Posts Tagged “Regulation”
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2012 Potpourri XXXVII
by Kevin Roche on Friday, December 7, 2012
Our latest Potpourri captures the excitement of the holidays with scintillating items on certificate of need program effects on utilization, the public’s views on health care costs and government’s role in health care, the cost of developing new drugs and a survey on physician compensation.
Tags: Drugs, Health Care Costs, Health Care Reform, Health Insurance, Physicians, Regulation
Limits on Use of Nurse Practitioners
by Kevin Roche on Tuesday, November 13, 2012
Everyone is concerned about health spending growth, the primary cause of which is unit price increases. So why are obvious methods to reduce unit price of services, like substituting less-expensive providers, ignored? An article in Health Affairs looks at limitations of use of nurse practitioners.
Tags: Health Care Costs, Health Care Quality, Physicians, Regulation
2012 Potpourri XXVIII
by Kevin Roche on Friday, September 14, 2012
Another brilliant edition of our Potpourri, focusing on individual health insurance rate reform, variation in traumatic care costs, genetic counseling and diabetes, small business and health care costs and savings from wellness programs.
Tags: Consumers, Health Care Costs, Health Care Reform, Health Insurance, Regulation, Wellness and Prevention
Comparative Regulatory Review of Drugs
by Kevin Roche on Wednesday, July 4, 2012
The New England Journal of Medicine contains an article on the relative review process and outcomes for the FDA, Health Canada, and the European Medicines Agency, with the surprising finding that the FDA is faster than its corresponding agencies.
Tags: Drugs, Government, Regulation
How to Counter Hospital Pricing Power
by Kevin Roche on Monday, May 28, 2012
Hospital unit prices appear to be the single largest cause of increased health spending, according to several lines of research. In a new report, the National Institute for Health Care Reform examines whether state rate regulation could help address the problem.
Tags: Health Care Costs, Hospital, Regulation
Regulatory Impediments to Pay-for-Performance
by Kevin Roche on Thursday, May 3, 2012
Pay-for-performance programs have enough problems demonstrating that they actually work to improve outcomes and now the Government Accounting Office has identified another potential problem for these initiatives–the federal fraud and abuse regulations.
Tags: Government, Pay For Performance, Regulation
2012 Potpourri XV
by Kevin Roche on Friday, April 27, 2012
Another tremendous edition of our Potpourri, featuring accountable care organization results, waste in our health system, self-referral costs, calculating hospital readmission rates and the benefits, if any, of telemonitoring frail seniors.
Tags: ACO, Care Management, Disease Management, Health Care Costs, Hospital Readmissions, Medicare, Physicians, Regulation, Telemedicine
Maryland’s Hospital Payment System
by Kevin Roche on Monday, September 26, 2011
Maryland is unique among the states in having an all-payer hospital rate regulation system. The most recent report on the system’s performance shows that it is continuing to constrain the grow of hospital spending. Payers, hospitals and patients seem happy with the system.
Tags: Health Care Costs, Hospital, Regulation
FDA Strategic Plan
by Kevin Roche on Tuesday, September 6, 2011
The Food & Drug Administration releases its strategic plan for regulatory science, identifying priority areas and implementation strategies for each. How the FDA carries out its strategy over the next few years will greatly affect both the medical products industry and overall health spending.
Tags: Devices, Drugs, FDA, Regulation
Regulation of Mobile and Wireless Health Technology
by Kevin Roche on Thursday, July 21, 2011
The FDA released a draft guidance on how it will regulate mobile and wireless healthcare devices and applications, which to a large extent follows proposed guidance from the mHealth Regulatory Coalition. The guidance may facilitate growth of this industry segment.
Tags: FDA, Mobile, Regulation, Wireless
FDA’s 510(k) Recommendations
by Kevin Roche on Monday, February 7, 2011
The FDA’s 510(k) medical device approval process has been criticized for requiring too little data on potentially harmful devices. The FDA undertook a review of the process and has issued a description of initial steps it plans to take, which the industry seems to view as acceptable.
Tags: Devices, FDA, Regulation
Personalized Medicine Reimbursement
by Kevin Roche on Friday, December 10, 2010
Personalized medicine sometimes gets lost in the debate over other major health care issues, but it is probably the single most significant development in the actual delivery of medical care and will be so for the next decade. A new report details reimbursement hurdles to growth of the field.
Tags: Care Management, Genomics, Personalized Medicine, Regulation
The Prevalence and Cost of Mandated Benefits
by Kevin Roche on Wednesday, November 3, 2010
The Council for Affordable Health Insurance puts out the latest in its series of reports on mandated benefits, looking at not just the number and type of mandates, but the incremental cost they add to insurance premiums; a cost which is ultimately borne by consumers.
2010 Potpourri XXXVII
by Kevin Roche on Saturday, October 9, 2010
The regular weekend lineup of health care news, including doctors trying to limit nurse anesthetists’ practices; text messaging for teenager dermatitis patients; Hewitt’s cost projections for 2011; physicians and the internet; how to calculate MLRs and use of incentive pay for physicians.
