Federal Freeze Targets Alabama Big Cuts Threaten UAB and Birmingham
By steve sPeNCer
On January 27, the Trump administration issued an order freezing payments on all federal grants. In response, Democratic attorneys general from 22 states filed a lawsuit contending that the President could not unilaterally override laws governing federal spending, and that the Administration’s policy unconstitutionally nullified Congress's power to decide how federal funds are spent.
This is a very big deal to Alabama. In 2022, the state received $18.7 billion or 43.1 percent of its total revenue from federal grants, according to The Pew Charitable Trusts. This doesn’t include over $20 billion in federal transfer payments.
The effects of the freeze will vary in different parts of the state, but this is certain: it could have a devastating effect on Birmingham. It’s not a secret that UAB has been the main driver of growth and prosperity in Birmingham. Many city leaders believe Birmingham could become a medical device capital. Now all that’s in question.
In the meantime, the drama has continued, as U.S. District Judge Loren AliKhan issued a temporary block on the funding freeze in late January. However, a few weeks later, a federal judge found that the administration had continued to freeze some federal funds in violation of the Judge’s order.
Even without the funding freeze, the White House has enacted barriers to the process for research grants. The NIH Study Sections meet in three cycles – winter, spring and fall – to review grant applications. Many winter 2025 meetings have been cancelled due to the administration constructing another roadblock: they
barred NIH from posting meeting notices on the Federal Register, which they are legally required to do within 15 days of a meeting. Without the notice, there could be no meeting; without the meeting, no grants. In addition, the White House also changed the required notice period from 15 days to 35 days before grant-review meetings so that, even if the agency will at some point be allowed to post notices, the grant renewal process will move slower.
The next shoe to drop was a deep cut in Indirect Costs (IDC). NIH dollars come with an indirect cost recovery rate which is used to support the infrastructure necessary for research: maintenance, utilities, support staff, and equipment, everything from microscopes, centrifuges to DNA sequencers, mass spectrometers
and all points in between. The Trump Administration plans to cut IDC from an average of 50 percent to 15 percent.
To understand how important Indirect Costs are, University of Pennsylvania issued this: “Conducting academic research incurs significant infrastructure costs – such as construction of specialized labs, utilities costs, technical equipment, and regulatory compliance. These indirect costs, have been carefully negotiated for decades using a rigorous review process. Even at the current rate of 62.5 percent, government funding covers only about half of these infrastructure costs.”
What This Means to UAB and Other Institutions
UAB employs over 28,000 people and it’s economic impact on Alabama
amounts to $12 billion a year. In fiscal year 2023, UAB received $413.7 million in National Institutes of Health (NIH) funding, which put it in the top one percent of all NIH-funded institutions. That year, UAB's Marnix E. Heersink School of Medicine received nearly $274 million in NIH funding, the school's highest NIH funding total ever, and the UAB School of Nursing received $10.3 million, while the UAB School of Public Health received $42 million . The funding freeze lays a brutal hit on UAB, and all the other institutions in Alabama that receive NIH funds, including Southern Research, Auburn University, HudsonAlpha Institute for Biotechnology in Huntsville, the University of South Alabama, Stillman College,
Caring for Autosomal Dominant Polycystic Kidney Disease
By James Harm, mD
Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder that affects about one in every 1,000 people. As the most common inherited kidney disease, ADPKD accounts for nearly five percent of patients who eventually develop end-stage kidney disease. The condition is caused by genetic mutations primarily in one of two genes — PKD1 and PKD2 — which lead to the formation of fluid-filled cysts in the kidneys, among other effects.
These cysts grow over time, often crowding out healthy kidney tissue and impairing kidney function. The growth of these cysts can lead to kidney failure, eventually requiring dialysis or a kidney transplant. As the cysts enlarge, patients may also experience symptoms such as early satiety, back pain, and abdominal discomfort.
How ADPKD is Diagnosed and Managed
ADPKD is often identified through imaging studies like ultrasounds or CT scans, especially when a patient has a family history of the condition. About 25
percent of new cases occur in individuals with no prior family history. This can result from a new, spontaneous mutation or in situations where patients have limited knowledge about their family health history.
