When it comes to buying medical practices, hospitals and health systems aren’t the only ones writing checks. In recent years, the number of private equity firms looking to purchase practices has continued to increase.
	
	There were $15 billion in deals in 2017, $22.3 billion in 2018 and there is well over $60 billion so far this year, according to the Medical Group Management Association (MGMA). “I don’t see it slowing down,” says Halee Fischer-Wright, MD, president and CEO of MGMA. “Last year, there were 200 private equity deals closed, and as we entered October, we are looking at about 250 to 300 deals this year.”
	
	The first wave of private equity investment hit specialties like orthopedics, dermatology, urology and gastroenterology, where potential profits were highest, but the firms are now expanding their targets. “I do see private equity drifting into primary care practices,” says Fischer-Wright. “They aren’t necessarily looking at buying small ones, but networks so they can control a region and have groups large enough to compete for contracts or drive rates.”
	
	In light of these developments, practices need to understand private equity, both as a possible source of expansion capital and as a potential owner of the local competition.
	
	


	
	Private equity firms work by pooling money from investors that they use to  buy businesses, create value beyond the purchase price, then sell off the combined portfolio company and return the profits to the investors, says William Spratt Jr., JD, partner, healthcare, for the law firm of Akerman LLP in Miami.
	
	Often, the strategy in healthcare is to either combine multiple practices of the same type to dominate a market, or create a large multispecialty practice.
	
	“A fair number are looking to acquire primary care practices, because they are recognizing that’s where all care starts,” says Spratt, who adds that the shift to value-based care is a major driver in this. “They recognize that primary care practices that have assumed risk-based contracts with third-party payers are attractive targets.”
	
	Spratt explains that if a private equity firm can aggregate, say, 10 primary care clinics in a market, and each has full risk contracts and is good at managing its patient population, that puts the combined company in a good position to negotiate more favorable rates with payers.
	
	The larger patient population also spreads the private equity firm’s risk, because the more patients under their control, the less likely one or two catastrophic cases will affect their quality ratings.
	
	“What a lot of private equity firms like to do is find a ‘platform’ practice-one that has demonstrated the ability to be successful in the market and in its specialty,” says Richard Zall, JD, chair of law firm Proskauer Rose’s healthcare group.
	
	This practice will usually have around a dozen physicians and two to four sites, with at least $5 million to $10 million in earnings before interest, taxes, depreciation and amortization (EBITDA). The firm then adds services to  the platform practice or combines it with other practices.
	
	Target platform practices are mostly identified by the equity firms’ business development people. Zall says they attend physician conferences and talk to people in the market to learn who the high-quality practices are and what payers think of them.
	
	Private equity is not a long-term owner in the practice. Physicians with an ownership stake in the acquired practice get an initial buyout plus some equity in the new private-equity controlled company, but investors are looking to get their money back usually in three to five years, says Fischer-Wright. “What we’ve seen is private equity is looking to get three to five times return on investment over that time,” she says.
	
	

The pros and cons of selling to private equity firms


	
	An offer from a private equity firm can be appealing to a primary care practice that wants to grow or is struggling to find the capital for the investments needed to succeed in value-based care.
	
	But for the deal to be successful, experts say, physicians must understand the goals of the private equity firm and be comfortable with its leadership team, because the practice will go through many changes.
	
	“When you sell to a private equity firm, you may have a physician or two that sits on the board of the new corporate entity, but it won’t be the physicians driving the major decisions,” says Fischer-Wright. “What the selling physicians often don’t think about is that if the private equity firm is successful and the practice gets sold to a second firm after five years, the physicians won’t have any say in the new company.”
	
	Spratt says most firms will pay 75 percent of the practice’s valuation at closing with physician owners receiving 25 percent in equity in the new holding company that is created. Physicians typically receive the same deal as the private equity firm for their 25 percent when the investors cash out by selling the holding company.
	
	As minority owners, however, they will have little to no say in how the new deal is structured or to whom the practice is sold. Some buyers are health systems and hospitals, so physicians trying to stay independent by selling to private equity may end up being owned by the very entities they were trying to avoid in the first place, experts say.
	
