January 8, 2016 – Do You Need Opioid Education?
| PRESIDENT’S MESSAGE
Dr. Joseph R. Maldonado
January 8, 2015
Volume 16, Number 1
For several years, MSSNY has fought state legislation aimed at mandating CME for chronic pain management and opioid abuse. The fight thus far has been successful but honestly, the odds of doing this again are slim. How can we all help to win the battle once and for all? The answer is: EVIDENCE that physicians are voluntarily educating themselves. While you may have already done this through other programs, I am asking every MSSNY member to ante up their non-financial contribution by signing up for one of the webinar times listed below. If we get sufficient numbers, we may be able to show robust evidence that we can do this voluntarily and a mandate is unnecessary. Short of doing this voluntarily and providing the State evidence of it, mandatory CME WILL succeed because much of the public believes many of us are prescribing inappropriately and abetting many patients in becoming addicted to prescription pain medications. Regardless of how you feel on what is the best solution, signing up will go a LONG way in our talks with legislators.
In New York, we have already reduced the incidence of doctor shopping by 86% because physicians are checking the Prescription Monitoring Program prior to prescribing a controlled substance. We have also supported legislation to increase access to naloxone to reduce deaths from overdose. We have also supported efforts to increase voluntary education and training for physicians on safe prescribing practices. Our efforts have proven successful. According to IMS data, New York has seen substantial decreases in the number of prescriptions written for oxycodone, hydrocodone and other controlled substances. New York’s utilization rate for these medications is below other states that currently require prescriber education of opioid medications. But there’s more to do.
If we educate ourselves now voluntarily, we may be able to stave off an extensive mandatory course in the near future.
Beginning on Tuesday, January 26, at 12:30 pm, MSSNY and the New York State Office for Alcoholism and Substance Abuse Services are presenting a free, four-part webinar series on opioid prescribing— Revisiting the Role of Opioid Analgesics for Simple and Complex Patients with Chronic Pain. This series will provide information on managing pain, understanding the potential for patient addiction, and determining best practices for safe, responsible opioid prescribing. Registration is now open here.
National experts Charles Morgan, MD, FASAM, FAAFP, DABAM and Patricia Bruckenthal PhD, APRN-BC, ANP, FAAN will compare and contrast the dual epidemics of chronic pain and opioid abuse and the implications on public health and explain the requirements of New York State laws/regulations with regard to prescribing of controlled substances.
On Wednesday, February 10, 2016 at 7:30 am, Charles E. Argoff, MD will discuss evidence-based best practice recommendations for opioid therapy for chronic pain, patient risk assessment and documentation.
On Tuesday, February 23, 2016, 7:30 am, Jeffrey Seltzer, MD will describe potential for patient addiction, screening, diagnosis and subsequent treatment or referral.
On Thursday, March 10, 2016 at 7:30 am, Charles E. Argoff, MD and Charles Morgan, MD, FASAM, FAAFP, DABAM will recommend tools to assist in the management of patients for whom opioids are indicated and prescribed and discuss strategies to reduce risk of treating pain in patients with substance use disorders.
Registration is now open to physicians here.
Registration is now open to physicians and other prescribers in your practice here.
We are strongly urging physicians to voluntarily take these webinars; please assist us in this endeavor. If there are any questions regarding this; please call Pat Clancy at 518-465-8085 ext 311.
Joseph Maldonado, M.D, MSc, MBA, DipEBHC
Please send your comments to firstname.lastname@example.org
MSSNY Fights for Guarantee Fund to Pay for Unpaid Health Republic Claims
MSSNY President Joseph Maldonado, MD, MSc, MBA strongly urged key State Senators this week to work to enact a Guarantee or other special fund to assure that Health Republic claims are completely paid, and that this legislation be enacted in the opening weeks of the 2016 Legislative Session. Dr. Maldonado’s statements were made as part of a Senate Health & Insurance Committees Roundtable discussion examining the demise of Health Republic, discussing solutions to minimize its adverse consequences, and working to prevent similar events in the future. The meeting was chaired by Senate Health Committee Chair Kemp Hannon and Insurance Committee Chair James Seward.
In addition to Dr. Maldonado, other participants in the roundtable discussion included MSSNY member Dr. Scott Hayworth, President of the Mt. Kisco Medical Group, as well as representatives of the Greater New York Hospital Association, the Healthcare Association of New York, the New York Health Plan Association, the Conference of Blue Cross/Blue Shield Plans, the National Association of Health Underwriters, United and Health Now. Also participating were DFS Executive Deputy Superintendent Troy Oechsner and New York State of Health Executive Director Donna Frescatore.
