MedClimate Health News Daily http://medclimate.com/feed en-us Copyright MedClimate, Inc2017 UnitedHealth asks judge to dismiss Medicare fraud case http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/regulatory/unitedhealth-doj-medicare-advantage-fraud-poehling?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/regulatory/unitedhealth-doj-medicare-advantage-fraud-poehling?utm_source=internal&utm_medium=rss Wed, 13 Dec 2017 09:36:50 CST Leslie Small at FierceHealthcare: Healthcare Having successfully beaten one fraud case brought against it by the federal government, UnitedHealth is asking a federal judge to dismiss a similar case. In a motion filed last Friday, the insurer argues that the court should throw out the DOJ's amended complaint, which accuses UnitedHealth of artificially inflating its Medicare Advantage risk scores in a bid to maximize government reimbursement. UnitedHealth asks judge to dismiss Medicare fraud case http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/regulatory/unitedhealth-doj-medicare-advantage-fraud-poehling?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/regulatory/unitedhealth-doj-medicare-advantage-fraud-poehling?utm_source=internal&utm_medium=rss Wed, 13 Dec 2017 09:36:50 CST Leslie Small at FierceHealthcare: Payer Having successfully beaten one fraud case brought against it by the federal government, UnitedHealth is asking a federal judge to dismiss a similar case. In a motion filed last Friday, the insurer argues that the court should throw out the DOJ's amended complaint, which accuses UnitedHealth of artificially inflating its Medicare Advantage risk scores in a bid to maximize government reimbursement. IHI 2017: Patient-centered care is not enough; it’s time to create a partnership of care http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-patient-centered-care-not-good-enough-it-s-time-to-create-what-derek-feeley?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-patient-centered-care-not-good-enough-it-s-time-to-create-what-derek-feeley?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 22:25:56 CST Ilene MacDonald at FierceHealthcare: Healthcare ORLANDO, Fla.—The relationship between physicians and patients has progressed from one that was once paternalistic to the more recent push to put patients at the center of their care. That’s an improvement, but Derek Feeley, president and CEO of the Institute for Healthcare Improvement (IHI), said it doesn’t go far enough. CliniComp sues Cerner for patent infringement http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/clinicomp-cerner-va-ehr-patent-infringement-lawsuit-remote-hosting?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/clinicomp-cerner-va-ehr-patent-infringement-lawsuit-remote-hosting?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 19:27:06 CST Evan Sweeney at FierceHealthcare: It Months after challenging the VA's decision to tap Cerner to replace its EHR, CliniComp is waging a new legal battle against the EHR giant, this time zeroing in on patent infringement claims. But Cerner may not be the only target: The company is also analyzing potential patent infringement cases against other EHR vendors. CliniComp sues Cerner for patent infringement http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/clinicomp-cerner-va-ehr-patent-infringement-lawsuit-remote-hosting?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/clinicomp-cerner-va-ehr-patent-infringement-lawsuit-remote-hosting?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 19:27:06 CST Evan Sweeney at FierceHealthcare: It Months after challenging the VA's decision to tap Cerner to replace its EHR, CliniComp is waging a new legal battle against the EHR giant, this time zeroing in on patent infringement claims. But Cerner may not be the only target: The company is also analyzing potential patent infringement cases against other EHR vendors. It’s not just primary care doctors that are in short supply, specialists are, too http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/practices/it-s-not-just-primary-care-doctors-are-short-supply-specialists-are-too?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/practices/it-s-not-just-primary-care-doctors-are-short-supply-specialists-are-too?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 16:00:35 CST Joanne Finnegan at FierceHealthcare: Healthcare It’s not just a shortage of primary care doctors that the country needs to worry about. The emerging shortage also includes physician specialists who will be needed to care for the aging bones, hearts, lungs and psyches of older Americans, even as these doctors age out of the workforce themselves, a new white paper contends. Physicians offer strategies to balance accountable and fee-for-service payment models http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/finance/accountable-care-organizations-challenges-savings-population-health-engagement?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/finance/accountable-care-organizations-challenges-savings-population-health-engagement?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 15:07:53 CST Paige Minemyer at FierceHealthcare: Healthcare Accountable care organizations are beginning to show positive results, but there are challenges inherent in being in both the value-based payment world and the fee-for-service world simultaneously. Luckily, there are steps that health systems can take to address these challenges and ease the transition to value-based care. AHA calls for more oversight of medical device cybersecurity as FDA outlines plans to modernize approvals http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/aha-fda-medical-device-cybersecurity-guidance-oversight-approval?