Health Care Law Blog

The statutes governing controlled substance prescribing, which were enacted in 2018, require a physician or other prescriber to establish a “bona fide prescriber-patient relationship” before prescribing any controlled substances.

Earlier this year, the Substance Abuse and Mental Health Services Administration (SAMHSA), a branch of the U.S. Department of Health and Human Services (HHS), finalized updates to the Confidentiality of Substance Use Disorder Patient Records regulation at 42 CFR Part 2 ("Part 2").

The Legislature has delayed the effective date of a key provision in the new controlled substance prescribing laws until March 31, 2019, or until the Michigan Department of Licensing and Regulatory Affairs (LARA) promulgates rules on the subject.

Governor Snyder recently signed into law Public Act 22 (Senate Bill 213), which revises the 2016 telehealth bill to clarify that health professionals in Michigan may prescribe controlled substances without an in-person examination. Michigan now joins a growing number of states that allow health professionals to prescribe controlled substances via telemedicine.

Significant changes to practice by physician assistants in Michigan will take effect on March 22, 2017. Any physicians (medical, osteopathic and podiatric), health facilities, and health agencies that work with PAs should take the steps needed to ensure compliance with the requirement by the effective date.

Healthcare executives and physicians take note: The Department of Justice is now cracking down on individuals, and not just companies, for False Claims Act, Stark law, and anti-kickback statute violations.

On July 6, 2016, the Centers for Medicare & Medicaid Services ("CMS") released the 2017 Outpatient Prospective Payment System ("OPPS") Proposed Rule (the "Proposed Rule"). The Proposed Rule explains how CMS plans to implement Section 603 of the Bipartisan Budget Act of 2015 ("Section 603"), which established a new site neutral payment policy for certain off-campus hospital outpatient departments.

Section 603 provides that, as of January 1, 2017, certain items and services provided by off-campus hospital outpatient departments will no longer be reimbursed under the more favorable OPPS, and will instead be paid under another "applicable payment system."

Modern Health Care has reported that hospitals often lose approximately $176,000 a year per each employed physician.

While this initially seems like a surprising statistic, it is understandable that hospitals lose money when they employ physicians. Physicians in private practice often pay their staff less than comparable hospital employees. When a hospital buys a physician’s practice, the benefit costs typically increase if the staff receives the hospital’s fringe benefit package. Moreover, hospital overhead is typically higher than a private physician practice with regard to HR costs and other support services.

Many systems claim that the only way to manage the health of a given population (which is what ACO and other similar payment structures are requiring) is to be fully integrated with employed physicians, so covering the losses incurred by employing physicians is the necessary cost of preparing for the new paradigm. The ugly, and legally problematic, truth is that most health systems look beyond the income generated by physicians for treating patients but also at income from physician ancillary referrals to justify the economic losses caused by acquiring physician practices. This raises concerns under the Stark law.

The U.S. Department of Justice (DOJ), and a handful of states, recently reached a settlement agreement with Adventist Health System (Adventist), resolving Stark Law issues, as well as allegations in two separate qui tam actions that included false claims. Generally speaking, the Stark Law limits physician referrals of designated health services or “DHS” for Medicare and Medicaid patients in instances where the physician - or an immediate family member of the physician - has a financial relationship with the DHS entity. 

Talk about adding insult to injury. A Virginia man woke up after his colonoscopy to learn that the surgical team had mocked, belittled and insulted him throughout the procedure.

Fearful that he would not remember the doctor’s post-op instructions, the man pressed record on his smartphone before receiving anesthesia. Upon listening to the recording after the procedure, he realized that the members of the surgical team began their rant as soon as he drifted off to sleep.

A very long legal battle may be nearing its final chapter after the U.S. Court of Appeals for the Fourth Circuit upheld a $237 million judgment against Tuomey Healthcare System in South Carolina. The judgment is an enormous sum for the regional health system and hospital, with even one of the Court of Appeals judges calling it a "death sentence." A three-judge panel heard the case at the Court of Appeals, so Tuomey could still seek reconsideration from all the judges of that Court or take the case to the U.S. Supreme Court. It may also opt to find a new partnership to keep the hospital afloat.