The roundtable discussion focused on the events leading to the collapse of Health Republic and legislative solutions to prevent against such insurer collapses in the future. This included extensive discussions whether revisions were necessary to New York’s law requiring DFS to approve premium rates as well as whether the State should enact a special Guarantee fund to address unpaid medical claims from physicians and hospitals for care to Health Republic-insured patients. In arguing for the necessity of a Guarantee fund, Dr. Maldonado highlighted the commitment of physicians to continue to deliver the care needed by their patients despite the knowledge that it was highly unlikely that Health Republic would able to cover these claims. In particular, he highlighted the tens of millions of dollars in outstanding claims that are owed to medical practices across New York State. For example, 5 medical practices in the Lower Hudson Valley alone are owed over $12 million. Moreover, MSSNY’s survey with close to 1,000 respondents showed 42% with outstanding claims to Health Republic, of which:
- 11% are owed $100,000 or more;
- 20% are owed $25,000 or more; and
- 49% are owed $5,000 or more.
Dr. Maldonado’s statement also noted that, in addition to these tangible financial consequences, there is another consequence to physicians – fear of “being burned” again in what may be viewed as risky health care initiatives. He noted that he had heard from many physicians who are now expressing great reluctance to participate in other new health coverage initiatives, as well as reluctant to participate in other reform initiatives that hold out the promise of upside financial benefits but also could potentially put their medical practices at risk. MSSNY’s statement included a statement from William Moorely, President & CEO of the Westchester County Association who expressed “deep concern wit the financial consequences to physician practices and patients across New York State as a result of The Collapse of Health Republic” and urged the enactment of legislatures to make physicians and hospitals whole.
Senate Health Committee Moving CPH Immunity Bill and Protection for Statements Made During Peer Review
The Senate Health Committee next week will advance two bills strongly supported by MSSNY. The first bill (S. 3461A, Hannon) would clarify that the statutory liability protections offered for physician participants in the Committee for Physicians’ Health (CPH) program extend to the organization who sponsors the program as well as to the employees of the sponsoring program acting without malice and within the scope of its functions for the committee. Assemblyman Gottfried has introduced the companion bill (A.7267) in the Assembly. Last year, the Senate passed the bill but it was never reported out of the Assembly Codes Committee.
The second bill (S.4698, Hannon) would extend the confidentiality provisions relating to discovery of testimony to apply to statements made by any person in attendance at peer-review committee that is a party to an action the subject matter of which was reviewed at such meeting. Assemblyman Gottfried has sponsored the companion bill (A.3353) in the Assembly.
MSSNY and OASAS to Conduct CME Webinars on Opioid Use; Registration Now Open
The Medical Society of the State of New York and New York State Office for Alcoholism and Substance Abuse Services are pleased to present a free, four part webinar series on opioid prescribing. Entitled, “Revisiting the Role of Opioid Analgesics for Simple and Complex Patients with Chronic Pain”, the series will begin on Tuesday, January 26, 2016.
A copy of the flyer can be found here.
Opioid abuse is a national epidemic that physicians and other prescribers have the power to help prevent. This series will provide information on managing pain, understanding the potential for patient addiction, and determining best practices for safe, responsible opioid prescribing.
Tuesday January 26, 2016, 12:30 p.m.
Faculty: Charles Morgan, MD, FASAM, FAAFP, DABAM and Patricia Bruckenthal PhD, APRN-BC, ANP, FAAN
- Compare and contrast the dual epidemics of chronic pain and opioid abuse and the implications on public health
- Understand requirements of New York State laws/regulations with regard to prescribing of controlled substances.
Wednesday, February 10, 2016, 7:30 a.m.
Faculty: Charles E. Argoff, MD
- Discuss evidence based best practice recommendations for opioid therapy for chronic pain, patient risk assessment and documentation.
Tuesday, February 23, 2016, 7:30 a.m.
Faculty: Jeffrey Selzer, MD
- Describe potential for patient addiction, screening, diagnosis and subsequent treatment or referral.
Thursday, March 10, 2016, 7:30 a.m.
Faculty: Charles E. Argoff, MD and Charles Morgan, MD, FASAM, FAAFP, DABAM
- Recommend tools to assist in the management of patients for whom opioids are indicated and prescribed.