In addition to kidney cysts, patients with ADPKD often experience earlyonset hypertension and are more prone to developing kidney stones. These issues often prompt imaging tests, which can ultimately lead to a diagnosis of ADPKD.
Kidney care close to home
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• Anniston
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Genetic testing has become much more accessible in recent years. It can help confirm the diagnosis and offer valuable information on the specific genetic mutation present, providing patients with a deeper understanding of their condition.
Once diagnosed, patients can benefit from lifestyle changes. For example, increasing fluid intake may help slow cyst growth by suppressing antidiuretic hormone (ADH), which encourages cyst growth. Controlling blood pressure is particularly important in ADPKD patients, and stricter blood pressure control is typically recommended compared to patients without the condition.
The approval of Tolvaptan in 2018 has been a significant development in ADPKD care. This medication blocks ADH and is specifically targeted at patients with ADPKD who are at risk for rapid progression. Tolvaptan can slow the progression of the disease, potentially adding valuable years before patients require dialysis or a kidney transplant. Its use requires special monitoring and management by a nephrologist.
Coinciding with the arrival of Tolvaptan, new methods for assessing
kidney disease progression in ADPKD patients have been developed. One such method involves measuring a patient’s height adjusted total kidney volume through specialized imaging. This measurement allows doctors to track how quickly the disease is advancing, predict which patients are at risk for rapid progression, and identify those who will benefit most from treatments like Tolvaptan.
A Personal Commitment to ADPKD Care
For more than 10 years, I’ve had the good fortune of specializing in the care of patients with ADPKD. My training in this field began when my institution participated in clinical studies of Tolvaptan. I’ve been among the first nephrologists in the state to incorporate its use into the management of patients after its approval. This experience helps me guide patients and work through any complications that may arise. Because ADPKD is a familial condition, I often have the privilege of caring for multiple generations in a family. It’s a rewarding experience to get to know families and guide them through the complexities of this condition.
James Harms, MD
Now Act for Patients in States Without Medicaid Expansion
By marti WeBB slay
Two Alabama Democratic representatives, Shomari C. Figures (AL-02) and Terri Sewell (AL-07) are sponsoring the Cover Outstanding Vulnerable Expansion-Eligible Residents Now (COVER Now) Act to expand health care coverage to millions of Americans who are still uninsured because of state-level refusals to accept federal Medicaid expansion funds.
Alabama is one of those states, so this legislation would establish Medicaid pilot projects in the state that would allow the Center for Medicare & Medicaid Services (CMS) to work directly with counties and cities to provide coverage for Alabamians who would qualify for Medicaid if the state had chosen to expand.
This is the third time the bill has been introduced in Congress. “I don’t think there’s a strong possibility that this makes it any further than it did in the last congress under similar dynamics, but it’s a fight we have to keep pushing,” said Figures, a lead co-sponsor of the bill.
“Statistically, Alabama has third lowest life expectancy in the US. We have some of the worst healthcare outcomes in the nation. A lot of that has to do with ac-
cess. I don’t think there could be a more important issue than helping people live longer, healthier lives.”
Figures said this issue goes beyond healthcare, important as that may be.
“It’s also an economic issue,” he said.
“It’s tough to recruit businesses and people to live in your communities when you don’t have a hospital; when you don’t have physicians. Over half the people in my district don’t have a pediatrician, let alone other specialists. We are on pace right now to lose every single hospital in my 13-county district that isn’t located in Mobile or Montgomery or Pike County.
That is unacceptable, especially through the lens of long-term viability in these communities. We have to do everything we can, both on the federal level as well as on the state level, to get healthcare resources, and if the state refuses to take advantage of something that the vast majority of states have taken advantage of, then we have to look at ways to bypass that resistance and provide healthcare to those that need it.”
The COVER Now Act would:
• Authorize CMS to contract directly with counties and other political subdivisions to establish demonstration
projects expanding Medicaid coverage to their residents.
• Offer participating entities the same deal previously made available to states: 100% federal funding for the first three years and a gradual reduction to 90% federal funding by year seven and thereafter.