Rural hospitals across the United States struggling to stay open

According to the National Rural Health Association, approximately 50 hospitals in the rural United States have closed since 2010. The number of annual closures is growing. Congressional healthcare budget cuts and policy changes significantly affect rural hospitals because rural hospitals often have a disproportionate number of patients who are covered under Medicare, Medicaid or who are uninsured. A number of factors affect and pose challenges to rural hospitals. One challenge is the difficulty of attracting talent, which often means paying more to healthcare professionals in order to recruit them for employment at a rural hospital.  Other challenges facing rural hospitals include:

• changing demographics;
• advances in medical practice that the hospital may be unable to implement;
• new federal regulations and standards that create additional compliance related pressure; and
• lower reimbursement rates for Medicare and Medicaid.

Closures of rural hospitals may force individuals to travel long distances for medical care, which may lead to an increase in mortality rates. The closures may discourage business ventures in rural areas due to the increased costs associated with not having a healthcare facility nearby. Metropolitan hospital closings have increased recently, but the existence of medical care alternatives in metropolitan areas typically reduces the effects that closures have on patients. 

The DHHS Health Resources and Services Administration (“HRSA”) has finally published the new National Practitioner Data Bank (“NPDB”) Guidebook.  The original Guidebook had not been updated since September 2001. 

The updated April 2015 NPDB Guidebook is available here.

The new Guidebook extensively covers the changes resulting from the 2013 merger of the NPDB and the Healthcare Integrity and Protection Data Bank (“HIPDB”).  The HIPDB was a separate data bank that received and disclosed reports of final adverse actions by federal and state agencies and health plans against practitioners, entities, providers, and suppliers.  After the merger, there were significant changes in the entities eligible to query and report, as well as the individuals and entities subject to reports. 

Foster Swift health care attorneys recently attended and presented at the 21^st Annual Health Law Institute on March 12 and 13, 2015. The two-day institute, which was co-sponsored by the Institute for Continuing Legal Education and the Health Care Law Section of the State Bar of Michigan, included presentations on recent statutory, regulatory, and case law developments in the health care industry.

Foster Swift Attorney Jennifer Van Regenmorter co-presented the “Michigan Health Law Update,” which provided an overview of Michigan’s most significant health law developments from the past year. This was Van Regenmorter’s third time presenting this yearly update at the Institute.

On Friday, October 17, Governor Rick Snyder signed the Right to Try Act, which allows patients to try experimental drugs and other treatments before they have been approved by the Food and Drug Administration (FDA). The law gives patients with advanced illnesses access to drugs that successfully cleared Phase 1 of an FDA approval. Phase 1 testing seeks to establish a drug's safety and profile and evaluates possible side effects. It involves 20-80 volunteers and lasts approximately one year.

While the healthcare industry has historically been knocked as slow to adapt to emerging technologies, the technological modernization of the industry is now occurring at a furious pace. From the digitization of health care records, to improved means of communications between doctors and patients, technology is transforming healthcare.

Tech behemoths like IBM, as well as scrappy Silicon Valley startups, have recognized the potential and are pouring resources into healthcare IT. According to data from investment company Rock Health, venture capital funding to healthcare information technology companies for 2014 reached $2.3 billion as of mid-year 2014. That's more than 10 times the nearly $200 million that was invested in healthcare IT in 2007.

One of the healthcare industry's newest tech innovations, called Figure 1, is the brainchild of a doctor named Josh Landy. Figure 1 is an Instagram-style app that allows doctors to share photos of patient conditions with other medical professionals in order to get their opinions regarding diagnosis and treatment.

The Office of the Inspector General for the United States Department of Health and Human Services (the “OIG”) recently issued a Special Fraud Alert regarding laboratory payments to referring physicians (the “Alert”). The Alert relates to two types of compensation arrangements - Specimen Processing Arrangements and Registry Arrangements - between clinical laboratories and physicians who order clinical laboratory tests that the OIG believes present a substantial risk of fraud and abuse under the federal anti-kickback statute.

Have you heard? Gov. Snyder signed four bills significantly changing the procedure for investigating and disciplining licensed health professionals under the Public Health Code on April 3. The four statutes take effect on July 1, 2014.

These important changes make it even more crucial for a health professional to consult with legal counsel experienced with the disciplinary process whenever he or she is contacted by the Bureau of Health Care Services (BHCS). 

Learn more about the changes. Read the article here. 

