Feds hide behind potential text message loophole in sunshine law

Feds hide behind potential text message loophole in sunshine law-washingtontimes: Christopher Horner, the researcher, has requested some phone text message records from Gina McCarthy, An Environmental Protection Agency assistant administrator whom President Obama has tapped for the top job. Mr. Horner wants to see the texts Ms. McCarthy was sending during the days she appeared before Congress over the past four years.

Health law still dropping in popularity, Kaiser poll finds

Health law still dropping in popularity, Kaiser poll finds-politico: The poll — a 1,203-person telephone survey from April 15 to April 20 — found that just 35 percent of Americans view Obamacare “very” or “somewhat” favorably, down 8 points since Election Day. Only once since the law passed has support run lower, when 34 percent took a favorable view of the law in October 2011.

Doctor: Stop nannying patient-doctor email

Doctor: Stop nannying patient-doctor email-politico: Jordan Shlain, a practicing physician and founder of HealthLoop, said all of his patients agreed to waive some level of privacy in order to have email exchanges with their doctors, a sign that people want direct access to their doctor.

Expert: Don’t be too hands-off with medical apps

Expert: Don’t be too hands-off with medical apps-politico: An advocate for health IT regulation worried Tuesday that the Obama administration had been too lenient with medical app developers, some of whom push programs that haven’t been evaluated for safety or medical efficacy.

Health care spending growth is at a record low. Here's the catch

Health care spending growth is at a record low. Here's the catch.-Cnnmoney: After years of scary, rocket-like growth, America's health care spending has slowed to record lows. That much we know for certain. What's less clear is why -- the weak economy or cost-control measures, including the earliest provisions of the Affordable Care Act. Since health care spending is a major driver of the federal deficit, that's a pretty critical question.

Hospital Inpatient Proposed Rule Phases In Some Pay Cuts, But Hospitals Dislike DSH Calculation

Hospital Inpatient Proposed Rule Phases In Some Pay Cuts, But Hospitals Dislike DSH Calculation-insidehealthpolicy: CMS late Friday (April 26) proposed increasing pay rates for hospital inpatient services by 0.8 percent in 2014, a move that drew praise from hospitals as CMS moderated some of the pay cuts recently pushed by Congress, including offsets for the short-term physician payment patch included in the January fiscal cliff deal. But hospitals objected to several other pieces of the rule: Public hospitals said CMS undestimated the costs of providing care to the uninsured; specialty hospitals said the readmissions policy punishes hospitals in poor neighborhoods; and long-term care hospitals complained that the rule subjects them to the “25 percent rule.”

If this was a pill, you’d do anything to get it

If this was a pill, you’d do anything to get it-washingtonpost: When Ken Coburn has visitors to the cramped offices of Health Quality Partners in Doylestown, Pa., he likes to show them a graph. It’s not his graph, he’s quick to say. Coburn is not the sort to take credit for other’s work. But it’s a graph that explains why he’s doing what he’s doing. It’s a graph he particularly wishes the folks who run Medicare would see, because if they did, then there’s no way they’d be threatening to shut down his program.

CDRH Details Path Forward For National Post-Market Surveillance System

CDRH Details Path Forward For National Post-Market Surveillance System-graysheet: The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.

FDA Convenes Industry, Physicians To Create International Transcatheter Valve Registry Consortium

FDA Convenes Industry, Physicians To Create International Transcatheter Valve Registry Consortium- graysheet: Experts from industry, government and professional medical societies have taken the first steps toward the creation of an international consortium of transcatheter valve registries. The goal is to establish an important resource for real-world data on transcatheter valve replacement technology and also serve as a model for future international cardiovascular device registry collaborations.

Democratic Senators Tell White House of Concerns About Health Care Law Rollout

Democratic Senators Tell White House of Concerns About Health Care Law Rollout-nytimes: WASHINGTON — Democratic senators, at a caucus meeting with White House officials, expressed concerns on Thursday about how the Obama administration was carrying out the health care law they adopted three years ago.Health and Human Services Secretary Kathleen Sebelius at a hearing Wednesday. Democrats in both houses of Congress said some members of their party were getting nervous that they could pay a political price if the rollout of the law was messy or if premiums went up significantly.

Sebelius Doesn't Know Specifically What Harkin Wants To Release Tavenner Hold

Sebelius Doesn't Know Specifically What Harkin Wants To Release Tavenner Hold-insidehealthpolicy: HHS Secretary Kathleen Sebelius said she does not know specifically what Senate health committee Chair Tom Harkin (D-IA) wants in order to release his hold on Senate floor action to confirm acting CMS Administrator Marilyn Tavenner as permanent agency chief. Following a House Appropriations panel hearing Thursday (April 24), Sebelius told reporters she knows Harkin is mad about the administration's proposal to use $454 million from the ACA's prevention fund to pay for expanding  federal health insurance exchanges, but she added “no one knows the specific issues beyond that.”

