- The week in hospital M&A
- FDA approves new class of multiple myeloma drug
- Is the behavioral health access problem actually a quality problem?
- Is the behavioral health access problem actually a quality problem?
- Westchester Medical Center names chief medical officer
- Strengthening the backbone of care: 7 rural workforce transformation strategies changing the labor landscape
- Ochsner Health back in the black through H1
- PA pay by specialty: cardiothoracic, vascular surgery top $162K
- Nurses at SSM Health outpatient practices move to unionize
- 6 recent hospital, health system CFO moves
- 62% of ASCs cancel, delay cases over anesthesia gaps
- The secret to success behind the top 1% of American hospitals
- Processed Foods Linked To Prostate Cancer Risk
- Novant Health gets North Carolina OK to build $324M hospital
- Screen Time Is Not All Bad For Kids' Brains
- Winter Is Coming: How Vaccines Help Protect Against Respiratory Illness
- Updated Statement Regarding the Division of Corporation Finance’s Role in the Exchange Act Rule 14a-8 Process
- Sleep Disturbances Linked To Genetic Alzheimer's Risk
- Pre-K Sets Kids Up For School Success, Study Says
- Expect Other Seniors To Act Their Age? Then Expect Problems With Your Own Memory, Study Says
- People With Disabilities Say Medicaid Income Limits Stifle Career Advancement
- A genomics library for the AI era
- BMS bags first FDA approval for CELMoD franchise with Zenbexus multiple myeloma nod
- Trump Team’s Use of Arcane Budget Rule Threatens Medicaid Coverage
- My Husband Was Kicked Out of Hospice for Dying Too Slowly
- Massachusetts moves to restrict kratom sales
- Meet the leaders of the fastest-growing dental practices
- Fierce Pharma Asia—Legend’s first profit; Taiho, Cullinan’s EGFR win; WuXi AppTec’s reprieve
- Will cardiology’s ASC strategy pay off? CVL’s new CEO is betting on it
- 5 numbers making dentists optimistic
- 25 state behavioral health policy updates
- Wisconsin woman accused of posing as fake dentist ordered to pay customer $144K
- Physician independence is making a comeback — why ASCs are leading the way
- Surgery Partners is betting on physician recruiting, not M&A, for growth: 5 things to know
- Dentists battle insurance woes: 5 updates
- Philadelphia dentist dies at 86
- 4 injured after car crashes into North Carolina pediatric dental office
- Ellis Hospital sues St. Peter’s over cardiologist noncompetes, warns of $75M revenue risk
- Mental healthcare provider gaps, by state
- Park Dental Partners posts $66.2M in Q2 revenue
- 28 new behavioral health study findings to know
- 23 new behavioral health projects to know
- Which services are hit hardest by CON?
- 5 gastroenterologists in the headlines
- Where spine, orthopedic ASCs are gaining ground
- Aspen Dental continues 2026 growth with new Chicago practice
- Major PBMs agree to offer TrumpRx pricing information to members
- Distalmotion gets FDA clearance for hernia repair system
- Providence reports $400M operating improvement halfway through 2026
- A look at where Aetna is seeing value-based care success in Medicare Advantage
- Nationwide program to quit smoking would save US $12B: Study
- Rare Bacteria In Coastal Waters Has Killed 7 This Summer
- Angelalign to appeal court’s decision in clear aligner patent infringement case
- It's crunch time for Karyopharm as company faces potential default next month
- UNC Health Pardee completes 23-bed behavioral health center
- Oregon State Hospital superintendent out after less than a month
- Affordable Care completes recapitalization, enters ‘next chapter’ of growth
- March of Dimes: Maternity care deserts persist, Medicaid cuts threaten to curb access further
- Trump administration refers scores of providers, pharmacies, PBMs to DOJ, OIG over past billing for pediatric gender-affirming care
- Socializing: A Prescription For Healthier Brain Aging
- Taking The Stairs May Lower Your Risk Of Dying From Heart Disease