• Allow participating entities to apply individually or jointly to establish a regional expansion project.
• Maintain existing Medicaid rules and systems which would apply to the local expansion programs.
• Authorize access to State Medicaid systems for participating entities, with additional federal administrative Medicaid funding for cooperation and federal penalties for non-cooperation.
Should a State expand, eligible beneficiaries enrolled in a local expansion program would be automatically enrolled into the State Medicaid program.
The COVER Now Act is one of the first bills Figures has sponsored since being elected. “When we went across the district campaigning, this was the number one issue, the one people consistently raised,” he said. “It had some traction last
year in the state legislature, but ultimately that fizzled out. But the status of our overall healthcare system in this state was amplified by several high profile hospitals closing in this district over the past year as well as some maternity services being scaled back at other institutions across the district and across the state.”
He believes Medicaid expansion is one way to strengthen the healthcare system, especially in our rural communities. “Since this was a top issue, we wanted to show people we were listening. We want to collaborate with people across the country that are dealing with the exact same issue. When we got here, we focused on addressing this issue first,” he said. “This is just step one.
“At the end of the day, there’s a stark reality. This is an opportunity for states to do what’s right and provide healthcare coverage that not only will save lives but also save hospitals.”
Moving Birmingham Forward.
Congressman Shomari C. Figures.
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DHS Rescinds Protected Areas Policy: What Healthcare Systems Should Know
By Nora Katz, BetH Neal PitmaN aND ColBey B. reagaN
On the newly installed Trump Administration's first day, the U.S. Department of Homeland Security (DHS) rescinded the Biden Administration's guidelines for immigration enforcement actions in or near protected areas, such as schools, hospitals and churches. The Jan. 20, 2025, rescission of the 2021 policy memo means that healthcare facilities are no longer considered protected areas from U.S. Immigration and Customs Enforcement (ICE) enforcement actions, including arrests. This change could lead to increased enforcement activities in many of these settings, potentially affecting both patients and healthcare providers.
In the healthcare industry, administrators face distinct challenges when navigating their organization's obligations and rights during a ICE action, specifically while balancing critical healthcare regulatory issues related to privacy and patient rights.
Immigration Enforcement Considerations
Potential interactions with ICE are
often unexpected and stressful. To effectively manage these situations, it is crucial to prepare in advance, develop a comprehensive response plan and ensure that all personnel who may interact with agents on-site – such as receptionists, healthcare providers and hospital administrators –are informed about their roles and whom to contact. Key considerations include:
• Public vs. Private Areas: Although ICE agents may enter public areas of a healthcare facility, they cannot access private areas such as examination rooms, offices and medical records areas without a valid warrant or consent from an authorized representative. Facility
employees should understand which areas ICE agents may enter without a warrant to avoid inadvertently consenting to a search. It is helpful to have a clear written policy designating which areas are closed to the public. Similarly, facilities should consider whether it is possible to view computer screens, patient documents or other sensitive information from public areas.
• Warrants and Legal Compliance:
Legal representatives should be advised of ICE actions immediately to verify the validity of any warrant presented and understand the legal obligations before complying. Identify who should be contacted in the event of an ICE action and make sure staff members understand that these individuals should be consulted before providing information or granting access to agents. Healthcare facilities are not required to provide information unless the request is pursuant to a valid warrant.
• General ICE Enforcement Considerations: It is important to document any interactions with ICE agents, make copies of all documents from ICE, obtain receipts for any
documents taken by ICE, and gather the name and contact information of the agent(s). ICE enforcement actions are not limited to arrests or seeking to obtain patient records. They also include compliance actions related to healthcare staff such as I-9 compliance audits and immigration fraud inspections.
Healthcare Regulatory Compliance
In addition to immigration enforcement considerations, healthcare systems must continue to comply with healthcare privacy laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA), Part 2 privacy protecting substance use disorder information found at 42 CFR Part 2 and state laws regarding patient privacy and protected health information (PHI). Providers also must balance these privacy restrictions against the obligations not to block access to or exchange of electronic health information as required by the 21st Century Cures Act's information blocking rule. Given the fact that most patient records are maintained electronically, this additional regulatory disclosure requirement should be considered.