IPAB Has to Go, Providers and Advocates Urge

IPAB Has to Go, Providers and Advocates Urge-healthleadersmedia: Some 500 healthcare provider groups and companies, patient advocates and employers on Thursday signed a letter to Congress urging repeal of the Independent Payment Advisory Board in fear that not only will its cost-cutting powers hurt patients' access to care, but that it will also raise costs for employers, and actually raise costs in the long run.

Obamacare exemption talk lights up Capitol Hill

Obamacare exemption talk lights up Capitol Hill-politico: The Obamacare war is on in Congress. A top aide to House Minority Leader Nancy Pelosi sent an email to Democratic offices Thursday afternoon, warning that “Republican trackers” are on Independence Avenue asking lawmakers about the effort to rework which health care insurance members of Congress must use. One Democratic leadership aide said trackers were asking lawmakers if they thought “it’s OK for members of Congress to be exempt from Obamacare?”

FDA's next-gen medtech surveillance bets heavily on unique device identifiers

FDA's next-gen medtech surveillance bets heavily on unique device identifiers-massdevice: The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices.

Medical device tax: Sen. Max Baucus's retirement and its effect on repeal

Medical device tax: Sen. Max Baucus's retirement and its effect on repeal-massdevice: It's unlikely that his waning days as chairman of the Senate Finance Committee will see Sen. Max Baucus (D-Mont.) having a "Come-to-Jesus" moment on the medical device tax, but his retirement does change the game on repealing the levy.

Harkin makes hurdle for Obama’s CMS chief

Harkin makes hurdle for Obama’s CMS chief-politico: Sen. Tom Harkin had a lot more than talk up his sleeve Wednesday morning as he blasted HHS Secretary Kathleen Sebelius for using a prevention fund — his pet project in the health care law — for other aspects of implementing that law. His strategy: keep one of the Obama administration’s nominees from her long-awaited Senate confirmation until the administration is ready to negotiate.

Baucus retires, a grateful nation cheers

Baucus retires, a grateful nation cheers-washingtonpost: With one glorious stroke Max Baucus has made it possible for two of America’s more interesting politicians to play bigger roles on the national stage. Not to be churlish, but I’ll take Ron Wyden and Brian Schweitzer over a dozen Max Baucii any day. Never has a politician done so much to lift the prospects of the republic simply by saying goodbye.

Sources: Obama plans W.H.-GOP budget group

Sources: Obama plans W.H.-GOP budget group-politico: President Barack Obama is reaching out to Republican senators — the most receptive participants from his recent “charm-offensive” dinners — to jump-start talks to reach a “grand bargain” on entitlements, spending and taxes, according to White House and Congressional officials. Obama — fighting against steep odds to reach a big legacy deal on deficits and debts — has personally pressed Congressional leaders for another shot at reaching an agreement similar to one that fell apart during negotiations with Speaker John Boehner (R-Ohio) in 2011.

Senator gives administration ‘F’ on public education for health-care law

Senator gives administration ‘F’ on public education for health-care law-washingtonpost: A Democratic senator who helped craft President Obama’s signature health-care law gave the administration “a failing grade” Wednesday for its efforts to educate the public and small employers about sweeping changes set to take effect in eight months.“I just see a huge train wreck,” Sen. Max Baucus of Montana told Health and Human Services Secretary Kathleen Sebelius at a hearing of the Senate Finance Committee, which he chairs.

MACPAC Fears Primary Care Pay Hike Burden Outweighs Benefit

MACPAC Fears Primary Care Pay Hike Burden Outweighs Benefit-insidehealthpolicy: Medicaid and CHIP Payment and Access Commissioners, at an April 11 meeting, pointed to administrative burdens that have come along with the change in rate setting, and Commissioner Mark Hoyt said it's impossible to overstate the complexity of the programmatic change and the amount of effort and cost spent on temporarily changing the Medicaid rates. Hoyt questioned if it makes sense, considering the amount of effort and time put into changing the rates, to rip it up after two years. Those paying for the change are going to say, “You've got to be freaking kidding me, we're spending a bloody fortune on this -- for what, to change the rates by a buck or two...This is a nightmare,” Hoyt warned commissioners.