	There may also be a compensation cut for the physician-owners selling the practice. The private equity firm typically compares the median compensation for physicians in that region with what the physicians in the targeted practice are making.
	
	“Traditionally, what happens is physician compensation decreases 30 percent,” says Fischer-Wright. She adds that doctors need to study the numbers to make sure the deal works for them in the long term. “The decrease in compensation may actually wipe out the value of the seven-figure check from private equity over their career.”
	
	If the right private equity partner can be found and physician owners understand the details, it does provide an option for sustainable growth. “To compete in healthcare in 2020, you need that investment in the EHR, the technology platform and more business management,” says Fischer-Wright. “I have yet to meet a physician who wants to spend more time on the business aspect of medicine. For more proactive practices, this is a funding source to become a sustainable practice.”
	
	In most cases, the private equity firm focuses on the business side of medicine and leaves the clinical decisions to the doctors. “For the best private equity firms, they understand that from a clinical perspective, they aren’t professional clinicians,” says Zall. “They are looking for partners on the clinical side that deliver high quality. They know that providing better patient care and delivering higher quality service will make them more successful and more likely to grow.”
	
	Instead, the equity firm usually focuses on streamlining administrative tasks, using economies of scale for purchasing, improving billing practices, brining in  new vendors and providing experienced executive leadership.
	
	“There are different models-some are more interested in physician leadership and directed growth while others might be just interested in taking over the platform and have the physicians be employees,” says Zall. “There is not just one size of private equity firm out there.”
	
	Understanding the culture of the private equity firm and how it operates are crucial to the deal succeeding for everyone in the long term, experts say. “Smaller practices don’t think about culture as a major driver of success,” says Fischer-Wright. “Where we’ve seen success, the cultures are complementary. It’s like dating: you really have to get to know your partner.”
	
	Zall advises looking at their track record with similar practices to see if  they understand the specialty and the geographic region, and what kind of return on investment they achieved with past deals. The objective measures are important, but so is the interpersonal dynamic.
	
	“Are these people you want to be meeting with early in the morning or late at night and making important decisions with?” says Zall. “Most successful deals have good chemistry. It works more often than you might think it would.”

Does private equity investment affect care quality?


	
	As the number of private equity deals for medical practices increases, some questions have been raised about its potential effect on the quality and delivery of care. Zirui Song, MD, Ph.D., assistant professor of healthcare policy at Harvard Medical School, says that not enough studies have been done to know for sure, but the fears from doctors about private equity’s influence are logical.
	
	“The need to derive a large financial return on investment that private equity firms might face when acquiring medical practices could create pressure to change practice patterns,” says Song. “It could mean increased utilization of certain services, it could change the way patients are diagnosed or treated if those decisions are influenced by the need to generate a financial return.”
	
	Song says he’s heard reports of physicians being concerned about utilization goals or to push certain products. There may be incentives for doctors to use certain services that are costlier or to refer to providers or labs that are also owned by the private equity firm. But he says there is no evidence of this beyond anecdotal accounts, because no studies have been done on the issue.
	
	In some cases, just combining practices can lead to higher insurance premiums for patients, as private equity firms use their leverage to negotiate better rates with payers, and if insurers pass along the price increase. However, physicians may benefit through increased profits, Zall says.
	
	“I think most of the successful private equity firms realize that to be successful, they have to deliver a better product,” he says. “It has to be more accessible, quality at least as good or better than what is in the market, and pricing has to be competitive because consumers are paying more of the bill.
	
	“Some firms may want to do a land grab and do a quick flip, but the better ones realize that if all they are doing is earning money through increased pricing, they will not be successful,” he says.
	
	Song says patients could benefit as well. “We know there is a lot of evidence that the U.S. healthcare system has a substantial amount of low-value care or wasteful care that is delivered,” he says. “To the extent that private equity can help provider practices be more efficient, cut down on unnecessary costs of production, that will help them be more lean in the delivery of healthcare services.”
	
	In the end, physicians have to decide whether the tradeoffs, including some loss of autonomy and compensation to the private equity firm is worth it to them and their patients.
	
	“We should not forget that delivery of healthcare is about the health of the patient and welfare of the patient population,” says Song. “The considerations of private equity ought to take into account the impact on patient well-being.”

