The Health Care Lawyer

New Website

2015-05-07T17:27:00.000-07:00

After three years, I am transferring my blog over to my firm's new website: www.walterslawpc.com

I will still post here but will maintain a blog at the new website www.walterslawpc.com

CMS Administrator to Resign

2015-01-20T06:02:00.001-08:00

According to an email from U.S. Department of Health and Human Services Sec. Sylvia Burwell, CMS director Marilyn Tavenner will be stepping down from her role at the end of February. Her resignation comes amid growing pressure from the new Republican majority over the roll out of the Affordable Care Act.

House passes bill to increase the ACA's 30 hour workweek to 40 hours

2015-01-09T05:40:00.000-08:00

On January 8, 2015, the U.S. House of Representatives passed a bill that increases the number of hours that an employee must work before their employee is required to provide insurance.

The Affordable Care Act requires employers with more than 50 full-time employees to provide health insurance or pay a penalty. Currently, the ACA defines "full-time" as 30 hours a week. The bill increases the definition of "full-time" to 40 hours a week.

The bill was supported by business groups who claim that the lower threshold keeps workers hours down. Other groups, however, dispute this claim. The congressional budget office claims that the change will increase the federal deficit by over $50 billion over the next decade.

The House bill heads to the Senate where the Republicans need six democrats to bring it to a vote.

CON Thanksgiving

2014-12-03T16:55:00.002-08:00

DCH kicked off Thanksgiving by denying Doctor's Hospital of Augusta's application for a short-stay acute care hospital. Both Athens Regional and Piedmont Newnan have applied for Neonatal Intensive Care services.

DaVita Settles FCA Lawsuit Over Illegal Kickbacks

2014-10-24T17:59:00.003-07:00

On October 22, 2014, the U.S. Department of Justice ("DOJ") announced that it entered into a settlement with DaVita HealthCare Partners to resolve a qui tam lawsuit under the False Claims Act brought by a former DaVita financial analyst. DaVita is one of the largest provider of dialysis services in the U.S. Under the settlement, DaVita (i) agreed to pay $350,000,000.00 to resolve claims that it paid kickbacks, in addition to a $39,000,000.00 civil forfeiture; and, (ii) entered into a Corporate Integrity Agreement with the DOJ.

According to the DOJ, the settlement resolves allegations that between 2005 and 2014, "DaVita identified physicians or physician groups that had significant patient populations suffering renal disease and offered lucrative opportunities to partner with DaVita by acquiring and/or selling an interest in dialysis clinics to which their patients would be referred for dialysis treatment."

The DOJ alleged that DaVita would allow potential physician partners to pay below fair market value for ownership in the joint venture dialysis centers which, in some cases, generated a pre-tax annual return of 100% for some physicians. DaVita also conditioned the deals on the physicians entering into secondary agreements which contained non-compete and non-disparagement agreements which, in effect, prevented the physicians from referring patients to competing facilities.

Highlights of the Corporate Integrity Agreement include:

DaVita appointed a Chief Compliance Officer and will maintain a CIO for five (5) years;
DaVita must provide an hour of compliance training to certain covered persons, including but not limited to health care providers who are joint venture partners and nephrologist who serve as medical directors of its dialysis centers;
The Office of Inspector General, with consultation of DaVita, will appoint a Monitor to approve certain policies and transactions;
DaVita must develop procedures for ensuring that its business arrangements do not violate the anti-kickback statute. Some of the procedures will address the selection of potential partners and valuation methods. The Monitor will have to approve these procedures.
DaVita must give notice to its joint venture partners and medical directors that (i) they may refer patients to and treat patients at non-DaVita owned dialysis centers; (ii) DaVita will not enforce any patient related non-solicitation or non-disparagement clauses contained in existing agreements; and, (iii) in connection with any business transaction where DaVita's ownership is reduced but remains above 0%, that DaVita will not enforce the investment non-compete agreement.
DaVita will have to unwind certain joint ventures.

Telemedicine In Georgia

2014-08-26T17:18:00.002-07:00

The Georgia Composite Medical Board recently passed a new Telemedicine rule. Ga. Rule 360-3-.07, "Practice Through Electronic or Other Such Means" sets minimum standards of practice while providing telemedicine. In order to provide "telemedicine," the following conditions must be met:

Treatment must be through a Georgia licensed practitioner, i.e. Physician, P.A. or Nurse Practitioner;
The Practitioner must have a history of the patient;
The Practitioner must examine the patient in person or provide the care at the request of a provider who has examined the patient or at the request of a child care nurse or examine the patient in a manner that is equal to or superior to a personal examination;
The Practitioner must provide their contact information to the patient, as well as provide follow up instructions; and,
The Practitioner must make an effort to annually examine their patients.

