Friday, June 28, 2013

Wrapping up Phase 1: New data bolsters the general direction of innovation over the next five years


Mobile operating system: Wrapping up Phase 1: New data bolsters the general direction of innovation over the next five years
PwC concludes Phase 1 of its Mobile Innovations Forecast, in which we have examined trends in the performance of core components of mobile devices and infrastructure. Based on new data for these components, our fundamental assessment is that the rate of performance increases for these seven enabling components of mobile innovation—memory, application processor, storage, infrastructure speed, device speed, imaging and display technology—is expected to decelerate only slightly between 2011 and 2016, relative to 2007 to 2011.
Continuing advances in display technology, imaging, infrastructure speed and application processors (quad versus single purpose strategy more than performance per se) appear more closely tied to mobile innovation bursts.
We do see a potential trouble spot with the coming introduction of ultra high definition (UHD) video. Will the massive data streams produced by UHD overwhelm the other components? We explore that issue in the article. On the other hand, we are enthused by the early breakthroughs demonstrated by smartphones that use contextual information to deliver new value to owners. And a major question as we move into Phase 2 of our exploration of mobile innovation is how many mobile operating systems (OS) and associated app store ecosystems will survive to relevancy by 2016?
Figure 5: Index component changes

 
This forecast exists within PwC’s framework for understanding various dynamics driving the broader technology sector today, a framework that suggests ways technology companies might navigate disruptions that are rich in opportunity.
Our coverage of the vast mobile ecosystem is an ongoing project comprising four phases. Phase 1 examined the performance improvements of existing technology components. Phase 2, launching soon, covers new capabilities being added to mobile devices. Phase 3 will review compelling new use cases. And Phase 4 will cover new business models.
To learn more about mobile innovation in the next few years, read or download the full article.


Walking Away From Medicare


About a year and a half ago, Dr. Leslie Kernisan, 37, a geriatrician in San Francisco, decided she couldn’t stand her medical practice any longer. Every day, she felt she was shortchanging her older patients.
“What I had in the way of time and resources to meet patients’ needs was so inadequate that it felt almost grotesque,” she told me recently.
Dr. Leslie KernisanDr. Leslie Kernisan
At the time, Dr. Kernisan was working at a community clinic filled with caring, committed professionals. They weren’t the problem. What was wrong, she felt, was a dysfunctional system of health care for seniors — and at the center of that was Medicare, the government’s insurance program for seniors.
So Dr. Kernisan did something highly unusual for a geriatrician. She decided to withdraw from Medicare and create a new kind of geriatrics practice.
Today, she spends as much time as her patients want reviewing their medical problems, their prognosis, how their care is being coordinated, and what caregivers can do to help. When people call for help, she calls them back within two hours. E-mails are answered in one business day; a request for a house call generates an appointment in no more than two days.
The price for all of this: $200 an hour, which patients pay out of their own pockets, for anything and everything she does. (Though Medicare doesn’t pay for her services, it does pay for medical tests and services provided to these patients by other physicians.)
Those fees are unaffordable for all but relatively well-off older adults, however. While people didn’t complain, Dr. Kernisan said she felt “terrible” about leaving patients who had relied on her and guilty toward colleagues who shouldered responsibilities she was giving up.
Still, she’d come to a breaking point, and it seemed impossible to go on as things were. “It was so stressful that I felt my own health and well-being were suffering,” Dr. Kernisan said.
Dr. Kernisan described her new geriatrics practice recently in a Hastings Center blog post and spent several hours talking with me about her decision to leave Medicare. Hers is an extreme example of the malaise afflicting geriatricians.
Earlier this year, my colleague Paula Span wrote about the drop in the number of doctors enrolled in fellowship training programs for geriatrics. The number of geriatricians, estimated at 7,222 last year, has fallen from a peak of 8,824 in 1996 and is far short of the estimated 25,000 geriatricians needed to serve the burgeoning population of older adults by 2025.
“Maintaining practice in geriatrics is very difficult unless you have some other form of support,” like an academic position or a medical directorship at a nursing home, said Dr. Peter Hollmann, chairman of the public policy committee of the American Geriatrics Society. “It’s one of the only fields in medicine where additional years of training yields less compensation, not more.”
At doctors’ offices and at the clinic where Dr. Kernisan worked, Medicare paid only for face-to-face visits, not phone calls or consultations with family members; reimbursements didn’t even begin to cover the effort required for thorough medical evaluations of medically complex patients. The only way to stay afloat financially, she found, was to pack in patients back-to-back in 15- to 30-minute slots.
“People would come in with a long list of concerns that they wanted to address, and you’re thinking, ‘How many of these can I follow up on?” Dr. Kernisan said. “And you ended up having to pick just two or three. If you’re conscientious, it’s distressing to feel you can’t do most of what you should be doing.”
Stressed and unable to sleep at night, the young doctor felt pulled between her professional passion for helping older patients and their families and her personal life, with the abundant demands of two small children.
One day, her 3-year-old asked, “Mommy, why are you always mad and always saying no?” At that point, Dr. Kernisan said, she was forced to recognize she was “always cranky at home and miserable going to work.” It was time for a change. In May 2012, she left the clinic where she’d worked part time as a medical director, and in October she opened her own practice.
That move coincides with a growing debate within her profession. Given the small numbers of geriatricians in the United States, should they even try to provide basic medical care? Or should they become consultants, called in on complex cases that require special expertise in the health concerns of older adults?
“A lot of geriatricians feel they might use their time more effectively working in teams with primary care physicians,” said Dr. Gregg Warshaw, a professor of family medicine and geriatrics at the University of Cincinnati.
Today, Dr. Kernisan describes herself as a coach and a consultant. Instead of delivering routine medical care, she conducts comprehensive, specialized geriatric assessments, evaluates care ordered by other doctors, and comes up with plans to fill gaps in care that other medical professionals haven’t addressed.
“I focus on things like pain, physical decline, falls, incontinence, frailty, the management of medical complexity — things that tend to be missed by primary care doctors who lack the time or expertise or both,” she said.
Sometimes, it’s not easy. Though Dr. Kernisan tries to work closely with a patient’s primary care doctor, some haven’t welcomed her input. “It’s a delicate issue,” she said. “The vast majority of the time, it has been a family or a geriatric care manager who calls me up, not a primary care doctor saying, ‘I need help with this older person.’”
Dr. Hollmann said, “I think it is a reasonable option for some number of geriatricians to have this kind of practice, but hopefully it won’t be too many, because we want Medicare patients to have access to care.”
Although there’s a lot of noise about physicians’ unhappiness with Medicare and some evidence of doctors restricting the number of Medicare members they’ll treat, only 3,423 physicians nationwide opted out of the government health program last year, according to the Centers for Medicare and Medicaid Services.
But those numbers aren’t necessarily reliable. When the Office of the Inspector General of the Department of Health and Human Services was asked to evaluate how many physicians were opting out of Medicare, it found that the Centers for Medicare and Medicaid Services and the agency’s contracts were not maintaining “sufficient data” to answer the question.
If you know of other geriatricians who’ve exited Medicare and set up new models of practice for older adults, tell us more in the comments section.



