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May 3, 2013

HHS Issues Streamline Applications For Health Coverage

The Centers for Medicare & Medicaid Services this week addressed criticism of the lengthy application forms they had proposed for enrolling uninsured people in health coverage.  On April 30 the...

May 2, 2013

Impact of Sequestration on Life Sciences--FDA Can't Travel(1)

The effects of sequestration on the Food and Drug Administration were apparent in a particular way at the BIO 2013 International Convention in Chicago that I covered—FDA officials didn’t have the...

May 2, 2013

Are Medicare Fraud Tipsters in Line for a Big Payday?

Medicare fraud tipsters may soon be rolling in the money, thanks to a recent HHS proposed rule that would increase reward money for a successful tip from a maximum of $1,000 all the way up to $9.9...

May 1, 2013

New ACO-type Models Highlighted In Reform Reports

It may be awhile before policymakers know if Accountable Care Organizations will fulfill their promise of lowering the cost of health care while improving outcomes, but experts have recently...

April 26, 2013

Are OIG Provider Compliance Reviews Coming Soon?

I spent the first part of this week at HCCA's Compliance Institute, and while there, I heard Inspector General Levinson suggest that OIG might be interested in performing compliance reviews on...

April 23, 2013

Sebelius Defends Using Prevention Fund for ACA Promotion

With the release of the Obama administration's fiscal 2014 budget proposal, it has become clearer how the Department of Health and Human Services has been funding implementation of the Affordable...

April 22, 2013

Senate Finance Committee To Hold April 23 Nomination Vote For Tavenner

The Senate Finance Committee April 23 will vote on the nomination of Marilyn Tavenner to be administrator of the Centers for Medicare & Medicaid Services. If the nomination is approved, as...

April 19, 2013

FDA To Try Again With Investigational Devices

FDA will replace a 2011 draft guidance on investigational devices after industry backlash.

April 19, 2013

OIG Takes Another Crack at Self-Disclosure Protocol

I spoke with OIG's Tony Maida this week about their recently revised self-disclosure protocol , and he told me the idea behind the revision was to increase transparency for providers. He told me...

April 11, 2013

Thoughts on the Supreme Court, Door Knobs, and Genes

A speaker at a recent gene patent conference I covered suggested that the Supreme Court has of late been retreating back to the ideas of an 1850 case about door knobs.

April 10, 2013

With Budget, Obama Takes MedPAC’s Advice

President Obama's FY 2014 budget request takes into account recommendations made by MedPAC.

April 10, 2013

CMS Budgets $5.8 Billion For Exchange Grants For Three Years

Under the fiscal 2014 budget proposal released April 10, the Centers for Medicare & Medicaid Services would spend $1.3 billion for grants to states to set up online exchange markets to sell...

April 10, 2013

Moving from Discretionary to Mandatory Spending for HCFAC

President Obama's April 10 budget proposal for fiscal year 2014 includes a 0.3 percent decrease in discretionary spending ($311 million) for the Health Care Fraud and Abuse Control account from...

April 10, 2013

Obama Proposes $400 Billion In Health Care Spending Cuts

As expected, President Obama April 10 proposed a fiscal 2014 budget plan that would trim about $400 billion from federal health care spending, the vast majority coming from Medicare. The biggest...

April 8, 2013

Tavenner Could Soon Be Approved by Senate As CMS Administrator

The Centers for Medicare & Medicaid Services could soon have its first Senate-approved administrator since 2006. CMS acting administrator Marilyn Tavenner is scheduled to appear before the...

April 5, 2013

Say Goodbye to the HIPDB

It's official: the Healthcare Integrity and Protection Data Bank will soon be no more. HRSA, in an effort to reduce regulatory burden, recently issued a final rule that will result in the transfer...

March 22, 2013

Stark Law Self-Disclosure Proving to Be Very Popular

Providers have embraced CMS's Stark law disclosure process, a CMS official said at a conference I attended this week. Troy Barsky, the director of CMS's Division of Technical Payment Policy, said...

March 21, 2013

First ACO Results Due This Summer, CMS Official Says

The first results of the Pioneer accountable care organization initiative will be available this summer, a Centers for Medicare & Medicaid Services official told Congress March 20. Richard...

March 15, 2013

OIG Updates Guidance for State False Claims Act Laws

For the first time ever, OIG has updated the guidelines for evaluating state false claims act laws, taking into account amendments made to the federal false claims act in 2009 and 2010. Under the...

March 14, 2013

Will Medtronic's New Device Be A Standard-Bearer?

