Life Science Compliance Update

June 21, 2016

CMS: Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care Proposed Rule

CMS recently released a proposed rule updating the Conditions of Participation (CoP) for 6,228 hospitals and critical access hospitals (CAH) that participate in the Medicare and Medicaid programs. By incorporating elements of the Department of Health and Human Services' (HHS) Quality Strategy and Centers for Disease Control and Prevention's (CDC) Strategy to Combat Antibiotic Resistant Bacteria, CMS says the revisions aim to reduce readmissions; ease barriers to care; stem hospital-acquired conditions, including infections; address workforce shortages; and advance non-discrimination protections. Comments on the proposed rule are due by Aug. 15. 

The implication of these and various other provisions will cost the industry between $773 million to $1.1 billion, according to the CMS. However, CMS also expects complying with the various parts of the policy will result in a net savings of up to $284 million.

"Working with tools provided by the Affordable Care Act, hospitals have taken significant steps to improve safety and quality in the past several years. Already, efforts to reduce healthcare-associated infections have resulted in reducing health care costs by nearly $20 billion and saving 87,000 lives," said Kate Goodrich, M.D., M.H.S., Director, Center for Clinical Standards & Quality, CMS. "This proposal further supports hospitals' safety and quality efforts by requiring all Medicare and Medicaid hospitals to have designated leaders in charge of specialized programs to prevent infections, improve antibiotic use, and follow nationally recognized guidelines."

Rule Details

Highlights of the rule include a requirement that hospitals must have infection prevention and antibiotic stewardship programs for healthcare-related infections and for the appropriate use of antibiotics. In addition, hospitals would be required to designate qualified leaders of such programs. In a statement to The Wall Street Journal, the American Hospital Association said, "The emphasis on good infection control and antibiotic stewardship is consistent with the important work hospitals are doing to reduce infections and preserve the effectiveness of our current antibiotics. We join CMS in recognizing the importance of these programs and are always looking to make them more effective."

The rule further requires hospital adopt non-discrimination policies on the basis of race, religion, national origin, sex and gender identity, sexual orientation, age, or disability. CMS specifically says that "discriminatory behavior, or even the fear of discriminatory behavior, by healthcare providers remains an issue and can create barriers to care and result in adverse outcomes for patients." The rule also proposes a clarification of the requirement for patient access to their health records to account for the electronic format in which records may be accessible. It notes that "the patient has the right to access their medical records, including current medical records, upon an oral or written request, in the form and format requested by the individual, if it is readily producible in such form and format (including in an electronic form or format when such medical records are maintained electronically); or, if not, in a readable hard copy form or such other form and format as agreed to by the facility and the individual, within a reasonable time frame."

This rule will also enable hospitals to create a policy that specifies the outpatient departments which would not be required to have a registered nurse physically present and alternative staffing plans established under such a policy. Hospitals would also be required to incorporate quality indicator data related to hospital admission and hospital-acquired conditions. Hospitals already compile data for the Hospital Inpatient Quality Reporting program, the Hospital Value-Based Purchasing Program, the Hospital-Acquired Condition Reduction Program, the Medicare and Medicaid Electronic Health Record Incentive Programs, and the Hospital Outpatient Quality Reporting program.

CMS further proposes that a patient's medical record contain information to justify all admissions and continued hospitalizations, support the diagnoses, describe the patient's progress and responses to medications and services, and document all inpatient stays and outpatient visits to reflect all services provided to the patient. The agency notes that it emphasizes "the distinctions between discharges and transfers as well as between inpatients and outpatients by proposing to revise §482.24(c)(4)(viii) so that the content of the medical record would contain final diagnoses with completion of medical records within 30 days following all inpatient stays, and within 7 days following all outpatient visits."

Some of the other proposals in the rule include changing the existing "licensed independent practitioner" term to only "licensed practitioner" which is intended to facilitate hospitals' use of physician assistants as appropriate. CMS also establishes a requirement that a CAH develop, implement, maintain and evaluate its own QAPI program to monitor and improve patient care and a requirement that individual patient nutritional needs are met in accordance with recognized dietary practices and the orders of the attending practitioner or a qualified, state-approved nutrition professional.



June 13, 2016

Better Patient Care Doesn’t Necessarily Equal Patient Savings

In October 2012, the Centers for Medicare and Medicaid Services launched the Comprehensive Primary Care Initiative, in collaboration with thirty-nine private and public payers. Primary care practices that participated in the Initiative were required to make changes in care delivery that would build their capability in five functional areas: (1) access to and continuity of care; (2) planned care for preventive and chronic needs; (3) risk-stratified care management; (4) engagement of patients and their caregivers; and (5) coordination of care with patients' other care providers.

The Initiative supports the efforts of the participating practices by offering enhanced payment, data feedback, and learning support, as well as presenting an opportunity to evaluate a new multipayer model of payment and primary care delivery, in a large and diverse set of practices.

A group of doctors and researchers recently published a study in the New England Journal of Medicine that assessed the effects the Initiative had on Medicare expenditures, the use of services, selected measures of the quality of care, and patient experiences during the first two years of the Initiative.

During the first two years of the Initiative, practices received a mean of $131,000 per clinician in care-management fees and reported improvements in approaches to the delivery of primary care in areas such as management of the care of high-risk patients and enhanced access to care. This amount did vary according to the practice and region, depending on the number of participating payers, the number of patients attributed to practices by each participating payer, and each payer's payment amount. Interestingly, however, changes in average monthly Medicare expenditures per beneficiary did not significantly differ between initiative and comparison practices.

The effects on Medicare expenditures varied quite a bit across Initiative regions. Initiative practices had significant reductions in expenditures when fees were not included in two regions: New Jersey and Tulsa. Significant increases in net expenditures were found when fees were included in Cincinnati-Dayton.