- Obesity not a 'zero-sum game' as patients crave optionality, Novo CEO says: Reuters
- AZ's blood pressure newcomer Baxfendy fails to meet cost-effectiveness bar, ICER says
- Sweet Tooth? It Could Be Shaping Your Decisions, Study Says
- Stressed Parents Turn To Screens For Help, Study Finds
- Gambling Linked To Mental Health Problems Among College Students
- Hospitals Say They Found A Tool To Help Reduce Childbirth Risks: Wristbands
- Listen to the Latest ‘KFF Health News Minute’
- People With Disabilities Say Medicaid’s Limits on Income Stifle Career Advancement
- Readers Speak Out on Work Requirements, Federal Data Grab, Opioid Payback Cash
- Abbott to pump up blood supply with $1M college sports prize amid US crisis
- Federal agencies release ‘Treatment First’ toolkit
- Neurocrine stands by blockbuster hopeful Vykat XR as Prader-Willi docs raise potential safety flags
- Appeals court tosses methodology for calculating NSA qualifying payment amounts
- UC San Diego Health, West Health launch $40M accelerator for 'tech-forward' coordinated care
- Epic releases Care Everywhere diagnostic image exchange to tackle healthcare's 'CD problem'
- FDA Wants More Information From Food Makers On New Food Chemicals
- Cityblock unveils partnership with Humana in North Carolina
- Antelope Recovery, offering SUD care for teens, to expand Spanish services in Colorado
- Legend interim CEO talks rising competition as Carvykti maker posts first profit
- Aspirin/Omega-3 Combo Matches Antibiotics In Treating Gum Disease, Trial Finds
- Endometriosis Linked To Higher Type 2 Diabetes Risk
- Cedar launches Kora Platform to build out agentic AI for medical billing
- Sharp HealthCare announces another reorganization affecting 260 workers
- Alfasigma gains arthritis drug, access to new markets with M&A play
- Common Health Coalition secures $100M from OpenAI Foundation to boost hepatitis C cure rates
- Lilly takes 6 companies to court for selling retatrutide knockoffs
- Tamiflu Helps Keep Severely Ill Kids Out Of The ICU, Study Finds
- 'Normal' Can Backfire During Doctor/Patient Discussions
- Experimental Pulse Oximeter Accurate Regardless Of Skin Tone, Researchers Say
- Suvi Health launches ambient AI solution for patients to reduce hospital stays and support care transitions
- The biggest payer and provider trends from Q2
- Patients Wary Of Governments, Companies Pushing AI As A Rural Healthcare Solution
- Hospital Prepayment Requirements Add New Wrinkles to Patients’ Financial Responsibility
- Hospitals Say They Found a Tool To Help Reduce Childbirth Risks: Wristbands
- Years After He Quit Smoking, a Lung Cancer Scan Saved His Life
- Fresenius pulls one batch of Actemra biosim over glass particle concerns
- Oracle Health debuts revamped patient portal with an AI upgrade
- Snapchat creates ad format to support pharma disclosure needs
- CMS ends Medicaid, CHIP funding for gender-affirming care for minors
- Healthcare CFOs face growing decision-making expectations. Many say they aren't ready
- Assort Health rolls out AI agent to automate referrals for specialty practices and health systems
- Claims data transparency empowers employers to act on affordability: survey
- Hims & Hers posts $753M in Q2 revenue as it preps for push into peptide market
- Executive Order Calls For Fewer Routine Childhood Vaccines, Doctors Push Back
- Biopharma saw a Q2 sales boom led by Lilly, Sanofi, Regeneron and Astellas
- Real-World Performance Of Alzheimer's Drug, Leqembi, Matches Trial Data, Study Finds
- Study Finds Undisclosed Chemicals In Most Personal Care Products
- Senators introduce bipartisan legislation to further antimicrobial resistance research
- CMS' mandatory VBC programs brought substantial administrative costs for hospitals: study
- Flagler Health secures $50M series B for AI-native MSK care platform expansion
- Attruby cruises toward blockbuster land as BridgeBio CEO spots ‘stabilizer-first’ ATTR market
- WuXi AppTec scores temporary win amid fight over DOD's Chinese military company brand
