Health Education Administrative Agency

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Top Ten Things To Know About Florida's Amendment 2

The Basics: Amendment 2 is a voter-initiated constitutional amendment legalizing medical marijuana possession and use. Amendment 2 establishes a caregiver-patient system for medical marijuana distribution. Caregivers must be...more

Prohibition on Pharmacy Inducements Beyond College of Pharmacists’ Authority

In Sobeys West Inc v. Alberta College of Pharmacists, 2016 ABQB 232, the Alberta Court of Queen’s Bench held that amendments to the College of Pharmacists’ Codes of Ethics and Standards of Practice prohibiting inducements to...more

Standard of Review in Discipline Matter

Professional Conduct Committee of the Saskatchewan College of Paramedics v. Bodnarchuk, 2015 SKCA 81, reinstating a decision of the College Discipline Committee. A paramedic was disciplined by a Discipline Committee of...more

Privacy and Security Guidance: Cloud Computing in the MUSH Sector

I. Purpose of this Guidance Document and How to Apply - This document is intended to be used by decision makers in the MUSH Sector when considering using cloud services....more

CMS Refuses to Count Family Practice Residents Who Train in Family Practice Settings

Last Friday Eastern Maine Medical Center sued Health & Human Services over the way CMS counted the number of residents in its graduate medical education program. According to the complaint, CMS refuses to count some of the...more

Food and Beverage News and Trends - Food and Beverage Alert (US): September 2014

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Poll indicates strong support by parents for school lunch standards. On...more

Federal Regulatory Agenda Update - June 2014

Federal regulatory activity is at an all-time high, with more than 3,700 regulations in just the past year. This has caused the Code of Federal Regulations to grow to 238 volumes with nearly 175,000 pages – 4,000 of which...more

Recent Cases of Interest to Regulators

Off Duty Conduct - Fountain v. British Columbia College of Teachers, 2013 BCSC 773 (British Columbia Supreme Court) - Fountain, a teacher, fired a shot from a rifle over the heads of his sons in the aftermath of...more

Next Accreditation System – Interview with Andy Roth, Member, Mintz Levin

Attorney Andy Roth, Member of Mintz Levin's Health Law Practice, explains the changes to the ACGME’s accreditation methodology with the adoption of the Next Accreditation System (NAS). ...more

A Reduction in the Utility of Civil Investigative Demands and the Interpretive Narrowing of "Person" under the False Claims Act

Executive Summary: False Claims Act actions against government contractors are on the rise. But two recent decisions offer potential limitations to false claims exposure, and may aid defendants in future FCA litigation.more

Program Director and Therapist Convicted In $205M Mental Healthcare Fraud

Just over two years after the raid on the Miami headquarters of mental healthcare chain American Therapeutic Corporation (American Therapeutic), a former program director and therapist in the Ft. Lauderdale office of the company were convicted of conspiring to defraud the Medicare program in a $205 million scheme. more

Wheaton College v. Sebelius and Belmont Abbey College v. Sebelius

Brief Of Amici Curiae Center For Constitutional Jurisprudence, American Civil Rights Union, And CATO Institute In Support Of Plaintiffs-Appellants And Reversal Of The Trial CourtNot Applicable