- Discuss strategies to reduce risk of treating pain in patients with substance use disorders
Physicians and other prescribers can take one or all of the webinars; each webinar has been accredited for one hour of continuing medical education credits. The Medical Society of the State of New York is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The Medical Society of the State of New York designates this live activity for a maximum of 1.0 AMA/PRA Category 1 credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
E-Prescribing Waiver Applications Now Available from BNE
With March 27, 2016 as the date that all prescriptions must be electronically submitted, the New York Bureau of Narcotic Enforcement has announced the availability of the Electronic Prescribing Waivers (EPW) application on the Health Commerce System (HCS).
A prescriber must have a HCS account in order to file an electronic prescribing waiver. Using the HCS account is the quickest way to file the EPW application.
This application allows an institution, medical group practice or an individual practitioner to submit a request for a waiver from the requirement to electronically prescribe. Following are links to instructions for completing the online application on the Health Commerce System, based on the type of requestor:
If physicians do not have an HCS account, a paper version is NOW available upon request. Please contact the BNE at 1-866-811-7957, option 1. The paper form is available for applications for institutions, group practices and individual practices and will be sent to requestors.
If physicians experience difficulties with their HCS account, please call: 1-866-529-1890.
If a prescriber experiences any issues with the on-line Electronic Prescribing Waiver, they should call 1-866-811-7957.
NYS Medical Marijuana Program Launched on January 7th
The New York State Department of Health initiated the state’s Medical Marijuana Program on January 7, 2016; this program will make approved forms of medical marijuana, available with a physician’s certification at designated dispensaries across New York State. The program provides access to medical marijuana to certified patients suffering from cancer, HIV/AIDS, ALS (Lou Gehrig’s disease), Parkinson’s disease, multiple sclerosis, intractable spasticity caused by damage to the nervous tissue of the spinal cord, epilepsy, inflammatory bowel disease, neuropathies and Huntington’s disease.
Physicians seeking to certify patients for the use of medical marijuana are required to take a four and ½ hour online educational program. The physicians CME certificate must then be forwarded to DOH. This course is available at TheAnswerPage, an established online medical education provider here.
The cost to take the course is $249, and practitioners will earn 4.5 hours of CME credit upon successful completion of the course.
Practitioners who wish to register with the department and certify their patients for the Medical Marijuana Program must:
- be qualified, by training or experience, to treat patients with one or more of the serious conditions eligible for medical marijuana;
- be licensed, in good standing as a physician and practicing medicine, as defined in article one hundred thirty one of the Education Law, in New York State;
- possess a Health Commerce System (HCS) Medical Professions Account user ID and password;
- possess an active Drug Enforcement Administration (DEA) registration number; and
- complete the four hour Department-approved medical use of marijuana course.
The course includes the following topics, which are required in the regulations: the pharmacology of marijuana; contraindications; side effects; adverse reactions; overdose prevention; drug interactions; dosing; routes of administration; risks and benefits; warnings and precautions; and abuse and dependence. Additional information regarding the practitioner registration process is available on the department’s Medical Marijuana Program webpage, which can easily be accessed via the this link. The NYS Department of Health has indicated that 150 physicians have taken the course and also said that a list of physicians names, who have given their consent to the DOH for their names to be made public, should be released shortly.
The department’s press release provided the following information: “In order to obtain medical marijuana, a patient must receive a DOH Medical Marijuana Program certification from a registered physician. The patient must then access DOH’s online Patient Registration System to apply for a registry identification card. Additional information regarding registration can be found here.
To apply for a registry card, certified patients will need: a valid DOH Medical Marijuana Program certification form issued and signed by a registered practitioner, photographic identification, documentation of his or her temporary or permanent New York State residency, and designated caregiver information, if applicable. A patient who is under the age of eighteen or who is otherwise incapable of consenting must apply through a proxy.
Patients with valid registry identification cards are then eligible to purchase medical marijuana from one of the dispensing locations across the State. DOH selected five registered organizations on July 31, 2015 to grow marijuana and manufacture it into approved forms. Each registered organization operates a manufacturing facility and four dispensing facilities. Information on the registered organizations can be found at here.