Any disciplinary sanction against a health professional’s license can have serious collateral consequences, such as termination from provider networks, loss of malpractice insurance or substantially increased rates, medical staff investigations and proceedings, adverse employment actions, and reports to the National Practitioner Data Bank. A recent Michigan Court of Appeals decision highlights an added risk that many health professionals and their attorneys may not have known. A relatively minor licensing sanction was used, with devastating effect, as evidence in an unrelated malpractice action.

A dentist was sued for malpractice following a root canal procedure in Holder v Schwarcz. The jury awarded $67,500 in damages and the trial court granted $151,555 in case evaluation sanctions. The dentist had been involved in an unrelated licensing investigation relating to root canals for another patient. The licensing action was resolved through a consent order. In a consent order, a health professional does not admit any allegations in the licensing complaint, but agrees that the board’s disciplinary subcommittee may treat them as true and enter a sanction for violating the Public Health Code. The sanction imposed against the dentist in the licensing action included probation for one year, a requirement for ten hours of continuing education, and a $5,000 fine. The sanction was fairly typical for a licensing case alleging negligent care.

A recent Michigan Court of Appeals decision offers a glimmer of hope to health professionals who face the unenviable prospect of appealing adverse decisions made by licensing boards. Since 1994, the Public Health Code has required that appeals by licensed health professionals from adverse licensing decisions be filed in the Michigan Court of Appeals. Over the past two decades, there have been very few cases where the Court of Appeals held that a decision by a licensing board was legally incorrect or factually unsupported.

The National Practitioner Data Bank (NPDB) has published a quick guide to assist hospitals and health care entities in reporting actions that adversely affect clinical privileges held by physicians, dentists and other health professionals.

The guide (We have identified that the following link is no longer active, and it has been removed) lists several “reporting scenarios” and indicates the type of report that may be required (initial adverse action report, revision-to-action report, correction report, or no report). The guide also summarizes the reasons for voiding a previous report (report was erroneously submitted, action was not reportable, or action was reversed or overturned).

The guide is a helpful starting point for a hospital or health care entity that is involved in a privileging action. However, the scope and timing of reporting requirements under the NPDB regulations can be quite complex. Considering the very serious implications from reporting—or not reporting—an adverse privileging action, it would be prudent to only use the guide as a quick reference and not as a decision-making tool.

If you have any questions about the guide, please contact Richard Kraus at 517.371.8104 or by using the email form below.

So far, July has been a busy month for health care fraud enforcement across the country.

On July 18, Divyesh Patel, owner of Alpine Nursing Care Inc. in North Randall, Ohio, was sentenced to two years in prison after pleading guilty to one count of conspiracy to commit health care fraud and four counts of health care fraud. Patel was also ordered to pay total restitution of $1,939,864 to the Medicaid Program in Ohio. According to court documents, Patel hired Belita Mable Bush as the office manager despite knowing that Bush had been convicted of a health care-related felony and excluded from involvement in billing federal health care programs. From June 1, 2006 to October 18, 2009, Patel conspired with Bush to defraud Medicaid by billing for services that had never been performed or that had been performed by excluded individuals. The conspiracy resulted in losses of approximately $1.9 million to the Medicare and Medicaid programs. Bush was convicted on similar charges and will be sentenced next month.

According to a recent Modern Healthcare article, up to 9 of the 32 Pioneer Accountable Care Organizations ("ACOs") may be leaving the program. Four have already notified providers of such withdrawal. Of the 9, 4 of the departing ACOs tentatively say they will be joining Medicare's lower- risk ACO alternative – the Medicare shared savings program. The deadline for deciding whether or not to remain in the Pioneer program is July 31, 2013.

The Michigan Department of Licensing and Regulatory Affairs (LARA) Corporations Division has recently implemented a new policy for professional service corporations requiring that the purpose clause in the articles of incorporation includes the type of license held. Previously, only the type of services provided was required.

For example, the purpose clause for a dental practice must now state that the purpose of the corporation is to provide "dental services through a licensed dentist."

This new policy is not stated in any of the LARA materials. However, Foster Swift attorneys and paralegals frequently work with LARA and can help streamline the creation of a professional services corporation by knowing these LARA policy insights.

If you have questions about the new policy or would like assistance with starting a professional services corporation, please contact an attorney at Foster Swift.

Julie C. LaVille authored this article as a Law Clerk.

