National Association of
Chiropractic Attorneys

"To promote the common business linterest of its members in, and the improvement of business conditions in,
the practice of chiropractic law."

 



Hugh MacPherson,1* Andrew Vickers,2 Martin Bland,1
David Torgerson,1 Mark Corbett,3 Eldon Spackman,4
Pedro Saramago,4 Beth Woods,4 Helen Weatherly,4 Mark Sculpher,4
Andrea Manca,4 Stewart Richmond,1 Ann Hopton,1 Janet Eldred1
and Ian Watt5


1Department of Health Sciences, University of York, York, UK
2Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA
3Centre for Reviews and Dissemination, University of York, York, UK
4Centre for Health Economics, University of York, York, UK
5Department of Health Sciences/Hull York Medical School, University of York, York, UK
*Corresponding author hugh.macpherson@york.ac.uk

Background: There has been an increase in the utilisation of acupuncture in recent years, yet the evidence base is insufficiently well established to be certain about its clinical effectiveness and cost-effectiveness. Addressing the questions related to the evidence base will reduce uncertainty and help policy- and decision-makers with regard to whether or not wider access is appropriate and provides value for money.

Aim: Our aim was to establish the most reliable evidence on the clinical effectiveness and cost-effectiveness of acupuncture for chronic pain by drawing on relevant evidence, including recent high-quality trials, and to develop fresh evidence on acupuncture for depression. To extend the evidence base we synthesised the results of published trials using robust systematic review methodology and conducted a randomised controlled trial (RCT) of acupuncture for depression.

Methods and results: We synthesised the evidence from high-quality trials of acupuncture for chronic pain, consisting of musculoskeletal pain related to the neck and low back, osteoarthritis of the knee, and headache and migraine, involving nearly 18,000 patients. In an individual patient data (IPD) pairwise meta-analysis, acupuncture was significantly better than both sham acupuncture (p < 0.001) and usual care (p < 0.001) for all conditions. Using network meta-analyses, we compared acupuncture with other physical therapies for osteoarthritis of the knee. In both an analysis of all available evidence and an analysis of a subset of better-quality trials, using aggregate-level data, we found acupuncture to be one of the more effective therapies. We developed new Bayesian methods for analysing multiple individual patientlevel data sets to evaluate heterogeneous continuous outcomes. An accompanying cost-effectiveness analysis found transcutaneous electrical nerve stimulation (TENS) to be cost-effective for osteoarthritis at a threshold of £20,000 per quality-adjusted life-year when all trials were synthesised. When the analysis was restricted to trials of higher quality with adequate allocation concealment, acupuncture was cost-effective. In a RCT of acupuncture or counselling compared with usual care for depression, in which half the patients were also experiencing comorbid pain, we found acupuncture and counselling to be clinically effective and acupuncture to be cost-effective. For patients in whom acupuncture is inappropriate or unavailable, counselling is cost-effective.

Conclusion: We have provided the most robust evidence from high-quality trials on acupuncture for chronic pain. The synthesis of high-quality IPD found that acupuncture was more effective than both usual care and sham acupuncture. Acupuncture is one of the more clinically effective physical therapies for osteoarthritis and is also cost-effective if only high-quality trials are analysed. When all trials are analysed, TENS is cost-effective. Promising clinical and economic evidence on acupuncture for depression needs to be extended to other contexts and settings. For the conditions we have investigated, the drawing together of evidence on acupuncture from this programme of research has substantially reduced levels of uncertainty. We have identified directions for further research. Our research also provides a valuable basis for considering the potential role of acupuncture as a referral option in health care and enabling providers and policy-makers to make decisions based on robust sources of evidence.

Trial registration: Current Controlled Trials ISRCTN63787732.

Funding: The National Institute for Health Research Programme Grants for Applied Research programme.

For full study (342 pages), see: HERE
Resources for Evidence Synthesis

This report introduces systematic reviews of the literature as a research methodology to summarize the existing evidence with a transparent, reliable, and valid approach. It covers the systematic review steps: (1) define the question, (2) create a protocol, (3) conduct a literature search and screen for inclusion, (4) document and assess included studies, and (5) evaluate and interpret the body of evidence. The report also provides resources for drawing conclusions and developing recommendations based on the systematic review. We performed a literature review and consulted with producers and consumers of systematic reviews over the course of the project to identify available resources. National Institute for Occupational Safety and Health (NIOSH) staff provided a draft systematic review framework and continuous input to ensure relevance and applicability to occupational safety and health questions. The report draws on key general existing guidance for systematic reviews as well as identified resources specific to occupational safety and health evidence synthesis. Occupational safety and health is an extensive multidisciplinary field and encompasses a broad spectrum of issues that affect the health and safety of individuals in the workplace. Standard systematic review tools and methods may need to be adapted . . .