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/aha-fda-medical-device-cybersecurity-guidance-oversight-approval?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 11:11:25 CST Evan Sweeney at FierceHealthcare: Healthcare Replying to a request for information, the AHA called on the FDA to improve its oversight of medical device cybersecurity, noting that the industry has yet to resolve concerns associated with legacy devices. Meanwhile, FDA Commissioner Scott Gottlieb, M.D., laid out a plan to modernize device approvals. AHA calls for more oversight of medical device cybersecurity as FDA outlines plans to modernize approvals http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/aha-fda-medical-device-cybersecurity-guidance-oversight-approval?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/aha-fda-medical-device-cybersecurity-guidance-oversight-approval?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 11:11:25 CST Evan Sweeney at FierceHealthcare: It Replying to a request for information, the AHA called on the FDA to improve its oversight of medical device cybersecurity, noting that the industry has yet to resolve concerns associated with legacy devices. Meanwhile, FDA Commissioner Scott Gottlieb, M.D., laid out a plan to modernize device approvals. AHA calls for more oversight of medical device cybersecurity as FDA outlines plans to modernize approvals http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/aha-fda-medical-device-cybersecurity-guidance-oversight-approval?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/aha-fda-medical-device-cybersecurity-guidance-oversight-approval?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 11:11:25 CST Evan Sweeney at FierceHealthcare: It Replying to a request for information, the AHA called on the FDA to improve its oversight of medical device cybersecurity, noting that the industry has yet to resolve concerns associated with legacy devices. Meanwhile, FDA Commissioner Scott Gottlieb, M.D., laid out a plan to modernize device approvals. Access to doctors varies widely across the country http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/practices/access-to-doctors-varies-widely-america-s-health-rankings?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/practices/access-to-doctors-varies-widely-america-s-health-rankings?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 11:03:13 CST Joanne Finnegan at FierceHealthcare: Healthcare If you live in Massachusetts, you may be healthier and have greater access to healthcare providers, according to a new report. America’s Health Rankings, the annual report on the nation’s health prepared by the United Health Foundation, was released this morning and ranks the country’s healthiest states. Congress not likely to reauthorize CHIP funding in 2017 http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/cms-chip/congress-not-likely-to-reauthorize-chip-funding-2017?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/cms-chip/congress-not-likely-to-reauthorize-chip-funding-2017?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 10:16:44 CST Leslie Small at FierceHealthcare: Payer Though Congress has passed a stopgap measure to help states facing funding shortfalls, lawmakers aren’t likely to approve long-term funding for the Children’s Health Insurance Program before the end of the year. Partisan disputes over how to pay for a CHIP funding bill haven't been resolved, and doing so will take a back seat to Republicans' bigger priority: passing their tax bill. Congress not likely to reauthorize CHIP funding in 2017 http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/cms-chip/congress-not-likely-to-reauthorize-chip-funding-2017?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/cms-chip/congress-not-likely-to-reauthorize-chip-funding-2017?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 10:16:44 CST Leslie Small at FierceHealthcare: Healthcare Though Congress has passed a stopgap measure to help states facing funding shortfalls, lawmakers aren’t likely to approve long-term funding for the Children’s Health Insurance Program before the end of the year. Partisan disputes over how to pay for a CHIP funding bill haven't been resolved, and doing so will take a back seat to Republicans' bigger priority: passing their tax bill. Study debunks idea that uninsured patients overuse the ER http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/uninsured-patients-emergency-care-medicaid-outpatient-care-health-affairs?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/payer/uninsured-patients-emergency-care-medicaid-outpatient-care-health-affairs?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 10:14:17 CST Paige Minemyer at FierceHealthcare: Healthcare Despite the common perception that the uninsured are more likely to visit the emergency room, new research contends that isn't actually the case. The study also found that the uninsured are less likely than other patient populations to visit other sites of care. 21st Century Oncology pays $2.3M to OCR for 2015 data breach, moves forward with class action settlement http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/21st-century-oncology-data-breach-ocr-settlement-class-action-cybersecuirty?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/21st-century-oncology-data-breach-ocr-settlement-class-action-cybersecuirty?