- Barbie And Ken Fade From Fantasy, Offer More Realistic Proportions, Study Finds
- Children Should Get Flu Vaccine, Top Pediatrics Group Recommends
- Together, Two Everyday Health Factors Double Death Risk In Midlife And Beyond
- Many States Cover Doula Care, But Access To A 'Birthing Bestie' Is Often Out Of Reach
- Patients Wary of Governments, Companies Pushing AI as a Rural Healthcare Solution
- A Federal Policy Is Complicating How Organizations Battle the Opioid Crisis
- Chairman Paul S. Atkins Letter to Robert Walley, Chair, CAT NMS Plan Operating Committee
- Trump signs executive order to overhaul pediatric vaccine recommendations
- Unapproved in US for decades, levosimendan stumbles in phase 3 as Tenax eyes narrow FDA path
- Jalapeño Recall Reaches Seven Grocery Chains In 26 States
- New Melanoma Drug, Tudriqev, Based On Herpes Virus Granted FDA Accelerated Approval
- Even Light Exercise May Lower Stroke Risk For People With A-fib
- Working At Home Makes Breastfeeding Harder, Not Easier, Study Says
- Kidney Dialysis: Here's What You Need To Know
- What 524B and QMSR Change About Medical Device Risk
- Taking Lean Manufacturing to the Next Level
- Why Few MedTech Sales Teams Are Using AI Where It Matters Most
- ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualms
- Abbott casts telenovela star Gabriela Spanic to take the drama out of colon cancer screening
- Bristol Myers Squibb lays out plan for $2.3B manufacturing facility in Houston
- Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug
- Zepbound Lowers Heart Attack, Stroke Risk Among Type 2 Diabetics
- Heart Problems Linked To Brain Shrinkage Among People With Genetic Risk For Alzheimer's
- Budget Battle Erupts In Nation's Capital Over Opioid Settlement Money
- Rising Global Heat Linked To Mental Health Risks In Children
- Quanterix hires GE Healthcare, Exact Sciences alum as chief commercial officer
- Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become visible
- Update on the SEC’s Work Toward Treasury Clearing Implementation [August 2026]
- FDA Reverses Course, Approves First mRNA Flu Shot
- Therapy Dogs Aid Stroke Rehab
- Can Yoga Calm A Grumpy Gut?
- Leo Pharma readies rare disease education push for 2nd annual GPP awareness day
- The Interface is the Risk: A MedTech Blueprint for AI and System Integration
- Restoring Regulatory Clarity: Statement on Technical Amendments to Rule 0‑1(a)(7)
- Beyond the Status Report: Using LLMs to Reveal the True State of SaMD Development
- Headstands and Summervaults: A Statement on Crypto Vaults and Lending Strategies
- Remarks at the Small Business Capital Formation Advisory Committee Meeting
Michigan healthcare freedom community forum
This post really is an advertisement for the services of Kelley Cawthorne, but also useful glimpse at the bureaucratic red tape which strangles health care projects. This post is referring, in large part, to the Michigan Certificate-of-Need, which is awarded by MDHHS' Certificate-of-Need Commission.
Kelley Cawthorne is a privately held, full-service lobby firm based in Lansing, Michigan which was founded in 1999. In 2023, they merged with Columbus, Ohio based Pappas & Associates (TPP), which was itself founded in 1995. Kelley Cawthorne is led by Melissa McKinley and Rob Elhenicky. Pappas & Associates continues to be led by Tom Pappas, a former Ohio legislator:
https://www.crainsdetroit.com/crains-content-studio/avoid-delays-healthcare-project-launch
Why does timing matter?
Missing one step can stall your healthcare project for months
By Carrie Linderoth - June 02, 2025After we become adults, we look forward to a life with less rules and more freedom. But as time passes, we trade our parents’ and provincial rules for statutes and administrative procedures that govern much of our daily lives whether we realize it or not. This is particularly true as we look to develop businesses, provide services, and address client needs.