The American Medical Association also released a summary of the "coverage of and payment for telemedicine."

OIG Issues Special Fraud Alert on Laboratory Payments

2014-06-27T13:12:00.001-07:00

On June 25, 2014, the Office of Inspector General (OIG) issued a Special Fraud Alert regarding certain laboratory payments to referring physicians. Specifically, the OIG discussed the following types of arrangements between laboratories and physicians that are suspect under the Anti-Kickback Statute:

     A.     Specimen Processing Arrangements.

             Specimen processing arrangements involve a laboratory paying a physician, directly or indirectly, to collect, process, and package patients' blood specimens. These payments are typically made on a per-specimen or per-encounter basis and often are associated with expensive or specialized test.

             The OIG stated that the Anti-Kickback Statute ("AKS") is implicated when a clinical laboratory pays a physician for services. A violation of the AKS, however, depends on the intent of the parties - to induce or reward referrals of Federal health care program business. The OIG went on to state that the probability that a payment is for an illegitimate purpose is increased when the payment exceeds fair market value or if it is for a service that the physician is paid for by a 3rd party.

     B.     Registry Payments.

              Registry payments involve laboratories paying a physician for certain specified duties. These duties include submitting patient data, answering patient questions about the registry, and reviewing registry reports. The OIG found that these payments could be appropriate in certain circumstances; however, it stated that the payments may induce physicians to order medically unnecessary duplicative test.

Not a good sign!

2012-01-26T14:30:00.000-08:00

The Congressional Budget Office issued a report concluding that most Medicare demonstration projects established under the Patient Protection and Affordable Care Act have not reduced Medicare spending. These projects include care coordination projects - very similar to Accountable Care Organizations. The main purpose and most important metric of ACOs is the reduction of Medicare spending.

Are you "uninsured"?

2012-01-19T14:21:00.000-08:00

To most of us, being uninsured is like being overwieght: you just know you if are uninsured. Thankfully, CMS has issued a proposed rule defining "uninsured." Seriously, the definition will be useful in calculating DSH payments.

CMS Issues Proposed Rule for the "Federal Sunshine Law"

2012-01-03T15:05:00.000-08:00

On December 19, 2011, CMS issued a proposed rule to implement the Federal Sunshine Law which requires drug and device manufacturers to disclose payments to physicians and teaching hospitals, as well as the disclosure of physician ownership in group purchasing organizations.

The Federal Sunshine Law and proposed rule require GPOs to report on an annual basis any ownership or investment interest by a physician or a physician's immediate family member. The proposed rule defines a GPO as an entity that "purchases, arranges for or negotiates the purchase of a covered drug, device, biological or medical supply which is operating in the U.S. or in a territory, possession, or Commonwealth of the U.S." The proposed rule excludes the following from the definition of a GPO: "entities that buy covered drugs, devices, biologicals or medical supplies solely for their own use, such as large practices or hospitals."

Under the Federal Sunshine Law, the following items must be reported about the investor: name, address, specialty, NPI, dollar amount invested, value of interest, and terms of interest.

The proposed rule request comments on, but does not address the following issues: (1) whether there is a minimum investment interest threshold; and, (2) whether an immediate family member investor's name should be reported.

The reporting requirements would begin March 31, 2013 for FY 12. The penalties for non-compliance are severe including a CMP for each knowingly violation between $10,000 and $100,000 upto a maximum of $1,000,000.00.

CMS is accepting comments through February 17, 2012. A copy of the proposed rule can be located here.

OIG Adv. Opinion - Online Physician EHR Service

2011-12-16T12:23:00.000-08:00

On December 7, 2011, the OIG issued a favorable opinion regarding an online company's proposal to offer physician "coordination services" to allow for the exchange of patient information with other providers to whom the physician refers. The service would only be avaiable to those physicians who purchase the company's services and those who enter into "trading partner agreements" with the company. Depsite the finding that the arrangement could influence referrals and the per-click nature of the fee structure, the OIG found that the payments would not be grounds for administrative sanctions under the anti-kickback statute.