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within 2-4 weeks of referral.
• We keep you informed about the patient’s treatment plan and make sure the loop is closed on your referral.
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• Privacy and PHI: Ensure that all staff are trained on HIPAA regulations and the importance of maintaining patient confidentiality, especially in the context of potential ICE interactions. HIPAA permits disclosures to law enforcement in certain circumstances and is limited to necessary information "required by law." Staff should tie in legal resources to ensure that the request is "required by law." As defined by HIPAA, this is a mandate in a law enforceable in court and includes court orders, court-ordered warrants, subpoenas or summons issued by a court, grand jury, inspector general or an administrative body authorized to require production of the information, a civil or authorized investigative demand, and Medicare audits. Disclosure of limited information to identify or locate a suspect, fugitive, material witness or missing person is permitted, but not DNA, dental records, or typing, samples or analysis of body fluids or tissue. Disclosures are also permitted when related to judicial or administrative proceedings but only under specific conditions in compliance with HIPAA.
• State Laws: Be aware of any statespecific laws that may provide additional protections for patient information and rights. For example, many states have established protections specifically for certain types of reproductive health information, HIV and mental health information.
Beth Neal Pitman
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happens
When physicians, scientists and researchers with extraordinary talent and passion are given the technology, the facilities, and the support, they achieve great things. The discoveries, innovations and clinical trials happening today will help shape the future of treatments and lead to cures.
Federal Freeze Targets Alabama,
continued from page 1
and Tuskegee University.
Even if the freeze is suspended, which at this point is an open question, the cut in IDC is potentially devastating. One source says this will result in $40 million annually lost to UAB. However, if UAB does $400 million in NIH grants, I calculate the loss to the institution at closer to $130 million. That could mean a loss in local economic activity of nearly $300 million.
Much of this may move north, as there has been talk in Canada of creating their own Marshall-type plan to bring research scientists there.
What This Means to Medicine
Over a decade of NIH supported research led to the idea that messenger RNA
could be used as a platform for vaccines, which led to the COVID vaccinations. NIH-backed research led to the development of the HPV vaccine, advancements in HIV treatment, CRISPR gene editing technology, and accurate blood tests for Alzheimer's disease, to name just a few of the many advances. Where would we be today without the Human Genome Project which was funded by the NIH? 386 of the 387 drugs the Food and Drug Administration approved between 2000 and 2019, and more than 100 Nobel prizes have been awarded to scientists based on NIH-funded work. So it’s safe to say that with these cuts, no one should expect the same medical progress in the future.
Caring for Autosomal Dominant Polycystic Kidney Disease,
Comprehensive Care of NAPC
At Nephrology Associates (NAPC), we offer comprehensive care for patients with ADPKD. Our team has the expertise needed to diagnose and manage ADPKD, from early-stage care to addressing complications as the disease progresses. We have experience interpreting the specialized imaging needed to characterize the disease, obtaining genetic analysis, and providing treatment.
We also work closely with kidney transplant centers, providing referrals for patients who may benefit from a kidney
continued from page 3
transplant. We’re dedicated to guiding our patients every step of the way. If you or a loved one has been diagnosed with ADPKD or is experiencing symptoms, contact us to schedule an appointment, learn more about your treatment options, and take control of your kidney health.
James Harm, MD attended Texas A&M University, where he graduated with a degree in biomedical science. He later attended UT Southwestern Medical School in Dallas, and continued his training at UAB for internal medicine residency and nephrology fellowship, where he served as chief nephrology fellow during his final year of training. He is board-certified in both nephrology and internal medicine. He is a member of the American College of Physicians and the American Society of Nephrology.
DHS Rescinds Protected Areas Policy,
continued from page 6
• Information Blocking: Information blocking requirements apply to electronic health information regardless of the format or manner of disclosure (i.e., oral or paper as opposed to electronic). Although HIPAA gives a covered entity the flexibility to decide not to respond to a request when disclosure is permitted without patient authorization, the information blocking rule requires immediate disclosure of electronic health information unless the disclosure is prohibited by law or an information blocking exception, such as the privacy or preventing harm exceptions, are met.
