Category Archives: Hospitals
Advocates Split on the Benefit of Banning Non-Compete Clauses!
The Federal Trade Commission (“FTC”) unilaterally issued a Proposed Rule to ban non-compete clauses in employment contracts. See blog. The first question is: Does the FTC have the legal authority to ban non-compete clauses? As a member of the American Society of Medical Association Counsel (“ASMAC”), the president, Greg Pepe, sent out an informal questionnaire to solicit comments by health care attorneys and heads of medical societies.
Greg said, “The respondents were split 50%/50% between medical society attorney members and private practice attorneys who are members. In general, the most common threads were as follows:
- The most common comment was that non-compete provisions in physician employment contracts impede the physician/patient relationship. This comment came up over and over in a number of ways.
- A few comments pointed out that rural areas were disproportionately harmed by non-competes, with physicians having to move away to comply.
- Hospital-based physician groups need non-competes to protect their arrangements.
- Exemptions for non-profits is a loophole that eviscerates the effort.
- ASMAC should be mindful of the divergent interests of its members and their client when considering this kind of commentary.
Very few people offered specific examples of the ways non-competes in physician contracts harmed physicians. If your organization takes steps to comment please keep ASMAC advised.”
I decided that ASMAC’s findings, even if informal, were important enough to post here on my blog. So, thank you, Greg, for heading this up.
I would like to pay particular attention to #4. Because, a week or so ago, I presented on RACMoniter the story about the FTC banning non-compete clauses, but failed to acknowledge the exemptions for non-profits, which is a HUGE exception. There are 6093 hospitals in the U.S. 1228 of the 6093 hospitals are for profit. The vast majority of hospitals are either government run or non-profit. If you notice above, the “anti-banning comment of non-competes” came from hospital-based physician groups (#3). That makes sense.
Most people, when asked, touts that non-compete agreements impede physician-patient relationships. Personally, as an attorney, non-compete agreements represent requiring me not being able to work at another law firm if I decided Practus, LLP, did not work out. Similarly, if I had attended med school and was working at a hospital in Angier, NC, which was in close proximity to my home, and received a better offer at a nearby hospital, why should I be impeded from working? Obviously, families need to have an income, and what if the physician was the sole breadwinner? The non-compete agreement could really adversely affect a family.
Non-compete agreements, also called restrictive covenants, are an increasingly common requirement for employment in many sectors, including health care. Sometimes non-compete agreements appear as a clause within a contract. Other times, they are separate contracts in and of themselves. Though common, the terms of non-compete agreements vary greatly.
Most people, even physicians, when presented with a contract, “fake” review the contract, and sign without digesting – or even reading – the material. Many don’t even know that a non-compete clause exists in their contracts. Until it’s too late.
Will the FTC’s Proposed Rule become permanent? So far, there have been 4.91k comments. One anonymous person posted: “I am completely in favor of forbidding noncompete agreements.” A woman posted: “I am a veterinarian and have worked close to 40 years. I have been an associate and a practice owner. I see no justification for non-competes and in fact feel it harms the entire profession. Non-competes are pervasive and notoriously difficult to fight. For many years now I have worked for corporations and have watched colleagues both attempt to negotiate non-competes and bear the brunt of legal battles if they attempt to challenge the non-compete. Should you really have to move your entire family to acquire a job? How do I harm a company by working for their competitor?”
A guy wrote: “These should’ve been banned a long time ago. Job mobility is important if we “really” believe in our economic system. Ban NDAs.”
A physician wrote: “As a physician I have suffered significant financial and personal hardship relating to a non-compete agreement. As a result of a non-compete I had to move across the country (twice). I suffered significant loss of income as a result of this not withstanding the expense of relocating twice within a year. My self and my family also suffered significant psycho-social ramifications and de-stabilization. I now also face another non-compete agreement that will essentially render me unable to leave my next position without tremendous harm to my life-long earning potential, credibly rendering me an indentured servant. The presence of a non-compete also removes any leverage an employee such as myself might have to negotiate agains unacceptable working or wage conditions.”
Unlike the commenters from ASMAC, which was split 50-50, it appears that many comments support banning non-compete agreements, but, remember, the not-for-profit exception!! The comment period is open through Mar 10, 2023.
340B Drug Pricing Program: Drug Companies Are Concerned!
The federal 340B Drug Pricing Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a discount of 25 percent to 50 percent. The program is intended to help safety-net health care providers stretch their financial resources to reach more financially vulnerable patients and deliver comprehensive services.
The 340B Drug Pricing Program has spiked in use. It has become more and more popular over the years.