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 10:02:12 CST Evan Sweeney at FierceHealthcare: It After filing for bankruptcy earlier this year, the Florida-based cancer care center that operates in 17 states agreed to pay a $2.3 million fine to OCR and settle a number of class action lawsuits that arose after a 2015 data breach. 21st Century Oncology pays $2.3M to OCR for 2015 data breach, moves forward with class action settlement http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/21st-century-oncology-data-breach-ocr-settlement-class-action-cybersecuirty?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/21st-century-oncology-data-breach-ocr-settlement-class-action-cybersecuirty?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 10:02:12 CST Evan Sweeney at FierceHealthcare: It After filing for bankruptcy earlier this year, the Florida-based cancer care center that operates in 17 states agreed to pay a $2.3 million fine to OCR and settle a number of class action lawsuits that arose after a 2015 data breach. 21st Century Oncology pays $2.3M to OCR for 2015 data breach, moves forward with class action settlement http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/21st-century-oncology-data-breach-ocr-settlement-class-action-cybersecuirty?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/21st-century-oncology-data-breach-ocr-settlement-class-action-cybersecuirty?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 10:02:12 CST Evan Sweeney at FierceHealthcare: Healthcare After filing for bankruptcy earlier this year, the Florida-based cancer care center that operates in 17 states agreed to pay a $2.3 million fine to OCR and settle a number of class action lawsuits that arose after a 2015 data breach. 21st Century Oncology pays $2.3M to OCR for 2015 data breach, moves forward with class action settlement http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/21st-century-oncology-data-breach-ocr-settlement-class-action-cybersecuirty?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/privacy-security/21st-century-oncology-data-breach-ocr-settlement-class-action-cybersecuirty?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 10:02:12 CST Evan Sweeney at FierceHealthcare: Payer After filing for bankruptcy earlier this year, the Florida-based cancer care center that operates in 17 states agreed to pay a $2.3 million fine to OCR and settle a number of class action lawsuits that arose after a 2015 data breach. Second health center leader steps down for mishandling of sexual harassment, bullying complaints http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/practices/second-health-center-leader-steps-down-mishandling-harassment-complaints-fenway-community?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/practices/second-health-center-leader-steps-down-mishandling-harassment-complaints-fenway-community?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 09:59:12 CST Joanne Finnegan at FierceHealthcare: Healthcare The mishandling of sexual harassment complaints at a Boston health clinic has led another top leader to step down. Robert H. Hale, who served as chair of the Fenway Community Health Center’s Board of Directors, resigned his position Monday, according to a statement released by the health center. Southern California hospitals brace for impacts of wildfires; Hurricane recovery in Puerto Rico leads to saline shortage http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/southern-california-hospitals-wildfires-puerto-rico-hurricane-maria-disaster-planning?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/southern-california-hospitals-wildfires-puerto-rico-hurricane-maria-disaster-planning?utm_source=internal&utm_medium=rss Tue, 12 Dec 2017 08:37:30 CST Paige Minemyer at FierceHealthcare: Healthcare As wildfires continue to burn in Southern California, regional hospitals prepare to treat patients who may be harmed by smoke inhalation, and some have been forced to transfer patients to other locations. And in Puerto Rico, the recovery from Hurricane Maria has led to a shortage of saline and other medical products in the mainland U.S. Omalizumab improves efficacy of oral immunotherapy for multiple food allergies http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/omalizumab-improves-efficacy-oral-immunotherapy-multiple-food-allergies http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/omalizumab-improves-efficacy-oral-immunotherapy-multiple-food-allergies Mon, 11 Dec 2017 23:30:00 CST NIH News Release Combination allows more than 80 percent of children to safely consume at least two foods to which they were allergic. ]]> 2018 trends to watch include ACA uncertainty, cyberthreats, patient experience: PwC http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/healthcare-trends-affordable-care-act-repeal-cybersecurity-ransomware-social?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/healthcare-trends-affordable-care-act-repeal-cybersecurity-ransomware-social?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 23:28:15 CST Ilene MacDonald at FierceHealthcare: Payer To face challenges that lie ahead in 2018, healthcare organizations must rely on the resiliency they've built up during a year of upheaval. The biggest threats executives will face next year include even more uncertainty over healthcare reform and new threats to data security, says Benjamin Isgur, leader of PwC's Health Research Institute. 2018 trends to watch include ACA uncertainty, cyberthreats, patient experience: PwC http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/healthcare-trends-affordable-care-act-repeal-cybersecurity-ransomware-social?