Tags: Health Care Quality, Health Insurance, Physicians, Regulation, Telemedicine
GAO Group Purchasing Organization Report
by Kevin Roche on Monday, October 4, 2010
Hospitals and other providers often use group purchasing organizations to facilitate obtaining goods and services at better prices and other terms. A GAO report looks at some of the business practices of these organizations.
Tags: Health Care Costs, Hospital, Regulation
2010 Potpourri XXXVI
by Kevin Roche on Saturday, October 2, 2010
The days shorten but the potpourri stays strong, this week including information on the safety of FDA-cleared devices; medication adherence; genetic tests; the FDA and CMS working together to review products; state all-payer databases and the increasing control of physician practices by hospital systems.
Tags: Care Management, Devices, Drugs, Health Care Costs, HIT, Hospital, Medicare, Personalized Medicine, Physicians, Regulation
Medicare Advantage Quality Ratings
by Kevin Roche on Friday, September 24, 2010
CMS is very enamored of quality ratings for providers of all types, including the Medicare Advantage plans, which are rated on a five-star basis. A new brief examines changes to this rating program.
Tags: Health Care Quality, Medicare, Regulation
Using Nurses Instead of Doctors
by Kevin Roche on Wednesday, September 8, 2010
Research shows that allowing nurse anesthetists to do their jobs without physician supervision does not pose additional risk to patients. Regulations and laws which limit this ability should therefore be eliminated.
Tags: Health Care Costs, Health Care Quality, Medical Care, Regulation
Medicaid’s Use of Generic Drugs
by Kevin Roche on Thursday, September 2, 2010
Medicaid programs, and other third-party payers, can save a lot of money by requiring use of generics when available. Some state laws, however, can significantly inhibit generic use, according to new research in Health Affairs.
Tags: Drugs, Government, Medicaid, Regulation
The Great MLR Calculation Debate
by Kevin Roche on Tuesday, August 31, 2010
The new health law attempts to dictate how much of insurance premiums insurers must spend on medical care, so of course there is now extensive haggling on defining the calculation. The NAIC has released its version, which now goes to HHS for review.
FDA’s Review of the 510(k) Process
by Kevin Roche on Tuesday, August 17, 2010
The Food and Drug Administration has been reviewing its 510(k) process, which is used for many medical device approvals. Two preliminary reports contain a series of recommendations designed to provide greater predictability in the process, while ensuring identification of significant safety concerns.
Tags: Devices, FDA, Regulation
GAO Report on Genetic Testing
by Kevin Roche on Thursday, August 12, 2010
Personalized medicine relies on genetic testing for much of its information. Direct-to-consumer genetic testing firms are widespread and a GAO report reveals that much of their work appears shoddy and their marketing deceptive. More regulation appears needed and on the way.
Tags: FDA, Personalized Medicine, Regulation
FDA/FCC Meeting On Wireless Health Devices
by Kevin Roche on Friday, August 6, 2010
Wireless or mobile communication technologies are enjoying a rapid spread in health care. Two of the primary federal agencies which might impact the development and spread of these technologies are the FCC and the FDA, which have agreed to work together in regulating them.
Tags: Devices, Regulation, Telemedicine, Wireless
Regulation of Laboratories’ Molecular Diagnostic Tests
by Kevin Roche on Friday, July 2, 2010
A critical component of personalized medicine is various molecular diagnostic tests. AHRQ has issued a lengthy report on the state of these tests, examining their quality and clinical utility.
Tags: Government, Medical Care, Personalized Medicine, Regulation
The FDA and Mobile Health
by Kevin Roche on Friday, June 25, 2010
An FDA lawyer posts an excellent summary of potential issues in regard to FDA’s regulation of mobile health devices and services. He suggests that industry adopt a proactive approach of proposing sensible regulations and guidance to FDA.
Tags: FDA, Mobile, Regulation, Telemedicine
Genetic Tests at Walgreens
by Kevin Roche on Wednesday, May 19, 2010
Direct-to-consumer genetic tests are becoming more prevalent. Pathway Genetics strikes a distribution deal with Walgreens, but draws FDA scrutiny over whether needed regulatory filings have been performed.
Tags: Personalized Medicine, Regulation
FDA Denial of IPhone Application
by Kevin Roche on Tuesday, March 23, 2010
Many telehealth, ehealth, mhealth, etc. product companies have assumed that their products and services will move easily through the FDA or that they don’t even need to interact with the agency. Recent statements by agency personnel, and handling of certain filings, should be warning that dealing with FDA regulations is not that simple.
Tags: Regulation, Telemedicine
Ensuring Drug Safety
by Kevin Roche on Thursday, October 8, 2009
Having taken heat on drug safety, the FDA has issued a new draft guidance on risk mitigation efforts by drug companies.
Tags: Drugs, Government, Pharmaceutical, Regulation
HIT and Privacy Laws
by Kevin Roche on Thursday, July 16, 2009
Health information technology is being pushed as one of the key methods to improve health care and reduce costs, but government itself has created barriers to its adoption and utility.
Tags: HIT, Medical Care, Regulation
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