Medtronic is taking a chance with FDA and CMS's new parallel review pilot.

March 11, 2013

J.D. Power and Associates Survey Finds Consumer Interest in Health Insurance Exchanges

The online health insurance exchange markets that will open for enrollment Oct. 1 under the Affordable Care Act are generating interest among consumers, marketing information company J.D. Power and...

March 8, 2013

Sequester May Take a Bite Out of Anti-Fraud Programs

It's still early days, and no one really knows what impact the sequester cuts will have on the economy, but I recently talked to a few health care experts who all agreed that the cuts have the...

March 8, 2013

CMS To Conduct Audits on EHR Use, Tavenner Says

The Centers for Medicare & Medicaid Services remains committed to ensuring Medicare providers adopt electronic health records, despite an increase in claims upcoding that may be related to the...

February 22, 2013

Is CMS Trying to Verify the Unverifiable?

I recently heard CMS's Peter Budetti speaking at the National HIPAA Conference, and he said CMS is working with other government agencies to create a methodology for calculating the value of cost...

February 22, 2013

Once Again, CMS Leaving Money on the Table

In what's by now a familiar story, a recent report from the OIG discovered that CMS has failed to collect $225 million in state Medicaid overpayments. Between fiscal years 2000 and 2009, the OIG...

February 22, 2013

Gene Patent Outlook Now Clearer in Australia, U.S. Still Waits

In Australia, things are clearer now for owners of gene patents than they were a week ago, while U.S. gene patent owners are still anxiously waiting for the April 15 oral arguments to begin before...

February 21, 2013

Providers Preparing for Sequestration Cuts, Attorney Says

Medicare providers already are taking steps in anticipation of sequestration cuts that are likely to occur March 1, including scaling back programs, eliminating positions and postponing...

February 15, 2013

Baucus to Hold Nomination Hearing for Tavenner

Senate Finance Committee Chairman Max Baucus plans to hold a confirmation hearing on the nomination of Marilyn Tavenner to be administrator of the Centers for Medicare & Medicaid Services. CMS...

February 14, 2013

Medicare, Still Risky After All These Years

To no one's surprise, the Medicare program has once again been found to be especially vulnerable to fraud, waste, and abuse. The GAO has designated Medicare as a high-risk program dating back to...

February 8, 2013

Medicare Physician Payment to be cut 25 Percent in 2014, CBO Says

Like a broken record, physicians again are facing a Medicare reimbursement cut unless Congress intervenes. The Congressional Budget Office said Feb. 5 that physicians' reimbursement will be reduced...

February 8, 2013

Lawmakers Introduce Device Tax Repeal Bills. Again.

Lawmakers introduce device tax repeal bills in the House and Senate.

February 5, 2013

IRS Rule Could Leave Some Families Without Affordable Health Insurance or Subsidies

The Internal Revenue Service (IRS) disappointed consumer groups and unions when it released a final rule Jan. 30 that could leave some families without  affordable health insurance coverage or...

February 5, 2013

Is the Sunshine Act Too Much of a Burden for the Health Care Industry?

A number of health care attorneys have told me that providers and drug and device manufacturers can expect significantly expanded administrative burdens courtesy of the recently released "Sunshine...

January 31, 2013

A Soybean Seed Case That Matters to Life Sciences

What does a Supreme Court case about the sale of soybean seeds have to do with life sciences? A lot, says the U.S. Solicitor General and life sciences attorneys. Bowman v. Monsanto ...

January 25, 2013

Hatch Says Medicare Eligibility Age Should Be Set At 67

Senate Finance Committee ranking minority member Orrin G. Hatch (R-Utah) wants Medicare's eligibility age hiked from 65 to 67, saying it must keep pace with increases in longevity in the...

January 24, 2013

PCORI Wants to Change Research to Focus on Patient Needs

PCORI director Joe Selby talks about how the organization wants to make comparative effectiveness research more patient-centered.

January 23, 2013

Hatch, Alexander Introduce Bill To Repeal Individual Mandate In ACA

Senate Finance Committee Ranking Member Orrin Hatch (R-Utah) and Senate Health, Education, Labor and Pensions Committee Ranking Member Lamar Alexander (R-Tenn.) Jan. 22 introduced legislation...

January 22, 2013

Time to Get Ready for Larger Penalties for HIPAA Violations

Health care providers are now facing significantly higher penalties for HIPAA violations, courtesy of an HHS final rule released Jan. 17. The HIPAA Enforcement final rule, which was part of an...