Senator Asks States If They Alert Medicare to Problem Physicians

by Charles OrnsteinTracy Weber and Jennifer LaFleur
ProPublica, June 28, 2013, 11:28 a.m.

A key U.S. senator sent letters to all 50 states this week asking how they sanction doctors in their state health programs and whether they alert the federal government when they do.
In his letters, Sen. Charles Grassley, R-Iowa, cited examples from a ProPublica report last month that found doctors who had been kicked out of state Medicaid programs for the poor were able to continue prescribing drugs to elderly and disabled patients in Medicare.
In 2005, for example, Florida booted Dr. Enrique Casuso from its Medicaid network using a provision that allows it to end contracts without cause on 30 days' notice. A memo justifying his removal said Casuso was seeing up to 81 Medicaid patients a day in addition to his non-Medicaid cases. Investigators found cases in which he lacked "awareness or oversight of the medication prescribed."
A copy of Casuso's termination letter was sent to Medicare. But Casuso continues to prescribe in Medicare's drug program, known as Part D, ProPublica reported.
In 2010, he prescribed more antipsychotics to elderly patients – 8,900, including refills dispensed – than any other doctor in the country. Many of those went to patients with dementia even though warnings from the Food and Drug Administration say the drugs increase the risk of death in such patients.
Casuso defended his prescribing, telling ProPublica the drugs were necessary to keep his patients safe and to calm them.
Physicians can be terminated from Medicaid for a variety of reasons. If they are terminated with cause, the state must prove misconduct. A termination without cause doesn't require any burden of proof. It may be because a doctor has stopped seeing Medicaid patients or because it is a quicker way of severing ties with a doctor suspected of wrongdoing.
The concern, Grassley wrote, is that while states use "without cause" terminations to quickly remove doctors from their Medicaid networks, the actions are not considered disciplinary and can't be used against doctors by Medicare. Terminations with cause, which are formal sanctions, can take much longer because they can be appealed.
"States' current practice of without cause termination from Medicaid may speed their ability to protect Medicaid patients, but it can expose Medicare recipients to potentially unsafe medical treatment and keeps tax dollars flowing to unworthy providers," wrote Grassley, the ranking Republican on the Senate Judiciary Committee.
Medicaid is jointly funded by states and the federal government, but is run by the states. Medicare is run by the federal government.
Grassley asked each state Medicaid program to indicate how it determines when to use the "without cause" provision and how it informs Medicare of its actions, if at all. Once states respond, Grassley plans to ask Medicare whether and how it acts on this information.
Physicians can continue to prescribe in Medicare unless they have been formally excluded from the program.
This is not the first time Grassley has questioned how Medicaid monitors prescribing by physicians and others. In 2010, he sent letters to all states asking for the names of the top prescribers of painkillers, antianxiety drugs and antipsychotics in their Medicaid programs. He followed up last year to ask whether the states had cracked down on those who wrote large numbers of prescriptions.
The senator also has focused on doctors' ties to drug companies. He was a key proponent of the Physician Payment Sunshine Act, which requires all drug and medical device makers to make public their payments to doctors beginning next year. And in 2009, he sent letters to prominent medical organizations seeking details about their industry financial support.
Justin Senior, the deputy secretary of Florida's Agency for Health Care Administration, said earlier this year that the ability to terminate a doctor's Medicaid contract without cause is "a tool that we can use when we see someone we feel might be doing something that is inappropriate."
In Florida, if physicians are expelled for cause from Medicaid, they cannot renew their state medical licenses. This can make the legal battle over such a termination much fiercer.
But Senior said that the physicians who are removed without cause have no blemish on their record. "They still have a license to practice medicine," he said. "They can happily make a living billing Medicare, Blue Cross ... billing whoever is willing to do business them."
Medicare could use these cases as tips to pass onto its own fraud investigators.
In his letter, Grassley cited two other examples from ProPublica's report:
  • Chicago psychiatrist Michael Reinstein wrote an average of 20,000 prescriptions for the antipsychotic clozapine in Part D each year between 2007 and 2009, and another 14,000 in 2010. Last year, he was suspended from Illinois Medicaid, and the Department of Justice has sued him for fraud. But he remains able to provide services under Medicare. Reinstein has treated patients at more than 30 Chicago-area nursing homes and long-term care facilities. He has defended his prescribing in media interviews.
  • Miami psychiatrist Fernando Mendez-Villamil was terminated without cause from Florida Medicaid in 2010 amid questions about his prescribing of mental health drugs. The Florida medical board also has accused him of giving patients as young as 3 a variety of such drugs without properly diagnosing or monitoring them. He remains eligible to prescribe in Medicare. His lawyer has said his client had done nothing wrong.
The Centers for Medicare and Medicaid Services, which oversees both programs, did not respond to a request for comment. Officials have previously declined to comment on the physicians named in this story.
In a statement, Grassley said he wants to "get first-hand information" to make sure actions taken by Medicaid programs don't leave Medicare patients at risk.


(CMS-R-267) Medicare Advantage Program Requirements

This Notice document was issued by the Centers for Medicare Medicaid Services (CMS)

