CMS Proposes Expanding Prior-Authorization Requirements

CMS Proposes Expanding Prior-Authorization Requirements-thegraysheet: CMS wants to require prior authorization for Medicare coverage of certain durable medical equipment, prosthetics, orthotics, and supplies items that are frequently subject to unnecessary use, the agency explains in a May 28 proposed rule (PDF). CMS is also proposing to expand its existing prior-authorization demonstration program for power mobility devices to 12 additional states, and two launch two addition prior-authorization demonstration programs.

How Republicans lose by winning

How Republicans lose by winning-politico: Establishment Republicans had a good night in Tuesday’s round of primaries, but they did so in part by adopting positions at odds with the long-term need to broaden the party’s support and move away from litmus-test issues. A wide range of Republicans see the party courting the same disaster it did in 2012, playing a base game that will keep it shut out of the White House.

White House Health Care Aide Named Deputy Chief Of Staff For Policy

White House Health Care Aide Named Deputy Chief Of Staff For Policy-insidehealthpolicy: Kristie Canegallo has been named the new White House Deputy Chief of Staff for Policy Implementation -- a position created in light of the problematic healthcare.gov rollout -- and will focus on ACA implementation, IT reform and a number of other domestic and national security priorities, the White House said Friday (May 16). Canegallo since February 2013 has been special assistant to the president and advisory to the chief of staff, and in that capacity spearheaded White House efforts on ACA implementation after the start of the first open enrollment period, the White House said.

Senate Republicans block tax bill over medical device tax

Senate Republicans block tax bill over medical device tax-massdevice: Senate Republicans, infuriated over Democrats' refusal to allow amendments to a bill that would extend some tax cuts, voted to block the tax extenders bill yesterday. The GOP bloc wanted to introduce an amendment that would repeal the 2.3% medical device tax enacted as part of Obamacare and another to strike a wind production tax credit. But majority leader Sen. Harry Reid (D-Nev.) closed off the minority's ability to introduce amendments and sent the tax bill to a cloture vote that need 60 "ayes" to pass.

POLITICO poll shows mounting danger for Dems

POLITICO poll shows mounting danger for Dems-politico: President Barack Obama’s job approval slump and voters’ entrenched wariness of his health care law are dogging Democrats ahead of the 2014 midterm elections, and Republicans have captured a lead in the areas home to the year’s most competitive races, according to a new POLITICO poll. In the congressional districts and states where the 2014 elections will actually be decided, likely voters said they would prefer to vote for a Republican over a Democrat by 7 points, 41 percent to 34 percent. A quarter of voters said they were unsure of their preference.

HRS2014: Social media lessons from some of cardiology's most-followed

HRS2014: Social media lessons from some of cardiology's most-followed-massdevice: Social media and healthcare are permanently intertwined, according to 3 of cardiology's most prominent online voices.  Drs. Kevin Campbell, Westby Fisher and Dave Albert spoke today about the benefits of having an active online presence to complement interaction in the field.

HRS2014: Smartphones as medical devices and the age of the self-quantified patient

HRS2014: Smartphones as medical devices and the age of the self-quantified patient-massdevice: There's a tsunami of consumer-generated health data on the horizon and care providers would do well to get on board, AliveCor founder and chief medical officer Dr. Dave Albert told an audience today at Heart Rhythm 2014, the Heart Rhythm Society's 35th Annual Scientific Sessions. Smartphones are everywhere and patients are increasingly interested in staying out of the clinic, using consumer-based monitors that can provide a rich picture of health and lifestyle.

Lawmakers mull ways to limit tax inversions

Lawmakers mull ways to limit tax inversions-politico: The Senate’s top tax writer said on Thursday that he is working on a plan to crack down on so-called corporate inversions in which companies slash their U.S. tax bills by moving their headquarters overseas, a practice starting to grab lawmakers’ attention. Finance Committee Chairman Ron Wyden (D-Ore.) declined to discuss specifics, but said he’s hashing out a proposal with Sen. Carl Levin (D-Mich.), the chamber’s most outspoken critic of corporate tax avoidance.

HHS Appointee Burwell Tells Senate Panel IPAB Will ‘Never Be Activated’

HHS Appointee Burwell Tells Senate Panel IPAB Will ‘Never Be Activated’-thegraysheet: HHS Secretary nominee Sylvia Mathews Burwell told the Senate Health, Education, Labor and Pensions Committee May 8 that she believes the Independent Payment Advisory Board created by the Affordable Care Act will never be triggered. As directed by the health reform law, IPAB is required to offer cost-cutting solutions after a year when Medicare cost growth exceeds defined thresholds. The proposals would be fast-tracked through Congress and automatically implemented.

Is Draft Guidance More Than Meets The Eye? Senators Seek Answers From FDA

Is Draft Guidance More Than Meets The Eye? Senators Seek Answers From FDA-thegraysheet: Four Republican senators are pressing FDA about charges from industry that the agency is using draft guidance documents to make substantive policy changes. The lawmakers want information from FDA on guidelines that currently remain in the draft stage, the agency’s plans for finalizing those guidances, and FDA’s policies for ensuring that its staff does not follow a draft guidance as if it is agency policy.