For more, see: HERE
Two Other Former Police Officers Indicted on Federal Charges

St. Louis, MO - Police Officer Terri Owens of the St. Louis Metropolitan Police Department (SLMPD); Dr. Mitchell Davis, a St. Louis chiropractor; and his wife Galina Davis, all pled guilty today to federal charges arising out of a scheme to obtain un-redacted accident reports for use in Dr. Davis’s practice.

According to court documents, between 2007 and 2016, Dr. Davis owned and operated Davis Chiropractic Clinic, now known as City Health and Chiropractic. Located on Lindell Blvd in St. Louis, the clinic primarily provided services to accident victims. Galina Davis assisted Dr. Davis in identifying, soliciting, and scheduling potential accident victims.

According to SLMPD policy, the SLMPD will provide un-redacted accident reports only to persons involved in the accidents, the companies insuring them, or the lawyers representing them. Un-redacted accident reports contain detailed information, including addresses, telephone numbers, birthdates, and insurance information of the occupants of the vehicles. Dr. Davis and Galina Davis knew that the SLMPD would not disclose un-redacted police reports to them. To get around this policy, Galina Davis and Dr. Davis recruited, solicited, and paid individual SLMPD police officers to obtain un-redacted accident reports for them.

According to court documents, while on duty, Officer Owens accessed the SLMPD computers and thereafter disclosed the un-redacted reports to Galina Davis and Dr. Davis in exchange for cash payments. Owens knew that she was acting contrary to the SLMPD policies. In an attempt to conceal the bribery payments, Galina Davis met the officer on parking lots of various retail stores and paid the officers in cash for each un-redacted accident report.

Using the information from the un-redacted reports, Galina Davis contacted accident victims, identified herself as Gail, Allison, Kelly, Laura, or Shannon, and offered the accident victims free services at Davis Chiropractic. Dr. Davis and Galina Davis focused on identifying accident victims from neighborhoods where there was a large concentration of low-income victims. They believed that low-income individuals would be more receptive to their solicitations and offers of free services.

Once the accident victims came to Davis Chiropractic, Dr. Davis encouraged and pressured them to rate their pain level as 8 or 9 on a scale of 1 to 10, with 10 being the worst. Dr. Davis told the patients that the higher pain level was necessary to obtain a higher settlement amount. Sometimes, patients would succumb to Dr. Davis’s pressure and enter a higher pain level. At other times, Dr. Davis entered a pain level in the patient records that was higher than the patients reported.

Dr. Davis routinely told patients that they needed about 21 chiropractic treatments, before the patients were examined and the nature, location, and severity of any injury had been determined. He also routinely referred accident patients to pain management doctors before there had been a determination that the patients needed the services. Dr. Davis told the patients that the chiropractic visits and the visits to pain management doctors would increase the amount of the insurance settlement. Dr. Davis’s share of the insurance settlement depended on the type and number of services that Davis Chiropractic provided to the accident victims.

Dr. Davis completed and submitted patient treatment records containing false information, which he knew insurance companies would consider in making settlement decisions.

Dr. Davis and the Government have stipulated that the loss resulting from the false statements in the patient health records is $550,000. The parties have further stipulated that the loss to the SLMPD is $146,000.

“This type of fraud affects more than the individuals involved. If the companies being defrauded pass on the cost, you end up paying more for insurance,” said Special Agent in Charge Richard Quinn of the FBI St. Louis Division. “It is particularly egregious when the fraud is committed by those in positions of public trust.”

Terri Owens, 55, appeared before United States District Judge Rodney W. Sippel and pled guilty to one count of accepting bribes in violation of 18 U.S.C. § 666. The bribery charges carry a penalty of up to ten years in prison, a fine of up to $250,000, or both. Sentencing is set for March 9, 2018.

Dr. Mitchell Davis, 47, of St. Louis County, appeared before Judge Sippel and pled guilty to one count of false statements relating to healthcare matters in violation of 18 U.S.C. § 1035, and one count of conspiracy to commit bribery and false statements in violation of 18 U.S.C. § 371. The health care related fraud charge carries a penalty of up to five years in prison, a fine of up to $250,000, or both. The conspiracy charge carries a penalty of up to five years in prison, a fine of up to $250,000, or both. Sentencing is set for March 9, 2018.