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/healthcare-trends-affordable-care-act-repeal-cybersecurity-ransomware-social?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 23:28:15 CST Ilene MacDonald at FierceHealthcare: It To face challenges that lie ahead in 2018, healthcare organizations must rely on the resiliency they've built up during a year of upheaval. The biggest threats executives will face next year include even more uncertainty over healthcare reform and new threats to data security, says Benjamin Isgur, leader of PwC's Health Research Institute. 2018 trends to watch include ACA uncertainty, cyberthreats, patient experience: PwC http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/healthcare-trends-affordable-care-act-repeal-cybersecurity-ransomware-social?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/healthcare-trends-affordable-care-act-repeal-cybersecurity-ransomware-social?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 23:28:15 CST Ilene MacDonald at FierceHealthcare: Healthcare To face challenges that lie ahead in 2018, healthcare organizations must rely on the resiliency they've built up during a year of upheaval. The biggest threats executives will face next year include even more uncertainty over healthcare reform and new threats to data security, says Benjamin Isgur, leader of PwC's Health Research Institute. 2018 trends to watch include ACA uncertainty, cyberthreats, patient experience: PwC http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/healthcare-trends-affordable-care-act-repeal-cybersecurity-ransomware-social?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/healthcare-trends-affordable-care-act-repeal-cybersecurity-ransomware-social?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 23:28:15 CST Ilene MacDonald at FierceHealthcare: It To face challenges that lie ahead in 2018, healthcare organizations must rely on the resiliency they've built up during a year of upheaval. The biggest threats executives will face next year include even more uncertainty over healthcare reform and new threats to data security, says Benjamin Isgur, leader of PwC's Health Research Institute. IHI 2017: Patient safety efforts must move beyond the hospital to encompass ambulatory, home settings http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-patient-safety-efforts-must-move-beyond-hospital-and-encompass-ambulatory-home?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-patient-safety-efforts-must-move-beyond-hospital-and-encompass-ambulatory-home?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 22:54:43 CST Ilene MacDonald at FierceHealthcare: Healthcare ORLANDO, Fla.—Hospitals have made great strides in patient safety initiatives, such as declines in medication errors, hospital-acquired infection rates and readmissions, but there's still work to be done in other settings including primary care practices, ambulatory surgical centers, dialysis and home settings, says the Institute for Healthcare Improvement's Tejal Gandhi, M.D. IHI 2017: Don Berwick shares his take on value-based care and CMS’ decision to cancel mandatory bundled models http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-don-berwick-shares-his-take-value-based-care-and-cms-decision-to-cancel?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-don-berwick-shares-his-take-value-based-care-and-cms-decision-to-cancel?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 22:32:30 CST Ilene MacDonald at FierceHealthcare: It ORLANDO, Fla.—Although he wishes the healthcare industry could transition more quickly to value-based care, Don Berwick, M.D., isn’t as sold on the complex incentive payment models used to reimburse that care. Some of the incentive programs are based on complicated formulas that confuse providers, he said during a press briefing Monday at the Institute for Healthcare Improvement's annual National Quality Forum. IHI 2017: Don Berwick shares his take on value-based care and CMS’ decision to cancel mandatory bundled models http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-don-berwick-shares-his-take-value-based-care-and-cms-decision-to-cancel?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-don-berwick-shares-his-take-value-based-care-and-cms-decision-to-cancel?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 22:32:30 CST Ilene MacDonald at FierceHealthcare: Payer ORLANDO, Fla.—Although he wishes the healthcare industry could transition more quickly to value-based care, Don Berwick, M.D., isn’t as sold on the complex incentive payment models used to reimburse that care. Some of the incentive programs are based on complicated formulas that confuse providers, he said during a press briefing Monday at the Institute for Healthcare Improvement's annual National Quality Forum. IHI 2017: Don Berwick shares his take on value-based care and CMS’ decision to cancel mandatory bundled models http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-don-berwick-shares-his-take-value-based-care-and-cms-decision-to-cancel?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/healthcare/ihi-2017-don-berwick-shares-his-take-value-based-care-and-cms-decision-to-cancel?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 22:32:30 CST Ilene MacDonald at FierceHealthcare: It ORLANDO, Fla.