MSSNY E-Prescribing Webinar Now Available on MSSNY CME Site
MSSNY e-prescribing webinar, entitled, “NYS Requirement for E-prescribing ALL Substances” is now available at MSSNY Continuing Medical Education site at http://cme.mssny.org/ Faculty for this program is Sandra Knapp, Manager, Official Prescription Program, NYS Department of Health, Bureau of Narcotic Enforcement. The requirement to e-prescribe all substances will become effective on March 27, 2016. The Medical Society of the State of New York designates this enduring activity for a maximum of 1.0 AMA/PRA Category 1 credit™. New registrants to the site will have to register and create a username and password, which should be retained and be used for continued access to the site. Once registered and logged into the site, physicians will be taken to an instruction page. Click on the menu on “My training page” to view and take the e-prescribing course. There are over 50 free courses that are also available. Further information on all these programs may be obtained by contacting Pat Clancy at email@example.com.
MSSNY is Member of The AMA’s Task Force on Opioid Abuse
The Medical Society of the State of New York is participating on the American Medical Association’s (AMA) national Task Force to Reduce Opioid Abuse. The task force, established in 2014, consists of over 20 medical national specialty organizations and MSSNY is one of the eight state medical societies on the task force. The goals of the task force are to:
- Increase physicians’ use of effective PMPs
- Enhance physicians’ education on appropriate prescribing
- Reduce the stigma of pain and promote comprehensive assessment and treatment
- Reduce the stigma of substance use disorder and enhance access to treatment
- Expand access to naloxone in the community and through co-prescribing.
The task force ultimate goals are to create a behavioral shift in physicians to create a sense of urgency that they are a part of the solution to the opioid epidemic and to tap into their fundamental desire to effectively help their patients and improve their patients’ health. The task force will also urge physicians to use PMPs to have a better—realistic—perspective about patients’ use of opioids. Dr. Frank Dowling, MSSNY Councilor and Pat Clancy, Vice President of Public Health and Education are MSSNY appointees to the task force.
MSSNY has also developed a page entitled, “Opioids: What One Doctor Can Do“ This page is located on the MSSNY website and is located in a blue box at the top of the home page: www.mssny.org The page provides information on the AMA Task Force, provides resources and best practices for physicians and also provides tools for physicians along with patient information.
MSSNY Announces 2016 Medical Matters Schedule
The Medical Society of the State of New York will begin its 2016 Medical Matters webinars on January 20, 2016 with a program entitled Immunizations During A Disaster, with Dr. William Valenti as faculty. All programs will begin at 7:30 a.m. Registration is now open to physicians and other public health officials.
Go to training session and upcoming sessions tab
Educational objectives for the January 20 program are:
- Review recommendations for immunizations during disasters
- Review recommendations for immunizations for responders
- Describe best practices to avoid vaccine preventable diseases (VPD) during disasters
- Describe the importance of herd immunity
Additional programs are: Public Health Preparedness 101 on February 17, 2016 and Radiological Emergencies on March 16, 2016. Further information on these programs can be found here.
The Medical Society of the State of New York is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The Medical Society of the State of New York designates this live activity for a maximum of 1.0 AMA/PRA Category 1 credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Further information or assistance in registering for any of these programs, may be obtained by contact Melissa Hoffman at firstname.lastname@example.org.
Legislative Advocacy Leadership Workshop for HCV Clinicians to Be Held January 15
A legislative leadership workshop will be held January 15, 2016 for HCV clinicians at Lenox Hill Hospital, 130 East 77th Street, NY, NY; Aron Board Room. The workshop is sponsored by the Empire Liver Foundation, HepCx, and NYC Health Department. Clinicians can learn about strategies to change policies and support legislation. The workshop will also be broadcast over WebEx. Further information and/or to register for the conference, please Eric Rude at email@example.com
REMINDER: All Prescriptions Must Be Sent Electronically Beginning March 27th
With the e-prescribing mandate quickly approaching on March 27th, we at MSSNY are concerned about the lack of preparedness expressed by New York doctors. Our recent survey showed that more than 40% of responding physicians are not yet prepared to meet the e-prescribing mandate.
- We DO NOT expect an extension of the deadline, and urge you to ACT NOW to ensure you are compliant with the law.
- As a MSSNY member, you qualify for a substantial discount on DrFirst’s industry-leading Rcopia® with EPCS GoldSM. The cost is $500 for a one-year license (a $299 discount) and includes e-prescribing for both legend drugs and controlled substances, as well as the DEA-required identity proofing and two-factor authentication soft token.