Galina Davis, 47, of St. Louis County, appeared before Judge Sippel and pled guilty to one count of conspiracy to gain illegal access to a protected SLMPD computer in violation of 18 U.S.C. § 371, and faces up to one year in prison, a fine of up to $100,000, or both. Sentencing is set for March 9, 2018.

Two other former police officers have been charged in a related case. On December 6, 2017, Marlon Caldwell, 50, of St. Louis City, and Cauncenet Brown, 42, of Perris, CA, were indicted by a federal grand jury on one count of conspiracy to accept bribes in return for disclosing un-redacted police reports in violation of 18 U.S.C. § 371. They each face a penalty of up to five years in prison, a fine of up to $250,000, or both.

The charges in an indictment are merely accusations, and the defendants are presumed innocent until and unless proven guilty.

This case is being investigated by the Federal Bureau of Investigation and the United States Department of Health and Human Services, Office of Inspector General. Assistant United States Attorneys Dorothy McMurtry and Reginald Harris are handling the case for the U.S. Attorney’s Office.

See HERE
Mapping the Path Forward

During an 18-month planning process, the National Center for Complementary and Integrative Health (NCCIH) carefully assessed how recent developments in science, medicine, and health care have affected the Center¹s strategic approaches in the diverse arena of complementary and integrative health. With input from NCCIH staff, stakeholders, and scientific advisors, and guidance from the broader National Institutes of Health (NIH) strategic plan, the Center took stock of its existing programs and priorities; the growing evidence base, research capacity, and scientific opportunities; and public health needs going forward.

The NCCIH Plan takes into account scientific gaps and opportunities subsumed under three scientific and two cross-cutting objectives:

Objective 1: Advance Fundamental Science and Methods Development
Objective 2: Improve Care for Hard-to-Manage Symptoms
Objective 3: Foster Health Promotion and Disease Prevention
Objective 4: Enhance the Complementary and Integrative Health Research Workforce (cross-cutting)
Objective 5: Disseminate Objective Evidence-based Information on Complementary and Integrative Health Interventions (cross-cutting)

In addition, the Plan contains a section on the Center¹s Top Scientific Priorities. This section will be "living," as it will be updated based on public health needs, new scientific opportunities, research results, changes in the Center¹s grant portfolio, and budgetary considerations. The set of Top Scientific Priorities does not encompass all of NCCIH¹s research interests, and the Center will also continue to rely on and will support highly meritorious grant applications covering an array of research highlighted in the broader Strategic Plan.

Outline of Draft Strategic Plan

Introduction

Objective 1: Advance Fundamental Science and Methods Development

Advance understanding of basic biological mechanisms of action of natural products, including probiotics. Advance understanding of the mechanisms through which mind and body approaches affect health, resiliency, and well-being. Develop new and improved research methods and tools for conducting rigorous studies of complementary health approaches and their integration into health care.

Objective 2: Improve Care for Hard-to-Manage Symptoms

Develop and improve complementary health approaches and integrative treatment strategies for managing symptoms such as pain, anxiety, and depression. Conduct studies in "real world" clinical settings to test the safety and efficacy of complementary health approaches, including their integration into health care.

Objective 3: Foster Health Promotion and Disease Prevention

Investigate mechanisms of action of complementary and integrative health approaches in health resilience and practices that improve health and prevent disease. Study complementary health approaches to promote health and wellness across the lifespan in diverse populations. Explore research opportunities to study and assess the safety and efficacy of complementary health approaches in non-clinical settings such as community- and employer-based wellness programs.

Objective 4: Enhance the Complementary and Integrative Health Research Workforce

Support research training and career development opportunities to increase the number and quality of scientists trained to conduct rigorous, cutting-edge research on complementary and integrative health practices. Foster interdisciplinary collaborations and partnerships.

Objective 5: Disseminate Objective Evidence-based Information on Complementary and Integrative Health Interventions

Disseminate evidence-based information on complementary and integrative health approaches to health care providers, researchers, policymakers, and the public. Develop methods and approaches to enhance public understanding of basic scientific concepts and biomedical research.
Top Scientific Priorities

Nonpharmacologic Management of Pain
Neurobiological Effects and Mechanisms
Innovative Approaches for Establishing Biological Signatures of Natural Products
Disease Prevention and Health Promotion Across the Lifespan
Clinical Trials Utilizing Innovative Study Designs to Assess Complementary Health Approaches and Their Integration into Health Care
Communications Strategies and Tools to Enhance Scientific Literacy and Understanding of Clinical Research.