In 2020, there were 8,100 provider sites (including both hospitals and pharmacies), but that number rose to 50,000 by 2020. New data released in August 2022 by the Health Resources and Services Administration suggest discounted purchases under the 340B program reached $44 billion in 2021, about 16% more than in 2020. Drug companies are concerned.
On November 30, 2022, the 340B Drug Pricing Program; Administrative Dispute Resolution Notice of Proposed Rulemaking (NPRM) was published in the Federal Register. Section 340B(d)(3) of the Public Health Service Act requires the establishment of an Administrative Dispute Resolution (ADR) process for certain disputes under the 340B Program. Under the statute, the ADR process is designed to resolve:
- Claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers; and
- Claims by manufacturers, after the manufacturer has conducted an audit of a covered entity, that a covered entity has violated the prohibition on diversion or duplicate discounts.
This NPRM proposes new requirements and more efficient procedures to make the 340B Program’s ADR process more accessible and efficient, including ensuring that ADR panels hearing disputes are comprised of subject matter experts on the 340B Program, and establishing an independent HRSA reconsideration process. The NPRM will be open for public comment through January 30, 2023. Please refer to the Federal Register (PDF – 315 KB) publication for instructions about how to submit comments.
The question is how does the new proposed rule mesh with the Inflation Reduction Act of 2022? If you recall, the Inflation Reduction Act of 2022 (IRA) allows Medicare to negotiate drug rates. It has been suggested that the following 10 medications will be the first 10 negotiated:
Does the IRA and 340B conflict? How can you negotiate prices of a drug if the drug is already discounted?
Gift Cards Violate AKS? Maybe NOT!!!
Is Giving Gift Cards to Medicaid Consumers Suffering Substance Abuse Issues Who Comply with Weekly Criteria To Promote Wellness Against the Anti-Kickback statute (AKS)?
Yes, but who cares?
OIG does not care and even published an opinion stating that OIG would not penalize the practice.
The AKS is a criminal law that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients). Remuneration includes anything of value and can take many forms besides cash, such as free rent, expensive hotel stays and meals, and excessive compensation for medical directorships or consultancies. In some industries, it is acceptable to reward those who refer business to you. However, in the Federal health care programs, paying for referrals is a crime. The statute covers the payers of kickbacks-those who offer or pay remuneration- as well as the recipients of kickbacks-those who solicit or receive remuneration. Each party’s intent is a key element of their liability under the AKS.
Criminal penalties and administrative sanctions for violating the AKS include fines, jail terms, and exclusion from participation in the Federal health care programs. Physicians who pay or accept kickbacks also face penalties of up to $50,000 per kickback plus three times the amount of the remuneration.
Safe harbors protect certain payment and business practices that could otherwise implicate the AKS from criminal and civil prosecution. To be protected by a safe harbor, an arrangement must fit squarely in the safe harbor and satisfy all of its requirements. Some safe harbors address personal services and rental agreements, investments in ambulatory surgical centers, and payments to bona fide employees.
However, study after study after study have demonstrated that people with substance abuse issues have a higher likelihood of success with monetary incentives. See article as an example.
OIG obviously understands the efficacy of gift cards. Maybe Congress can back up OIG because, you can be sure that, if the proposed rule is passed, litigation will ensue. People will claim that the FTC does not have the legal authority to issue such a rule in violation of the AKS.
Non-Compete Clauses Banned, According to Proposed Rule
Non-compete clauses have dominated the health care field for years. Generally, noncompete clauses place restrictions on a person’s ability to work in three different ways:
- geographical restrictions,
- time restrictions, and
- line of business restrictions
On January 5, 2023, the Federal Trade Commission (“FTC”) released a notice of proposed rule-making to prohibit employers from imposing noncompete clauses on workers. Noncompete agreements block people from working for competing, potential employers or starting a competing business, after their employment ends.
Data show that non-compete clauses affect about one and five American workers, approximately 30 million people. However, non-compete clauses are predominantly in healthcare. By far, doctors employed by hospitals sign more non-compete agreements than any other profession. The theory behind eliminating non-compete agreements is that non-compete causes prevent employees from accepting better opportunities that offer higher pay or better working conditions.
Non-compete clauses are common and have been a contentious issue for decades. Some theorize that non-competes disrupt the physician-patient relationship and remove physicians who are already in short supply from the workforce.
I say, eliminating noncompete agreements may evolve healthcare.
As written, the federal rule will supersede state laws that currently govern noncompete and would apply retroactively, invalidating existing agreements.