—Although he wishes the healthcare industry could transition more quickly to value-based care, Don Berwick, M.D., isn’t as sold on the complex incentive payment models used to reimburse that care. Some of the incentive programs are based on complicated formulas that confuse providers, he said during a press briefing Monday at the Institute for Healthcare Improvement's annual National Quality Forum. Intermountain, Cerner among those meeting with the White House about interoperability http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/intermountain-cerner-white-house-ehr-interoperability-cms-seema-verma-jared-kushner?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/intermountain-cerner-white-house-ehr-interoperability-cms-seema-verma-jared-kushner?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 19:21:42 CST Evan Sweeney at FierceHealthcare: It Intermountain Healthcare, Cerner, HIMSS and The Sequoia Project all confirmed they would be attending a meeting on interoperability hosted by the White House Office of American Innovation scheduled for Tuesday afternoon. Intermountain, Cerner among those meeting with the White House about interoperability http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/intermountain-cerner-white-house-ehr-interoperability-cms-seema-verma-jared-kushner?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/intermountain-cerner-white-house-ehr-interoperability-cms-seema-verma-jared-kushner?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 19:21:42 CST Evan Sweeney at FierceHealthcare: It Intermountain Healthcare, Cerner, HIMSS and The Sequoia Project all confirmed they would be attending a meeting on interoperability hosted by the White House Office of American Innovation scheduled for Tuesday afternoon. Intermountain, Cerner among those meeting with the White House about interoperability http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/intermountain-cerner-white-house-ehr-interoperability-cms-seema-verma-jared-kushner?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/ehr/intermountain-cerner-white-house-ehr-interoperability-cms-seema-verma-jared-kushner?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 19:21:42 CST Evan Sweeney at FierceHealthcare: Healthcare Intermountain Healthcare, Cerner, HIMSS and The Sequoia Project all confirmed they would be attending a meeting on interoperability hosted by the White House Office of American Innovation scheduled for Tuesday afternoon. New NIH consortium award to enhance clinical trials for Alzheimer’s disease, related dementias http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/new-nih-consortium-award-enhance-clinical-trials-alzheimers-disease-related-dementias http://medclimate.com/external/index.php?https://www.nih.gov/news-events/news-releases/new-nih-consortium-award-enhance-clinical-trials-alzheimers-disease-related-dementias Mon, 11 Dec 2017 18:00:00 CST NIH News Release Effort streamlines study infrastructure to improve recruitment diversity, advance research. ]]> FDA to add new voluntary approval pathway for medical devices http://medclimate.com/external/index.php?http://www.healthcareitnews.com/news/fda-add-new-voluntary-approval-pathway-medical-devices http://medclimate.com/external/index.php?http://www.healthcareitnews.com/news/fda-add-new-voluntary-approval-pathway-medical-devices Mon, 11 Dec 2017 15:15:28 CST walmeida at Healthcare IT News - Government & Policy The U.S. Food and Drug Administration is planning to add a new voluntary, alternative pathway for medical devices, FDA Commissioner Scott Gottlieb, MD, announced Monday. The flexible pathway will lean on more modern criteria for a reference standard and allow comparisons to standards that are more closely aligned with the particular technology FDA is being asked to evaluate. The new framework will let device manufacturers demonstrate substantial equivalence by meeting objective performance and safety rules. Gottlieb said this will include FDA-recognized standards, guidance documents, or a combination of the two. Further, the pathway will be available to pre-specified mature device categories that meet or exceed the safety and performance criteria of existing devices on the market. Gottlieb said the approach will make it easier for the agency to adopt a new product framework that meets international consensus standards. The new pathway would be voluntary and manufacturers could opt to continue to use the current 510(K) evaluation pathway. Regulatory processes for the agency have remained relatively the same since its first implementation about 40 years ago, Gottlieb wrote. The 510(K) pathway for device approval, for instance, requires manufacturers to show a new device is substantially equivalent to similar devices already on the market and it demands comparisons to devices often up to 40 years old.  “FDA recognizes that such direct comparison testing creates burdens for 510(K) applicants, especially when many new devices are designed in novel ways, using more advanced technologies,” Gottlieb wrote. “It’s sometimes hard to identify sufficient, appropriate predicate devices in order to conduct testing. This can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process with few, if any, benefits to patient safety.” The FDA will release its draft guidance on the new 510(K) pathway in the first quarter of 2018. Twitter: @JessieFDavis Email the writer: jessica.davis@himssmedia.com Additional Topics: PolicyPolicyDisable Auto Tagging: Short Headline: FDA to add new voluntary approval pathway for medical devicesNewsletter hed: FDA to add new voluntary approval pathway for medical devicesNewsletter teaser: The framework would use more modern criteria, allowing comparisons to standards more in line with the tech being evaluated, according to Commissioner Scott Gottlieb.