Read more HERE
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Chiropractor Sentenced for Obstructing Investigation Of Health Care Fraud Involving D.C. Medicaid Program Defendant Tried to Influence Assistant's Statements to FBI Regarding Fraudulent Medicaid Billing


WASHINGTON ­ Rehman Mirza, 43, a chiropractor who practiced in Suitland, Md., was sentenced today to seven months in prison and an additional six months in home confinement after earlier pleading guilty to obstructing a criminal health care fraud investigation, announced U.S. Attorney Channing D. Phillips and Paul M. Abbate, Assistant Director in Charge of the FBI¹s Washington Field Office.

Mirza, of Woodbridge, Va., pled guilty in May 2015 in the U.S. District Court for the District of Columbia. He was sentenced by the Honorable Ketanji Brown Jackson, who found Mirza¹s conduct "egregious" and held that he had "abused a position of public trust." In addition to prison and home confinement, the Court ordered Mirza to pay $48,450 in restitution to the D.C. Medicaid program and to perform 40 hours of community service.

The underlying fraud involved D.C. Medicaid payments for home care services to be performed by personal care aides, working for home care agencies. Personal care aides, also known as PCAs, are supposed to assist Medicaid beneficiaries in performing activities of daily living, such as getting in and out of bed, bathing, dressing, keeping track of medication, and so forth. In order to be covered for such benefits, the beneficiaries must get prescriptions from physicians or advanced practice registered nurses. D.C. Medicaid only reimburses for home care services if a physician determines after a physical examination that the beneficiary has functional limitations impairing activities of daily living. The prescriptions, also known as "intakes," dictate the frequency and duration of the services to be provided. The prescriptions are translated later into plans of care, which also must be signed by the physician.

In the District of Columbia, a typical prescription, or "intake," calls for eight hours of personal care services per day for five days per week, or eight hours per day for seven days per week. Over the six-month time span authorized by such a prescription, D.C. Medicaid would pay between $16,952 and $23,732 for personal care services provided to one beneficiary.

Mirza is licensed as a chiropractor in Maryland and Virginia, but is not licensed as a chiropractor in the District of Columbia, and is not licensed as a physician. He worked at Capital Health LLC, d/b/a Capitol Health Chiropractic in Suitland, Md. He was not authorized to prescribe personal care services, and he was not enrolled as a provider in D.C. Medicaid.

The scheme: According to a statement of offense, signed by the government as well as the defendant, Mirza and others carried out a scheme to defraud the D.C. Medicaid program from approximately November 2012 through at least June 2013. Personal care aides, working for at least seven home care agencies, brought hundreds of D.C. Medicaid beneficiaries to Mirza, and after brief examinations, Mirza wrote prescriptions and plans of care, listing himself and signing as the "ordering physician" even though he was not a physician and was not legally or medically qualified and could not determine whether the services were medically necessary.

Seeing D.C. Medicaid beneficiaries and signing their intakes and plans of care became Mirza¹s primary source of income. Mirza initially was paid $125 for each D.C. Medicaid beneficiary brought to his office by a personal care aide, but he later increased the size of the cash payments to $200. Mirza¹s prescriptions, or "intakes," typically included a diagnosis such as "chronic severe back pain" and called for services for eight hours a day, seven days a week, for six months. The personal care aides would insist that Mirza write the name of the PCA on the intake before it was sent to the home care agency; it was understood this was so the personal care aides would receive their kickback from the home care agency for each D.C. Medicaid beneficiary the PCA brought to Mirza and then to the home care agency.

During the course of the fraud scheme, Mirza signed hundreds of prescriptions and plans of care, and in exchange collected at least $48,450 in cash payments from personal care aides. Home care agencies used Mirza¹s prescriptions and plans of care to support and justify their claims for payment to Medicaid ­ even though the paperwork was invalid on its face because it was not prescribed or signed by a physician as required.

The obstruction: When Mirza was approached by the FBI in his office and questioned about his role, he denied he had any involvement with Medicaid. After the agents served Mirza with a subpoena for his patient files and other documents, the agents told Mirza they planned to interview his office assistant. After the agents left, Mirza offered to drive his assistant home. During that car ride, Mirza attempted to obstruct the government¹s investigation, by attempting to influence his 22-year-old assistant¹s statements to the FBI, telling the assistant not to use certain words, encouraging and suggesting that she not be fully truthful, and ensuring that their stories would match so that Mirza would not be "implicated" by his assistant. For example, Mirza tried to convince his assistant they had nothing to do with Medicaid and instructed the assistant not to say the word "Medicaid" at least ten times during the course of their 45-minute conversation.