This proposed rule comes with criticism and legal obstacles that will surely be tested. So for all of you who jumped up and down for the new proposed rule, expect litigation because as much as eliminating noncompete clause is awesome for physicians, hospitals will be adversely affected.
Many people have complained that the rule is over broad and vague. Challenges include whether the FTC has the authority to issue the non-compete rule under Section 5 of the FTC Act, the primary section the FTC cites as providing its rulemaking authority. Section 5 gives the FTC authority to police both “unfair methods of competition” and “unfair or deceptive acts or practices” affecting commerce. Although Section 18 of the FTC Act contains an explicit grant of rulemaking authority to the FTC for unfair or deceptive acts or practices, the statutory authority for the FTC’s ability to make rules for unfair methods of competition is less clear. Even if the federal courts conclude that the FTC had the authority to make a rule under the FTC Act, there will be challenges to the legality of the non-compete rule itself. The FTC claims that the non-compete rule is based on a finding that non-compete clauses constitute an “unfair method of competition and therefore violate Section 5 of the Federal Trade Commission Act.”
To address these problems, the FTC’s proposed rule would generally prohibit employers from using noncompete clauses. Specifically, the FTC’s new rule would make it illegal for an employer to: enter into or attempt to enter into a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.
The proposed rule would apply to independent contractors and anyone who works for an employer, whether paid or unpaid. It would also require employers to rescind existing noncompetes and actively inform workers that they are no longer in effect.
The agency estimates that the new rule could boost wages by nearly $300 billion a year and expand career opportunities for about 30 million Americans.
The commission invites the public to submit comments. The FTC will review the comments and may make changes, in the final rule, based on the comments and on the FTC’s further analysis of the issue. Comments are due 60 days after the federal register publishes the proposed rule. You have until March 6 to comment.
A Brave New World: No Covenants Not to Compete???
“On January 5, 2023, the Federal Trade Commission released a Notice of Proposed Rulemaking (NPRM) to prohibit employers from imposing noncompete clauses on workers. True to their name, noncompetes block people from working for a competing employer, or starting a competing business, after their employment ends. Evidence shows that noncompete clauses bind about one in five American workers, approximately 30 million people. By preventing workers across the labor force from pursuing better opportunities that offer higher pay or better working conditions, and by preventing employers from hiring qualified workers bound by these contracts, noncompetes hurt workers and harm competition.” Link.
Physician noncompete contracts are a common but sometimes contentious issue, as they have the potential to disrupt the physician-patient relationship and remove physicians — who are already in short supply — from the workforce.
Eliminating noncompete agreements will evolve health care.
The Commission invites the public to submit comments on this proposed rule. The FTC will review the comments and may make changes, in a final rule, based on the comments and on the FTC’s further analysis of this issue. Comments will be due 60 days after the Federal Register publishes the proposed rule. You have until Match 6th to comment.
2023 Changes to the Physician Fee Schedule … Starting Now!
Happy 2023 to all my bloggies out there!! Over the New Year’s celebration, thousands gathered in a wet NYC to watch the ball drop. There was a shooting in Mobile, AL, killing one person and injuring 9. About 40 people died in Buffalo over the holidays due to severe cold weather. And a man named Jay Withey rescued 24 people in Buffalo during the blizzard. My friend got COVID and gave it to her mom. I took my 98-year-old grandma out for sushi and played pickleball with my mom and daughter.
Why the word vomit?
Well, it’s a New Year and a new start. I am choosing to have a positive attitude for 2023. Yes, you get audited. Yes, the government blows. Sometimes you do not get rainbows and applesauce every day. But the hard times give you strength. It’s the challenging times that teach you to appreciate the good. I have decided to think about life as school. You may not want to go, but it’s required. Attendance is required.
On the syllabus for today, should you choose to participate, is the 2023 Physicians Fee Schedule (“PFS”). On November 01, 2022, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule that includes updates and policy changes for Medicare payments under the PFS, and other Medicare Part B issues, effective on or after January 1, 2023. Well, guess what, folks? It is January 2, 2023.
For most services furnished in a physician’s office, Medicare makes payment to physicians and other professionals at a single rate based on the full range of resources involved in furnishing the service. In contrast, PFS rates paid to physicians and other billing practitioners in facility settings, such as a hospital outpatient department (“HOPD”) or an ambulatory surgical center (“ASC”), reflect only the portion of the resources typically incurred by the practitioner in the course of furnishing the service.
Conversion factor
There was a 3% supplemental increase to PFS payments in 2022. That increase expires in 2023. The final 2023 PFS conversion factor is $33.06, a decrease of $1.55 to 2022 PFS conversion factor of $34.61.