• Substance Use Treatment: Facilities may also be subject to the additional privacy protections for Part 2 substance use disorder information. Part 2 regulations are intended to encourage individuals to seek treatment by preventing disclosure of treatment records from resulting in employment
discrimination or potential adverse consequences in civil or criminal proceedings. Part 2 records can be disclosed in a criminal proceeding or investigation only pursuant to a court order after notice and an opportunity for hearing.
Conclusion
The rescission of the DHS protected areas policy presents new challenges for healthcare systems. By proactively preparing for potential interactions with ICE and ensuring compliance with healthcare regulations, healthcare providers can safeguard patient privacy and rights while minimizing legal risks. It is essential for healthcare systems to review their policies and training programs to adapt to this new enforcement environment.
Beth Neal Pitman is a partner in Holland & Knight's Birmingham, Alabama, office. Nora Katz and Colbey Reagan are partners in the firm's Nashville, Tennessee, office.
Alabama Doctor Receives Patents on New Medical Tools
ChristopherS.Carter,MDEmlyBellCasey,MD
MonteKetchum,DOJose0.Ortega,MDT.DanielSmith,MDJayS.Umarvadia,MD
ChristopherM.Beaumont,MDAndrewM.Cordover,MDJeffreyC.Davis,MD
Welcome Or. Pitts!
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By steve sPeNCer & laura FreemaN
Since founding GastroCare PC in 1982, Adi B. Reddy, MD has performed at least 50,000 colonoscopies. After working with so many cases over the years, Reddy has gained a good deal of insight about the procedure, which prompted him to design several new tools that will improve the mechanics of colonoscopies.
GARDENDALE
CharlesC.Pitts,Jr.,MDMarcusA.Rothermich,MDNormanE.Waldrop,Ill,MD (205) 939-3699
AL
GARDENDALE | 323 Fieldstown Road, Ste 105 | Gardendale AL 35071 PELHAM | 3143 Pelham Pkwy | Pelham AL 35124
| UAB St. Vincent’s Trussville | 7201 Happy Hollow Road | Trussville, AL 35173
Ascension St. Vincent's Birmingham Ortho Sports Tower 805 St. Vincent's Drive, Ste 100 Birmingham, AL 35205
CULLMAN 1301-A Bridge Creek Drive NE Cullman, AL 35055
323 Fieldstown Road, Ste. 105 Gardendale, AL 35071
HOOVER Crossroads at Greystone 5406 US Highway 280 East Suite D106 Hoover, AL 35242
PELHAM 3143 Pelham Parkway Pelham, AL 35124
TRUSSVILLE
The first is a tool that should make polyp removal simpler and faster. “When we find polyps, we use a snare tool to loop around them and then pull it tight to remove the tissue,” Reddy said. “The problem is that it’s easy for the polyp to fall away as it detaches, and then we have to search for it. Finding and retrieving the detached polyp can take a while, especially if prep has been less than perfect. Even if the search becomes frustrating and time-consuming, we have to do it because we need to send the specimen to the lab to determine whether it is benign or malignant. If it’s a malignancy, we need to know what we are dealing with and how advanced it is so we can help patients understand what to expect and arrange for follow-up care if needed.
Ascension St. Vincent's Trussv ille 7201 Happy Hollow Road Trussv ille, AL 35173
“Working with endoscopic procedures on a daily basis, I realized that we needed a tool that can capture the polyp as it is being removed and then retrieve it through the main tube. That led to the idea for an enhanced design. It combines the snare wire loop with a mesh specimen basket. I worked with a bioengineering student at the university here in Tuscaloosa to refine the design. Now that the patent has been approved, we’re working on the next steps in process of bringing it to market.”