This investigation was conducted by the FBI¹s Washington Field Office.

This case is being prosecuted by Assistant U.S. Attorney Ted Radway, and was investigated by Assistant U.S. Attorney Radway and former Special Assistant U.S. Attorney Dangkhoa Nguyen. Assistance was provided by Paralegal Specialist Corinne Kleinman.

The FBI has set up a hotline number to report suspected incidents of Medicaid fraud: 855-281-1242. People can also provide information by e-mail to HealthCareFraud@ic.fbi.gov.

Numerous agencies are participating in the broader investigation into Medicaid fraud, including the U.S. Department of Health and Human Services, Office of Inspector General; the U.S. Secret Service; the Medicaid Fraud Control Unit of the District of Columbia¹s Office of the Inspector General; the Social Security Administration, Office of Inspector General; the Internal Revenue Service-Criminal Investigation; the U.S. Immigration and Customs Enforcement (ICE) Office of Homeland Security Investigations (HSI); the Office of Labor Racketeering and Fraud Investigations, Office of Inspector General, Department of Labor; and the Medicaid Fraud Control Unit of the Maryland Attorney General¹s Office.

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Billed private insurance companies and government health care agencies for services that were not performed.

LOUISVILLE, Ky. ­ A Louisville chiropractor pleaded guilty to numerous charges today, including health care fraud, obstruction of a criminal investigation, and tampering with a witness for his role in billing private insurance companies and government health care agencies for services that were never performed, announced United States Attorney John E. Kuhn, Jr.

According to the plea agreement, Devin Thauberger, age 46 , conspired to submit fraudulent claims to Medicare, Passport, Anthem, Humana, Geico, Shelter, Nationwide, Allstate and other insurance carriers, that falsely and fraudulently sought reimbursement for services which were never provided to patients, including times in which Thauberger was out of the country and unable to provide services.

Between April 2009 and March 2014 the defendant admits to knowingly executing a scheme to defraud health care benefit programs by submitting claims for services, which were never performed. According to the charges, false claims were submitted and billed on at least thirteen occasions and totaled nearly $214,672.11. Then between May 2015 and July 2015, Thauberger, while being on bond, aided and abetted by others, submitted claims to Allstate, a health care benefit program, for services which were never performed.

Also, beginning in August 2013, and continuing until at least July 2014, Thauberger admitted to willfully obstructing the criminal investigation of Federal health care violations by altering or causing patient records to be altered and attempting to influence the testimony of witnesses.

During all times relevant to this indictment, Thauberger was a doctor of chiropractic, licensed to practice in the state of Kentucky, and had been a chiropractor for approximately nine (9) years. Thauberger Chiropractic, P.S.C. (TCP) was a Kentucky corporation located at 8511 Preston Highway, in Louisville, Kentucky. Defendant Thauberger was the president and sole owner of TCP from 2005 through all times relevant to this Indictment.

Co-defendant Trisha Muir, pleaded guilty to a single charge on September 1, 2015, before District Judge Greg N. Stivers. According to the plea agreement, beginning in 2010, she became employed by TCP and reported directly to defendant Thauberger. By April 2011, Muir was responsible for billing for services purportedly provided by TCP, which included submitting reimbursement claims to insurance companies and patients for chiropractic services purportedly provided by TCP. After Muir became aware of the investigation, she admitted to participating in concealing the fraud, and instructed others to do the same, by making changes to patient files and other documentation to support the fraudulent billings.

At sentencing, the United States has agreed to dismiss counts 3, 4, 5, and 6 of the Second Superseding Indictment, agree that a sentenced of 41 months in prison is the appropriate disposition of this case, not object that the last 5 months of the sentence be served on home incarceration and stipulate that the amount of loss involved in this case is $214,672.11 which the defendant must pay by the date of sentencing. Sentencing is scheduled before Judge Stivers on June 2, 2016, in Louisville.

This case is being prosecuted by Assistant United States Attorneys Lettricea Jefferson-Webb and Joe Ansari and is being investigated by the Federal Bureau of Investigation (FBI), the U.S. Department of Health and Human Services Office of Inspector General and the Kentucky Office of Attorney General¹s Kentucky Medical Fraud Control Unit.