Statutory provisions are the first things we think about when looking to transact business. And while laws are important, statutes often delegate their legal authority to appointed departments who then promulgate rules. These rules are typically administered by civil servants and are subject to a process that has a specifically articulated timeline.
The timelines are often put forward by regulators to offer certainty to applicants when engaging in the process. But what can occur instead are significant delays. And, in some cases an inability to move forward. This is particularly true for any proposed project that requires a permit or another type of State approval to operate. New market entrants often invest a lot of resources in equipment, real estate, and staffing to bring a venture to fruition, only to be met with resistance from a process that is not navigable by a lay person.
As such, it is important to research what process is prescribed in rules before making decisions that can cost millions of dollars both in resources and in time. Michigan has nuanced rules across most Departments that can add months and years to the start of a project. Developing a detailed business plan and procuring resources can go to waste if you don’t first determine when you can begin operations. However, being proactive on understanding timelines can save money, reduce stress and create opportunities for success. Additionally, becoming an expert, or finding an expert to assist in navigating the processes can distinguish your project from other participants and create a competitive advantage.
For example, buying equipment before regulatory approval is issued forces an applicant to expend dollars and pay interest on something that cannot be used. But, understanding the timeline and process for approval can allow additional negotiating time and an opportunity to defer financial obligations until actual operations have started and money is coming into the venture.
Before undertaking a new venture, here are some steps to consider:
1. Research the statute that pertains to your project – Review the law that oversees your project to make sure your plans meet the prescribed regulations.
2. Determine if the statutes delegates oversight to a department that has set forth rules – take a second look at all of the provisions to ensure you didn’t miss anything.
3. Review rules that govern the process for beginning your project – make certain your review includes the conditions and timeline for project approval and continuation.
4. Talk to the department that oversees the rules – learn how the department administers the rules to avoid unforeseen delays or disapproval.
5. Find an expert that practices in the field – it’s easy to misinterpret the intent of a regulatory provision, and working with someone with experience can eliminate unnecessary hurdles.
In the healthcare space, background research is particularly important as regulation at every level impacts decisions. Federal rules and regulations set forth a process that may or may not run concurrent to State and local regulations. For example, providers looking to establish a new service in Michigan are subject to local rules such as zoning when determining a location. Secondarily the State may have licensing and safety regulations overseeing the ability to provide the service at all. And the Federal Government has a key role in the success or failure of a service line as they ultimately oversee the Centers for Medicare and Medicaid (CMS) and determine an applicant’s eligibility for reimbursement from government payers.
Timing is the most critical component in these transactions. All these levels have lead time required to process and potentially approve a project. However, waiting for one process to be complete before beginning the next level of applications can impact the viability of a project. In this instance, if state and local decision makers approve a new healthcare service, but CMS has not granted approval for reimbursement by government payers, the project could fail before it even starts. The same holds true for private third-party payors with credentialing requirements.
Financing obligations begin as soon as equipment and services are obtained. But if the revenue stream is dependent upon a separate approval process that has a lag time of several months, insolvency becomes a likely reality as expenses far exceed income. Even if projects are eventually approved for reimbursement, the financial obligations can become hard to overcome after an extended period of no income. However, a carefully timed concurrent application plan can provide a new market entrant with the ability to bring a project online and receive reimbursement in a similar timeframe to create the best opportunity for success.
Great ideas don’t get the desired results if they are not executed at the right time. But good ideas and great planning can be a recipe for success. Following a commonsense plan with the help of experience in the field can set your project apart from the masses. It sounds cliché, but you never get a second chance to make a first impression – so make your project’s first impression the best having a plan to make it thrive.
Don’t navigate healthcare policy alone. Contact Carrie Linderoth today at clinderoth@kelley-cawthorne.com for trusted advice and support.
Carrie Linderoth is a partner at Kelley Cawthorne who specializes in healthcare policy, Certificate-of-Need, and Michigan Medicaid issues.
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