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Reddy’s second invention offers advantages for both the medical team and the patient. In performing a colonoscopy, physicians use CO2 to inflate the colon, a process known as insufflation. “For insufflation, we usually have one source for CO2 that opens up the colon and another source for water to rinse the surface so we can get clear visualization,” Reddy said. “The physician operates this with a foot pump that isn’t always easy to use in the low light environment we usually have in a procedure room. When there’s only one water bottle and it runs out, that’s a delay when we have to stop what we’re doing to replace it.
“My new design combines CO2 and an uninterrupted water supply in one unit. It also adds two other functions
without the need for extra cords or connections. Due to the nature of the procedure, unpleasant odors can be a problem. By adding a feature that releases calming essential oils, we not only improve the working environment for the team—we make it more pleasant for patients entering the procedure room when they might also benefit from the relaxing effects of essential oils that have been shown to help with stress.
“Music is another element that fosters a good environment for both the team and the patient. The unit adds that capability. Instead of the clutter of four pieces of equipment and the tangle of four cords, all the functions are there in one compact, streamlined design.”
Reddy has also designed an adjustable garment, or colonoscopy shorts, aimed at protecting the patient’s dignity and making cleanup of surfaces and linens after the procedure easier.
Just before being wheeled into the procedure room, patients may want to make one last visit to the restroom. If they are wearing a gown with a back opening, getting to the bathroom without feeling exposed isn’t easy.
“The colonoscopy shorts cover the patients into the procedure room. When they are under and it’s time for the procedure to begin, a detachable panel allows access to introduce the tube. The design also has absorbent padding to keep surfaces and bedding cleaner in case of leakage that might continue during recovery,” Reddy said.
All three inventions have patent approval, so Reddy is now working on plans to bring these to market.
Adi B. Reddy, MD
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UAB St. Vincent’s Utilizes New Drug-coated Balloon Technology for Cardiac Patients
By laureN JoHNstoN
Doctors from UAB St. Vincent’s are impressed with the new AGENT drugcoated balloon technology and look forward to seeing how it will improve care for cardiac patients experiencing in-stent restenosis (ISR). ISR is a problem that occurs when a coronary artery that has been treated with a stent narrows or has blockage.
AGENT is Boston Scientific’s new coronary drug-coated balloon (DCB) and the first and only FDA approved coronary DCB on the market. This DCB delivers a targeted anti-proliferation drug dose without introducing an extra layer of metal. It’s designed to imprint the drug onto the inner surface of the coronary artery when the balloon is inflated.
UAB participated in the clinical trials that led to FDA approval. Josh Cockrell, MD at UAB St. Vincent’s East and David Cox, MD at UAB St. Vincent’s Birmingham were among the first in Alabama to deploy AGENT in qualifying patients in the fall of 2024.
“New technologies are always exciting, especially when it’s going to improve
patient outcomes,” Cockrell said. “I’ve been practicing for 12 years, and you see this recurring problem with even the best stents. About 10 percent come back and need to be intervened on again inside the stents, so we’re happy to bring the AGENT to our patients.”
In the past, medical professionals had limited options when treating a patient with in-stent restenosis. This included balloon angioplasty, which allows a small balloon to be inflated in the artery without any drug coating. The other option was to add another layer of drug-
coated stent into the artery, which leaves metal behind.
“When you leave metal behind, if you have to put another stent in, it becomes an issue of mechanics. You can dilate the vessel only so much, but you’re leaving another layer of metal,” Cox said. “The early stents were like folded up paper clips shoved in the artery. They were bulky, difficult to deliver, and difficult to get back across later on. The newer stents have become thinner and sleeker, but even with that, if you put two or three layers of stent in, the lumen of
the vessel is going to be constricted.”
AGENT DCB provides an alternative to adding another metal stent inside the artery. Balloons with drug coating have been used for peripheral arterial disease for many years with good results, but this is a new technology for coronary artery disease. Both Cockrell and Cox have seen promising results in the patients that have received AGENT.
“It’s shown significant reductions of about 50 percent in both the need for repeat interventions and for stent thrombosis overall,” Cockrell said.
With a typical angioplasty, the balloon is inflated for about 10 to 15 seconds. With AGENT, the DCB needs to be inflated between 30 seconds to a minute to allow the anti-proliferation drug time to absorb and adhere to the vessel wall.