The U.S. Food and Drug Administration is planning to add a new voluntary, alternative pathway for medical devices, FDA Commissioner Scott Gottlieb, MD, announced Monday.

The flexible pathway will lean on more modern criteria for a reference standard and allow comparisons to standards that are more closely aligned with the particular technology FDA is being asked to evaluate.

The new framework will let device manufacturers demonstrate substantial equivalence by meeting objective performance and safety rules. Gottlieb said this will include FDA-recognized standards, guidance documents, or a combination of the two.

Further, the pathway will be available to pre-specified mature device categories that meet or exceed the safety and performance criteria of existing devices on the market. Gottlieb said the approach will make it easier for the agency to adopt a new product framework that meets international consensus standards.

The new pathway would be voluntary and manufacturers could opt to continue to use the current 510(K) evaluation pathway.

Regulatory processes for the agency have remained relatively the same since its first implementation about 40 years ago, Gottlieb wrote. The 510(K) pathway for device approval, for instance, requires manufacturers to show a new device is substantially equivalent to similar devices already on the market and it demands comparisons to devices often up to 40 years old. 

“FDA recognizes that such direct comparison testing creates burdens for 510(K) applicants, especially when many new devices are designed in novel ways, using more advanced technologies,” Gottlieb wrote. “It’s sometimes hard to identify sufficient, appropriate predicate devices in order to conduct testing. This can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process with few, if any, benefits to patient safety.”