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Local Chiropractor and Billing Assistant Sentenced on Health Care Fraud Charges

St. Louis, MO ­ Dr. Donald Havey was sentenced to 51 months in prison and ordered to pay restitution of $2,276,221 on charges involving a scheme to bill Medicare for expensive custom ankle-foot orthotics that were never provided to the patients. His billing assistant, Susan Reno, was sentenced earlier to five years of probation and ordered to pay restitution of $10,571.

According to court documents, Havey owned and operated companies that sold orthotic devices through Spinal Decompression of Chesterfield; Senior Care, Inc.; Advanced Custom Orthotics, Inc.; and Missouri Custom Orthotics. Susan Reno and her company, Pinnacle Billings and Collections, provided billing services for Havey and each of his companies.

Beginning in 2009 and continuing to 2014, Dr. Havey defrauded Medicare, Medicaid, other public and private health insurance companies and patients by submitting false reimbursement claims for custom orthotic boots. The boots actually provided to the patients did not contain the custom features described in the reimbursement claims. Dr. Havey employed chiropractors to market his "Fall Prevention Program" to nursing homes and to sell the orthotic boots in Missouri and other states, including Texas, Alabama, California, Georgia, Illinois, Kentucky, Massachusetts, Mississippi, Oklahoma, Rhode Island and Tennessee. Dr Havey and the chiropractors employed by him told the nursing homes that the program would reduce falls by almost 20% and would improve the patients¹ quality of life, but deliberately concealed from the nursing homes that the real purpose of the program was to sell orthotic boots to nursing home patients. Dr. Havey also told the nursing homes that there would be little or no cost to the patients, when he knew that a Medicare patient could be charged as much as $500 if the patient did not have supplemental insurance.

Dr. Havey knew Medicare would scrutinize any company that submitted claims for a large number of very expensive orthotic boots, so he attempted to conceal from Medicare the number of orthotic boots that he and his companies were selling. To accomplish this, Dr. Havey and Susan Reno submitted false claims under several of the companies. As an example, a chiropractor assessed and ordered orthotics for five Medicare patients residing in the same facility on the same day. Dr. Havey and Susan Reno submitted two of the residents¹ claims to Medicare using Advanced Custom Orthotics as the supplier and the other three were billed to Medicare using Senior Care Orthotics as the supplier.

Medicare paid Dr. Havey between $2,400 and $2,600 for each pair of orthotics boots. The loss to Medicare, Medicaid and the private insurance companies was over $2.2 million.

Havey, St. Louis County, MO, pled guilty in October to one felony count of health care fraud and appeared this morning for sentencing before United States District Judge John A. Ross. Susan Reno, St. Louis County, MO, pled guilty in October to one misdemeanor count of submitting false reimbursement claims to Medicare and was sentenced in January to five years of probation and ordered to pay restitution of $10,571.

This case was investigated by the U.S. Department of Health and Human Services, Office of Inspector General, the Federal Bureau of Investigation and the Missouri Medicaid Fraud Control Unit. Assistant United States Attorney Dorothy McMurtry handled the case for the U.S. Attorney¹s Office.

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Revised FDA Guidance Concerning Dietary Supplements Labeling
By Amaru Sanchez and Robert Hibbert // March 10, 2016

On March 7, the US Food and Drug Administration (FDA) announced the availability of revised guidance for industry titled "A Dietary Supplement Labeling Guide: Chapter II. Identity Statement" (Revised Guidance).1 The Revised Guidance provides clarification on whether the term "dietary supplement" may be used as the entire statement of identity for a product without other identifying or descriptive terms. Comments can be submitted to Docket 2004D-0487 on the draft Revised Guidance at any time.

The Revised Guidance comes as a result of an inaccurate statement in the 2005 guidance for the industry titled "A Dietary Supplement Guide."2 The inaccurate statement pertained to the negative response to a question as to whether or not the term "dietary supplement," by itself, could be considered a statement of identity. The negative response ran directly contrary . . .

More HERE
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HHS Says Copies of Patients¹ Medical Records Should be Free of Charge
February 26, 2016
by Heather Landi
Vendome Healthcare Media

The U.S. Department of Health and Human Services (HHS) issued guidance stating that healthcare providers should provide individuals who request access to their medical information with copies of their protected health information (PHI) free of charge.

"While covered entities should forgo fees for all individuals, not charging fees for access is particularly vital in cases where the financial situation of an individual requesting access would make it difficult or impossible for the individual to afford the fee," the HHS guidance stated.