On Tuesday, June 11, 2013, the Drug Enforcement Administration (“DEA”) announced that it had reached an $80 million civil settlement agreement, the largest in DEA history, with Walgreen Co. (“Walgreens”) to resolve allegations involving an “unprecedented number” of record-keeping and dispensing violations under the Controlled Substance Act (“CSA”). According to the DEA’s Press Release, Walgreens negligently allowed controlled substances, including Oxycodone and other prescription painkillers, to be diverted into the black market.

The Treasury Department and IRS continue to roll out new regulations related to the implementation of the Patient Protection and Affordable Care Act ("PPACA"). On May 10, 2013, the Treasury Department and IRS released the draft regulations, "Computation of, and Rules Relating to, Medical Loss Ratio", which are intended to help Blue Cross and Blue Shield ("BCBS") organizations comply with the Medical Loss Ratio (“MLR”) rules created by the PPACA.

On March 7 and 8, 2013, the members of Foster Swift’s Health Care Law Group attended the 19^th Annual Health Law Institute. This two-day institute, which is co-sponsored by the Institute for Continuing Legal Education and the Health Care Law Section of the State Bar of Michigan, focused on recent legal developments in health care law. Specific topics addressed at this year’s Health Law Institute included:

Under the Patient Protection and Affordable Care Act, companies that provide drugs, medical devices, biologicals or other medical supplies covered by certain government programs (Medicare, Medicaid or the Children's Health Insurance Program) are required to annually report certain payments they make to physicians. According to a recently issued final rule, payment categories will include:

As previously discussed, the Patient Protection and Affordable Care Act requires employers to provide notice to their employees related to Health Insurance Exchanges (the “Notice”). The specifics concerning the Notice may be found here. The Notice was required to be given to each current employee not later than March 1, 2013.

In 2008, the Michigan Supreme Court concluded that domestic partnership policies intended to provide health care benefits to same sex couples violated Michigan law.  Specifically, National Pride at Work v Governor held that such policies violated the Michigan Marriage Amendment (“Marriage Amendment”) by recognizing same sex domestic partnerships as analogous to a marriage or similar union.  (The Marriage Amendment recognizes the union of one man and one woman as the only agreement recognized as a marriage and also prohibits public employers from providing health insurance benefits to their employees' same-sex domestic partners.)

The Office for Civil Rights of the Department of Health and Human Services recently released its final rule (the "Rule") modifying the Health Insurance Portability and Accountability Act ("HIPAA") and implementing the statutory requirements of the Health Information Technology for Economic and Clinical Health Act (“HITECH”).  (The Rule was originally expected to be released in February of 2010 when HITECH became effective.) In short, the Rule: modifies HIPAA’s privacy, security and enforcement rules; changes HIPAA’s enforcement rules to increase penalties consistent with HITECH; provides a final rule on breach notification; and modifies HIPAA as required by the Genetic Information Nondiscrimination Act.

The new rule is approximately 563 pages and can be accessed here.  If you have any questions about how the Rule may impact your health care practice, please contact Nicole Stratton at (517) 371-8140 or by using the form below.

The Michigan Board of Dentistry has adopted several new rules governing the handling and disposal of amalgam waste for dentists and dental practices.  

There are some exceptions for oral and maxillofacial surgeons; oral and maxillofacial radiologists; oral pathologists; orthodontists; periodontists; and dentists providing services in a dental school or hospital, or through a local health department. 

Hospitals are required to report certain adverse clinical privileging actions and medical malpractice payments to the National Practitioner Data Bank (NPDB).  Since the NPDB was established by the Health Care Quality Improvement Act (HCQIA) in 1986, compliance with these reporting obligations has been largely entrusted to hospitals with little enforcement action by the United States Department of Health and Human Services.  There are now reports that the federal government has begun auditing compliance by hospitals with the NPDB reporting requirements.

As President Obama moves into his second term, health care reform moves forward with him. Wholesale repeal of the Patient Protection and Affordable Care Act (PPACA) now seems highly unlikely. With the majority of the PPACA provisions slated to go into effect in 2014, employers need to be ready.

Foster Swift has developed guides to aid employers with their preparation efforts. Click the links below to download these guides.

Documents updated 07-12-2013

If you have any questions regarding health care reform, please contact a member of the Foster Swift Health Care Law Group.

Curiously, traditional registered nurses ("RNs"), excepting Canadian and Mexican RNs under NAFTA, lack a general temporary visa category to work in the United States. While there are favorable provisions for an RN to obtain permanent resident status (a “Green Card”) based upon employment, the lengthy eligibility wait time for the permanent visa category limits the practical usefulness of these provisions in many cases. Currently, temporary visa options for nurses are limited to the following.