January 22, 2013

NAIC Calls For State-By-State Health Reinsurance Pools

The federal government should scrap a proposal to create a national health reinsurance pool and rely instead on state-by-state collections for the program, the organization that represents state...

January 17, 2013

Hike In Medicare Age Won't Dramatically Increase Corporate Health Care Costs, CEO Says

Businesses already are developing strategies to keep their workers productive for longer periods of time, so raising Medicare's eligibility age may only incrementally increase health care costs for...

January 16, 2013

Is Anyone Watching Over Community Mental Health Centers?

Effective oversight of community mental health centers (CMHCs) is lacking, and Medicare might be wasting taxpayer money as a result, the OIG said in a recent report. A review of nine Medicare...

January 15, 2013

Orphan Drugs Receive More Regulatory Attention in U.S. and Canada

Orphan drugs are called that because the biopharma industry is said to have little interest in developing and marketing drugs that are intended for only a small number of patients suffering from very rare conditions. And yet 40 percent of FDA-approved drugs in 2012 were orphan drugs, and there are plans for consideration of a regulatory orphan drug framework in Canada in 2013.

January 9, 2013

Hospitals Concerned About Series of Budget-Cutting Bills Moving Through Congress

Federation of American Hospitals President Chip Kahn says he is worried that a series of plans that may be considered by Congress and the White House in 2013 to reduce federal spending may be worse...

December 18, 2012

CMS Faces Questions Over Predictive Modeling Report

CMS recently released a long-delayed report on the first year results of its predictive modeling program, and while the report includes some positive results, questions remain over the accuracy of...

December 18, 2012

Eighteen States and D.C. To Create State-Based Exchanges

Eighteen states and the District of Columbia have made the commitment to open state-based exchanges through which individuals and small businesses can purchase health insurance under the Affordable...

December 17, 2012

Europe Welcomes Unitary Patent Cost Savings but Worries about Enforcement

Europe looks like it will finally have a unitary patent system that will reduce the costs of a patent. But the plan has caused concerns about the sudden speed toward approval and the way in which the patents will be enforced

December 14, 2012

States Differ in Assessment of Health Law Flexibility, Cost

   

December 14, 2012

AHA Finds Medicare Is Spending More on Sicker Patients

New report finds evidence that Medicare patients are getting sicker, and it's not just because of coding changes.

December 13, 2012

Is CMS Sending a Mixed Message on EHRs?

While CMS is actively encouraging the use of EHRs through the meaningful use incentive program, it may be sending a mixed message courtesy of a recent transmittal. Effective Dec. 10, the transmittal...

December 7, 2012

Raising Medicare Eligibility Age Could Be Part Of Budget Deal

Raising Medicare's eligibility age could become a key component of a deal between the White House and Congress to avert the so-called fiscal cliff, but critics say raising the age would shift costs...

December 4, 2012

Fate of Medicare Physician Pay Fix Likely Linked To Fiscal Clliff Negotiations

It appears the fate of a Medicare pay cut for physicians rests on when and if the White House and congressional negotiators reach agreement on a plan to avert the so-called fiscal cliff, the package...

December 4, 2012

To Patent or Not to Patent May Be the Question, Attorneys Say

At a conference I attended recently, a session followed up on an idea of companies looking into the possibility of trade secret protection for their inventions rather than patents.

November 28, 2012

HHS Releases Three Proposals to Implement ACA

The torrent of regulations to implement the major provisions of the Affordable Care Act began in earnest Nov. 20 when the Department of Health and Human Services issued two proposed rules and...

November 27, 2012

Attorneys Ears Perk Up at Millions of Dollars in Potential New Revenue from Patent Term Adjustments

It was interesting to hear attorneys at a recent biotech conference I attended get very excited about the millions of additional dollars a patent term adjustment can bring in.

November 27, 2012

Will the Medicare Fraud Strike Force Be Expanding Soon?

Are we likely to see the Medicare Fraud Strike Force expand to additional cities in the near future? According to Sam G. Sheldon, deputy chief of the fraud section in the DOJ's criminal division,...

November 15, 2012

FAH Urges Congress To Delay Or Cancel Sequestration Cuts

The Federation of American Hospitals is urging Congress to postpone or delay Medicare spending cuts associated with the sequestration law, saying hospitals will be forced to layoff thousands of...

November 8, 2012

With Presidential Election Over, More ACA Rules Expected

With the presidential election now in the rear-view mirror, the Obama adminisratiion is likely to quickly begin issuing several crucial rules governing the implementaiton of the Affordable Care Act....