"Providing individuals with access to their health information is a necessary component of delivering and paying for health care. We will continue to monitor whether the fees that are being charged to individuals are creating barriers to this access, will take enforcement action where necessary, and will reassess as necessary the provisions in the Privacy Rule that permit these fees to be charged," the agency wrote.

The HHS' newly released FAQs does clarify that healthcare providers covered by the Health Insurance Portability and Accountability Act (HIPAA) can charge individuals a fee for providing a copy of their PHI, "but only within specific limits."

The HIPAA Privacy Rule permits a covered entity to impose a reasonable, cost-based fee to provide the individual with a copy of the individual¹s PHI, or to direct the copy to a designated third party. The fee may include "only the cost of certain labor, supplies, and postage," HHS stated.

"A covered entity may include reasonable labor costs associated only with the: (1) labor for copying the PHI requested by the individual, whether in paper or electronic form; and (2) labor to prepare an explanation or summary of the PHI, if the individual in advance both chooses to receive an explanation or summary and agrees to the fee that may be charged," the HHS guidance stated.

And, HHS also clarified that if a limited fee is charged, healthcare organizations must inform individuals in advance of the approximate fee and should post on their websites or otherwise make available to individuals an appropriate fee schedule for regular types of access requests.

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The Department of Health and Human Services today issued a proposal to align and modernize how Medicare payments are tied to the cost and quality of patient care for hundreds of thousands of doctors and other clinicians. The Notice of Proposed Rulemaking is a first step in implementing certain provisions of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). This legislation ­ supported by a bipartisan majority and stakeholders such as patient groups and medical associations ­ ended more than a decade of last-minute fixes and potential payment cliffs for Medicare doctors and clinicians, while making numerous improvements to America¹s health care system.

³The legislation Congress passed a little over a year ago was a milestone in our efforts to advance a health care system that rewards better care, smarter spending, and healthier people,² said HHS Secretary Sylvia M. Burwell. ³We have more work to do, but we are committed to implementing this important legislation and creating a health care system that works better for doctors, patients, and taxpayers alike. We look forward to listening and learning from the public on our proposal for how to advance that goal.²

Currently, Medicare measures the value and quality of care provided by doctors and other clinicians through a patchwork of programs. Some clinicians are part of Alternative Payment Models such as the Accountable Care Organizations, the Comprehensive Primary Care Initiative, and the Medicare Shared Savings Program‹and most participate in programs such as the Physician Quality Reporting System, the Value Modifier Program, and the Medicare Electronic Health Record (EHR) Incentive Program.

Congress streamlined these various programs into a single framework to help clinicians transition from payments based on volume to payments based on value. Today¹s proposed rule would implement these changes through the unified framework called the Quality Payment Program, which includes two paths:
The Merit-based Incentive Payment System (MIPS)
Advanced Alternative Payment Models (APMs).
³We are working with the medical community to advance our collective vision for Medicare payment reform,² said Dr. Patrick Conway, CMS acting principal deputy administrator and chief medical officer. ³By proposing a flexible, rather than a one-size-fits-all program, we are attempting to reflect how doctors and other clinicians deliver care and give them the opportunity to participate in a way that is best for them, their practice, and their patients. Reducing burden and improving how we measure performance supports clinicians in doing what they do best ­ caring for their patients.²

Merit-based Incentive Payment System (MIPS)

Most Medicare clinicians will initially participate in the Quality Payment Program through MIPS. The ACA moved many Medicare payment systems, including that for clinicians, towards value, and MACRA builds on that work. Consistent with the goals of the law, the proposed rule would improve the relevancy and depth Medicare¹s quality-based payments and increase clinician flexibility by allowing clinicians to choose measures and activities appropriate to the type of care they provide. MIPS allows Medicare clinicians to be paid for providing high value care through success in four performance categories: Quality, Advancing Care Information, Clinical Practice Improvement Activities, and Cost.
Quality (50 percent of total score in year 1): For this category, clinicians would choose to report six measures from among a range of options that accommodate differences among specialties and practices.
Advancing Care Information (25 percent of total score in year 1): For this category, clinicians would choose to report customizable measures that reflect how they use technology in their day-to-day practice, with a particular emphasis on interoperability and information exchange. Unlike the existing reporting program, this category would not require all-or-nothing EHR measurement or redundant quality reporting.
Clinical Practice Improvement Activities (15 percent of total score in year 1): This category would reward clinical practice improvements, such as activities focused on care coordination, beneficiary engagement, and patient safety. Clinicians may select activities that match their practices¹ goals from a list of more than 90 options.
Cost (10 percent of total score in year 1): For this category, the score would be based on Medicare claims, meaning no reporting requirements for clinicians. This category would use 40 episode-specific measures to account for differences among specialties.
The proposed rule seeks to streamline and reduce reporting burden across all four categories, while adding flexibility for physician practices. CMS would begin measuring performance for doctors and other clinicians through MIPS in 2017, with payments based on those measures beginning in 2019.

