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Showing 51 posts in Regulatory.

And Then There Was One: Economic Pressures Squeeze Metro Detroit Hospitals into Consolidation

Reduced reimbursements. A shift toward global payment. A demand for integration, quality of care and medical specializations. In order to compete amidst today’s healthcare market pressures, independent hospitals in Michigan and around the nation are increasingly deciding that they cannot go it alone. A recent Detroit News article reveals how this trend is playing out in Metro Detroit, with one of the region’s last two independent hospitals poised for acquisition.   

Observers of Detroit’s healthcare environment are reportedly not surprised by the news that Crittenton Hospital Medical Center has signed a letter of intent to join St. Louis-based Ascension Health, the largest Catholic and nonprofit health system in the nation. With Monroe-based Mercy Memorial Hospital announcing on January 6 that it is joining the ProMedica health care company, the Crittenton deal will leave Doctors’ Hospital in Pontiac as the region’s last remaining independent hospital.

Laura Wotruba, spokeswoman for the Michigan Health and Hospital Association, said that this is not a Michigan issue, but rather a widespread pattern. “[It is] a national trend [and] something we’ve been seeing around the country.” Read More ›

Categories: Electronic Health Records, Health Care Reform, HIPAA, HITECH Act, Hospitals, News & Events, Regulatory

CMS Finalizes Changes to Unnecessary, Obsolete, Counterproductive or Excessively Burdensome Regulations

cms finalizes changesOn May 7, 2014, the Centers for Medicare and Medicaid Services (“CMS”) issued a Final Rule to reform Medicare regulations identified as “unnecessary, obsolete, counterproductive or excessively burdensome” to hospitals and other health care providers. The changes are part of the Obama administration’s “regulatory lookback” in connection with Executive Order 13563, “Improving Regulation and Regulatory Review.” The Final Rule makes a number of clarifications and revisions to policies set forth in both the May 16, 2012 final rule and the February 7, 2013, proposed rule. CMS estimates the reforms could save providers nearly $660 million annually and $3.2 billion over five years.

Below is a brief summary that highlights some of the issues CMS is attempting to address. Please refer to the Final Rule, or contact us, to explore the full extent of the changes in more detail. Read More ›

Categories: Compliance, Hospitals, Medicare/Medicaid, Providers, Regulatory

Foster Swift Attorneys Attend Annual Health Law Institute

Foster Swift Attorneys Attend Annual Health Law InstituteFoster Swift health care attorneys are getting ready to attend the 20th Annual Health Law Institute March 6 and 7. The Institute provides attorneys with the opportunity to learn about the most recent statutory, regulatory, and case law developments in the health care industry. Co-sponsored by the Health Care Law Section of the State Bar of Michigan, this educational opportunity offers a range of presentations from numerous leaders in the health care legal community. Read More ›

Categories: Health Insurance Exchange, HIPAA, Medicare/Medicaid, Regulatory

FDA Issues Final Guidance on Mobile Medical Apps

On September 23, 2013, the U.S. Food and Drug Administration (FDA) issued final guidance governing the development of mobile medical apps. The FDA will focus its oversight on apps that it deems potentially harmful to consumers if they do not function properly. This, therefore, largely excludes the majority of medically-oriented mobile apps currently on the market as they pose minimal risk to consumers. Read More ›

Categories: Regulatory

Michigan Senate Panel Moves Three Alternative Medicaid Bills Out of Committee

In early July, we updated our readers regarding the status of the Medicaid expansion debate in Michigan. At that time, a House-passed bill - supported by Governor Snyder - languished in a Senate committee because it was blocked by Senate Republicans who opposed the measure. Get an update ›

Categories: Health Care Reform, Medicare/Medicaid, Regulatory

Regulators Can Sue Over Pay-for-Delay Drug Settlements Between Brand Name and Generic Drug Makers

generic drug makersOn June 17, 2013, the U.S. Supreme Court ruled that brand name drug makers can be sued for paying generic drug makers to delay the introduction of low-cost versions of popular medicines to the marketplace. The Court's 5-3 ruling is a victory for the Federal Trade Commission (“FTC”), and reverses a lower-court ruling that shielded drug makers from liability.

So-called "pay-for-delay" or reverse payment arrangements between brand name and generic drug makers result in payments being made to generic drug makers in order delay the launch of competing generic drugs. These settlements often stem from litigation, or threatened litigation, brought by brand name drug makers against generic drug makers who try to sell products prior to the patent expiration period. In this case, the FTC argued that pay-for-delay agreements cost consumers as much as $3.5 billion per year, while the pharmaceutical industry alleged that such deals are legitimate means of settling patent disputes. Read More ›

Categories: Pharmacy, Regulatory

New LARA Policy for Professional Services Corporations

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.

Categories: Licensing, Physicians, Regulatory

Medicaid Expansion Debate in Michigan Rages On

medicaid expansion debateA key component of the Patient Protection and Affordable Care Act ("PPACA") involves expanding Medicaid to anyone who earns up to 133 percent of the poverty level. In its landmark ruling last year the Supreme Court, while upholding PPACA, ruled that states could not be compelled to expand the joint federal-state Medicaid program.

State legislatures and governors across the country have considered whether to expand Medicaid, with only 23 states and the District of Columbia implementing an expansion according to the Henry J. Kaiser Family Foundation. Under the PPACA, 100 percent of the cost of the Medicaid expansion will be covered by the federal government from 2014 through 2016. The federal government's contribution will gradually decline until reaching 90 percent in 2022 and beyond. What's happening in Michigan? ›

Categories: Health Care Reform, Insurance, Medicare/Medicaid, Regulatory

Walgreens Agrees to Record $80 Million Settlement with DEA

WalgreensOn 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. Read More ›

Categories: Compliance, Fraud & Abuse, Hospitals, Pharmacy, Physicians, Regulatory

IRS Issues New Regulations Affecting the “Blues” Under Health Reform

irs issues new regulationsThe 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. Here's the background ›

Categories: Health Care Reform, Hospitals, Insurance, Physicians, Regulatory