Foster Swift lawyers were well represented at the Annual Meeting of the State Bar of Michigan's Health Care Law Section held on September 19th. Gilbert Frimet, Gary McRay, Jennifer Kildea Dewane, and Nicole Stratton, members of Foster Swift Health Care Law Practice Group, all traveled to Detroit to attend the meeting. 

The Board of Medicine and the Board of Osteopathic Medicine have proposed amendments to the administrative rules governing the delegation of prescribing authority to physician assistants.  Under the existing rules, a physician may only delegate to physician assistants the authority to prescribe controlled substances that are listed in the Federal Drug and Enforcement Administration’s (“DEA’s”) Schedules 3 to 5.  The proposed amendments would eliminate that limitation and allow physicians to authorize physician assistants to prescribe Schedule 2 controlled substances.

Governor Rick Snyder in a press conference this morning proposed a total overhaul of Blue Cross Blue Shield of Michigan ("BCBSM").  Governor Snyder's proposal would:

1. covert BCBSM to a non-profit mutual company;
2. end its tax exemption; and
3. remove Attorney General review of requested rates. 

In essence, Michigan would treat BCBSM as it would any other health insurer as BCBSM would be regulated by the Insurance Code.  While this proposal may seem drastic, it is not surprising given recent regulation orders by the Office of Financial and Insurance Regulation ("OFIR") curtailing BCBSM's use of most favored nation clauses ("MFN Clauses") and rejecting the low rates that it charges to hospitals and other providers.

On August 17, 2012, the Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) announced that they will hold a joint public workshop addressing insurers’ use of most-favored-nation clauses (“MFNs”).  The all-day workshop will be held on September 10, 2012 in Washington DC and will be in-person, free and open to the public.  At the workshop, the agencies intend “to explore the use of MFN clauses and the implications for antitrust enforcement and policy.”  The workshop will also include a series of panel discussions examining the legal treatment of MFNs, the economic theories concerning MFNs, and their impact upon the health care industry.

For health care managers, there are a number of available options and strategies to consider when planning for retirement.  In addition to traditional employer plans, an exempt health care provider may also offer supplemental plan options to its managers and highly compensated employees.  Taking advantage of such benefits may prove to be a wise investment decision for health care managers.

It is now widely accepted that planning for retirement is vitally important.  However, many business owners, including physicians, fail to properly plan for the transition of their businesses upon the owner’s or primary physician's retirement.  In fact, lack of succession planning is one of the most common reasons small medical practices fail.  In order to avoid such a result in your practice, please consider the following succession planning tips:

The Health Information Technology for Economic and Clinical Health Act ("HITECH Act"), passed in 2009, imposed new requirements on health care providers (among others) related to the privacy and security of Protected Health Information ("PHI").  Included in the HITECH Act's requirements was a mandate that the Department of Health and Human Services’ ("HHS") Office for Civil Rights ("OCR") conduct audits to analyze the processes, controls and policies of certain covered entities.  The pilot program for such audits began in 2011 and will conclude in December, 2012.

In response to growing concerns about prescription drug abuse, there has been a significant increase in investigative and enforcement activities by state licensing authorities as well as local, state and federal law enforcement. We have been contacted by physicians who want to care for patients with chronic or intractable pain but are concerned about the consequences to their licenses and practices that might result if investigators question their decision to prescribe controlled substances.  Given the current environment, it is a good idea for physicians to refresh themselves on the legal requirements for effective pain management.

Health care reform law requires that providers who enrolled in Medicare prior to March 25, 2011, submit enrollment revalidation information upon request by the Centers for Medicare and Medicaid Services ("CMS") or its contractors.  Any provider that fails to submit the requested revalidation information within 60 days of receiving such a request risks interruption or deactivation of Medicare billing privileges.  Revalidation for all providers who enrolled in Medicare prior to the above date will occur between now and March of 2015 on a steady basis.  Providers can check the lists provided at CMS's website to determine if they were already sent a revalidation notice that was perhaps overlooked in the mail.