The number of hospitalizations also did not change significantly for Initiative practices over the two year period. The only significant difference that the researchers found were a 3% reduction in primary care visits for Initiative practices compared to comparison practices and small changes in two of the six patient experience domains: discussion of decisions regarding medication with patients and the provision of support for patients taking care of their own health.

The researchers concluded that while practices that are participating in the Initiative have reported progress in transforming the delivery of primary care, these practices have not yet shown savings in expenditures for Medicare Parts A and B after accounting for care management fees, nor have they shown an appreciable improvement in the quality of care or patient experience.


The study did suggest that Initiative practices are transforming care delivery; however, they have not yet generated savings in Medicare Part A and B expenditures that are sufficient to cover care-management fees. The 3% reduction in primary care visits suggests the non-billable calls, emails, and interactions related to care management may have reduced, or even supplanted, the need for office visits.

The study also provided some possible reasons as to why the results were not more favorable. One such reason was that practices may need more time to fully implement changes in care delivery that translate to improved outcomes. It is also possible that practices will reduce expenditures enough to offset a lower fee; that CMS will reduce its average fee to $15 per beneficiary per month in the last two years of the Initiative, reducing not only the gross savings required to reach cost neutrality, but also the resources available to achieve those savings.

The study had several limitations, one of which was that practice participation in the Initiative is voluntary, and the analysis was limited to their attributed fee-for-service Medicare beneficiaries. The fact that patient experience was not measure prior to the start of the Initiative also makes it difficult, since there may have been preexisting differential trends between Initiative and comparison practices.

As CMS continues to pay for health care through alternative payment models that reward quality and value, the Initiative may help inform future policies guiding models for primary care delivery in the United States.

May 27, 2016

CMS Administrator Goes to Twitter to Explain the Proposed Rule for the Medicare Access and CHIP Reauthorization (MACRA)

In an very unusual move for a government regulator, the CMS acting administrator Andy Slavitt took to Twitter to explain his agency's strategy around the new Medicare payment law, also known as MACRA. This comes as CMS released the long-awaited proposed MACRA rule which is open for comment until June 27. The proposed rule creates a "Quality Payment Program" to replace old reporting programs. There two tracks, the first called the Merit-based Incentive Payment System (MIPS) consolidates components of the Physician Quality Reporting System (PQRS), the Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program. A second track involves alternative payment models (APM). Because of the high bar set to qualify for the APM track, CMS projects that only 30,000 to 90,000 clinicians will be in the APM track. An estimated 687,000 to 746,000 physicians will be in MIPS.

Here are the highlights from Slavitt's tweet-storm:


1- Today I will summarize how much listening we've been doing around #MACRA & lay out the opportunities to hear the basics & get engaged.

3:04 PM - 21 May 2016


2. Our goal is to close the gap between Washington DC and front line realities of patient care. In May, we have over 35 events on #MACRA.

3:06 PM - 21 May 2016


3. We've hosted ten #MACRA webinars this month with over 30,000 attendees.

3:06 PM - 21 May 2016


4. To join one of our five upcoming #MACRA webinars, visit: …

3:07 PM - 21 May 2016


5. We're hosting #MACRA listening sessions. We've visited specialties, PC, & rural. You can invite #CMS to events …

3:10 PM - 21 May 2016


6. With each event, we take common Qs & answer them through fact sheets. Our latest is on #MACRA & small practices: …

3:11 PM - 21 May 2016

7. We post new content each week. Join the #CMS #MACRAlistserv to keep up-to-date: …3:11 PM - 21 May 2016


8. Or you can visit our #MACRA website to learn the latest: …

3:12 PM - 21 May 2016


He continued the next day:


Today, I will lay out some of the top interest & feedback areas we have heard for the Quality Payment Program under#MACRA.

11:32 AM - 22 May 2016


1. One area of input is the need to use #MACRA to increase focus on practice of medicine/pt care, not reporting/measurement & paperwork.

5:30 PM - 22 May 2016


2. A 2nd area is how small practices will fare relative to larger sized practices under #MACRA. We put this out: …

5:33 PM - 22 May 2016


3. A 3rd area is the availability of payment models like med homes, ACOs, including how they overlap & how to ease the path in to qualify.

5:34 PM - 22 May 2016


4. We have received other questions around flexibility, burden, timing, specialty care & payment adjustments.

5:37 PM - 22 May 2016


5. Will create fact sheets 4 key questions as we answer them as we've been doing.

5:39 PM - 22 May 2016


6. My takeaways: first, very encouraged by all the engagement, particularly the critics.

5:42 PM - 22 May 2016


7. My takeaways: Second, people want a philosophical change- a program that doesn't get in the way of practicing medicine, but supports it.

5:44 PM - 22 May 2016


8. My takeaways: third, walking thru basics has been critical. Payment adjusts., measurement, paperwork r all better than today's Medicare.

5:49 PM - 22 May 2016


9. My takeaways: fourth, more time, more to learn, more#MACRA meetings coming up. 35 in May alone. Grateful for all the engagement.

5:54 PM - 22 May 2016



Stakeholders have been struggling with the rule's complexity and length, so it is not surprising that CMS wants to explore all possible avenues for communication. It is unlikely these tweets will do much to change the confusion and challenges facing physicians, but it is laudable that the government is thinking outside of the box and looking to connect over social media. But the biggest takeaway seems to be that CMS recognizes the complexity of the rule and this could be insight into the possible comments that should be sent to the agency. 60 days to analyze one of the most important Medicare regulations in a quarter century is simply not sufficient. CMS is bound by difficult congressional deadlines, but it may be smart for all of Washington, D.C. to rethink the MACRA implementation process. It is too important for physicians and patients alike to rush through massive changes that almost no physician truly understands.


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