Medicare Shared Savings Program Final Rule Released

2011-10-21T06:52:00.000-07:00

The Dept. of Health & Human Services has released its Final Fule establishing the Medicare Shared Savings Program (the "Program") which will allow providers to coordinate care and share savings if they meet certain quality standards. At this point, it remains to be seen whether the final rule alleviates the cost concerns of the proposed rule, but it does do away with the shared losses in year 3 of the one-sided model. Highlights of the Final Rule include:
-A requirement that an Accountable Care Organization (ACO) be accountable to at least 5,000 beneficiaries for at least three (3) years;
-A requirement that an ACO governing board have both providers and beneficiaries;
-The grouping of quality measures into four (4) domains: patient experience, care coordination and patient safety, preventative health, and at-risk populations;
-A one-sided model in which providers only share in savings (50% of savings), but are not at risk for losses (increases in health care costs); and,
-A two-sided model in which ACO providers share in losses, but receive a higher percentage (60%) of savings.

In addition to the Program, DHHS announced a complementary program, the Advanced Payment Model, which will test whether pre-payment of shared savings will increase participation of physician owned and rural ACOs. This model is only open to physician-owned organizations, critical access hospitals and rural providers.

The final rule can be accessed here.

The 4th Circuit Punts

2011-09-09T11:07:00.000-07:00

On September 8th, the U.S. Fourth Circuit Court of Appeals issued two decisions dismissing challenges to the Accountable Care Act. The decisions, however, did not address the consitutional issues of the individual mandate.

In Virginia v. Sebelius, the Court held that the state lacked standing to bring the suit. In Liberty Univ. v. Geitner, the Court held that the Anti-Injunction Act denied the U.S. District Court for the Western District of Virginia of jurisdiction because the case was a pre-enforcement action seeking to restrain the assessement of a tax.

The 11th Circuit Speaks

2011-08-15T11:12:00.000-07:00

On Friday, the 11th Circuit held that the individual mandate in the health care reform bill was unconstitutional. The Court ruled that the Commerce Clause does not allow Congress "to mandate that individuals enter into contracts with private insurance companies for the purchase of an expensive product from the time they are born to the time they die" and "that the individual mandate cannot be supported by the tax power." The Court did, however, hold that the Medicaid expansion was constitutional and that the mandate could be severed from the remainder of the other reforms.
While it was expected - at least for those of us who believe that Congress cannot compel an individual to buy a private product in order to live in this country - that the individual mandate was held unconstitutional, it is interesting that the Court discussed the true intention of the individual mandate. The congressional purpose of the individual mandate is to reduce "cost-shifting." However, the bill exempts illegal aliens and some low-income individuals from the mandate. According to the Court's opinion, illegal aliens account for 18.9% of all cost-shifting and low-income people account for 34.8% of cost-shifting. The Court recognized that "the primary person's regulated by the individual mandate are not cost-shifters but healthy individuals who forgo purchasing insurance" and, therefore "Congress sought to mitigate its reforms' regulatory costs on private insurers by compelling healthy Americans outside the insurance market to buy the insurer's product."

In short, the 11th Circuit stated what Congress recognized but would not say: that health care reform placed a huge cost burden on health insurers that quite frankly, in my opinion, could put health insurers out of business. Therefore, Congress created the individual mandate as a backdoor funding mechanism.

Medicare providers face double risk of cuts

2011-08-06T08:13:00.000-07:00

Congress' kick the can down the road "Super Committee" bill not only failed to ease the concerns of rating agencies (http://www.washingtonpost.com/business/economy/sandp-considering-first-downgrade-of-us-credit-rating/2011/08/05/gIQAqKeIxI_print.html), but also created extended worry for health care providers.

The health care industry faces a double whammy this year. The "debt-ceiling" established a twelve (12) member committee to search for an additional $1.5 trillion in cuts. As Medicare accounts for a large percentage of federal spending, it is certainly on the table. In addition, if the "Super Committee" does not act, providers will see a 2% cut in 2013. But wait there's more...

The short-term patch to Medicare physician payment rates (due to decline by 29% in 2012) expires this year. If Congress does not pass another short-term fix by the end of the year, physicians face an additional $25 billion in reimbursement cuts. Hence the double whammy.

Yet another revision to the physician supervision rule

2011-08-02T12:24:00.000-07:00

In 2011, CMS removed from the definition of "direct supervision" (42 C.F.R. 410.27) the requirement that a supervising physician be present "on the same campus" or in the off-campus department of the hospital" and instead required that the supervising physician be "immediately available."