In January, when the Department of Health and Human Services announced that qualifying health insurance plans under Obamacare would have to cover contraceptives and "morning after" pills, many religious institutions — most notably the Catholic Church — vehemently objected to being forced to fund health care that violates their religious beliefs. More than 30 lawsuits challenging the contraceptive mandate have now been filed across the country by various individuals and religious institutions. Two of those suits have been consolidated for the first appellate argument on the issue: one brought by Wheaton College, a Christian liberal arts college in Wheaton, Illinois, and another brought by Belmont Abbey College, a North Carolina college based around a Benedictine abbey. The legal point here is somewhat technical, but incredibly important for anyone who thinks his freedom of conscience may be violated by the government in the future (a category that includes essentially everyone). As originally promulgated, the contraception mandate included a narrow exemption for religious institutions, one that wasn't available to religiously affiliated colleges. After the strong backlash against the mandate, HHS issued a "safe harbor statement," saying that the government wouldn't enforce the mandate for one year against certain non-profit organizations religiously opposed to covering contraception. In other words, the contraception mandate is still in place but just won't be enforced — but only for a year and individuals are still free to sue to enforce it against their religiously opposed employers. HHS also issued an Advance Notice of Proposed Rulemaking that announced the department's consideration of more permanent methods of accommodating religious institutions. Because of the safe harbor notice and the ANPRM, the district court dismissed the colleges' lawsuits for lack of standing and ripeness — holding that the colleges aren't currently suffering any injury and it was too early to challenge the proposed rule. Now at the U.S. Court of Appeals for the D.C. Circuit, the colleges argue that they are in fact suffering a current injury and that the mere possibility of a future rule that may accommodate them in some way is too remote to terminate their case. Cato joined the Center for Constitutional Jurisprudence and the American Civil Rights Union on an amicus brief supporting the colleges. We argue that the trial court misapplied the constitutional test for standing by not focusing on the facts that existed at the outset of the case; subsequent government actions, such as the ANPRM, are irrelevant to the preliminary question of standing. We also argue that the trial court's ruling compromises the principle of separation of powers by giving the executive branch the power to strip a court of jurisdiction merely by issuing a safe harbor pronouncement and an ANPRM (which doesn't legally bind an agency to act in any way). It is thus entirely speculative whether the agency will alleviate the harms that the colleges are suffering. Without intervention from the courts, therefore, the colleges are left in legal limbo while facing immediate and undeniable harms to their religious freedom: On one hand, they can't challenge the constitutionality of a final regulation. On the other, they can't very well rely on a proposed regulatory amendment that may be offered at some unknown point in the future. The trial court rulings in the Wheaton College and Belmont Abbey College cases are frightening examples of judicial abdication that permit the expansion of executive power far beyond its constitutional limits. Please see full brief below for more information. more

Sports Law -- Oct 01, 2012: California Passes the Nation's First Ever "Student-Athlete Bill of Rights"

Athletes enrolled in California's four-year institutions of higher education, public or private, will be protected by a first-in-the-nation law signed by Governor Jerry Brown last week. The Student-Athlete Bill of Rights, effective January 1, 2013, applies to California universities that generate more than $10 million annually in athletics-related media revenue. It will be codified as Section 67450 et seq. of the Education Code. more

Massachusetts "Gift Ban" Law: Emergency Regulations Implement Partial Repeal

On September 19, 2012, the Massachusetts Department of Public Health (“DPH”) amended the Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations (the “Code of Conduct”). The amended regulations modify the obligations of pharmaceutical and medical device manufacturers by: (1) implementing recent changes to the governing statute; (2) eliminating certain disclosure requirements; and (3) clarifying manufacturer obligations with respect to registration and reporting non-compliance. The revised Code of Conduct relaxes certain restrictions on interactions between manufacturers and health care practitioners. Please see full alert below for more information.more

Massachusetts DPH Proposes Amendments to Regulations to Implement Gift Ban Law Changes

On September 19th, the Massachusetts Department of Public Health (“DPH”) published emergency amendments to its regulations, 105 CMR 970.000 et seq. (“Proposed Regulations”), designed to implement recent changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, M.G.L. c. 111N (the “Gift Ban Law”). The amendments to the Gift Ban Law were discussed in more detail in a previous post. Although the Gift Ban Law’s strict prohibitions on payments and other transfers of value to health care practitioners (“HCPs”) remain largely intact, the Gift Ban Law now permits pharmaceutical and medical device manufacturers covered by the Gift Ban Law (“Manufacturers”) to...more

Update: Massachusetts Amends 105 C.M.R. 970.000 “Gift Ban” Law

Amendments allow for more relaxed rules regarding the provision of modest meals and refreshments for educational interactions, require new quarterly reporting, provide a sunset date on certain provisions in anticipation of federal reporting requirements, and establish a new mandated disclosure provision to instances of noncompliance.more