Summary
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in theFederal Registerconcerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Dates
Comments must be received by August 27, 2013:
Addresses
When commenting, please reference the document identifier or OMB control number (OCN). To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___ Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
For Further Information Contact
Reports Clearance Office at (410) 786-1326.
Supplementary Information
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (seeADDRESSES).
CMS-10199Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy
CMS-10484End Stage Renal Disease (ESRD) Application Access Request Form
CMS-R-38Conditions of Certification for Rural Health Clinics
CMS-10266Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants
CMS-10237Part C—Medicare Advantage and 1876 Cost Plan Expansion Application
CMS-10198Collection Requirements Pertaining to the Creditable Coverage Disclosure to CMS On-Line Form and Instructions
CMS-R-267Medicare Advantage Program Requirements
CMS-10137Solicitation for Applications for Medicare Prescription Drug Plan 2015 Contracts
CMS-43Application for Hospital Insurance Benefits for Individuals with End Stage Renal Disease
CMS-1763Request for Termination of Premium Hospital and/or Supplementary Medical Insurance
CMS-1728-94Home Health Agency Cost Report
CMS-10174Collection of Prescription Drug Event Data from Contracted Part D Providers for Payment
CMS-10305Part C Medicare Advantage Reporting Requirements and Supporting Regulations
CMS-10488Enrollee Satisfaction Survey Data Collection
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in theFederal Registerconcerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.
Information Collections
1. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy; Use: We provide coverage for carotid artery stenting (CAS) with embolic protection for patients at high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis between 50 percent and 70 percent or have asymptomatic carotid artery stenosis ≥ 80 percent in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), a trial under the CMS Clinical Trial Policy (NCD Manual § 310.1, or in accordance with the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7).
Accordingly, we consider coverage for CAS reasonable and necessary (section 1862(A)(1)(a) of the Social Security Act). However, evidence for use of CAS with embolic protection for patients with high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis ≥ 70 percent who are not enrolled in a study or trial is less compelling. To encourage responsible and appropriate use of CAS with embolic protection, we issued a Decision Memo for Carotid Artery Stenting on March 17, 2005, indicating that CAS with embolic protection for symptomatic carotid artery stenosis ≥ 70 percent will be covered only if performed in facilities that have beendetermined to be competent in performing the evaluation, procedure and follow-up necessary to ensure optimal patient outcomes. In accordance with this criteria, we consider coverage for CAS reasonable and necessary (section 1862(A)(1)(a) of the Social Security Act). Form Number: CMS-10199 (OCN: 0938-1011); Frequency: Yearly; Affected Public: Business or other for-profit, Not-for-profit institutions; Number of Respondents: 1,000; Total Annual Responses: 1,000; Total Annual Hours: 500. (For policy questions regarding this collection contact Lori Ashby at 410-786-6322.)
2. Type of Information Collection Request: New Collection (Request for a new OMB control number); Title of Information Collection: End Stage Renal Disease (ESRD) Application Access Request Form; Use: We are developing a new suite of systems to support the End Stage Renal Disease (ESRD) program. Due to the sensitivity of the data being collected and reported, we must ensure that only authorized personnel have access to data. Personnel are given access to the ESRD systems through the creation of user IDs and passwords within the QualityNet Identity Management System (QIMS); however, once within the system, the system determines the rights and privileges the personnel has over the data within the system. Such access rights include: Viewing and reporting, updating adding and deleting.
The sole purpose of the ESRD Application Access Request Form is to identify the individual's data access rights once within the ESRD system. This data collection is currently being accomplished under “Part B” of the QualityNet Identity Management System Account Form. Once the ESRD Application Access Form is approved, the QualityNet Identity Management System (QIMS) Account Form will be revised to remove Part B from the QIMS data collection. The ESRD Application Access Request Form will be a new form and will be assigned its own OMB Control number. The ESRD system accounts created using the current QIMS Account Form—Part B will not need to submit an ESRD Application Access Form for the creation of their account since that information was collected under Part B.