November 6, 2012

NIH Exercising “March-In” Rights—Is the Fifth Time the Charm?

The National Institutes of Health has denied four petitions to exercise its “march-in” rights under the Bayh-Dole Act. I wrote a number of stories on the fourth, the Fabrazyme petition. On   Oct....

November 2, 2012

Stark Self-Disclosure Agreements Reveal Lengthy Path to Resolution

If you're planning on entering the CMS self-referral disclosure protocol (SRDP), be prepared to wait. I recently obtained the 10 settlement agreements that have been reached under the SRDP in...

November 1, 2012

Health Insurance Subsidies Likely to Cost More Than Forecast, Former CBO Director Warns

The projected cost of the subsidies provided by the Affordable Care Act to low- and moderate-income people to make health insurance affordable has escalated 24 percent since the law was enacted in...

November 1, 2012

Medicare Home Health Reimbursement Could Be Cut In Deficit Deal, Dombi Says

Medicare reimbursement to home health agenices could be targeted for reduction as part of sweeping budget deficit deal that may be consisdered by Congress in 2013, according to Bill Dombi, vice...

October 26, 2012

House Republicans Subpoena MA Demo Documents

The House Oversight and Government Reform Committee Oct. 22 sent a subpoena to the Department of Health and Human Services for documents related to the creation of a Medicare managed care...

October 25, 2012

OIG Reviews of Electronic Health Records on the Rise

EHR users, beware: the OIG is looking at you. The coming year should see an increase in OIG reviews of EHR use, according to an HCCA webinar I attended this week. Specifically, the OIG will be...

October 25, 2012

European Drug Approval Agency Appears to Get Back Its Parliament’s Trust

The European Medicines Agency, the European equivalent to the FDA for drug approval, has evidently convinced the European Parliament that it has its act together as far as conflicts of interest in the agency are concerned.  

October 18, 2012

Seniors Would Pay More Under Premium Support, Kaiser Says

Premiums would have risen for the majority of beneficiaries if Medicare had been operating as a premium support program in 2010 because most of them would have been in areas where their current...

October 16, 2012

Trouble Brewing for Medicare's Predictive Modeling Program

Two Republicans Senators continued their quest to gather information on CMS's anti-fraud predictive analytics program, sending a letter to the agency this week calling for the delivery of a report...

October 12, 2012

Senate Republicans May Have Difficulty Repealing ACA Using Reconcilation, Former GOP Aide Says

A former Republican aide on the Senate Finance Committee says Republicans' promise to repeal the Affordable Care Act next year using the budget reconciliation process may run into difficulty because...

October 12, 2012

FDA Head Says Sequestration Will Hit Agency's Key Personnel

The Food and Drug Administration Commissioner said at a meeting I attended that if the“sledgehammer of sequestration” takes effect FDA would suffer significant loss of critical personnel.

October 11, 2012

Will Affordable Care Act Health Insurance Exchanges Lead to Demise of Employer-Sponsored Coverage?

Will the health insurance exchange markets that will be created in all states in 2014 under the Affordable Care Act primarily be a new channel for employers to purchase coverage, as the Obama...

October 10, 2012

When In Doubt, Self-Disclose

With providers facing increasing penalties for Medicare and Medicaid program violations, self-disclosure is on the rise, an OIG official said at a recent conference I attended. Tony R. Maida, a...

October 10, 2012

Changes Coming To ACA Even if Obama Relected, Former GOP Aide Says

Republican presidential nominee Mitt Romney will attempt to repeal the health care reform law if he is elected president, but the law may be changed in some significant ways even if President Obama...

September 27, 2012

Are Hospitals Doing Enough to Secure Electronic Health Records?

According to a  recent DOJ-HHS letter, hospitals are not doing enough to prevent electronic health records from being used to defraud Medicare and will likely face increased investigations and...

September 26, 2012

Hospitals Could Face More Medicare Cuts Next Year, Attorney Says

Hospitals may find their Medicare reimbursement on the chopping block again in 2013 as Congress and the White House look for ways to cut the federal budget deficit, according to a California...

September 26, 2012

States Choose Small Group Plans As Benchmarks For Essential Health Benefits

A major requirement of the Affordable Care Act is that most fully-insured individual and small group health insurance plans must offer a comprehensive set of benefits called "essential health...

September 21, 2012

House Energy and Commerce Committee OKs Bill Removing Commissions From Medical Loss Ratio

Washington lobbyists will tell you that insurance agents are among the most powerful forces in American politics, since they come close to having an office on every corner.  That influence is in...