Medical device tax: Repeal efforts hinge on "prearranged" deal with the Senate, Reps say

Medical device tax: Repeal efforts hinge on "prearranged" deal with the Senate, Reps say-massdevice: House Republicans seeking to strike the medical device tax must stray from "the regular order" and ensure support in the Senate before sending the upper house a repeal bill, according to members of the House's powerful Ways & Means Committee.

Could "sunshine" rules squash medical innovation?

Could "sunshine" rules squash medical innovation?-massdevice: Researchers warn that burdensome rules governing relationships between physician entrepreneurs and medical device manufacturers could harm one of the industry's most important sources of innovation.

Study: Hospitals earn big bucks when surgeries go wrong

Study: Hospitals earn big bucks when surgeries go wrong-politico: When patients suffer from complications on the operating table, hospitals reap huge profits, according to a new study to be published Wednesday in the Journal of the American Medical Association.“We’ve known for a while that we’re paying for quantity instead of quality, but the magnitude of the numbers behind what that meant has never been articulated,” Dr. Atul Gawande, one of the study’s authors, said in a phone interview. “What we found is they’re eye-popping.”

Hospitals serving the uninsured face challenge under Obamacare

Hospitals serving the uninsured face challenge under Obamacare-washingtonpost: Under the Affordable Care Act, the safety-net hospitals will gain a new source of revenue when millions of the uninsured gain coverage. At the same time, the law’s spending cuts could prove challenging for hospitals that tend to operate with relatively small profit margins. “This is a time of uncertainty for them,” said Stu Guterman, vice president of the Commonwealth Fund. “On the one hand, they should be thrilled because a lot of the patients they treat will have payment attached to them. On the other, they’re losing some of the funding they rely on.”

Regular order of Congress is in disarray on budget

Regular order of Congress is in disarray on budget-politico: Nearly a month after the great budget debates of March, there’s no prospect soon of even appointing a formal House-Senate conference to try to resolve the differences. And rather than be the fall guy again, Appropriations Committee leaders are making plans to move ahead with what could be wildly different assumptions come May and June.

President Obama's budget: Impact on health care

President Obama's budget: Impact on health care-politico: The health care sector saw some huge gains and losses in last week’s White House budget presented by President Barack Obama. It will not pass the Congress or become law, but the document underscores White House priorities. And if grand bargain negotiations resume this year, the document could become the floor, exciting some health players and making others nervous.

ACO’s May Lead Providers To Medicare Advantage

ACO’s May Lead Providers To Medicare Advantage-insidehealthpolicy: ACOs might be a spring board to Medicare Advantage and other capitated-pay models, according to some MedPAC commissioners and accountable care organization representatives. Many Medicare Payment Advisory Commission members raised concerns at a recent meeting that ACOs are not designed to last because at some point they will have wrung out all of the inefficiencies and there will be no more savings to share with providers, but other commissioners and industry officials said it doesn't matter as long as Medicare entices providers to coordinate care, after which point they can transition to other pay models based on care coordination.

Device Industry Seek Attention At Upcoming U.S.-Europe Talks

Device Industry Seek Attention At Upcoming U.S.-Europe Talks-graysheet: Device industry groups say they convened this week with senior U.S. and European Union government officials to press for global regulatory convergence for medical technology to be on the agenda in upcoming negotiations on the Transatlantic Trade and Investment Partnership. The TTIP effort was announced jointly by President Obama and European Commission President José Manuel Barroso in February to advance trade and investment and address regulatory and other non-tariff barriers.

Note to doctors: Beware of social media

Note to doctors: Beware of social media-politico: A policy paper released Thursday by the American College of Physicians and the Federation of State Medical Boards takes on how doctors should deal with everything from Facebook to cellphone photos to texts."It is important for physicians to be aware of the implications for confidentiality and how the use of online media for non-clinical purposes impacts trust in the medical profession," Humayun Chaudhry, president and CEO of the federation, said in a statement.

Medical device tax repeal bill gains enough co-sponsors to pass House

Medical device tax repeal bill gains enough co-sponsors to pass House-massdevice: Representatives in the U.S. House are set to repeat their vote to repeal the medical device tax, now that a bill to do away with the 2.3% sales levy has enough legislators behind it to ensure passage in the lower chamber.

FDA releases draft Sunshine Law guidelines

FDA releases draft Sunshine Law guidelines-massdevice: The document seeks to answer lingering questions about how reporting should be carried out, how bias is determined and which physician/manufacturer relationships must be reported. The guidance has been updated from a May 2011 version, based on recommendations from 13 individuals and interested parties, according to the federal watchdog agency.