The QIMS Account Registration and the ESRD Application Access Request forms are required for identity and security management of individuals accessing the Consolidated Renal Operations in a Web Enabled Network (CROWNWeb) system and the End Stage Renal Disease Quality Incentive Program (ESRD QIP) system. The CROWNWeb system is the system that is mandated for the Medicare and Medicaid Programs Conditions of Coverage for End-Stage Renal Disease Facilities, Final Rule published April 15, 2008. Form Number: CMS-10484 (OCN: 0938-NEW); Frequency: Annually; Affected Public: Business and other for-profits; and not-for-profits; Number of Respondents: 27,000; Total Annual Responses: 27,000; Total Annual Hours: 6,750. (For policy questions regarding this collection contact Victoria Schlining at 410-786-6878.)
3. Type of Information Collection Request: Reinstatement with change of a currently approved collection; Title of Information Collection: Conditions of Certification for Rural Health Clinics; Use: The Rural Health Clinic (RHC) conditions of certification are based on criteria prescribed in law and are designed to ensure that each facility has a properly trained staff to provide appropriate care and to assure a safe physical environment for patients. We use these conditions of participation to certify RHCs wishing to participate in the Medicare program. These requirements are similar in intent to standards developed by industry organizations such as the Joint Commission on Accreditation of Hospitals, and the National League of Nursing and the American Public Association and merely reflect accepted standards of management and care to which rural health clinics must adhere. Form Number: CMS-R-38 (OCN: 0938-0334); Frequency: Recordkeeping and Reporting—Annually; Affected Public: Business or other for-profits; Number of Respondents: 9,716; Total Annual Responses: 9,716; Total Annual Hours: 33,304. (For policy questions regarding this collection contact Mary Collins at 410-786-3189.)
4. Type of Information Collection Request: Reinstatement with change of a currently approved collection; Title of Information Collection: Conditions of Participation: Requirements for Approval and Reapproval of Transplant Centers to Perform Organ Transplants; Use: The Conditions of Participation and accompanying requirements specified in the regulations are used by our surveyors as a basis for determining whether a transplant center qualifies for approval or re-approval under Medicare. We, along with the healthcare industry, believe that the availability to the facility of the type of records and general content of records is standard medical practice and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. Form Number: CMS-10266 (OCN: 0938-1069); Frequency: Yearly; Affected Public: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 226; Total Annual Responses: 528; Total Annual Hours: 2,523. (For policy questions regarding this collection contact Diane Corning at 410-786-8486.)
5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Part C—Medicare Advantage and 1876 Cost Plan Expansion Application; Use: Organizations wishing to provide healthcare services under Medicare Advantage (MA) and/or MA organizations that offer integrated prescription drug and health care products must complete an application, file a bid, and receive final approval from us. Existing MA plans may request to expand their contracted service area by completing the Service Area Expansion application. Any current 1876 Cost Plan Contractor that wants to expand its Medicare cost-based contract with CMS can complete the application. Information is collected to ensure applicant compliance with our requirements and to gather data used to support its determination of contract awards. Form Number: CMS-10237 (OCN 0938-0935); Frequency: Yearly; Affected Public: Business or other for-profits and Not-for-profits institutions; Number of Respondents: 566; Total Annual Responses: 566; Total Annual Hours: 22,955. (For policy questions regarding this collection contact Melissa Staud at 410-786-3669.)
6. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Creditable Coverage Disclosure to CMS On-Line Form and Instructions; Use: Most entities that currently provide prescription drug benefits to any Medicare Part D eligible individual must disclose whether their prescription drug benefit is creditable (expected to pay at least as much, on average, as the standard prescription drug plan under Medicare). The disclosure must be provided annually and upon any change that affects whether the coverage is creditable prescription drug coverage. Form Number: CMS-10198 (OCN: 0938-1013). Frequency: Yearly and semi-annually; Affected Public: Business or other for-profits and not-for-profit institutions, State, Local, or Tribal Governments. Number of Respondents: 85,610; Total Annual Responses: 87,265; Total Annual Hours: 7,272. (For policy questions regarding thiscollection contact Roslyn Thomas at 410-786-9621.)
7. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Medicare Advantage Program Requirements; Use: Medicare Advantage (MA) organizations and potential MA organizations (applicants) use the information to comply with the application requirements and the MA contract requirements. We will use this information to: Approve contract applications, monitor compliance with contract requirements, make proper payment to MA organizations, determine compliance with the new prescription drug benefit requirements, and to ensure that correct information is disclosed to Medicare beneficiaries (both potential enrollees and enrollees). Form Number: CMS-R-267 (OCN: 0938-0753). Frequency: Yearly. Affected Public: Individuals or households and Business or other for-profits; Number of Respondents: 18,043,776; Total Annual Responses: 21,935,728; Total Annual Hours: 8,529,541. (For policy questions regarding this collection contact Dana Burley at 410-786-4547.)
8. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Solicitation for Applications for Medicare Prescription Drug Plan 2015 Contracts; Use: The information will be collected under the solicitation of proposals from prescription drug plans, Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage, Cost Plans, PACE, and EGWP applicants. We will use the information collected to ensure that applicants meet our requirements and to support the determination of contract awards. Form Number: CMS-10137 (OCN: 0938-0936); Frequency: Yearly; Affected Public: Business or other for-profits and Not-for-profits institutions; Number of Respondents: 254; Total Annual Responses: 254; Total Annual Hours: 2,319. (For policy questions regarding this collection contact Linda Anders at 410-786-0459.)
9. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Application for Hospital Insurance Benefits for Individuals with End Stage Renal Disease; Use: The CMS-43 application is used (in conjunction with CMS-2728) to establish entitlement to, and enrollment in, Medicare Part A (and Part B) for individuals with end stage renal disease. The application is completed by a Social Security Administration (SSA) claims representative or field representative using information provided by the individual during an interview. The CMS-43 application follows the questions and requirements used by SSA to determine Title II eligibility. This is done not only for consistency purposes, but because certain Title II and Title XVIII insured status and relationship requirements must be met in order to qualify for Medicare under the end stage renal disease provisions. Form Number: CMS-43 (OCN: 0938-0800); Frequency: Once; Affected Public: Individuals or households; Number of Respondents: 60,000; Total Annual Responses: 60,000; Total Annual Hours: 24,960. (For policy questions regarding this collection contact Lindsay Smith at 410-786-6843.)
10. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Request for Termination of Premium Hospital and Supplementary Medical Insurance; Use: The CMS-1763 provides us and the Social Security Administration (SSA) with the enrollee's request for termination of Part B, Part A or both Part B and A premium coverage. The form is completed by an SSA claims or field representative using information provided by the Medicare enrollee during an interview. The purpose of the form is to provide to the enrollee with a standardized format to request termination of Part B, Part A premium coverage or both, explain why the enrollee wishes to terminate such coverage, and to acknowledge that the ramifications of the decision are understood. Form Number: CMS-1763 (OCN: 0938-0025); Frequency: Once; Affected Public: Individuals or households; Number of Respondents: 14,000; Total Annual Responses: 14,000; Total Annual Hours: 5,833. (For policy questions regarding this collection contact Lindsay Smith at 410-786-6843.)
11. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Home Health Agency Cost Report; Use: In accordance with sections 1815(a), 1833(e) and 1861(v)(1)(A) of the Social Security Act, providers of service in the Medicare program are required to submit annual information to achieve reimbursement for health care services rendered to Medicare beneficiaries. In addition, 42 CFR 413.20(b) requires that cost reports are required from providers on an annual basis. Such cost reports are required to be filed with the provider's Medicare contractor. The Medicare contractor uses the cost report not only to make settlement with the provider for the fiscal period covered by the cost report, but also in deciding whether to audit the records of the provider. Section 413.24(a) requires providers receiving payment on the basis of reimbursable cost provide adequate cost data based on their financial and statistical records that must be capable of verification by qualified auditors. Besides determining program reimbursement, the data submitted on the cost reports supports the management of federal programs. The data is extracted from the cost report and used for making projections of Medicare Trust Fund requirements and for analysis to rebase home health agency prospective payment system. The data is also available to Congress, researchers, universities, and other interested parties. While the collection of data is a secondary function of the cost report, its primary function is to reimburse providers for services rendered to program beneficiaries. Form Number: CMS-1728-94 (OCN: 0938-0022): Frequency: Yearly; Affected Public: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 11,563; Total Annual Responses: 11,563; Total Annual Hours: 2,613,238. (For policy questions regarding this collection contact Angela Havrilla at 410-786-4516.)
12. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Collection of Prescription Drug Event Data from Contracted Part D Providers for Payment; Use: The information users for this information collection request include Pharmacy Benefit Managers, third party administrators and pharmacies and prescription drug plans, Medicare Advantage plans that offer integrated prescription drug and health care coverage, Fallbacks and other plans that offer coverage of outpatient prescription drugs under the Medicare Part D benefit to Medicare beneficiaries. The data is used primarily for payment, but is also used for claim validation as well as for other legislated functions such as quality monitoring, program integrity, and oversight. Form Number: CMS-10174 (OCN: 0938-0982); Frequency: Monthly; Affected Public: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 747; Total Annual Responses: 947,881,770; Total Annual Hours: 1,896. (For policy questions regarding this collection contact Ivan Iveljic at 410-786-3312.)
13. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Part C Medicare Advantage Reporting Requirements and Supporting Regulations; Use: There are a number of information users of Part C reporting, including central and regional office staff that use this information to monitor health plans and to hold them accountable for their performance. Other government agencies such as the Government Accountability Office have inquired about this information. Health plans can use this information to measure and benchmark their performance. CMS intends to make some of these data available for public reporting as “display measures” in 2013. Form Number: CMS-10305 (OCN: 0938-1115); Frequency: Yearly and semi-annually; Affected Public: Business or other for-profits; Number of Respondents: 588; Total Annual Responses: 6,715; Total Annual Hours: 200,918. (For policy questions regarding this collection contact Terry Lied at 410-786-8973.)
14. Type of Information Collection Request: New Collection (Request for a new OMB control number; Title of Information Collection: Enrollee Satisfaction Survey Data Collection; Use: Section 1311(c)(4) of the Affordable Care Act (ACA) requires the Department of Health and Human Services (HHS) to develop an enrollee satisfaction survey system that assesses consumer experience with qualified health plans (QHPs) offered through an Exchange. It also requires public display of enrollee satisfaction information by the Exchange to allow individuals to easily compare enrollee satisfaction levels between comparable plans. HHS intends to establish an enrollee satisfaction survey system that assesses consumer experience with the Marketplaces and the qualified health plans (QHPs) offered through the Marketplaces. The surveys will include topics to assess consumer experience with the Marketplace such as enrollment and customer service, as well as experience with the health care system such as communication skills of providers and ease of access to health care services. We are considering using the Consumer Assessment of Health Providers and Systems (CAHPS®) principles (http://www.cahps.ahrq.gov/about.htm) for developing the surveys. We are also considering an application and approval process for enrollee satisfaction survey vendors who want to participate in collecting ESS data. The application form for survey vendors includes information regarding organization name and contact(s) as well as minimum business requirements such as relevant survey experience, organizational survey capacity, and quality control procedures.
The Marketplace Survey will provide (1) actionable information that the Marketplaces can use to improve performance, (2) information that we and state regulatory organizations can use for oversight, and (3) a longitudinal database for future Marketplace research. The CAHPS® family of instruments does not have a survey that assesses entities similar to Marketplaces, so the Marketplace survey items were generated by the project team. The QHP survey will (1) help consumers choose among competing health plans, (2) provide actionable information that the QHPs can use to improve performance, (3) provide information that regulatory and accreditation organizations can use to regulate and accredit plans, and (4) provide a longitudinal database for consumer research. CMS plans to base the QHP survey on the CAHPS® Health Plan Survey.
We are planning for two rounds of developmental testing for the Marketplace and QHP surveys. The 2014 survey field tests will help determine psychometric properties and provide an initial measure of performance for Marketplaces and QHPs to use for quality improvement. Based on field test results, there will be further refinement of the questionnaires and sampling designs to conduct the 2015 beta test of each survey. We plan to request clearance for two additional rounds of national implementation with public reporting of scores for each survey in the future. A summary of findings from the testing rounds will be included when requesting clearance for the additional two rounds of national implementation with public reporting, which will take place in 2016 and 2017. Form Number: CMS-10488 (OCN: 0938-NEW); Frequency: Annually; Affected Public: Individuals and Households, Business or other for-profits and Not-for-profit institutions; Number of Respondents: 251,671; Total Annual Responses: 251,671; Total Annual Hours: 86,014. (For policy questions regarding this collection contact Kathleen Jack at 410-786-7214.)
Dated: June 25, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2013-15558 Filed 6-27-13; 8:45 am]