Medicare Audit Challenges to Paying Nursing and Allied Health Program Pass-Through Costs

The Medicare program shares in the costs for approved nursing and allied health education programs operated by hospitals, a matter which has become a recent focus in Medicare audits of hospitals operating such programs.more

Proof of Pertussis (Whooping Cough) Booster Required for Students Entering Sixth and Ninth Grades

The Illinois Department of Public Health has announced that beginning in the 2012-2013 school year, students entering grades six and nine need to show proof of receiving the Tdap vaccine (in addition to having received a physical). The Tdap vaccine protects against tetanus, diphtheria, and pertussis (whooping cough). more

Payment Matters: CMS's Non-Hospital Training Rules Again Upheld

In the recently decided case University Med. Ctr., Inc. v. Sebelius [PDF], the U.S. District Court for the District of Columbia upheld CMS policies regarding nonhospital training agreements as those policies were applied in 1999. As all teaching programs are aware, hospitals have been permitted since 1997 to include, in both their indirect medical education (IME) and direct medical education (DGME) payment calculations, time spent by residents training in non-hospital sites. As a condition to hospitals' receiving those payments, however, CMS regulations have required that there be a written agreement between the hospital and non hospital site and that the agreement specify that the hospital was incurring all or substantially all of the costs of the non-hospital site training. CMS then interpreted this policy as requiring that the written agreement be in place prior to the training actually taking place. Plaintiff University Medical Center challenged these requirements as applied to training that took place in 1999. The court, however, rejected the challenge.more

White Collar Crime & Investigations Law Update -- March 2012

In This Issue: "The Second Semester Begins: Outcome of High School SAT Scandal Prosecutions May Hinge Upon Privilege Issues" and "Health Care, Pharmaceutical and Medical Device Fraud Investigations-Unprecedented Developments in Federal Prosecutions" Excerpt from "The Second Semester Begins: Outcome of High School SAT Scandal Prosecutions May Hinge Upon Privilege Issues" The SAT cheating scandal in Nassau County underscores every school district's need for quality, proactive advice whenever a traditional school disciplinary matter may require referral to law enforcement. As the Nassau County District Attorney's arrests and press releases have pointed out, transgressions that may have previously been handled internally within a school now carry the potential for criminal prosecution. Because these investigations now tend to grow beyond original expectations, the value of having independent counsel perform investigations cannot be understated. Independent counsel reduces the risk of conflicts of interest and the costly litigation that can follow. For that reason, a school district cannot rely on traditional advice and procedures that may box an investigation into the confines of compliance with the New York State Education Law. Sophisticated student schemes and aggressive law enforcement both create the real prospect of parallel proceedings, in which violations of school rules will also be investigated to see whether criminal statutes have been violated. What a school district must guard against is whether it makes promises to students who participate in the school disciplinary process. If a school subsequently refers cooperating students for criminal prosecution, it may open itself up to litigation when those students allege that the school violated confidentiality or disciplinary settlement terms. Please see full alert below for more information. more

ACGME Announces its Next Accreditation System

On February 22, 2012, the Accreditation Council for Graduate Medical Education (ACGME) announced the roll-out of its “Next Accreditation System” (NAS) for all graduate medical education (residency and fellowship) programs that hold ACGME accreditation. The ACGME, the accrediting agency for approximately 9,000 residency programs in 133 specialties and subspecialties across the country, anticipates that the NAS will significantly transform the existing accreditation system into a more outcomes-focused and less administratively burdensome process. According to the ACGME, the NAS will: •replace the process of site visits and program evaluations every several years with periodic data submissions to the ACGME that include the reporting of outcomes through the educational milestones, the resident survey, a new faculty survey, and operative/case log data... Please see full article below for more information. more

Payment Matters: CMS Instructs Teaching Hospitals on Reporting FICA Tax Refunds for Medical Residents