Articles

What it is, what these firms want, and why your practice might be a target

Private equity in healthcare

Physicians can adopt administrative and care management processes to deliver cost-effective vaccination services that simultaneously provide highest-quality patient care. While vaccination is mostly identified with immunizing children against diseases, providing vaccination services in a clinically and economically efficient way is foundational to the health of all patients and can add to a practice’s income stream.
	
	“Adults need to be vaccinated; that’s a starting point,” says Jesse Hackell, MD, FAAP, who has led Pomona Pediatrics, in Pomona, N.Y., since founding it in 1987. “It’s not just against immunococcal disease; it’s shingles, chicken pox, measles and HPV. Just because you’re older doesn’t mean that you don’t need vaccines.”
	
	Hackell adds that providing vaccinations can net a fair return. “Vaccine administration can be a profit center for a practice if it’s done correctly. It’s not a huge profit center but it’s possible to provide a margin.”
	
	


	
	Successful vaccination programs require buy-in from the entire practice staff and a smooth-running operation where all the details are handled properly. Doing so requires a “vaccine champion,” says Hackell.
	
	The champion is the advocate who persuades everybody in the practice, clinicians and office staff alike, to embrace and promote the goal of vaccination. “Even the folks answering the phones must tell people ‘If you’re coming in for a well visit, we’re going to give you some vaccinations, too, if you need them, so bring your records,” says Hackell.
	
	The champion also serves as the knowledge resource for the practice-the person who knows what the vaccines are for, their indications, recommendations, and schedules. In a practice with multiple physicians the champion usually is a clinician, who could be a nurse, a physician or even a physician’s assistant.
	
	Running the program on a day-to-day basis requires a second essential person: a vaccination coordinator, who centralizes control of all program workflow processes, from ordering and inventory to administration and billing.
	
	Among other responsibliites, the coordinator must properly maintain vaccines, syringes and related supplies; ensure the integrity of the vaccine records system; and establish protocols for administering and storing the vaccines.
	
	


	
	Doctors won’t get rich providing vaccination services, but modest revenue gains are possible. How?
	
	“It comes down to buying them at the lowest possible price, using them expeditiously, and keeping track of them so that you’re not wasting vaccines,” explains Jamie Loehr, MD, FAAFP, owner of Cayuga Family Practice, in Cayuga, N.Y.
	
	Practices can reduce the prices they pay for vaccines when they buy directly from manufacturers or join a vaccine purchasing group, in which independent practices combine to negotiate reduced fees for bulk vaccine purchases.
	
	“There’s a convenience factor if you buy from a supplier, but the prices tend to be a bit higher,” says Loehr. Manufacturer rebates may be available to direct buyers and purchasing group members, too.
	
	Noting that pricing isn’t going to vary much among groups, Jeff Winokur, a vaccine procurement and administration expert and president of Atlantic Health Partners, a Delray Beach, Fla. vaccine purchasing group, suggests that practices look for other ways to determine which purchasing group would be the best fit.
	
	“Is there a cost to join a group program? Do they provide educational information about vaccines, including updates on indication changes and the availability of a vaccine? Do they do any advocacy on your behalf with payers? Do they have expertise for vaccines in the age range that a practice has?”
	
	Since manufacturers have standard policies on replacing expired vaccine stock, “buying groups can help make sure their members understand those policies, as well as return policies, for instance, with flu,” adds Winokur. “Different flu manufacturers have different policy answers to questions like ‘Okay, I have 20 doses left. What do I do with them?’ ”
	
	Practices also can learn when manufacturers are going to raise their prices. Then, depending on what they have in stock and how much they’ll be using in the short term, they can decide whether to buy more  during the period between the announcement and the effective date of the price hike.
	What’s critical financially is for the practice to get a decent return on the cost of the vaccines. “They should look at their major insurers to see what the payments are for the vaccines, and if they’re not making a significant margin on the vaccine product, they need to renegotiate that,” Hackell advises. “If you’re not getting 25 per cent above the private sector cost, you’re going to lose money.”
	