Now, CMS, in its 2012 outpatient prospective payment system (OPPS) proposed rule, intends to further revise physician supervision policy. The proposed rule states that the Advisory Panel on Ambulatory Payment Classification Systems will serve as the independent review body that evaluates and recommends supervision levels to CMS for CPT codes and that CMS will issue decisions based on the panels recommendations.

CMS Increases reimbursement for Hospices

2011-08-02T10:50:00.000-07:00

On Friday, CMS issued a final regulation that will give hospices a 2.5% increase in FY 2012. This increase is based on a 3% increase in the wage index. In addition to the reimbursement increase, the final rule will:

Change the way it counts hospice patients for the 2012 cap accounting year and beyond. The final policy for counting the number of Medicare hospice beneficiaries in care for a given cap year calculates the cap based on the number of days of care the patient received in that cap year for each hospice. This rule also finalized that the new counting method be applied to past cap years in certain instances.

Allow hospice providers who do not want a change in their patient counting method to elect to continue using the current method.

Allow any hospice physician to perform the face-to-face encounter regardless of whether that same physician recertifies the patient’s terminal illness and composes the recertification narrative.

Implement a hospice quality reporting program, which includes a timeframe for reporting, as required by section 3004 of the Affordable Care Act. The measures that are being adopted in this final rule for the FY 2014 program are one measure endorsed by the National Quality Forum related to pain management and one structural measure that assesses whether a hospice administers a Quality Assessment and Performance Improvement (QAPI) program that contains at least three indicators related to patient care.

CoP's anyone?

2011-06-20T13:25:00.000-07:00

CMS, on June 17th, published a proposed rule that would establish, for the first time, Conditions of Participation for Community Mental Health Centers ("CMHC's") to participate in Medicare. It is uncertain the effect on CMHCs that accept Medicaid but not Medicare. Medicare pays for partial hospitalization services by CMHCs. The CoP's address the following areas:

-                    Establishing qualifications for CMHC employees and contractors.
-                    Requiring CMHCs to notify clients of their rights and to investigate and report violations of client rights. These proposed requirements also promote continuity of care by emphasizing the need for communication regarding client needs at the time of discharge or transfer.
-                    Convening of a treatment team, developing an active treatment plan, and coordinating services to ensure an interdisciplinary approach to individualized client care.
-                    Creating a Quality Assessment and Performance Improvement (QAPI) program. The QAPI program will require CMHCs to identify program needs by evaluating outcome and client satisfaction data and making changes, as necessary, to improve their quality of care.
-                   Setting organization, governance, administration of services, and partial hospitalization services requirements, with an emphasis on governance structure.

The proposed rule allows CMS to survey CMHCs for compliance, but does not grant deeming authority for CMHCs to accrediting organizations.

The proposed rule is available via the Federal Register (Rule CMS-3202-P).

2011-06-14T12:28:00.000-07:00

On May 4th, Gov. Deal signed SB 178 into law which creates a new license category of long-term care provider for assisted living communities. Several advocacy groups for seniors supported this bill as it will allow assisted living communities to provide more services to seniors, and therefore, giving seniors more living options.

DCH will hold a townhall meeting on June 22nd to allow advocacy groups, providers and stakeholders an informal discussion with DCH about the development of proposed rules for the new legislation. Information about the meeting is contained in the link below:

http://dch.georgia.gov/00/article/0,2086,31446711_31450193_171956551,00.html

FQHC Advanced Care Practice demonstration project

2011-06-09T18:52:00.000-07:00

Earlier this week, DHHS announced the Federally Qualified Health Center ("FQHC") Advanced Care Practice demonstration project. The project will pay an estimated $42,000,000 over a three year period to 500 FQHC's to coordinate care for Medicare patients.
http://www.hhs.gov/news/press/2011pres/06/20110606a.html

Welcome

2011-06-08T14:23:00.001-07:00

Welcome to The Health Care Lawyer blog. After representing health care providers for several years, I decided to create a forum to talk about current health care topics.

My health care practice focuses on providers. So most of the topics here will be related to provider issues. Particularly, we will focus on fraud and abuse, licensing, managed care, medical staff, privacy, reimbursement and tax-exempt issues. Sometimes, if it is Georgia specific or related to "health care reform", I'll discuss health insurance matters.

So please comment and share with friends.