The Office of Inspector General ("OIG") for the Department of Health and Human Services recently issued an alert, which warned that “physicians who reassign their right to bill the Medicare program and receive Medicare payments by executing the CMS-855R application may be liable for false claims submitted by entities to which they reassigned their Medicare benefits.”  The OIG stressed that physicians remain liable for claims submitted using their provider numbers, even when the claims for services are submitted by another party under a contractual arrangement.  The potential for liability also exists for other types of practitioners who enter into reassignment agreements.

On December 7, 2011, the final rules for Speech-Language Pathology were filed with the Michigan Secretary of State.  Among other things, the final rules require that any person who intends to practice speech-language pathology in Michigan must be licensed by December 7, 2013.  The rules also detail the requirements for licensure and give deference to individuals who have been certified by the American Speech-Language-Hearing Association.

For more information about the licensure requirements for speech language pathologists and to obtain a copy of the current licensure application packet, please contact one of the health care law attorneys at Foster Swift.

Many questions surround the creation and implementation of accountable care organizations ("ACOs").  Included in these questions were concerns about the tax implications of an exempt non-profit organization in joining an ACO.  In 2011, the Internal Revenue Service ("IRS") was active in providing guidance on that issue.  Specifically, the IRS addressed issues related to inurement or impermissible private benefit that arise from a tax-exempt organization's participation with an ACO.  It also considered the unrelated business income tax implications for the receipt of shared savings by an exempt organization.

A recent case highlights why a plan sponsor must use caution when agreeing to provide COBRA coverage that extends beyond the maximum COBRA coverage period.  The court in Bekaert Corporation v. Standard Security Life Insurance Company of New York, 2011 WL 3568028 (N.D. Ohio) recently held that an employer who offered extended COBRA coverage pursuant to a separation agreement with a particular employee was not entitled to stop-loss coverage.  In Bekaert,a retiree received extended COBRA continuation health coverage pursuant to a separation agreement with the employer.  The retiree's medical claims were paid under the employer's self-funded health plan and then were submitted for reimbursement under the employer's stop-loss policy as excess loss claims.  The stop-loss carrier denied the claims, stating the retiree was not a covered person under the stop-loss policy.

On November 29, 2011, the State Bar of Michigan's Health Care Law Section presented a webinar entitled "Making Sense of 'Meaningful Use' Incentives for Electronic Health Record Adoption," which was attended by a number of Foster Swift health care attorneys.  This program gave a wonderful overview of the procedural requirements in obtaining incentive payments for the use of electronic health records ("EHR").

The NLRB has decreed that, starting on January 31, 2012, health facilities must post a notice informing those on payroll of their rights to negotiate as a group and join a union…but stay tuned.

Currently, the notice is required to list:

• the rights that an employee has under the National Labor Relations Act ("NLRA");
• what is illegal for an employer to do under the NLRA;
• what is illegal for a union to do under the NLRA; and
• what to do if there has been a violation of rights under the NLRA.

The NLRB has copies of a sample notice available.  The notice may be printed on multiple pieces of paper, but it must be 11-by-17-inches in size and placed in a conspicuous location. The National Labor Relations Board (the "NLRB") finalized its rule requiring this notice in the August 30, 2011 federal register.

In a recent decision, the Michigan Court of Appeals held that a physician can be liable for discrimination under Michigan law for refusing to provide artificial insemination services to a single woman. Moon v Michigan Reproductive & IVF Center, PC.

A woman contacted a physician at a clinic about in vitro fertilization services.  When the physician learned that the woman was single, he advised her that the clinic did not offer insemination services to single women.  Afterwards, the woman sued the clinic for discrimination based on marital status.

In 2010, the United States Supreme Court in Citizens United v. Federal Election Commission ("Citizens United") reinforced the free speech rights of corporations and labor unions to participate in the political process through independent communications expressly advocating the election or defeat of a clearly identified candidate.  Also in 2010, the United States District Court for the Western District of Michigan held in Michigan Chamber of Commerce v. Land¹ ("Michigan Chamber of Commerce") that corporations could pool their resources with other corporations in order to exercise their rights to make independent expenditures expressly advocating the election or defeat of a candidate.

The U.S. Department of Health and Human Services released the final rules for Accountable Care Organizations ("ACOs") on October 20, 2011.  (The final rules will be officially published in the November 2, 2011 issue of the federal register.)  The Centers for Medicare and Medicaid Services issued a press release that contains an overview of the ACO initiative as well as relevant links to related documents.