Why Republican senators like Obama’s Medicare nominee

Why Republican senators like Obama’s Medicare nominee-washingtonpost: For the first time in nearly a decade, the top spot at one of the federal government’s most important agencies is close to getting filled. The Senate Finance Committee met Tuesday to consider the nomination of Marilyn Tavenner, President Obama’s pick to run the Centers for Medicare and Medicaid Services.This is an agency with a budget of nearly $1 trillion. It oversees the entitlement programs largely seen as the biggest threat to the federal budget—not to mention the entire implementation of the Affordable Care Act.

UnitedHealthcare Teams Up With Health Systems On Device Research To Drive Purchasing Decisions

UnitedHealthcare Teams Up With Health Systems On Device Research To Drive Purchasing Decisions-graysheet: Medical devices will be the focus of a new comparative effectiveness research collaboration between insurer UnitedHealthcare and several large U.S. hospital chains, announced April 9. The goal of the joint venture, called SharedClarity, is to identify the best-performing devices in a range of categories and use the information to drive the health systems’ purchasing decisions.

Wall Street: Not a lot of bargains among medtech stocks

Wall Street: Not a lot of bargains among medtech stocks-massdevice: Medical technology stocks of all stripes have been enjoying a pretty exceptional run in the market, as healthcare has actually been 1 of the leading sectors in the recent rally. Unfortunately for investors, however, revenue, profits, and free cash flow have not been improving at the same rate, and the number of real bargains in the market has shrunk noticeably. While there are still a few opportunities that look undervalued, investors are increasingly finding themselves faced with a limited menu of attractive options.

Grassley: Tavenner's Response On MA Rate Leak Will Show If She Is 'Worthy' Of Confirmation

Grassley: Tavenner's Response On MA Rate Leak Will Show If She Is 'Worthy' Of Confirmation-insidehealthpolicy: Washington insiders expect that a Senate probe into an investors note that went out half an hour before CMS officially announced its decision to reverse course on proposed Medicare Advantage rate cuts will create a temporary bump but is unlikely to derail Marilyn Tavenner's confirmation as CMS administrator. Senate Finance senior Republican Charles Grassley (IA) put the acting CMS chief on notice Monday to expect to be grilled at Tuesday's confirmation hearing about how the information was leaked.

New Medicare cuts threaten non-profit hospitals - Moody's

New Medicare cuts threaten non-profit hospitals - Moody's-reuters: (Reuters) - Not-for-profit U.S. hospitals began confronting another threat to their shaky finances last week with the start of reductions to Medicare that are included in the universal federal spending cuts known as sequestration, Moody's Investors Service said on Monday.

Will the House move on medtech tax repeal?

Will the House move on medtech tax repeal?-massdevice: Anonymous D.C. insiders say that "the House is not ready to send any tax vehicle to the Senate right now," a potential disappointment for those hoping to leverage a recent non-binding Senate vote to bring down the medical device tax.

South Korean medical device approvals up 7% in 2012

South Korean medical device approvals up 7% in 2012-massdevice: The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

Medical Device Innovation Consortium Sets Priorities To Advance Reg Science

Medical Device Innovation Consortium Sets Priorities To Advance Reg Science-graysheet: The Medical Device Innovation Consortium is officially up and running and planning its priority projects. The public-private partnership was formed in December 2012 with the goal of advancing medical device regulatory science. The MDIC board, which held its first meeting in late February, includes leaders from medical device manufacturers, FDA, the National Institutes of Health, CMS and patient advocacy groups

FDA's new global cardiovascular registry to start with transcatheter heart valves

FDA's new global cardiovascular registry to start with transcatheter heart valves-massdevice: The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."

MedPAC: ACOs Are Locating Mostly In Areas With High MA Penetration

MedPAC: ACOs Are Locating Mostly In Areas With High MA Penetration-insidehealthpolicy: Accountable Care Organizations are locating primarily where Medicare Advantage is strong, according to Congress' Medicare advisers, who on Thursday (April 4) will review research on the some 250 ACOs, but there are some exceptions that could be interesting, according to a consultant. Maps of ACOs and MA plan penetration, based on 2012 data, show areas of inconsistency on both coasts and in Mountain states.

Questions Loom On Bonus Structure As House GOP Floats Updated 'Doc Fix'

Questions Loom On Bonus Structure As House GOP Floats Updated 'Doc Fix'-insidehealthpolicy: Some 80 percent of physicians likely would need to be eligible for bonuses to get provider groups to support legislation replacing the Sustainable Growth Rate formula, Rep. Mike Burgess (R-TX) told Inside Health Policy on Wednesday (April 3) as House Republicans floated an updated version of their “doc fix.” The GOP plan is to cut the SGR's base pay rate and give bonuses to physicians who meet as-yet determined performance goals to make up for that cut, he said, but questions remain on how the bonus system would be set up. Burgess also noted that the legislative outline does not prohibit doctors from charging seniors more for Medicare services, which has been called “balance billing” but which Burgess calls “fair billing.”