“The first coronary angioplasty was done in the late 1970s,” Cox said. “One of the big fallbacks about balloon angioplasty was that whenever you inflate a balloon in a coronary artery, there’s about a 40 to 50 percent chance that in six months that artery will restenose. That’s often a reaction to being stretched.
(CONTINUED ON PAGE 15)
Josh Cockrell, MD
David Cox, MD
The countdown has begun!
HIPAA Security Rules have changed. The clock started on March 7. EVERYTHING that used to be optional IS NOW MANDATORY. EVERYTHING.
MANDATORY multi-factor authentication (MFA)
MANDATORY biannual vulnerability scans
MANDATORY encryption of all ePHI
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MANDATORY annual penetration tests
MANIFESTO
MANDATORY network segmentation
OUR HERO (IS THIS YOU?):
MANDATORY log retention
MANDATORY asset and network inventory
Our HERO is the ambitious Practice Manager whose life is wrapped up in the success of the business – income, mortgage, retirement, even the kids’ college. They have a sense of humor but are constantly thinking about ways to improve their business, maximize productivity, and MANAGE RISK. They’re passionate about their business and take it personally when a competitor, hacker, or employee threatens their mission to improve the world.
OUR ENEMY:
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You have 180 days to comply!
Apathetic or complacent US businesses who are willing to accept UNLIMITED RISK by ignoring today’s threats. Business owners who think, “it won’t ever happen to me.” Foreign Governments seeking footholds in the US or leverage. Cybercriminals who believe that all Americans are rich and therefore justified targets. Global crime syndicates who employ thousands in an Enterprise organizational structure. IT and Cybersecurity companies who take advantage of unwitting customers with Projects and Hourly Billing. The Cybersecurity industry as a whole, which has bored and confused the entire US public into a state of wanton vulnerability, while the hackers get better every day.
WHO/WHAT ARE WE FOR:
Practice Managers who are mature enough to understand that THEY OWN ALL THEIR COMPANY’S RISK, and who are willing to have routine, honest, and candid discussions about CYBER RISK MANAGEMENT and CYBERSECURITY / REGULATORY COMPLIANCE. They understand that by getting buttoned up and taking RISK seriously, they can maximize productivity, retire earlier, and send the kids to college debt-free. We are for HAVING FUN while making clients SAFER FROM CYBERCRIME. You know, CybertechnoLOLogy!
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Time for Spring Cleaning – Is Your HIPAA House Ready?
By: Kelli FlemiNg
When it comes to compliance with the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”), is your house in order? Has someone recently looked underneath the counter and tidied up? When it comes to health care providers, periodically checking in on your HIPAA compliance efforts and cleaning up loose ends will go a long way in your compliance efforts. Here are five areas that I recommend “spring cleaning” in order to boost your HIPAA compliance efforts:
cybersecurity landscape that poses numerous threats, providers should consider reviewing and updating their existing HIPAA policies and procedures. For example, changes to HIPAA that address the privacy of protected health information (“PHI”) concerning reproductive health care took effect on December 23, 2024. These changes require updates to written policies, the addition of a new attestation form, revisions to existing forms, and changes in procedures addressing the disclosure of reproductive health care information. Thus, now would be a good time to review and update your HIPAA policies and procedures.
1. Policies and Procedures. Many health care providers enacted HIPAA policies and procedures shortly after the passage of the HIPAA regulations, but have failed to revise and update their HIPAA compliance plans since. With changes in the law, operational transitions, and a
2. Training. When it comes to HIPAA compliance efforts, the first line of defense in ensuring that PHI is secured appropriately and compliantly is training your employees. While employees should always be trained
Jay Fitts, MD
upon hire, they should also be trained periodically thereafter. I recommend that clients conduct routine, formal HIPAA training, at a minimum, at least once a year. Consider the type of training that is appropriate for your organization and how often training should be conducted based on the culture of your organization. Training can be conducted in a variety of forms: web-based tutorials, attendance at seminars, self-study, etc. If an unauthorized use or disclosure occurs or if a policy or procedure is changed, conduct additional training. Whenever training is conducted, whether internally or externally, the training must be documented. The documentation should include the date the training was conducted, the employees that were trained, the topics discussed, and a copy of any training materials that were utilized. With the changes to HIPAA concerning reproductive health care, now would be a good time to undertake additional training initiatives.