Advanced Alternative Payment Models

Thanks to new tools created by the Affordable Care Act, increasing numbers of Medicare clinicians are participating in alternative payment models, which are helping transform how our health care system delivers care. Building on the Affordable Care Act, the bipartisan MACRA legislation created additional rewards for clinicians who take this further step towards care transformation. Medicare clinicians who participate to a sufficient extent in Advanced Alternative Payment Models ­ would be exempt from MIPS reporting requirements and qualify for financial bonuses. These models include the new Comprehensive Primary Care Plus (CPC+) model, the Next Generation ACO model, and other Alternative Payment Models under which clinicians accept both risk and reward for providing coordinated, high-quality care.

Many clinicians who participate to some extent in Alternative Payment Models may not meet the law¹s requirements for sufficient participation in the most advanced models. The proposed rule is designed to provide these clinicians with financial rewards within MIPS, as well as to make it easy for clinicians to switch between the components of the Quality Payment Program based on what works best for them and their patients.

We expect that the number of clinicians who qualify as participating in Advanced Alternative Payment Models will grow as the program matures.

Beginning a Dialogue

In implementing the law, we were guided by the same principles underlying the bipartisan legislation itself: streamlining and strengthening quality-based payments for all physicians; rewarding participation in Advanced Alternative Payment Models that create the strongest incentives for high-quality, efficient, and coordinated care; and giving doctors and other clinicians flexibility regarding how they participate in the new payment system. Today¹s rule incorporates input from patients, caregivers, clinicians, health care professionals, and other stakeholders, but it represents only the first step in an iterative implementation process.

HHS looks forward to feedback on the proposal and will accept comments until June 26, 2016.

Comments may be submitted electronically through our e-Regulation website at http://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/eRulemaking/index.html?redirect=/eRulemaking

For more information about today¹s proposals, including a fact sheet, please visit: http://go.cms.gov/QualityPaymentProgram.

See: http://www.hhs.gov/about/news/2016/04/27/administration-takes-first-step-implement-legislation-modernizing-how-medicare-pays-physicians.html

See also: The proposed final rule for the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA). The rule consolidates various payment systems to establish a single reimbursement program for eligible professionals. Be forewarned, the proposed final rule is 962 pages long.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10032.pdf READ HERE

Medicare Coverage for Chiropractic Services ­ Medical Record Documentation Requirements for Initial and Subsequent Visits

Provider Types Affected

This MLN Matters® Special Edition article is intended for Chiropractors and other practitioners who submit claims to Medicare Administrative Contractors (MACs) for chiropractic services provided to Medicare beneficiaries.

This article is part of a series of Special Edition (SE) articles prepared for Chiropractors by CMS in response to the request for educational materials at the September 24, 2015, Special Open Door Forum titled: "Improving Documentation of Chiropractic Services." Other articles in the series are SE1602, which details the use of the AT modifier on chiropractic claims and SE1603, which identifies other useful resources to help chiropractors bill Medicare correctly for covered services.

See ALSO

Use of the AT modifier for Chiropractic Billing (new information along with information in MM3449)

Provider Types Affected


This Special Edition (SE) MLN Matters® article is intended for Chiropractors and other practitioners who submit claims to Medicare Administrative Contractors (MACs) for chiropractic services provided to Medicare beneficiaries. This article is part of a series of Special Edition (SE) articles prepared for Chiropractors by the Centers for Medicare & Medicaid Services (CMS) in response to the request for educational materials at the September 24, 2015, Special Open Door Forum titled: Improving Documentation of Chiropractic Services.

See ALSO

Educational Resources to Assist Chiropractors with Medicare Billing

Provider Types Affected

This Special Edition (SE) MLN Matters® article is intended for Chiropractors submitting claims to Medicare Administrative Contractors (MACs) for chiropractic services provided to Medicare beneficiaries. This article is part of a series of SE articles prepared for Chiropractors by CMS in response to the request for educational materials at the September 24, 2015 Special Open Door Forum titled: Improving Documentation of Chiropractic Services.

See ALSO
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