Medicare buy-in a budget solution?

Medicare buy-in a budget solution?-politco: To get to a budget deal, could Washington buy in to a Medicare buy-in?That’s the question left hanging by a recent Urban Institute paper which maps out one path to bridge the partisan divide over Republican demands that the eligibility age for Medicare be adjusted upward from 65 to 67 so as to conform with Social Security.The GOP would get the higher age it wants. But in turn, it must agree to allow 65- and 66-year-olds — who would be left out in the cold — to buy in to Medicare until they are 67.

FDA issues new guidance on medical device user fee refunds and exceptions

FDA issues new guidance on medical device user fee refunds and exceptions-massdevice: The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.

The FDA sends medtech reviewers into the field | MassDevice.com On Call

The FDA sends medtech reviewers into the field-massdevice: MASSDEVICE ON CALL — The FDA is looking for medical device companies to participate in its "Experiential Learning Program," so that the agency's reviewers can get a 1st-hand look into medtech design and manufacturing. Participating companies would host tours for healthcare regulators as part of a training mechanism to give the reviewers a sense of the medtech development life-cycle and the "challenges faced throughout development, testing, manufacturing, and clinical use," according to an FDA notice.

OBAMACARE CREDITS COULD TRIGGER SURPRISE TAX BILLS

OBAMACARE CREDITS COULD TRIGGER SURPRISE TAX BILLS-associatedpress: President Barack Obama's new health care law will offer subsidies to help people buy private health insurance on state-based exchanges, if they don't already get coverage through their employers. The subsidies are based on income. The lower your income, the bigger the subsidy.

Gain In Procedures From Newly Insured Under Health Reform Will Offset Device Tax, Analyst Says

Gain In Procedures From Newly Insured Under Health Reform Will Offset Device Tax, Analyst Says-graysheet: A Wells Fargo analysis on the expected increase in device utilization rates based on expanded insurance coverage due to provisions of the Affordable Care Act will offset the financial impacts of the 2.3 percent device excise tax.

A fiscal deal or fiscal crisis?

A fiscal deal or fiscal crisis?-politico: Now that Congress and the president have agreed to fund the government for the rest of this fiscal year — removing the threat of a government shutdown — Washington should use this opportunity to get past the crisis-driven fiscal policy of recent years and put the focus squarely where it belongs: on the long term.

CAN MASS MARKETING HEAL THE SPLITS ON 'OBAMACARE'?

CAN MASS MARKETING HEAL THE SPLITS ON 'OBAMACARE'?-associatedpress: With the nation still split over President Barack Obama's health care law, the administration has turned to the science of mass marketing for help in understanding the lives of uninsured people, hoping to craft winning pitches for a surprisingly varied group in society.

EU Parliament Considers More Stringent Medical Device Regulations

EU Parliament Considers More Stringent Medical Device Regulations-graysheet: Continuing the argument from the committee’s Feb. 26 meeting, Dagmar Roth-Behrendt of Germany, the rapporteur of the committee, advocated that a more extensive pre-market approval process should be created for Europe. “I want to have a centralized pre-market authorization for the highest class [of medical devices],” she said in her opening remarks. (See "Pre-Market Question Attracts Debate At EU Parliament Session On Device Reforms" — "The Gray Sheet," Mar. 11, 2013.) “Doctors insist on pre-market authorization,” she said later.

FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says

FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says-graysheet: The two agencies formally launched a pilot program for parallel review in 2011, opening up a collaborative effort that allows CMS to begin considering a national Medicare coverage policy for select new technologies as FDA is reviewing the safety and efficacy of a device for regulatory approval. (See "Calling All Innovators: FDA And CMS Seek Candidates For Parallel Review Pilot" — "The Gray Sheet," Oct. 17, 2011.) The goal is to speed up the time it takes a manufacturer to move from product development to securing Medicare reimbursement, a high priority for any device firm looking to gain a marketing edge.

Lawsuit over health care tax could kill ‘Obamacare’

Lawsuit over health care tax could kill ‘Obamacare’-washingtontimes: “Obamacare” looks increasingly inevitable, but one lawsuit making its way through the court system could pull the plug on the sweeping federal health care law. A challenge filed by the Pacific Legal Foundation contends that the Affordable Care Act is unconstitutional because the bill originated in the Senate, not the House. Under the Origination Clause of the Constitution, all bills raising revenue must begin in the House.