3. Risk Analysis. We are seeing a large increase in cyber-incidents impacting
the health care industry. The Office for Civil Rights (“OCR”) recently reported that there has been a 264 percent increase in large breaches reported involving ransomware attacks since 2018. Given the large number of individuals impacted, these incidents are triggering investigations. When these matters are investigated, penalties are oftentimes imposed because covered entities do not have an up to date risk analysis. In fact, OCR has a “Risk Analysis Initiative” that penalizes entities for not complying with the HIPAA risk analysis requirements. Thus, it is important to document in written form what your risks are and how you will address them, and now would be a good time to update any prior risk analysis.
4. Breach Reporting. Most people are aware of the obligation to notify individuals, along with OCR, when a breach incident has occurred and, covered entities should have a process in place to ensure that breach reporting occurs timely. However, in addition, entities should have a mechanism for employees and patients to report
At UAB Medical West, our team of orthopedic specialists are dedicated to helping patients restore mobility and enhance their quality of life. We are committed to bringing quality orthopedic care to the residents of West Jefferson County, AL, and are thrilled to welcome Dr. Jay Fitts to our team. Dr. Fitts specializes in spine surgery and is now accepting new patients at both our main hospital location and our Hoover location. To schedule an appointment, call us today at (205) 481-8570.
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Time for Spring Cleaning,
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potential concerns regarding the use and disclosure of PHI. The reporting process should be well-publicized, flexible, transparent, and familiar to all employees. The only way to improve HIPAA compliance efforts is if you are aware of potential concerns or issues. Having a workable reporting process without a fear of retaliation helps ensure those issues are made known. Now would be a good time to ensure that the reporting process is working and effective.
5. Instilling a Culture of Compliance . As with every compliance effort, instilling a culture of compliance within the organization is important. Your employees are your best line of defense, as well as your biggest risk area when it comes to compliance eff orts. Thus, having employees invest in adhering to HIPAA compliance efforts and understanding its importance goes a long way in your compliance efforts. In that regard, have leadership attend training sessions, reward compliance efforts, stress the importance of adherence to HIPAA policies and procedures, and disincentive inappropriate behavior. A compliant environment begins at the top.
UAB St. Vincent’s Utilizes Drug-coated
Balloon Technology,
That problem was improved upon with stents that came out and were used widely in the early 90s.”
One of the early pioneers of coronary stenting was Gary Roubin, MD when he was at UAB. As stent technology improved with different alloys of metal and later the addition of an antiproliferative drug coating, the percentage of restenosis dropped to about 10 percent. While the stents provided improvements, there were still limitations. If a second stent is needed because of in-stent restenosis, there’s about a 35 percent chance that restenosis will occur again.
Right now, AGENT DCB is only being deployed in patients with severe cases of restenosis who already have one or two prior stents. In the U.S., this is not being used on every blockage doctors encounter.
“In Europe, they're treating even de novo lesions with drug-coated balloons,” Cox said. “Sometimes you get a blockage in a main vessel, and you've got blockage extending into a branch vessel. They'll treat it with a drug-coated balloon up front, but we're not at that point in the United States.”
As this technology progresses and more studies are completed, Cox and
continued from page 12
Cockrell hope to see the cost of the balloon go down and expect to see a more widespread use in patients. They see the potential for AGENT to be used for patients with coronary disease who may have long legions that are too long for stents, who have multiple lengths of stents already, who have small vessel blockages that are too small for stents, or for bifurcation stenting.
“Bifurcation is a branch point stenting,” Cockrell said. “When you stent a vessel that's at a branch point, it becomes a lot more complicated if you're using two different stents. The idea is that maybe in the future, we could put a stent in one branch and then use the drugcoated balloon in the other branch.”
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