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PA DOH Releases Proposed Temporary Medical Marijuana Regulations for Doctors

On April 11, 2017, the Department of Health (DOH) released the much anticipated proposed temporary regulations for physicians that among other items, set forth requirements regarding: the physician registry, the completion by...more

Repeal Efforts Fail (for now): Can Obamacare Survive?

With the House GOP pulling the American Health Care Act (AHCA) due to lack of sufficient support even within its own party, Obamacare is not out of the woods. The ACA’s two pillars, the individual marketplaces and...more

Pennsylvania Issues Grower/Processor and Dispensary Permit Applications for Medical Marijuana Program

On January 17, 2017, the Pennsylvania Department of Health (“DOH”) released grower/processor and dispensary permit applications (“Applications”), which can be found on Pennsylvania’s Medical Marijuana Program website. DOH...more

Trump Takes First Step Toward Dismantling ACA and Buys Time with an Executive Order: Is it Substantive or Merely Symbolic?

Hours after taking the oath of office President Donald Trump signed a broadly worded executive order (“Order”) intended to minimize if not eliminate the impact of the ACA’s least popular provisions. With the Order President...more

Futures in Doubt of CMS’ New Mandatory Bundled Payment Models and Medicare Shared Savings Program Track 1+

Word spread quickly Monday (December 20, 2016) about CMS’ issuance of final regulations (to be published in the Federal Register on January 3, 2017) rolling out new mandatory bundled payments models for Acute Miocardial...more

House Passes 21st Century Cures Act

On November 30, 2016, the House overwhelmingly passed (392-26) the 21st Century Cures Act (“Bill”). The Bill moves on to the Senate next week and it is projected to pass in the Senate as well. Notably, the Bill seeks to...more

Arbitration Agreements in Nursing Homes

In a final rule published today in the federal register (“Final Rule”), CMS announced numerous changes to the consolidated Medicare and Medicaid requirements for participation for long term care (LTC) facilities (42 CFR part...more

Third Circuit Puts Penn State Hershey/Pinnacle Merger on Hold

Last week, the Third Circuit Court of Appeals held that the merger between Penn State Hershey Medical Center and PinnacleHealth System, the two largest hospitals in Harrisburg, Pennsylvania, may not move forward at this time....more

10/4/2016  /  FTC , Hospital Mergers , Hospitals , Mergers

CMS Hears and Responds to Physician Feedback Regarding MACRA

On September 8, 2016, CMS announced in its blog that it will allow physicians to select their level of participation for the first performance year of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) Quality...more

New Grower/Processor Regulations Released

On August 18, 2016, the Secretary of Pennsylvania’s Department of Health (“DOH”), Dr. Karen Murphy, announced that the DOH has posted draft temporary regulations (“Regulations”) focusing on the 25 medical marijuana...more

OCR Announces New HIPAA Guidance on Ransomware

In response to the increasing prevalence of ransomware cyber-attacks by hackers on electronic health information systems in hospitals and medical practices, the Department of Health and Human Services (HHS) Office for Civil...more

Medical Marijuana in Pennsylvania: What Physicians Should Know

On April 17, 2016, Governor Wolf signed Act 16 of 2016, making Pennsylvania the 24th state (plus the District of Columbia) to legalize marijuana for medical use. Physicians, not surprisingly, will play a vital role in...more

Heads-Up! HIPAA Phase Two Audits Begin – Business Associates Included!

The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) finally announced on March 21 that it is ready to begin Phase Two of its HIPAA audit program, which will include business associates. These...more

3/24/2016  /  Covered Entities , HHS , HIPAA Audits , HITECH , OCR

OCR Announces Two Significant HIPAA Breach Settlements

On consecutive days, the Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) recently announced two large HIPAA breach settlements. On March 16, 2016, OCR announced that it entered into a...more

Does Arbitration Belong in the Nursing Home World?

As part of admission into a nursing home, a facility typically requires prospective residents to agree to binding arbitration. Arbitrating disputes generally allows nursing facilities to handle disputes without incurring the...more

Gun Control and HIPAA

In the wake of recent gun violence and in a concerted effort to protect public safety, the Department of Health and Human Services (HHS) released a final rule published in the Federal Register January 6, 2016, that modifies...more

FTC Loses in LabMD Data Security Case: ALJ Sets High Bar for Consumer Harm

On November 13, 2015, an administrative law judge (“ALJ”) ruled against the Federal Trade Commission (“FTC”) in its high-profile data security case against LabMD. The ALJ ruled that the FTC had failed to show that LabMD’s...more

11/25/2015  /  Actual Injuries , ALJ , Data Security , FTC , LabMD , Section 5

ALJ Rules Against FTC in LabMD Data Security Action: Sets High Bar for Proving Consumer Harm

Last June we wrote about the FTC’s enforcement action against LabMD, a medical testing laboratory, which was forced to wind down its business because of the costs associated with challenging the FTC since 2013. Using its...more

Executives in the Crosshairs: DOJ Increases the Focus on Individuals to Combat Corporate Wrongdoing

Earlier this month, the Deputy Attorney General of the Department of Justice (“DOJ”) released a memorandum (“Guidance”) setting forth six key steps to which DOJ attorneys should adhere in the investigation of corporate...more

The Time is Right for Hospitals to Ensure 501(r) Compliance

Updated requirements for hospitals to maintain their tax-exempt status under Section 501(r) of the Internal Revenue Code are nothing new. They were enacted as part of the Affordable Care Act in 2010. However, at the end of...more

Physician Group to Pay $750,000 to Settle a HIPAA Violation

In August 2012, a Physician Group—comprising of nearly 20 physicians—reported its HIPAA breach to HHS, which resulted from a laptop bag containing the employee’s laptop and a computer server backup being stolen from an...more

9/4/2015  /  Data Breach , HHS , HIPAA , PHI , Physicians , Settlement

Revamped Telehealth Bill Referred to the House and Energy Commerce Committee and the House Committee on Ways and Means

On July 7, 2015, U.S. Reps. Mike Thompson, Gregg Harper, Diane Black, and Peter Welch announced the introduction of a new version of the July 2014 telehealth legislation (H.R. 5380) called the Medicare Telehealth Parity Act...more

Senate Approves Medicare “Doc Fix” Legislation

We wrote in late March about the U.S. House of Representatives passing SGR legislation intended to be a permanent cure to Medicare’s “doc fix” legislation. ...more

On the Horizon … A Possible “Permanent” Cure to Medicare’s “Doc Fix”

In a historic bipartisan moment, the U.S. House of Representatives passed a nearly 300-page bill that is intended to “repeal the Medicare sustainable growth rate [“SGR”] and strengthen Medicare access by improving physician...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

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