The FDA will release its draft guidance on the new 510(K) pathway in the first quarter of 2018.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com

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Disable Auto Tagging: 
Short Headline: 
FDA to add new voluntary approval pathway for medical devices
Newsletter hed: 
FDA to add new voluntary approval pathway for medical devices
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The framework would use more modern criteria, allowing comparisons to standards more in line with the tech being evaluated, according to Commissioner Scott Gottlieb.
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What health insurance executives think of the GOP's plan to repeal the individual mandate http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/aca/health-insurance-executives-individual-mandate?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/aca/health-insurance-executives-individual-mandate?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 15:11:35 CST Leslie Small at FierceHealthcare: Payer Though the debate continues over how much damage would result from repealing the individual mandate, health insurance leaders seem to be expecting the worst. Independence Blue Cross CEO Daniel Hilferty, for example, said that eliminating the mandate could lead to consumer behavior that drives up costs for everyone. What health insurance executives think of the GOP's plan to repeal the individual mandate http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/aca/health-insurance-executives-individual-mandate?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/aca/health-insurance-executives-individual-mandate?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 15:11:35 CST Leslie Small at FierceHealthcare: Healthcare Though the debate continues over how much damage would result from repealing the individual mandate, health insurance leaders seem to be expecting the worst. Independence Blue Cross CEO Daniel Hilferty, for example, said that eliminating the mandate could lead to consumer behavior that drives up costs for everyone. Rural health crisis escalates: Sometimes there’s only 1 doctor in town (if you’re lucky) http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/practices/rural-health-crisis-shortage-providers-karen-tomky?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/practices/rural-health-crisis-shortage-providers-karen-tomky?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 15:04:20 CST Joanne Finnegan at FierceHealthcare: Healthcare In rural areas in Colorado, Oklahoma and North Carolina, doctors, their assistants and patients feel the effects of a shortage of healthcare providers. In communities in Colorado, doctors are retiring—or dying—with no one to take their place. FDA's Gottlieb suggests corporate-sponsored monitoring program could curb opioid epidemic http://medclimate.com/external/index.php?http://www.healthcareitnews.com/news/fdas-gottlieb-suggests-corporate-sponsored-monitoring-program-could-curb-opioid-epidemic http://medclimate.com/external/index.php?http://www.healthcareitnews.com/news/fdas-gottlieb-suggests-corporate-sponsored-monitoring-program-could-curb-opioid-epidemic Mon, 11 Dec 2017 13:46:30 CST walmeida at Healthcare IT News - Government & Policy U.S. Food and Drug Administration Commissioner Scott Gottlieb, MD, presented the idea of creating a corporate-sponsored, nationwide prescription drug monitoring program as a way of curbing opioid abuse. The proposal is just one of several made today at an FDA workshop on options that would enhance opioid safety. [Also: HHS opioid code-a-thon seeks new technologies to help stem epidemic] If enacted, the FDA would require drug sponsors to form a national prescription drug monitoring program as part of the drug approval process. Gottlieb explained the agency believes it could be more effective in helping providers identify patients who may by abusing opioids and provide real-time alerts about potentially harmful drug combinations. Currently, 49 states already operate statewide PDMPs, but each has its own rules and enforcement policies. Missouri has been in an ongoing battle to create a statewide database, but to no avail. A unified system potentially could eliminate the current patchwork system. [Also: New opioid adherence pilot program utilizes digital pill] Gottlieb didn’t expand further on the idea or explain how in-depth the organization was in exploring the idea. However, the FDA announced today that it plans to hold a public hearing to bring together stakeholders to discuss this idea and the others introduced at today’s workshop. The FDA is also considering working with medical professional societies on a framework to outline appropriate opioid prescribing and dispensing tailored to different medical needs, which will then be incorporated into product labeling. As part of the labeling, Gottlieb said the FDA is looking into packaging certain opioids in units that align with this framework that could later be linked to quality metrics. The agency is also looking into educational requirements and changes to the opioid prescription process. “While we recognize that some of the ideas we’re exploring are unprecedented, the tragic truth is that this crisis is so immense that we need to consider a range of more impactful options that we may not have considered before,” Gottlieb said. “Ultimately we believe it’s our obligation to identify and explore every option available to us,” he continued. “We’re determined to make sure that, when combined with other efforts we and others are taking, new steps yield meaningful results.” Twitter: @JessieFDavis Email the writer: jessica.davis@himssmedia.com Additional Topics: PolicyPolicyDisable Auto Tagging: Short Headline: FDA's Gottlieb suggests monitoring to curb opioid epidemicNewsletter hed: FDA's Gottlieb suggests corporate-sponsored monitoring program could curb opioid epidemicNewsletter teaser: The agency believes a nationwide prescription drug monitoring program could be more effective in helping providers identify patients who are potentially abusing or misusing opioids.

