November 25, 2014

FDA Issues Restaurant Menu Nutrition Label Regulations

Today, the FDA unveils final regulations mandated by the Affordable Care Act on restaurant menu and food vending machine labeling of nutrition information. The rules have been under development for several years and were subject to intensive lobbying from nutrition groups, grocery stores, movie theaters and pizza delivery chains.

CQ Roll Call’s Georgina Gustin reports (subscription) that the FDA sifted through over a 1,000 comments that addressed complex details on the scope of the menu label regulations. Grocery stores complained that the rule would force supermarket chains to label as many as 15,000 additional items. Pizza chains objected to menu boards at retail locations that primarily offer pizza through a delivery service. The FDA released the text of the final menu label and vending machine rules early this morning. The regulations will be officially published on Dec. 1

 

 

By Paul Jenks Posted at 1:13 p.m.
Uncategorized

Bipartisan Duo Seeks Evidence-Based Policy Policymaking

The difficulty of implementing and reviewing provisions of the Affordable Care Act and parsing the details of the Medicare provider payment process illustrates the extreme complexity of many federal programs. Congress in the past has recognized the need for some assistance. The Congressional Budget Office advises lawmakers on fiscal impact of legislation and the Medicare Payment Advisory Commission has long advised Congress on possible adjustments to Medicare payments. However, guidance on gauging the likely effectiveness of most federal programs is largely left to lawmakers to sift through conflicting studies and analysis.

Last week, Washington Democratic Sen. Patty Murray and Wisconsin Republican Rep. Paul D. Ryan introduced a measure  (S 2952) seeking to establish a new commission to study ways to improve the analysis of program effectiveness and to consider a possible clearinghouse for federal program data and surveys. The concept takes a page from rigorous analysis used for medical research and seeks to apply a similar evidence-based approach to policy making. The proposed commission is a long way away from any formal congressional policy effectiveness agency but the effort seeks find a more rigorous approach to examining the complexities of policy options. However, the new board is not charged with addressing a way to vet the political factors that influence the creation and ongoing maintenance of federal programs.

 

 

November 24, 2014

CBO Offers Some Uncomfortable Deficit Reduction Options

Congressional anxiety over the federal debt level and consistent annual budget deficits has recently taken a back seat to other battles. Also, deficit worries were put on hold by last year’s bipartisan budget agreement that set 2014 and 2015 spending levels. However, the budget battle will resume again next year and will be spurred by required action on raising the ceiling on the federal debt limit. Republican control over both chambers, plus the development of the annual congressional budget plan, will likely shift the focus back onto efforts to reduce deficit spending.

Health care program spending figures prominently in any debate on budgetary and deficit matters. The Congressional Budget Office last week compiled a summary of policy choices available to manage deficit and debt levels. Many of the items have been debated in Congress in the past and are highly contentious. The budgetary advisory agency estimated 10-year savings from several policy options including:

  • Limiting funding for the National Institutes of Health (savings: $11.5 – $34.7 billion)
  • Increasing the excise tax on cigarettes (added revenue $34.7 billion)
  • Limiting medical malpractice awards (savings: $60.4 billion)
  • Change Medicare cost-sharing rules and restricting Medigap policies (savings: $111 billion)
  • Increasing premiums for Medicare Parts B and D (savings $ 314 billion)
  • Requiring drug manufacturers to pay minimum rebates on Medicare Part D drugs (savings $103 billion)
  • Requiring minimum out-of-pocket fees for military retirees (savings: $27 billion)
  • Raising military retiree health plan enrollment fees and restrict coverage options (savings: $19 – $73 billion)

 

 

 

Look Ahead: Spending Bill Action and Tavenner and Gruber Testimony

Congress and much of Washington, DC pauses this week for the Thanksgiving holiday. Lawmakers will return next week to finalize decisions on an extension of current year funding for federal agencies. Meanwhile, a House committee on Dec. 9 is seeking to grill Centers for Medicare Services Administrator Marilyn Tavenner regarding inaccuracies in reporting on health insurance exchange enrollment statistics. The committee is also seeking testimony from embattled health care overhaul law adviser Jonathan Gruber regarding a series of past comments on the development of the health care law.