On March 10, 2010, the IRS determined that medical residents are exempt from FICA taxes based on the student exception, for tax periods ending before April 1, 2005. Although the refunds apply to tax periods ending before April 1, 2005, hospitals actually received these refunds during their FYs 2009, 2010 and 2011 cost years. Because hospital wage data from FYs 2009, 2010 and 2011 will be used to develop wage indexes for federal fiscal years (FFYs) 2013, 2014 and 2015, respectively, CMS recently issued instructions directing its contractors to inform teaching hospitals how they should report these refunds. CMS Pub. 100-20, Transmittal 1010, Change Request 7685, Dec. 30, 2011. CMS has instructed that the refund must be reported in a way that does not impact a hospital’s wage-related costs for wage index purposes. Hospitals have until January 30, 2012 to submit revisions to the reporting of their FY 2009 costs, which is currently being reviewed to develop the FFY 2013 wage index. The FICA refund consists of two parts: (I) the refund to the hospital of the employer’s share and (II) the refund to the hospital of the resident employee’s share, which the hospital must return to the resident. Please see full alert below for more information.more

GME FTE Resident Counts Found Subject to Revision without Reopening of the 1996 Cost Report

In Kaiser Foundation Hospitals v. Sebelius, No. 11-92 (D.D.C. Dec. 12, 2011), the U.S. District Court for the District of Columbia held that despite the passing of the three-year limitation period prohibiting the reopening of a Medicare cost report, providers may challenge their number of 1996 full-time equivalent (FTE) residents for purposes of their direct and indirect graduate medical education (collectively, GME) reimbursement calculation in a later open year. By way of background, Medicare reimburses teaching hospitals for the costs associated with providing GME. Medicare calculates this reimbursement based in part on the number of FTE residents participating in a particular hospital’s teaching program. In 1997, Congress limited GME reimbursement by indefinitely capping the number of FTE residents that a hospital could claim in future years at the number of FTE residents that the hospital listed in its final Medicare cost report for the 1996 fiscal year. more

Health Law Alert -- A Dentist's Best Answer To An Investigation By The New York State Education Department's Office Of Professional Discipline

As you know, with the exceptions of physicians, attorneys, and a handful of other professions, professional misconduct (the failure of a licensed professional to meet expected standards of practice) of all other professions, including dentists, is investigated and prosecuted by the New York State Education Department's Office of Professional Discipline (OPD). Minor forms of misconduct may be handled through advisory letters or administrative warnings issued by the OPD; these administrative actions are confidential. The penalties for more serious misconduct range from a fine to the revocation of the license to practice, in accordance with the nature of the misconduct and its consequences. When the OPD investigates a complaint involving a clinical issue, the first stage includes interview of the complainant (and other potential witnesses) and requesting dental charts, billing records and radiographs from the dentist's office. Thereafter, before a decision is made concerning whether formal misconduct charges should be brought, the dentist may be given the opportunity for a personal interview with an OPD investigator. The purpose of this interview is for the dentist to explain his/her treatment. In the past, it was almost a certainty that an interview would follow a request for a patient's dental records. Recently, however, it appears that the OPD is less likely to pursue formal charges when the chart is well documented, explains treatment and the existence of chronic or acute conditions which can otherwise explain a poor clinical outcome. In recent months, we have seen that well documented treatment records can survive OPD scrutiny and, when coupled with effective communication by counsel, can lead to an administrative closure of the matter – without discipline and without the necessity of attending an investigatory interview to explain one's actions. This is a welcome development because an administrative closure, without a personal interview, greatly reduces a dentist's risk, cost and time. Please see full alert below for more information. more

The History of Health Care

As a student in Advanced Legal Writing at Kaplan University, our project and papers dealt with real life issues. But, of course, the names and places are fiction. This particular paper was a preliminary short essay to what would finally be prepared for the courts. This is a student paper, not an actual case. Briefly, I have described the history of medicare, medicaid, health laws, insurance companies, and up to date briefings on the interactions.more

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