	Buying online directly from the manufacturer keeps the balance sheet in the black for Loehr, who notes that the savviest insurance companies pay $2 to $3 more than the lowest market prices they can find for vaccines. Accordingly, he says, he’ll make $2.50 if he buys the vaccine for $50 direct from the manufacturer, but lose that same amount if he buys it from a retailer.
	
	


	
	Helping patients stay current on their vaccinations not only keeps them healthy but  produces a steady source of revenue. Immunize.org, a website that provides information on starting and operating a vaccination program, shows how to make this an efficient, labor-saving workflow process (and a subtle marketing tool) for physicians. The site provides templates for standing orders, which lets staff take a general policy rule and apply it to specific patients, so the doctor doesn’t have to be present for a vaccine administration.
	
	“With a standing order you can tell them, ‘You’re due for a vaccination today. Would you like to have it?’ And if they say ‘yes’, you give it to them without needing an individual patient order from the physician,” says Loehr. “The site has a bunch of different standing orders in different languages for different vaccines.”
	
	Practices also can install alerts in their EHR when a patient is due for a vaccination or provide phone call reminders for that purpose. 
	
	Doctors can compete with the convenience of pharmacy and retail clinic vaccinations by holding in-and-out vaccination clinics – especially for flu shots – where patients can get vaccinated within minutes without having to complete paperwork or schedule appointments.
	
	Winokur suggests letting patients know about this service before the flu season begins, and designate certain days and/or times that make it easy for patients to take advantage of these streamlined services.
	
	


	
	As important as profitability and patient participation is having protocols for safely storing and handling vaccines.
	
	The CDC’s best practice guidance specifies a few essential steps for safe storage: immediately checking newly-delivered vaccine packages for damage by examining and documenting the condition of the vaccine and its shipping container; comparing the amounts, lot numbers and expiration dates of the vaccines against the packing invoice to see that they match; and accurately monitoring and recording vaccine temperatures.
	
	If there’s no package temperature indicator, the coordinator should check that the packaging has enough insulation and refrigerant to chill vaccines to the correct temperature. In either case, it’s necessary to ensure that inactivated vaccines are unfrozen.
	
	Vaccines should be stored in a refrigerator designated just for that purpose, with a built-in temperature indicator. They should be kept on the middle shelf, with older vaccines in front, and none of them touching the refrigerator sides or the freezer. The practice must keep daily temperature records and save them for at least three years. “And you must have an alarm on that fridge if it goes down, where someone gets notified to make repairs quickly,” says Cristy Good, MPH, MBA, a senior industry advisor with the Medical Group Management Association, in Englewood, Colo.
	
	Recordkeeping should include lot numbers, too. “It’s important to track those lot numbers in your EHR because if there’s ever a recall, you’ll need to pull out a list of patients who received [vaccines from] that lot number,” says Good. Additionally, doctors should make sure their purchasing contracts with vaccine manufacturers tell them if recalled products yield a refund or credit.
	
	The coordinator also should do a weekly inventory to track expiration dates so that soon-to-expire vaccines aren’t wasted. (Most expired doses of vaccines can be returned for credit.)
	
	“You need to have a process in place that tracks what expires first so that you use that first,” says Good. “But you also need to keep track of your supply and demand, so that you don’t stock up vaccines at the wrong time of the year or the season.”
	
	Government agencies such as the CDC help practices plan for these needs by issuing alerts about when a flu or other disease outbreak has begun. Analytics-based EHR programs that leverage population health data also can guide practices in anticipating what amounts and types of vaccines they’ll need at a given time.
	
	Other workflow aids with robust predictive logic are state immunization registries, which contain patient vaccine records and tell when patients are due for immunizations. 
	
	Consistently emphasizing the necessity of vaccines, exercising diligent inventory and storage control and making price-conscious vaccine purchases are integral to a vaccination program that provides needed care for your patients while enhancing practice revenue. And don’t forget common-sense efficiency.
	
	“You can’t afford to have wasted doses,” Hackell says.

While vaccination is mostly identified with immunizing children against diseases, providing vaccination services in a clinically and economically efficient way is foundational to the health of all patients and can add to a practice’s income stream.