Senate Republicans want answers from FDA commish Hamburg on draft guidances

Senate Republicans want answers from FDA commish Hamburg on draft guidances-massdevice: Four Republican senators are asking FDA commissioner Dr. Margaret Hamburg for some answers on the federal watchdog agency's practice of issuing draft guidances to cover medical device and drug review policies. In the May 6 letter the legislators – Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.) and Orrin Hatch (R-Utah) – say they're concerned that the draft guidances are being used by the FDA "to make substantive policy changes."

Burwell Pledges To Work With Senators On ACA Issues Going Forward

Burwell Pledges To Work With Senators On ACA Issues Going Forward-insidehealthpolicy: HHS Secretary-nominee Sylvia Mathews Burwell on Thursday (May 8) refused to commit to Senate health committee Republicans that she would allow non-ACA compliant policies to be renewed in perpetuity, but the current Office of Management and Budget Director did say she would work with senators on a number of Affordable Care Act issues. The nominee made the comment during a relatively tame confirmation hearing, which took place as the Senate Finance Committee continues the vetting process.

Shuren Highlights CDRH Actions To Ease Trial Burdens On Capitol Hill

Shuren Highlights CDRH Actions To Ease Trial Burdens On Capitol Hill-thegraysheet: Jeffrey Shuren emphasized recent efforts by FDA’s device center to reduce premarket clinical trial burdens in return for strong postmarket controls during the May 6 inaugural roundtable of the House Energy and Commerce Committee’s “21st Century Cures” initiative. Shuren also put his support behind clinical trial networks as a strategy to speed data gathering during the session on Capitol Hill, which lawmakers organized to identify strategies for accelerating the development of new medical treatments.

CMS Loosens Physician-Oversight Rules As Part Of Regulatory Relief Effort

CMS Loosens Physician-Oversight Rules As Part Of Regulatory Relief Effort-insidehealthpolicy: CMS announced Wednesday (May 7) that it no longer requires doctors to be on site at critical access hospitals, rural health clinics and health centers, and Medicare now permits registered dietitians and nutritionists to order patient diets directly without requiring the physicians or other practitioners to sign off on them first. This is the second time since 2012 that streamlined hospital regulations coincided with the American Hospital Association's annual meeting in Washington.

RAC Recoveries Fall As Two-Midnights, Program Pause Implemented

RAC Recoveries Fall As Two-Midnights, Program Pause Implemented-insidehealthpolicy: Medicare Recovery Audit Contractor recoveries fell from a high point of $1.4 billion in the last quarter of fiscal 2013 down to $665 million in the second quarter of 2014 after the two-midnights rule -- and the subsequent enforcement delay -- barred the contractors from looking into short hospital admissions, CMS data show. While a coalition of RAC stakeholders say recoveries will only continue to shrink as CMS' program pause is taken into account, hospital officials say they expect the RACs will look back at claims when the pause ends.

FDA Catches Heat For Plans To Up Standards For Hospital Glucose Meters

FDA Catches Heat For Plans To Up Standards For Hospital Glucose Meters-thegraysheet: FDA’s draft guidance on hospital glucose meters circulated in January has made waves with manufacturers and clinicians, including many who believe the agency has gone too far in its pursuit of more accurate meters in hospitals by proposing standards that are virtually impossible to meet. What’s more, hospital lab managers say language in the draft guidance has set off activity by other authorities that could prevent access to glucose meters in hospitals for critically ill patients.

Hospitals may have to publish their prices

Hospitals may have to publish their prices-massdevice: MASSDEVICE ON CALL — U.S. Medicare regulators want hospitals to open up about the prices they charge for their services. The agency issued a proposed order to require hospitals to publish price-lists, or make them available upon request.

TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot

TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot-graysheet: FDA hopes that a new pilot program for accepting electronic-only 510(k)s will be for device makers what TurboTax is for taxpayers: a guided computer interface that accelerates and improves the quality of submissions while preventing errors that create delays. The agency launched the CDRH eSubmissions Pilot Program April 30 for select device categories and it is accepting requests from companies interested in participating immediately.

CMS Floats Option Of Short Inpatient Hospital Stay Payments

CMS Floats Option Of Short Inpatient Hospital Stay Payments-insidehealthpolicy: CMS is soliciting feedback from hospitals on alternatives to pay for short inpatient stays as part of the proposed hospital inpatient payment rule unveiled Wednesday (April 30), following a hospital lawsuit and strong industry lobbying to change the current controversial two-midnights inpatient admission rule.

FDA seeks electronic medtech guinea pigs

FDA seeks electronic medtech guinea pigs-massdevice: U.S. medical device regulators are looking for volunteers to test out a software-based version of its 510(k) submission program, an alternative to submissions that traditionally require paper copies or compact discs. The new "CDRH 510(k) eSubmissions Pilot Program" will guide users through creating and submitting a 510(k) medical device review application electronically. The FDA is hoping a few guinea pigs will volunteer to run the course and provide feedback.

State physician licensing a barrier to telemedicine

State physician licensing a barrier to telemedicine-politico: The Federation of State Medical Boards has angered patient and industry groups by releasing a model policy for telemedicine that opponents say will slow expansion of remote medical care and make it especially hard to connect poor, aged and rural populations with doctors.