Surgeon data: 'Historic' move for NHS


By Nick Triggle   Health correspondent, BBC News

Only heart surgeons have published individual performance data so far

The first wave of new performance data for individual surgeons in England is being published in what is being hailed as a historic moment for the NHS.
Vascular surgeons have become the first of a new group of nine specialities to publish the information, including death rates.
It appears on the NHS Choices website. The other groups will follow in the coming weeks.
But the move has been overshadowed by some surgeons refusing to take part.
They were able to do this because of data protection laws, although earlier this month Health Secretary Jeremy Hunt warned that those refusing to take part would be publicly named.
Just six out of nearly 500 vascular surgeons, who specialise in procedures on the arteries and veins, including stents, have opted out.
But NHS Choices states none of the six had results outside the normally expected range.

This is an historic moment for surgery, and I'm enormously proud of what surgeons up and down the country have achieved”

Prof Norman WilliamsRoyal College of Surgeons
They have been named as Richard Bird, Patrick Kent, Robert Lonsdale, Manmohan Madan, Peter McCollum and Leszek Wolowczyk.
They, and their reasons for opting out - including not agreeing with publication of the data - are detailed on the website.
Vascular surgeon Peter McCollum told BBC Radio 4 that he opted out because the data was "inherently flawed".
"Bad surgeons will not be picked up by this process - and it puts pressure on younger surgeons not to do any difficult surgery at all."
He said he would prefer data to be analysed on a unit level, rather than for individual surgeons, because this would give a better picture of outcomes.
Nonetheless, the move to publish this data is being viewed as a significant milestone.
To date, individual performance data has only been published for heart surgeons.
But for years there has been debate about whether other areas of medicine should follow.
The publication of surgery-specific data was first called for in 2001 by Prof Sir Ian Kennedy, who chaired the inquiry into the excessive number of deaths of babies undergoing heart surgery in Bristol.

'Clam up'