How to build an efficient vaccination program

Migraines are not just bad headaches, they’re the most common severe primary headache disorder, affecting about 12 percent of the population, according to Noah Rosen, MD, director of the Headache Center at the Northwell Institute for Neurology and Neurosurgery in Manhasset, N.Y.
	
	Rosen says that headaches are divided into two basic classifications: primary headaches and secondary headaches.
	
	“Secondary headaches are when a headache is secondary to another condition such as a tumor or a spinal leak,” Rosen says. “A primary headache is where the headache itself is the problem.” Migraines fall into the latter category.
	
	For those who don’t want to turn to medical intervention, physicians can recommend a variety of management strategies that may circumvent or reduce the need for medication:
	
	


	
	“So many headache disorders are triggered events,” Rosen explains.  The more researchers learn about migraines, he says, the more they appear to be related to neuro-inflammation, which can be triggered by numerous factors from diet to caffeine withdrawal.
	
	Hence, lifestyle modifications can be very important. “That includes eating regularly, hydrating well, regular sleep and stress reduction,”  Rosen says.
	Additionally, people with migraines should attempt to track and record their headache triggers, though Rosen says only about 70 percent of migraine patients ever identify a trigger for their headaches.
	
	


	
	In the same vein as lifestyle modifications, Rosen points out, “There is some evidence for the preventative benefits of migraine with regular aerobic exercise.” Yoga has also been shown to have some positive effects on migraine.
	
	Additionally, physical therapy, massage, and acupuncture have all been linked to migraine relief, but do not yet have enough consistently validated research behind them to prove their effectiveness. However, all of these modalities are likely to bring temporary relief and while not causing any harm, he says.
	
	


	
	Other validated treatments include psychological interventions, including cognitive behavioral therapy and biofeedback, which is a form of computer-aided progressive relaxation training, Rosen explains.
	
	Biofeedback often accompanies mindfulness training, in which a person pays very careful, focused attention to a set of stimuli or activities.
	
	


	
	Rosen says that there is also some evidence for the efficacy of several over-the-counter supplements including magnesium, riboflavin, coenzyme Q-10, and feverfew.
	
	“Riboflavin and co-enzyme Q-10 work upon the energy metabolism in the cell, on the mitochondria,” he explains. “There are several mitochondrial diseases that have a high association with headache disorders, so that may be the mechanism by which it has the effect.”
	
	Rosen warns, however, that not all supplements contain the ingredients or dosage levels they claim to, so it might make sense to seek out manufacturers that publish their quality control data.
	
	


	
	Finally, Rosen says, there are a number of medical devices on the market for migraine and cluster headaches. These include nerve stimulators, electrical TENS units and trans-cranial magnetic stimulators. Clinical evidence varies for each item.
	
	Some items may be cost-prohibitive because they are not covered by insurance.
	
	“You have to take a realistic assessment of what is the cost of this disease to your patient and what are the best options. Even a single lost day [to migraine] can be devastating,” he says.
	
	


	
	In order to begin to understand the triggers and patterns surrounding patient migraines, headache specialist Stephanie Nahas, MD, MSEd, recommends patients keep a migraine journal or calendar.
	
	Nahas, an associate professor of neurology at Thomas Jefferson University in Philadelphia, and director of the university’s Headache Medicine Fellowship Program for the Jefferson Headache Center, says journals are useful to gauge the actual burden of illness the patient is experiencing.
	
	Writing down the details of a migraine attack can reveal how migraines impair a person’s daily ability to function at home, at work, and in leisure, as well as the frequency of attacks and what medications are required to control them, she says.
	
	Additionally, a migraine journal can help patients distinguish between actual triggers and those that are merely coincidental.
	
	“Many patients may not be sure they have real triggers or not, so keeping track can help to tease out what’s a trigger,” Nahas says.
	
	Triggers can run a wide gamut, including sleep, diet, exercise, dehydration, stress, and hormones.
	
	With a journal, a patient can notice the circumstances surrounding a migraine. “You can take notice of how your sleep was the night before, did you exercise today, how’s your hydration and are you stressed out,” Nahas says.
	
	A journal can also help to track the benefits of what is known as a “protector,” which Nahas calls “the opposite of a trigger.” Protectors are factors that make it less likely that a person will have an attack. This could be a new medication, lifestyle modifications, acupuncture, and so on.
	