Everyone in the health care industry is confronted with consolidation.  If you are a health care provider, you are likely to be confronted with it as governmental regulations and cost pressures continue to prompt alliances and networks among competitors.  Also, anyone looking to engage in the new Accountable Care Organizations created by the Health Reform Act most likely will be joining forces with additional health care entities.  As a health care business attorney, I have been on both sides of the table.  If you are considering an alliance, here are a few suggestions for you to consider based upon my experience in selecting an alliance or network partner.

The latest edition of the Foster Swift Health Care Law Newsletter has just been released.  Topics include Electronic Health Records, Medicare Reimbursement for Resident Research and Hospital Community Needs Assessments.  In order to whet your appetite, below is a brief summary of the articles:

All providers and suppliers that were enrolled with the Medicare program prior to March 25, 2011 will be asked to revalidate their enrollment information in the near future.  According to a statement issued by the Department of Health and Human Services' Centers for Medicare and Medicaid Services ("CMS"), intermediaries will begin contacting providers and suppliers to do the following:

The 11^th Circuit Court of Appeals recently issued a decision declaring that the "individual mandate" provisions of the Patient Protection and Affordable Care Act ("PPACA") are unconstitutional.  This decision directly conflicts with the decision issued by the 6^th Circuit Court of Appeals earlier this summer.

The US Supreme Court recently delivered a victory to data miners and pharmaceutical manufacturers in a June 23, 2011 decision, which held that a Vermont statute was an unconstitutional restriction of free speech rights.  In William Sorrell v IMS Health, Inc., 564 US --- (2011), the Court reviewed a Vermont statute that prohibited the use of prescriber-identifiable information (details of a physician's prescription practices) for marketing or promoting a prescription drug.   The statute was intended to target the practice of "detailing" a pharmaceutical representative's use of a particular physician's prescribing history to tailor a sales pitch to that physician in an effort to persuade him or her to prescribe certain (high profit or brand name) drugs.  Because various Circuit Courts of Appeal had reached opposite conclusions on the constitutionality of similar statutes, the United States Supreme Court agreed to hear the case.

The month of June has been flush with medical professionals heading to jail for Medicare fraud.

Most recently, a Miami-Dade county doctor, Dr. Rene de los Rios was given a lengthy 20 year sentence for his participation in a Medicare fraud scheme.  Dr. de los Rios falsified hundreds of patient records to the tune of $46.2 million for HIV therapy.  Many of his patients received kickbacks.  While, Dr. del los Rios' attorney argued for a shorter sentence (given his client's 72-years of age), the U.S. District Judge refused and instead chastised Dr. del los Rios for violating his medical oath, stealing from the vulnerable government program, and disgracing himself.

The Centers for Medicare and Medicaid Services ("CMS"), like other federal agencies, generally has 20 days (plus a 10 day extension) to respond to requests for information under the Freedom of Information Act ("FOIA").  However, CMS responses seem to take quite a bit longer.

Last week, I received a response to a FOIA request that I filed with CMS in March of 2010.  That's right: 2010.  In its response, CMS explained that when it is busy, it utilizes a "first-in, first-out" approach when responding to requests.

While most of the media attention related to medical marihuana has been focused on employment issues and the location of marihuana dispensaries, a Michigan physician is also receiving some press because of criminal charges recently filed against her.

On April 15, 2011, as part of a Drug Enforcement Agency ("DEA") investigation into Dr. Ruth A. Buck's potential prescription drug crimes, the DEA also charged Dr. Buck criminally with aiding and abetting the distribution of marihuana.

A recent decision by the Michigan Court of Appeals imposes a substantial obstacle to enforcing contracts that prohibit physicians from soliciting or servicing patients after leaving employment or separating from a practice. Steiner v Bonanni (decided April 7, 2011).

Through Executive Order 2011-4 ("Order"), Governor Snyder has ordered that the Department of Energy, Labor and Economic Growth be reorganized and renamed the Department of Licensing and Regulatory Affairs, effective as of April 24, 2011.  Especially important to those in the health care industry is the fact that the Bureau of Health Professions, the Bureau of Health Systems and the Controlled Substances Advisory Commission will be transferred from the Department of Community Health ("MDCH") to the Department of Licensing and Regulatory Affairs.  The Governor announced that the transfer will allow MDCH to concentrate on the actual health care delivery aspects of its duties while allowing Licensing and Regulatory Affairs to oversee the licensing and professional regulatory aspects of these functions.