- If you buy now, you’ll be ready when the deadline arrives, and DrFirst will extend your software license from now until March 27, 2016 at no additional charge. To purchase online, visit www.drfirst.com/MSSNY and use coupon code MSSNY, or call the MSSNY E-prescribing Hotline at 866-980-0553.
- To learn more, register for DrFirst’s educational e-prescribing webinar to help you learn more about I-STOP and the patient safety and workflow benefits of using e-prescribing. Sign-up today using the registration link below
- 1/19 @ 12:00 pm – http://www.drfirst.com/mssny/mssny-lp/#webinar
Longtime MSSNY Counsel Don Moy Retiring from Kern Augustine Conroy & Schoppmann
Kern Augustine Conroy & Schoppmann, P.C. would like to announce that as of December 31, 2015, one of its partners, the esteemed Donald (“Don”) R. Moy, Esq. has retired. Over the past ﬁve years, the partners, attorneys, staff and clients of Kern Augustine Conroy & Schoppmann have had the honor and privilege of working with Mr. Moy, one of the most honorable, knowledgeable and respected attorneys in the world of healthcare law, and he will truly be missed.
Don Moy’s career has been dedicated to the counseling of physicians, other healthcare professionals, and medical societies and other professional associations in matters pertaining to the regulation of the profession, including state and federal regulatory issues. Prior to working with KACS, Mr. Moy served as the Senior Vice President and General Counsel to the Medical Society of the State of New York (“MSSNY”) for 25 years.
As the firm transitions as MSSNY’s General Counsel, David Vozza and David Adelson will take over Mr. Moy’s role with MSSNY, however, Mr. Moy will also be available to the firm on a consulting Of Counsel basis to ease and bolster the transition. Mr. Vozza and/or Mr. Adelson can be reached at 1-800-445-0954 or via email at firstname.lastname@example.org and email@example.com, respectively.
AG Announces Settlements to Stop Prohibited ‘Direct Access Testing’
DirectLabs and LabCorp Are Prohibited from Enabling New Yorkers to Receive Clinical Laboratory Testing Without Required Medical Provider Oversight
Attorney General Schneiderman recently announced agreements with Direct Laboratories LLC and Laboratory Corporation of America that prevent these companies from enabling New Yorkers to undergo clinical laboratory testing without a licensed medical provider’s involvement, as required by New York State law.
DirectLabs, a Louisiana-based company, advertises “direct access” to laboratory testing, and sells requisitions directly to consumers, with no physician involvement, for over 250 different tests and testing packages, including tests for parasites, heavy metals, thyroid levels, vitamin levels, various cancer markers, and specific diseases such as celiac disease and rheumatoid arthritis. Without a health provider overseeing the test results in the context of a person’s clinical overall presentation, these test results can give consumers a mistaken impression to the detriment of their health – particularly where tests may have a propensity for either false positives or false negatives.
“My office is committed to helping all New Yorkers take control of their health and make educated health care decisions,” Attorney General Schneiderman said. “However, enabling consumers to purchase laboratory tests for serious medical conditions without consulting a physician does not help New Yorkers control their health, but rather risks placing their health in jeopardy. Licensed medical providers are essential to ensuring consumers undergo testing that will yield clinically useful results and that the results are properly interpreted in light of the patient’s medical condition as a whole.”
DirectLabs has been able to offer its direct testing service because of its relationship with LabCorp. LabCorp provided DirectLabs with the technology needed to generate requisitions and receive test results, and LabCorp processed specimens based on DirectLabs’ requisitions. As a result of DirectLabs’ and LabCorp’s actions, New Yorkers were able to undergo clinical laboratory testing without ever consulting a health care practitioner, even when New York State law requires that such testing be performed only at a licensed practitioner’s request.
The settlement with DirectLabs and LabCorp comes after an investigation by the Attorney General’s Health Care Bureau showed that DirectLabs sold requisitions for a wide range of tests, and that these requisitions were automatically generated with a licensed chiropractor’s name – who had never seen or spoken with the patients – in exchange for a $24 “access fee” payment. Consumers could then take those requisitions to a LabCorp patient service center to have the testing performed at reduced prices negotiated between LabCorp and DirectLabs. The chiropractor whose name appeared on the requisitions not only never met or spoke with any of the approximately 1,100 consumers whose laboratory tests he authorized, he did not follow up with any of the consumers about the test results.