	The calendar can also be of great value to the physician, Nahas says, as a way of monitoring acute medication use. “If somebody has headache more than 10 days a month, you need to monitor how often they’re using acute medication to treat attacks because they could get into trouble with rebound headache,” she says.
	
	Rebound headaches are part of a cycle where the patient has to keep taking more and more medication to treat the migraine and the migraines then begin to increase in frequency and intensity.
	
	Migraine journals eventually begin to reveal patterns that can also help patients prepare a pre-emptive strategy, Nahas says.
	
	Additionally, journals enable the patient to express their feelings about migraine’s impact on their lives, and bring it to someone else for validation and help.
	
	If a physician recommends a patient begin using such a journal, physicians must then  look at them during the visit. “Because nothing insults somebody more than being told to do something but then the doctor doesn’t care that you did it,” Nahas says.

Managing patients with migraines

Even though physicians have been able to bill CCM since 2015, they still run into problems in terms of getting paid, says Kim Garner Huey, CPC, owner of KGG Coding and Reimbursement Consulting in Birmingham, Ala. Here are some common reasons for denials and how to avoid them:
	
	

Reason for denial: Multiple providers bill CCM for the same patient during the same 30 days.

 Communicate with specialists regarding who will bill for the CCM. “This code was really intended for primary care, but it’s not restricted to primary care,” says Huey.

Reason for denial: Physician bills CCM more than once every 30 days.

 Set up an alert in the practice management system that prevents physicians from reporting CCM before 30 days have elapsed, says Huey.
	
	

Reason for denial: Insufficient documentation.

: This problem often surfaces during post-payment audits, says Huey. Avoid recoupments by ensuring that documentation reflects the intent of the code-i.e. to manage all of the patient’s chronic conditions. “CMS intended a very personalized, hands-on type of medical management,” she adds. Documentation such as ‘Patient is taking medications as prescribed’ is not sufficient. Instead, she says to document the following:

List of all of the patient’s conditions with as much specificity as possible

Why these conditions place the patient at significant risk of death, acute exacerbation/ decompensation, or functional decline

Comprehensive care plan-What the physician is doing to manage the diagnoses. If a specialist is managing a condition, the primary care physician should note the specialist’s name, the date of the last appointment, and a brief summary of the visit.

For more information about CCM, including patient and practitioner eligibility as well as the service elements included in the code, visit the CMS web site.

Even though physicians have been able to bill CCM since 2015, they still run into problems in terms of getting paid.

How to avoid common chronic care management denials

The proposed rules released by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) in October 2019 include new exceptions and safe harbors, as well as clarifications to the Physician Self-Referral (Stark) Law, the Anti-Kickback Statute and the civil monetary penalty prohibition against beneficiary inducements.
	
	These much-anticipated proposed rules aimed at removing regulatory barriers to coordinated care and value-based care provide some of the most extensive changes to these laws in response to the HHS’s “Regulatory Sprint to Coordinated Care.”
	
	


	
	The OIG proposes new safe harbors and modifications to existing safe harbors to promote outcome-based payment arrangements that reward improvements in patient health.
	
	Notably, the OIG’s proposed rule includes three new safe harbors for value-based arrangements protecting arrangements for improved care quality and outcome and efficiency, and arrangements under which the value-based enterprise (VBE) is at substantial or full downside financial risk. The OIG also proposes to expand protections under the Anti-Kickback Statute and the civil monetary penalty law for improved coordination of patient care and health outcomes.
	
	Under the proposed rules, CMS-sponsored models, such as the Innovation Center models, can now operate under a safe harbor which would likely replace the current model-by-model fraud and abuse waiver process.
	
	Acknowledging the increased use of technology in patient care and the need for the safe protection of patient information, the OIG’s proposed rule includes a new safe harbor for cybersecurity technology and services donations and modifications to the electronic health records safe harbor. The OIG’s proposed rule also includes modifications to the personal services and management contracts safe harbor to include a change in the requirement for compensation to be set in advance and the protection of outcome-based payment arrangements.
	