What is a conversion factor (“CF”)? It is a convoluted equation that sets Medicare rates that differs depending on whether the health care service is rendered within a facility or out. CF is set by statute.
Evaluation and Management (“E/M”) Visits
For 2023, there are 25 codes that are going away. Here are the codes that are being deleted.
- Hospital observation services codes 99217—99220, 99224–99226
- Consultation codes 99241, 99251
- Nursing facility service 99318
- Domiciliary, rest home (eg, boarding home), or custodial care services, 99324—99328, 99334-99337, 99339, 99340
- Home or resident services code 99343
- Prolonged services codes 99354—99357
There is also a new Section entitled “initial and subsequent services,” which applies to hospital inpatient, observation care and nursing facility codes. It applies to both new and established patient visits. The AMA says,
“For the purpose of distinguishing between initial or subsequent visits, professional services are those face-to-face services rendered by physicians and other qualified health care professionals who may report evaluation and management services. An initial service is when the patient has not received any professional services from the physician or other qualified health care professional or another physician or other qualified health care professional of the exact same specialty and subspecialty who belongs to the same group practice, during the inpatient, observation, or nursing facility admission and stay.”
Admission and Discharge on the Same Day
Lastly, at least for this blog, codes 99234-99236, which are used for hospital inpatient or observation care and include the admission and discharge on the same day. The patient must be in the facility for greater than 8 hours. See the below table for reference:
These are just a few of the PFS 2023 changes. Stay tuned for new Medicare and Medicaid news on this blog by me, Knicole Emanuel.
Are UTIs Preventable? OIG Says Yes and CMS Will Audit!
I hope everyone had a fantastic Thanksgiving and are now moving toward the Christmas or Hanukkah holiday. As I discussed last week, CMS and its contracted auditors are turning their watchdog eyes toward nursing homes, critical access hospitals (“CAHs”), and acute care hospitals (“ACHs”). You can hear more on this topic on Thursday, December 8th at 1:30 when I present the RACMonitor webinar, “Warning for Acute Care Hospitals: You Are a Target for Overpayment Audits.”
October 2022, OIG published a new audit project entitled, “Potentially Preventable Hospitalizations of Medicare-Eligible Skilled Nursing Facility Residents.”
Residents of nursing homes and long-term care facilities are frequently transferred to an Emergency Department as an inpatient when they need acute medical care. A proportion of these transfers may be considered inappropriate and may be avoidable, says OIG.
OIG identified nursing facilities with high rates of Medicaid resident transfers to hospitals for urinary tract infections (“UTIs”). OIG describes UTIs as being “often preventable and treatable in the nursing facility setting without requiring hospitalization.” A 2019 OIG audit found that nursing facilities often did not provide UTI detection and prevention services in accordance with resident’s individualized plan of care, which increases the chances for infection and hospitalization. Each resident should have their own prevention policy for whatever they are prone to get. My Grandma, for example, is prone to UTIs, so her personal POC should have prevention measures for trying to avoid contracting a UTI, such as drinking cranberry juice and routine cleansing. In addition to UTIs, OIG noted that previous CMS studies found that five conditions were related to 78% of the resident transfers to hospitals: pneumonia, congestive heart failure, UTIs, dehydration, and chronic obstructive pulmonary disease/asthma. OIG added a sixth condition citing that sepsis is considered a preventable condition when the underlying cause of sepsis is preventable. In my humble opinion, the only condition listed as preventable that is actually preventable is dehydration.
OIG’s new audit project involved a review of Medicare and Medicaid claims related to inpatient hospitalizations of nursing home residents with any of the six conditions noted previously. The audit will focus on whether the nursing homes being audited provided services to residents in accordance with the residents’ care plans and related professional standards (or whether the nursing homes caused preventable inpatient admissions due to non-compliance with care plans and professional standards).
What can you do to prepare for these upcoming audits? Review your facilities’ policies, procedures, and practices germane to the identification of the 6 conditions OIG flagged as preventable. Ensure that your policies and procedures lay out definitive steps to prevent or try to prevent these afflictions. Educate and train your staff of detection, prevention, treatment, and care planning related to the six conditions. Collect and analyze data of trends of frequency and cause of inpatient hospitalizations and determine whether these inpatient hospitalizations could have been prevented and how.
In summary, be prepared for audits of inpatient hospitalizations with explanations of attempted prevention. You cannot prevent all afflictions, but you can have policies in place to try. As always, it’s the thought that counts, as long as, it’s written down.
My Halloween blog from Yesterday: Medicare Dollars Vanish!