U.S. Food and Drug Administration Commissioner Scott Gottlieb, MD, presented the idea of creating a corporate-sponsored, nationwide prescription drug monitoring program as a way of curbing opioid abuse.

The proposal is just one of several made today at an FDA workshop on options that would enhance opioid safety.

[Also: HHS opioid code-a-thon seeks new technologies to help stem epidemic]

If enacted, the FDA would require drug sponsors to form a national prescription drug monitoring program as part of the drug approval process. Gottlieb explained the agency believes it could be more effective in helping providers identify patients who may by abusing opioids and provide real-time alerts about potentially harmful drug combinations.

Currently, 49 states already operate statewide PDMPs, but each has its own rules and enforcement policies. Missouri has been in an ongoing battle to create a statewide database, but to no avail. A unified system potentially could eliminate the current patchwork system.

[Also: New opioid adherence pilot program utilizes digital pill]

Gottlieb didn’t expand further on the idea or explain how in-depth the organization was in exploring the idea. However, the FDA announced today that it plans to hold a public hearing to bring together stakeholders to discuss this idea and the others introduced at today’s workshop.

The FDA is also considering working with medical professional societies on a framework to outline appropriate opioid prescribing and dispensing tailored to different medical needs, which will then be incorporated into product labeling.

As part of the labeling, Gottlieb said the FDA is looking into packaging certain opioids in units that align with this framework that could later be linked to quality metrics. The agency is also looking into educational requirements and changes to the opioid prescription process.

“While we recognize that some of the ideas we’re exploring are unprecedented, the tragic truth is that this crisis is so immense that we need to consider a range of more impactful options that we may not have considered before,” Gottlieb said.

“Ultimately we believe it’s our obligation to identify and explore every option available to us,” he continued. “We’re determined to make sure that, when combined with other efforts we and others are taking, new steps yield meaningful results.”

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com

Additional Topics: 
Disable Auto Tagging: 
Short Headline: 
FDA's Gottlieb suggests monitoring to curb opioid epidemic
Newsletter hed: 
FDA's Gottlieb suggests corporate-sponsored monitoring program could curb opioid epidemic
Newsletter teaser: 
The agency believes a nationwide prescription drug monitoring program could be more effective in helping providers identify patients who are potentially abusing or misusing opioids.
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Moody's: 2018 global healthcare outlook stable as demand for services continues to rise http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/finance/moody-s-investors-service-global-healthcare-outlook-stable?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/finance/moody-s-investors-service-global-healthcare-outlook-stable?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 13:22:12 CST Paige Minemyer at FierceHealthcare: Healthcare The global financial outlook for the healthcare industry in 2018 is stable, says Moody's Investors Service. Moody's predicts that in many countries healthcare will represent a rising portion of their gross domestic product, which offers plenty of chances for healthcare companies to grow. However, it could tighten governments' purse strings. Moody's: 2018 global healthcare outlook stable as demand for services continues to rise http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/finance/moody-s-investors-service-global-healthcare-outlook-stable?utm_source=internal&utm_medium=rss http://medclimate.com/external/index.php?http://www.fiercehealthcare.com/finance/moody-s-investors-service-global-healthcare-outlook-stable?utm_source=internal&utm_medium=rss Mon, 11 Dec 2017 13:22:12 CST Paige Minemyer at FierceHealthcare: Payer The global financial outlook for the healthcare industry in 2018 is stable, says Moody's Investors Service. Moody's predicts that in many countries healthcare will represent a rising portion of their gross domestic product, which offers plenty of chances for healthcare companies to grow. However, it could tighten governments' purse strings.