	Notably, the OIG states that the proposed protection for outcome-based payment arrangements would not apply to pharmaceutical manufacturers; manufacturers, distributors, and suppliers of durable medical equipment, prosthetics, orthotics or supplies (DMEPOS); and laboratories. Other proposed changes include new protections for bundled warranty arrangements that apply to at least one item and service, a new statutory exception for telehealth technologies furnished to in-home dialysis patients, and modifications to the local transportation exception.
	
	


	
	CMS issued its proposed rule focused on modernizing and clarifying the Stark Law. Similar to the OIG’s proposed rule, CMS’s proposed rule creates new and permanent exceptions to the Stark Law for value-based arrangements.
	
	While the OIG’s definition of VBE expressly excludes manufacturers, distributors, and suppliers of DMEPOS, CMS seeks comments on whether or not to exclude DMEPOS providers from the definition of VBE and seeks comments on the roles that DMEPOS providers play in the coordination of care.
	
	Noting the continued importance of price transparency and its impact on a patient’s freedom of choice, CMS seeks comments about the role of price transparency in coordinated care – specifically, whether to include a requirement for price transparency in the value-based arrangement exceptions.
	
	CMS proposes new exceptions for cybersecurity donations and for limited remuneration to a physician, as well as modifications to the current electronic health records exception. As expected, CMS also proposes clarifications to definitions and important Stark Law terms that the industry has grappled with for years-including commercial reasonableness, the volume or value standard as well as fair market value.
	
	CMS also discusses the period of disallowance, application of the isolated transaction exceptions and other clarifications to compensation exceptions.
	
	


	
	The proposed rules provide an opportunity to give feedback to CMS and OIG on the expansive modifications to laws that have widespread influence throughout the health care industry. CMS and the OIG consider each comment received in promulgating final rules – and these final rules will have far-reaching impacts for health care as the transition to value-based care continues. The rules are scheduled to be published in the Federal Register on October 17, 2019.
	
	Based on the rules being published in the Federal Register October 17, comments will be due by December 31, 2019.

The proposed rules released by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) in October 2019 include new exceptions and safe harbors, as well as clarifications to the Physician Self-Referral (Stark) Law, the Anti-Kickback Statute and the civil monetary penalty prohibition against beneficiary inducements.

Proposed changes to Stark Law  & Anti-Kickback Statute, explained

Despite the large number of doctors and nurses who crowded the operating room, it was eerily quiet. All in attendance stared in silent horror at the large dark-red tumor that protruded from the vagina of the young girl lying anaesthetized on the table under the merciless spotlight.
	
	Just hours earlier, the ten-year-old had been brought into the hospital by her parents for “bleeding.” When the emergency room doctor saw the large lesion he immediately called the gynecologic oncologist. Now in the operating room, two gowned physicians carefully removed the tumor and controlled the bleeding. Afterwards the child was moved to the recovery room, and from there to the gynecological floor.
	
	As a second-year ob/gyn resident, I was on my first gynecologic-oncology rotation, and the girl became one of my patients. Being on the oncology service, I was captivated by the complex operations and enthralled by the surgical skills of the oncologist who, in my opinion, operated like a virtuoso. During surgery, his movements were like those of a gifted musical conductor, lightly moving the tip of his scalpel or scissors as he effortlessly separated tissues, opened surgical planes and exposed blood vessels, nerves and the ureters, all with minimal blood loss.
	
	I was fascinated. The operating room was the focus of my attention. I was far more interested in the technical aspects of surgery than in the patients we operated upon. I quickly performed my daily assignments including rounds, patient admissions and discharges, dictations and outpatient clinics, so I could spend as much time as possible at the operating table. I participated in as many surgeries as I could, even when it meant arriving earlier and staying at the hospital after hours when I was not on call. I thought I had found my calling. Learning to operate like this oncologist, I thought, would enable me to save countless lives.
	
	In the weeks that followed, this little girl was to change this naive view. She made me a better physician.
	
	The pathologic result confirmed the worst possible diagnosis-an aggressive sarcoma. After an intense discussion by the oncologic team, I was present when her parents were called in and the aggressive nature of the tumor and the very small likelihood of survival were explained to them. The team recommended the immediate removal of their daughter’s uterus, ovaries, and as much of the intra-abdominal tumor as possible, to be followed by chemotherapy. The signed consent form was stained with their tears. I was saddened by the need to remove the uterus and ovaries from such a young person, but since I knew the grim prognosis associated with sarcomas, I understood the rationale for radical surgery as the best option.
	