Happy Halloween. This year I am dressing as Freddy Krueger and my daughter, who is 17, says, “that’s so 80’s.” I guess some younger kids will just think I’m a spooky lady in a green and red sweater with knives for fingers. In honor of Halloween, I would like to tell you three ghost stories, of Medicare money that has vanished never to be found.
First, a ghoulish report from OIG states that CMS has not done enough to recoup Medicare payments found in 12 hospitals. Nothing like a report saying “CMS isn’t getting enough money” to make CMS “trick or treat” with more audits. According to the OIG report, CMS is short staffed, like almost every employer in America. Apparently, CMS claims to have too many phantoms instead of employees to track down every dollar, which I must say, makes me superstitious. If CMS is claiming to not have enough resources to track down money that has been targeted at 12 hospitals, how is it conducting the other audits nation-wide?
Among the 12 hospitals, supposedly, there is an eerie $82 million allegedly owed to CMS.
OIG recommended recouping all the money, but, according to OIG, CMS has provided insufficient information. Specifically, CMS did not provide information on the status of appeals hospitals levied against OIG’s overpayment findings. CMS didn’t provide information on the reason for the appeal or status of the action. Personally, I am just happy the hospitals appealed.
The second ghost story entails CMS’ continual audit of providers, especially the Medicare Advantage plans, which are nightmares. CMS has agreed to release the audits of 90 MA plans conducted between 2011 and 2013. These records are expected to demonstrate more than $600 million in MA overpayments due to alleged upcoding. Chilling!
Finally, a NC hospital system, Atrium Health, publicly announced that in 2019 it provided $640 million to Medicare patients that were never paid for. You would think this spine chilling unless you knew the tax breaks associated with the charity. But for the same year that Atrium’s website says it recorded the $640 million loss on Medicare, the hospital system claimed $82 million in profits from Medicare and an additional $37.2 million in profits from Medicare Advantage in a federally required financial document. Sleight of hand and hocus pocus!
The Catastrophic Effect of Natural Disasters on Medicare Audits
When natural disasters strike, Medicare and Medicaid audits become less important, and human safety becomes most important. During Hurricane Ian, 16 hospitals were evacuated in Florida alone. Hospitals and long-term care facilities were without water.
Approximately, 8,000 patients were evacuated from 47 nursing homes and 115 assisted living facilities. Seventy-eight nursing homes lost power and all had to implement emergency plans involving generator power. Did the providers continue to bill during this time? If so, could regulations be followed in the midst of a pandemic.
These natural disasters impact future Medicare and Medicaid audits. Obviously, during natural disasters a hospital may not be able to maintain the two-midnight rule or determine whether a patient is in observation status or in-patient. You may be surprised to hear that there are no automatic audit exceptions during a disaster.
The general rule, which has exceptions, is a 30-day extension for records requests. Broadly speaking, Medicare fee-for-service has three sets of potential temporary adjustments that can be made to address an emergency or disaster situation. These include:
- Applying flexibilities that are already available under normal business rules. This is on an individual basis;
- Waiver or modification of policy or procedural norms by CMS; and
- Waiver or modification of certain Medicare requirements pursuant to waiver authority under § 1135 of the Social Security Act. This waiver authority can be invoked by the Secretary of the DHHS in certain circumstances.
These waivers are not automatic.
Section 1135 of the Social Security Act authorizes the Secretary DHHS to waive or modify certain Medicare, Medicaid, CHIP, and HIPAA requirements. Two prerequisites must be met before the Secretary may invoke the § 1135 waiver authority. First, the President must have declared an emergency or disaster, and the Secretary must have declared a Public Health Emergency (PHE).
Waivers authorized by the statute apply to Medicare in the context of the following requirements:
- conditions of participation or other certification requirements applicable to providers;
- licensure requirements applicable to physicians and other health professionals;
- sanctions for violations of certain emergency medical standards under the Emergency Medical Treatment and Labor Act (EMTALA)
- sanctions relating to physician self-referral limitations (Stark)
- performance deadlines and timetables (modifiable only; not waivable); and
- certain payment limitations under the Medicare Advantage program.
Following a disaster, such as Ian, there is no standing authority for CMS to provide special emergency/disaster relief funding following an emergency or disaster in order to compensate providers for lost reimbursement. Congress may appropriate disaster-specific special funding for such; but absent such special appropriation, Medicare does not provide funding for financial losses.
In the context of Medicare audits, providers can obtain extensions to audit requests. Audits will only be suspended on a case-by-case basis, which means it is a subjective standard. Natural disasters are awful, and we probably need more comprehensive audit exceptions.