Understanding the data
It is important not to view the surgeons' performance data as a league table.
Surgeons all carry out a different range of procedures, even within the same specialty. They also deal with a different number of cases each year, on both high and low-risk patients.
Some surgeons will have many complex patients. Also, some procedures are inherently riskier than others.
What the tables do show are the number of times a procedure has been performed by a surgeon over a year, the mortality rate and - after adjusting for risk - if the outcomes fall within an acceptable range.
It's acknowledged that surgeons need to perform a certain number of operations to keep their skills at a high level.
But some doctors have been resistant to widening publication of data for eight surgical specialties and cardiology, as there is a fear that it may give a misleading impression.
Those doctors who take on the most difficult and complex cases may appear to be performing badly, when in fact they could be the leading specialists in their field.
The specialities taking part account for about 4,000 surgeons, more than half the workforce.
Alongside mortality rates, the data includes information on other aspects such as length of stay in hospital after a procedure.
NHS medical director Sir Bruce Keogh told the BBC: "This has been done nowhere else in the world, and I think it represents a very significant step.
"A number of great British institutions have lost some element of public trust recently because they're seen to clam up when things go wrong.
"It's my ambition that we in the NHS do exactly the opposite and we share the way we perform and what we offer our patients with the public, who I think really deserve to see how well we're performing, because everybody owns the NHS."
'Celebration'
http://news.bbcimg.co.uk/media/images/68427000/jpg/_68427502_68427501.jpg
Sir Bruce Keogh says the public deserves to see the data
Prof Norman Williams, president of the Royal College of Surgeons, said: "This is an historic moment for surgery, and I'm enormously proud of what surgeons up and down the country have achieved.
"It has been a difficult and complex undertaking carried out in a short timescale but we see this as the beginning of a new era for openness in medicine.
"It is early days, but it will change for the better the nature of the bond between patient and surgeon, which is based on both openness and trust."
The college said that overall it looked as if more than 99% of doctors had agreed to the release of the data this summer with fewer than 30 expected to resist.
On BBC Radio 4's Today programme, Ian Martin, a surgeon and president of the Federation of Surgical Specialty Associations, said: "What we're seeing today is almost a celebration that British surgery has the confidence to allow the public and patients, quite rightly, to have an insight into the workings behind what they do.
"But I think there are some qualifications here, and it's important to understand that this data has limitations.
"We've got to be incredibly careful when we tell the public that what we tell them is qualified and they understand what that means."
http://news.bbcimg.co.uk/media/images/68430000/jpg/_68430946_68430945.jpg
Vascular surgeon David Mitchell says the data will reassure some patients that have concerns
Cardiac surgeon Prof Ben Bridgewater added: "We've been collecting data on cardiac surgery since 1996 and we've been publishing it at individual surgeon level since 2005, and what we've seen associated with that is big improvements in quality: the mortality rates in cardiac surgery today are about a third of what they were ten years ago.
"We liken it to the British Olympic cycling team, whereby you just tighten up on every little thing that you do, and every member of the team tightens up on every little thing that they do, and that leads to big improvements in quality."
'Transparency'
In a discussion on the programme, Sir Bruce said the data would force surgeons to think twice before risky operations.
"With difficult cases, these results force people to think more carefully and encourages surgeons to send those more difficult cases on to other more specialised surgeons."
But he denied that publishing the data would make surgeons more risk averse.
He said: "Secrecy is not the way forward - transparency really is."
Roger Taylor, who analysed the data for the Today programme, said he applauded the doctors who had the courage to publish their data.
But he said it was important to put the information in context.

"It would be interesting knowing the volume of operations done by each doctor because those who did fewer operations tend to have poorer outcomes."

U.S. Attorney’s Office settles with individuals in Medicare fraud case

TEDDY KULMALA

Posted: Thursday, June 27, 2013 8:43 p.m. 
UPDATED: Friday, June 28, 2013 9:06 a.m.

The U.S. Attorney’s Office announced on Thursday that the government has reached settlements with three emergency medical technicians and one paramedic regarding allegations they assisted the Williston Rescue Squad in defrauding Medicare.
The four employees allegedly defrauded Medicare by transporting patients who clearly did not need ambulance transport for weekly dialysis treatments, according to a statement from U.S. Attorney Bill Nettles. The settlements ranged from $2,000 to $5,000 and were based on the individual’s ability to pay.
The District of South Carolina has been investigating the unnecessary transportation of dialysis patients for several years and has settled with numerous offending ambulance companies; however, this is the first time line individuals who assisted in the transports and created false records to support medical necessity have been the subject of an investigation. In this case, the individuals documented the patients were transported by stretcher when they walked to the ambulance.
Medicare only reimburses providers for non-emergency ambulance transports if the patient transported is bed-confined or has a medical condition that requires ambulance transportation.
Nettles said Medicare pays about $50,000 a year for ambulance transportation of one dialysis patient. “When it is medically necessary, ambulance transportation is appropriate,” he said. “But when it is not, it is fraud and could not be perpetrated without the assistance of these licensed individuals.”
The Williston Rescue Squad in February agreed to pay the United States $800,000 to resolve allegations that it violated the False Claims Act by making the false claims for payment to Medicare.
The settlement revolved around a lawsuit filed by a clinical social worker at a facility that regularly received patients transported by Williston’s ambulances, according to previous reports. The “whistle-blower” in that case received $160,000 as her share of the government’s recovery.
Teddy Kulmala covers the crime beat for the Aiken Standard and has been with the newspaper since August 2012. He is a native of Williston and majored in communication studies at Clemson University.
http://www.aikenstandard.com/article/20130627/AIK0101/130629554/1008/AIK0102/us-attorney-x2019-s-office-settles-with-individuals-in-medicare-fraud-case