	I had watched as the young girl was brought to the operating room and anesthetized. I was one of the surgeons to operate on her. Unlike the way I had felt during previous surgeries, this time I noticed that I was unable to concentrate on only the technical aspects of the operation. I realized that caring for her before surgery, and seeing her parents grapple with the shocking diagnosis had created in me an unfamiliar level of emotional involvement.
	
	During the child’s post-operative course, I found myself spending more time than usual in her room and came to better know her and her family. I sensed that our relationship had changed. She and her parents shared their fears with me and described the details of their lives, as if I were a confidante, a relative, an older brother.
	
	Fortunately, her recovery was uneventful, and she was discharged home.
	
	Three weeks later she returned for her first round of chemotherapy. Just a month before she had been a typical youngster, going to school, doing her homework, and visiting friends. Now she was in a hospital room, surrounded by strangers who poked and prodded her and subjected her to painful treatments. She suffered from vomiting and diarrhea, side effects of the therapy.
	
	Once again, I did my best to help her deal with the pain, fear and anxiety. Her familiarity with me seemed to ease her discomfort. Her parents, who put on a brave face while she was awake, shared their heartache with me while she slept. I watched them tenderly care for her, struggling with the knowledge that she was unlikely to survive while still hoping for a cure.
	
	By the time she returned for her second round of chemotherapy I was no longer on the gynecologic-oncology rotation, but she and her family requested that I continue to be her caregiver. She asked that I be the one to start her IV access and begin the chemotherapy drip. My program director and the oncologist agreed that it would make it easier on her and her family, so I became the resident in charge of her care.
	
	My bond with her and her family grew. It was painful to see her lose her hair and become more and more swollen from the combination of medications and anemia. While her parents hid their agony from her and her younger sister, they continued to share their pain and fears with me.
	
	While I knew my involvement made this awful experience a little easier for them, it was becoming harder for me. I was no longer able to use my white coat as a shield. I lost the ability to dissociate from the suffering of my patient. Watching her vomit again and again despite the medications she received in order to decrease the side effects of the chemotherapy, seeing her become weaker and paler with every passing day, it became impossible for me to leave my feelings behind when I went home. Even more difficult was that while I watched the life slowly leaving her body, my wife and I were expecting our first child.
	
	I was again called upon by her and her parents to participate in her third round of chemotherapy. She looked very different from the girl her parents had brought to the emergency room just three months earlier. Her small frame seemed lost in the big hospital bed. She was pale, bald, swollen and too weak to talk. I sat in her room and held her hand, watching her condition rapidly deteriorate. I saw her family come to accept the failure of modern medicine to save their child. I was there when she passed away.
	
	The death of this little girl and the agony of her family broke my heart. My glorified view of oncologic surgery became more realistic, as did my understanding of the limits of medical therapy. More profoundly, I learned the importance of opening my heart to my patients, making time to listen to their stories and acknowledging their fears and pain. I understood that even when I cannot cure a disease and heal my patients, I must strive to make their experiences better by salving the spirit as well as the body. I learned that I can do this by lowering my personal shield and, when appropriate, not hiding my emotions. I learned to make sure they know that I care.

Ran Neiger, MD, practices maternal-fetal medicine in Dayton, Ohio. Before that he was a tenured professor and director of obstetric services and a maternal-fetal Medicine unit in Knoxville, Tenn. He was born and raised in Israel, and attended medical school at Ben Gurion University in Israel. He completed his Ob/Gyn residency in Savannah, Georgia, and a fellowship in maternal-fetal medicine in Providence, Rhode Island.

November 25, 2019 edition

Private equity in healthcare

How to build an efficient vaccination program

Managing patients with migraines

How to avoid common chronic care management denials

Proposed changes to Stark Law & Anti-Kickback Statute, explained

2019 Physician Writing Contest Winner: The patient who lowered my shield

Medical Economics cartoon: Is there too much malpractice prevention?