Under the settlement with DirectLabs, DirectLabs will no longer operate in New York State and must refund all customers with requisitions that have not yet been presented to a laboratory for testing to be performed. Under the settlement agreement with LabCorp, LabCorp’s patient service centers in New York will no longer accept specimens for examination pursuant to requisitions generated by DirectLabs or any similar company. Further, LabCorp will ensure that requests for laboratory testing submitted by health care providers are within the provider’s scope of practice as set forth by the New York State Education Department and that the providers’ licenses are current. DirectLabs is obliged to pay a $24,500 penalty, while LabCorp will pay a $225,000 penalty.
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Holding of 2016 Date-of-Service Claims for Services Paid Under the 2016 Medicare Physician Fee Schedule
In order to implement corrections to technical errors discovered after publication of the MPFS rule and process claims correctly, Medicare Administrative Contractors will hold claims containing 2016 services paid under the MPFS for up to 14 calendar days, (i.e., Friday, January 1, 2016 through Thursday, January 14, 2016). The hold should have minimal impact on provider cash flow as, under current law, clean electronic claims are not paid sooner than 14 calendar days (29 days for paper claims) after the date of receipt.
MPFS claims for services rendered on or before Thursday, December 31, 2015 are unaffected by the 2016 claims hold and will be processed and paid under normal procedures and time frames.
- EHR Direct or Data Submission Vendor (QRDA I or III) – 1/1/16 – 2/29/16
- Qualified clinical data registries (QCDRs) (QRDA III) – 1/1/16 – 2/29/16
- Group practice reporting option (GPRO) Web Interface – 1/18/16 – 3/15/16
- Qualified registries (Registry XML) – 1/1/16 – 3/31/16
- QCDRs (QCDR XML) – 1/1/16 – 3/31/16
Submission ends at 8:00 P.M. Eastern Time on the end date listed. An Enterprise Identity Management (EIDM) account with the “Submitter Role” is required for these PQRS data submission methods. Please see the EIDM System Toolkit for additional information.
Eligible Professionals who do not satisfactorily report quality measure data to meet the 2015 PQRS requirements will be subject to a negative PQRS payment adjustment on all Medicare Part B Physician Fee Schedule (PFS) services rendered in 2017.
For questions, please contact the QualityNet Help Desk 1-866-288-8912 or via email at Qnetsupport@hcqis.org from 7:00 a.m. – 7:00 p.m. Central Time. Complete information about PQRS is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.
USPSTF Releases Draft Recommendation on Who Should Use Statins
On December 21, the US Preventive Services Task Force (USPSTF) issued a draft recommendation on “who qualifies for cholesterol-lowering statins.” In the new “draft guidelines” released for public comment, the USPSTF says “the…medications will be of most benefit to some people ages 40 to 75 whose risk of cardiovascular disease over the next decade is at least 10 percent. The USPSTF concluded that people with a 10% or greater risk of heart problems in the next 10 years, based on the 2013 AHA-ACC calculator, and who have diabetes, high cholesterol, high blood pressure or who smoke, can lower their risk of having a heart attack or stroke by a ‘moderate amount’ by taking a statin.”
The draft recommendation states that USPSTF maintains that “there’s not enough evidence to recommend screening all children and teens for high cholesterol.” It remains unclear “if such screening up to age 20 reduces the risk of cardiovascular disease in adulthood.
FDA Lifts Lifetime Ban on Blood Donations from Gay Men
On December 21, 2015, the Food and Drug Administration lifted a decades-old lifetime prohibition on blood donation by gay and bisexual men. The FDA will continue to ban “men who have had sex with men in the past year, however, saying that the measure was needed to keep the blood supply safe.” Dr. Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research, spoke at a press conference and said that the 12-month deferral period was “supported by the best available research,” and that the newest blood tests are “highly accurate but not perfect,” which is “why the elimination of all deferrals is not feasible at this time.” However, gay rights groups consider the lifting of the life time ban, “a major stride toward ending a discriminatory national policy, but had wanted blanket bans for gay men to be removed entirely.”
Dr. Marks said the policy change is “backed by sound scientific evidence” and will “continue to protect our blood supply.” The FDA had “considered eliminating all restrictions on blood donations from gay and bisexual men, but concluded that would increase the transmission of HIV through the blood supply by 400 percent.” Dr. Marks said Monday that “an increase of that magnitude is not acceptable.” Dr. Marks wrote in a statement that the FDA “will continue to actively conduct research in this area and further revise our policies as new data emerge.”
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