House committees have been active in delving into the details of the implementation of the health care law. Republican control of Senate starting next year, offers the opportunity for increasing the number Senate committee hearings on the health law.

Meanwhile, a bill (HR 669) seeking to expand data collection on sudden infant deaths quickly passed the Senate last week. The amended bill requires a final House vote, which is possible before the end of year. The added data on deaths hopes to aid research on more than 4,800 sudden unexpected deaths of babies or children under the age of 4 who die without any clear cause.

 

November 21, 2014

Rule Updates Clinical Trial Data Disclosure; Watchdog Group Questions NIH Role in Research Protection Update

The Department of Health and Human Services today published a notice of proposed rules on reporting requirements for clinical trials on new drug products. The rules clarify requirements on posting clinical trial results on the federal website – ClinicalTrials.gov. The site contains information on more than 178,000 clinical trials and seeks to prevent duplication of trials and can quickly signal concerns about unsafe or ineffective drugs.

The website is a joint project of the Food and Drug Administration and the National Institutes of Health. However, a public watchdog group this week questioned continuing role of the NIH in the development broader looming rules on human medical research protections. The group, Public Citizen, claims that NIH is the largest federal sponsor and conductor medical research on human subjects and involvement in rule revisions poses a conflict of interest.

Week In Review: Ebola Response

Congressional committees this week wrapped up a series of  Ebola response review hearings and advanced bills authorizing international aid funding and streamlining Ebola drug research. Panels examined the Ebola response in West Africa, following Centers for Disease Control and Prevention action this week expanding traveler screening to persons arriving in the U.S. from Mali.

CQ HealthBeat’s (@CQHealthTweet) John Reichard reported (subscription) that aid groups in Africa noted a slowing in the outbreak in West Africa (except for Sierra Leone) but that the international response is hindered by shortages of medical workers and protective gear. Other committees examined the limits of domestic preparedness in combating the virus and efforts speed drug and vaccine development.

Meanwhile, the Senate Health, Education, Labor and Pensions Committee on Wednesday quickly approved a measure (S 2917) allowing Ebola drug research in an existing FDA program that expedites drug research for tropical diseases. On Thursday, the House Foreign Affairs Committee, in a voice vote, advanced a measure authorizing $1.8 billion in emergency Ebola response aid through the U.S. Agency for International Development.

The White House has requested $6.2 billion in emergency funding for domestic and international efforts to help combat the Ebola epidemic. After the Thanksgiving holiday recess, lawmakers will return to craft a year-end spending package, which will likely include some of the requested Ebola response funding.

 

By Paul Jenks Posted at 11 a.m.
Uncategorized

Bill Action Update: Sudden Infant Death and Rural Hospital Supervision Bills

The Senate can pass bills very fast — if senators want to. Following committee action on Wednesday on a bill (HR 669) seeking to improve data collection on sudden infant deaths, the Senate on Thursday quietly approved the measure by voice vote. However, an added substitute amendment to the bill offered by Iowa Democratic Sen. Tom Harkin forces another House vote on the revised measure.

Separately, the Senate on Thursday also completed action on a measure (HR 4067) that allows continued easing of enforcement instructions on the supervision of outpatient therapeutic services in critical access and small rural hospitals. The measure now heads to the White House for likely presidential approval.

 

November 20, 2014

Pallone Chosen to Battle GOP Health Law Repeal Efforts

The House Energy and Commerce Committee is the primary House venue for most health policy matters. The leadership of the committee and its health panel vies with House Ways and Means Committee as chief shepherds of health measures and entitlement program financing changes. Democrats on the Energy and Commerce Committee have long been led by retiring Reps. Henry A. Waxman of California and John D. Dingell of Michigan. On Wednesday, Democrats rejected an earlier party planning group decision and selected New Jersey Rep. Frank Pallone, Jr. over California Rep. Anna G. Eshoo.

