Roll Call: Latest News on Capitol Hill, Congress, Politics and Elections
November 23, 2014

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.

 

Spotlight: Ebola Preparedness, Nurse Vigils and Private Group Efforts in Africa

A House Energy and Commerce Committee panel this morning examines domestic health system preparedness for treating Ebola patients. The committee quizzes FDA Commissioner Tom Frieden, plus other HHS officials on readiness to handle patients with the Ebola virus. The session also features the chiefs of Texas and Nebraska hospitals that have treated Ebola patients.

At the same time this morning, a nurse advocacy group, which held a vigil at the White House last week to raise awareness about concerns of woeful health facility preparedness policies for health professionals, takes its case to steps of the headquarters of the Department of Labor’s Occupational Safety and Health Administration.

This afternoon, a House Foreign Affairs Committee panel hears the perspective of several private groups who have been providing health services to Ebola patients in West Africa. Witness at the hearing include representatives from International Medical Corps, Global Communities and Africare.

 

 

 

 

 

 

November 17, 2014

Examining the Impact Stopgap Spending and a Federal Shutdown

Congress will have to pass some form of a spending bill by Dec. 11, which is when congressional authority for temporary continuing spending expires. Appropriators are keen on a complete omnibus bill, which will fund the federal government, including health agencies and programs, through the end of fiscal year 2015. However, an omnibus bill is vexed by the complexities of agreeing on all the spending program details and funding levels, plus anxiety over looming administration action on immigration policy.

A likely alternative is a new stopgap spending bill, or continuing resolution, which would fund the government at largely current levels into the first few months of 2015. The short-term spending bill could include added funding elements for Ebola response efforts.

Budget chiefs at federal agencies likely wince at the idea of another continuing resolution (CR) because it greatly complicates federal budgeting and spending. A 2012 Congressional Research Service report explained that a CR not only adds to paperwork but agencies could also delay hiring, issuing grant awards and cut back on travel expenses. However, the alternative to a CR is a federal government shutdown, which poses much more severe headaches and federal employee furloughs. A Government Accountability Office report issued last week examined the impact of last year’s federal shutdown on HHS agencies.

 

 

Week Ahead: Examining the U.S. Response to Ebola

Congress this week is busy negotiating options and a pathway toward a year-end spending package. However, a wide range of committees also catches up on reviews of U.S. activities and conditions in West Africa regarding the outbreak of the Ebola virus. A Senate committee on Wednesday is poised to advance a bill that adds Ebola drugs to an existing FDA priority drug review program. Additionally, a separate Senate committee mulls overall public health preparedness concerns with FDA Commissioner Thomas Frieden.

Meanwhile, two House Energy and Commerce panels review Ebola response efforts with Frieden and the status drug development activities with National Institute of Health officials. Another House panel this week discusses efforts by private groups battling the virus in West Africa.

Exchanges Open to Less Turmoil

Round two of policy enrollment on the Affordable Care Act’s health insurance exchanges began this weekend and the main healthcare.gov website is functioning this morning. Later this week a House committee offers a reminder on last year’s exchange website opening failure in a hearing with the former chief federal technology officer about planning for the 2014 enrollment disaster.

In a Sunday interview, Department of Health and Human Services Secretary Sylvia Mathews Burwell claimed that 100,000 people had submitted insurance applications over the weekend, though she did not elaborate on whether they were new polices or renewal applications.

The exchanges are challenged this year by higher expectations of enrollment activity. However, Burwell reiterated that an original estimate of 13 million enrollees has been reduced to less than 10 million. Also, Burwell did not directly address the topic of the cost of insurance plans and HHS released a trove of data on plan pricing only a few hours before the Nov. 15 exchange opening. An initial analysis by the Washington Post shows wide regional disparity of premium levels with increased premiums for many of the most popular policies offered on federal exchanges.

However, this year’s premium levels are largely based upon estimates compiled earlier this year and HealthBeat’s (@CQHealthTweet) Rebecca Adams reported (subscription) in April that insurance company financial risk protection provisions offered by the health law would likely minimize major price increases for 2015 plans. The insurer risk protection provisions are temporary and are also subject to likely congressional scrutiny next year. Additionally, actual consumer payments are also greatly aided by premium subsidies. The Supreme Court next year will weigh in on the legal applicability of the special tax breaks for policies purchased in states covered by the federal insurance exchanges.

 

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