While the Democrats will be a minority in the House next year and have less influence on legislative matters than their counterparts in the Senate, the committee leadership post is a prominent position to offer viewpoints on health topics. CQ HealthBeat’s (@CQHealthTweet) Kerry Young reported (subscription) that Pallone will play a major role in critiquing GOP efforts to repeal or weaken the Affordable Care Act, since Pallone played a key role in crafting the House version of the health law. Separately on Wednesday, Republicans on the committee also named subcommittee leaders.

 

Ebola Drug Development and Sudden Infant Death Reporting Bills Advance

The Senate Health, Education, Labor and Pensions Committee on Wednesday quickly approved a bill (S 2917) that adds Ebola drug research to an existing FDA drug development program for tropical diseases. The measure now heads toward possible final Senate action before the end of the year. A companion House measure (HR 5729) was introduced earlier this week.

Additionally, retiring committee chairman, Iowa Democratic Sen. Tom Harkin on Wednesday announced committee approval of a measure (HR 669) expanding reporting and data about sudden and unexpected infant deaths. The additional data collection hopes to bolster federal programs and research on the tragic deaths. A possible final Senate vote on the bill this year would complete congressional action on the bill.

 

Feedback Sought on Hospital Payment Overhaul Proposal

The chairman of House Ways and Means health panel on Wednesday weighed in on ongoing anxiety over Medicare billing policies for short hospital stays with a draft bill seeking to fix Medicare hospital payment policies. Texas Republican Rep. Kevin Brady is seeking input on a draft measure that revises the Medicare payment process for hospitals, crafts a new rate for short hospital stays and adjusts hospital stay definitions and the payment appeals process.

Confusion over the definition of short inpatient stays has complicated hospital Medicare payments and confused patients.  Medicare auditors have targeted single-day stays in an effort to stamp out improper billing practices but the payment rejections have caused an enormous backlog in the federal payment claim denial appeals process. Comments and suggestions on the new draft House measure may be incorporated into a new bill after the start of the 114th Congress in January.

By Paul Jenks Posted at 8:34 a.m.
Hospitals

November 19, 2014

Heavy Pot Use May Harm the Brain, Study Shows

weed 7 120408 1 240x261 Heavy Pot Use May Harm the Brain, Study Shows

A woman smokes marijuana rolled as a blunt. Photo by CQ Roll Call

In the wake of states voting to legalize marijuana across the country – and even in Washington’s own backyard – a new study funded by the National Institute on Drug Abuse found that heavy pot use may actually harm the brain.

“We have seen a steady increase in the incidence of marijuana use since 2007,” said one of the study’s authors, Francesca Filbey, in a press release. Filbey, director of cognitive neuroscience research in addictive disorders at the Center for BrainHealth, added that “research on its long-term effects remains scarce despite the changes in legislation surrounding marijuana and the continuing conversation surrounding this relevant public health topic.”

Supporters of loosening marijuana laws have long argued that the drug has little long-term effect on cognition and is less harmful and addictive than cigarettes or alcohol. But the NIDA-funded research suggests that using pot can have a negative impact on the brain, depending on duration and age of first use.

The study found that chronic marijuana use, which is defined as at least four times per week over the past six months, is correlated to adverse changes in the areas of the brain linked to reward, decision making and motivation.  Researchers noticed the impact was greater in individuals who started using pot at an earlier age, implying that developing brains are more susceptible to marijuana’s negative effects.

On the flip side, the study also found that long-term marijuana use can enhance some brain circuits, although researchers acknowledged that the brain could just be compensating for reduced function in other regions as a result of the drug.

NIDA said additional studies are still needed to determine if heavy marijuana use directly caused these effects, but it remains to be seen whether lawmakers will seize on the research in an effort to block recently passed legislation in DC to legalize pot.  Some Republicans have already signaled they would use the annual appropriations process to prevent the District’s marijuana laws from moving forward.

Workers Like Workplace Health Plans As Employer Mandate Looms

On January 1, the Affordable Care Act’s controversial mandate for employers to offer health care coverage begins for large employers and a small employer requirement begins in 2016. While the coverage requirement has generated concerns about job losses, plus complaints over added employer expenses and regulatory burdens, the concept of providing insurance coverage is popular with employees.

This week, the Employee Benefit Research Institute released its annual workplace benefits survey and found that 86 percent of workers rate health insurance as the most important employee benefit. Health insurance ranks higher than other benefits such as retirement savings plans. Additionally, nearly half of workers polled indicate that an employers benefit package is important in their decision to accept or reject a job offer.

By Paul Jenks Posted at 11:19 a.m.
Insurance

The Other Physician Payment Extension Deadline

A seemingly permanent fixture on the congressional agenda is ongoing action to thwart cuts to Medicare payments to physicians and other health care providers. Congress is always focused on the annual effort to halt substantial Medicare payment cuts to doctors. However, there is another looming deadline on enhanced Medicaid payments to primary care physicians.

The Affordable Care Act included a provision that allowed for increased Medicaid payments to primary care physicians at 100 percent parity with Medicare payment rates. The revised payment program began in 2013 but the enhanced payment term was limited to two years and is now set to expire. Unlike the Medicare physician payment deadline, which expires on March 31, 2015, the Medicaid parity payment adjustment expires on Dec. 31, 2014.

A prepared Senate bill (S 2694) offers a parity payment extension for two more years and adds payments to other physician groups. The White House’s initial request for a stopgap-spending bill in September also included a suggestion for an extension of Medicaid payments. Congress now is scrambling to craft the elements of a final year-end omnibus spending bill or another stopgap funding resolution. If the Medicaid payment parity adjustment expires, physician groups likely will to press for retroactive adjustments in next year’s spending bills.

 

 

November 18, 2014

Preventive Health Services Recommendations for Children

Increased access to preventive care was one of the objectives of the Affordable Care Act. Insurance policies sold through state and federal insurance exchanges are required to cover a variety of preventive services, all with the hope of early treatment and avoiding complex and costly health care services.

The health care law charges the U.S. Preventive Services Task Force to report annually on gaps in preventive services coverage and offer recommendations on preventive care priorities. On Monday, the group released its 2014 report, which reviews this year’s recommendations and focuses on preventive care for children and adolescents. The report describes recommendations on screening and tests for a range of conditions for children:

  •  Alcohol Misuse
  • Cervical Cancer:
  • Child Maltreatment
  • Chlamydia and Gonorrhea
  • Dental Caries
  • Depression
  • Developmental Dysplasia of the Hip
  • Drug Use, Illicit or Nonmedical
  • Genital Herpes Simplex
  • Gonococcal Ophthalmia Neonatorum
  • Hearing Loss
  • Hepatitis B
  • HIV
  • Hyperbilirubinemia:
  • Hypertension, Primary:
  • Hypothyroidism, Congenital:
  • Iron Deficiency Anemia:
  • Lead:
  • Lipid Disorders:
  • Obesity
  • Phenylketonuria
  • Sexually Transmitted Infections
  • Scoliosis, Idiopathic
  • Sickle Cell Disease
  • Skin Cancer
  • Speech and Language Delay and Disorders
  • Suicide Risk
  • Testicular Cancer
  • Tobacco Use
  • Visual Impairment

Mulling the Cost of a Physician Payment Fix

Every year for nearly two decades Congress has adjusted the Medicare physician payment formula to avoid payment cuts. The annual – and sometimes monthly – ‘doc fix’ adjustment is the result of a set payment formula that has regularly forced reductions in physician payments.

Ideally, lawmakers and physician groups have long sought to eliminate the formula, instead of haggling over annual adjustments. However the cost of a complete repeal of the formula is an expensive proposition. The current stopgap fix for physician payments ends on March 31 and CQ Roll Call’s Melissa Attias on Monday reported (subscription) on some Republican interest to eliminate the vexing payment formula as early as this year. However, any repeal effort must overcome demands for fiscal offsets to pay for either a complete repeal or another annual extension of relief from a payment cut. The Congressional Budget Office on Friday conveniently reminded lawmakers of the cost options in an update of its analysis of the budgetary impact of various physician payment adjustment alternatives.

 

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